CN1733116A - Medicinal preparation for treating hypertension and its preparing process - Google Patents

Abstract

The invention provides a Chinese medicinal preparation for treating hypertension and its preparing process, which is prepared from eucommia bark, motherwort, selfheal, baikal skullcap root and uncaria rhynchophylla jacks.

Description

Pharmaceutical preparation of treatment vascular hypertension and preparation method thereof

Technical field: the present invention relates to a kind of pharmaceutical preparation for the treatment of vascular hypertension and preparation method thereof, belong to technical field of medicaments.

Background technology: vascular hypertension is a kind of with systolic arterial pressure and diastolic pressure rising, normal with the functional and organic systemic disease of changing into feature of the heart, brain, kidney and peripheral blood vessel.Along with growth in the living standard, the people who suffers from vascular hypertension is more and more.At present, the treatment of vascular hypertension is mainly brought high blood pressure down by the hypertension pill of taking some Western medicine, but these medicine side effect are bigger, easily repeatedly, in case blood pressure also can produce some untoward reaction after can raising and take medicine again after the drug withdrawal.Former six disclosed " compound eucommia bark sheets " promulgated by the ministries or commissions of the Central Government are a kind of medicines for the treatment of vascular hypertension; Its preparation method is: the hook taking rattan is partly pulverized, a part is carried with Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae water in addition; Then the Ramulus Uncariae Cum Uncis powder of dried cream powder and pulverizing according to a mixed after tabletting obtain product; The problem that exists is: the amount of taking is bigger, and needs of patients is taken 5 at every turn; Tablet is a coated tablet in addition, so diabetics should not use.

Summary of the invention:

The objective of the invention is to: a kind of pharmaceutical preparation for the treatment of vascular hypertension and preparation method thereof is provided, this product antihypertensive effect is good, evident in efficacy, and safe in utilization, have no side effect and untoward reaction, taking the back is difficult for repeatedly, taking dose reduces, and product can satisfy the crowd's use that comprises diabetics in addition.To solve the problem that prior art exists.

The present invention is achieved in that according to listed as parts by weight it is prepared from for 200～500 parts with 600～900 parts of Cortex Eucommiae (parched), 600～900 parts of Herba Leonuris, 200～500 parts of Spica Prunellaes, 200～500 parts of Radix Scutellariaes and Ramulus Uncariae Cum Uncis;

Specifically, calculate according to weight, it is prepared from Cortex Eucommiae (parched) 781.67g, Herba Leonuri 781.67g, Spica Prunellae 468.33g, Radix Scutellariae 468.33g and Ramulus Uncariae Cum Uncis 468.33g; Described pharmaceutical preparation is tablet, capsule, soft capsule, granule, drop pill, oral liquid or syrup.

This product is preparation like this: weighting raw materials material Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae, Radix Scutellariae and Ramulus Uncariae Cum Uncis, and get the part Ramulus Uncariae Cum Uncis and add alcohol reflux 1～4 time, each 1～3 hour, filter, merge extractive liquid, reclaims ethanol and is concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 2～4 times, and each 0.5～2 hour, collecting decoction, filter, filtrate was left standstill 12～36 hours, drew supernatant, and the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, add above-mentioned Ramulus Uncariae Cum Uncis extract fine powder, mixing, drying is pulverized, promptly get the effective ingredient of medicine of the present invention, the effective ingredient that obtains is added the adjuvant that needs, is prepared into required preparation according to conventional method; As: tablet, capsule, soft capsule, granule, drop pill, oral liquid or syrup.

Specifically, tablet of the present invention is preparation like this: weighting raw materials material Cortex Eucommiae (parched) 600g, Herba Leonuri 600g, Spica Prunellae 200g, Radix Scutellariae 200g and Ramulus Uncariae Cum Uncis 280g, the hook taking rattan adds alcohol reflux 1 time, each 3 hours, filter merge extractive liquid,, reclaim ethanol and be concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction filters, and filtrate was left standstill 12 hours, draw supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis extract fine powder, mixing, drying is pulverized, add an amount of alcohol granulation, drying is pressed into 1000, promptly.

Capsule of the present invention is preparation like this: weighting raw materials material Cortex Eucommiae (parched) 781.67g, Herba Leonuri 781.67g, Spica Prunellae 468.33g, Radix Scutellariae 468.33g and Ramulus Uncariae Cum Uncis 468.33g, hook taking rattan 250g adds alcohol reflux 2 times, 1.5 hours for the first time, 1 hour for the second time, filter merge extractive liquid,, reclaim ethanol and be concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and all the other Ramulus Uncariae Cum Uncis, Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 3 times, and each 1 hour, collecting decoction, filter, filtrate was left standstill 24 hours, drew supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis extract fine powder, mixing, dry, pulverize, make granule, encapsulated, make 1000, promptly.

Medicine of the present invention has the kidney invigorating, suppressing the hyperactive liver, and the effect of heat clearing away is mainly used in the vascular hypertension of the liver-yang hyperactivity of suffering from a deficiency of the kidney.Prove that through clinical trial this medicine can improve the hyperpietic's of the liver-yang hyperactivity of suffering from a deficiency of the kidney clinical symptoms, comprise dizzy, headache, agitation, insomnia, tinnitus and soreness of the waist and knees etc., and has a blood pressure lowering effect preferably, evident in efficacy, and safe in utilization, have no side effect and untoward reaction.Therefore, compared with prior art, it is good, evident in efficacy that the present invention has an antihypertensive effect, and safe in utilization, have no side effect and untoward reaction, take the difficult advantage repeatedly in back, taking dose reduces, and product can satisfy the crowd's use that comprises diabetics in addition; Change into after the capsule preparations as: product because the change of technology, dose be reduced to one time 3.

Below be clinical trial data of the present invention:

EXPERIMENTAL DESIGN: adopt parallel control, multi-center clinical trial design at random, distribute by table of random number: odd number is the treatment group, and even number is a matched group.Qualified experimenter's random assortment is to treatment group and matched group, and 140 examples are organized in treatment, matched group 50 examples.All cases all should strictly be controlled variable factor, guarantee to have compliance preferably.

Research purpose: (one) observes the toxic and side effects and the untoward reaction of this product compound eucommia bark sheet, and its safety is made an appraisal; (2) estimate the curative effect that this product compound eucommia bark sheet treatment hypertension (liver-yang hyperactivity of suffering from a deficiency of the kidney card) is improved clinical symptoms.

Therapeutic scheme:

(1) case is selected:

1, diagnostic criteria:

(1) hypertension diagnostic criteria: systolic pressure is equal to or higher than 18.6kpa (140mmHg), and diastolic pressure is equal to or higher than 2.0kpa (90mmHg), can be diagnosed as hypertension.Clinical manifestation is overabundant liver-fire or syndrome of hyperactivity of yang due to yin deficiency person.

(2) differential diagnosis in tcm standard: the liver-yang hyperactivity of suffering from a deficiency of the kidney card: dizzy, headache, irritated insomnia, tinnitus, soreness of the waist and knees, red tongue with yellow fur or thin white or few tongue, wiry and frequent pulse or stringy and thready pulse and count.

Above-mentioned syndrome, as long as dizzy, headache, irritated insomnia occur, tinnitus, wherein two～three symptoms promptly can be used as the case standard of including in.

2, the checking case is included standard in:

(1) patient who meets hypertension diagnosis and differential diagnosis in tcm standard can include the checking case in, is main identifying object with II phase hypertension.

(2) age is 40-70 year person.

3, exclusion standard:

(1) obviously adds folder disease or complication person;

(2) age is below 40 years old, person more than 70 years old;

(3) I, III phase hyperpietic;

(4) with primary disease, psychosis, malignant tumor patients such as serious cardiovascular, liver, kidneys;

(5) do not meet the standard of including in, not medication in accordance with regulations can't be judged not umbra sound curative effect verifier of curative effect or data.

(2) trial drug:

1, treatment group: 5 of this product compound eucommia bark sheets (eucommia bark depressor sheet), three times on the one, around serveing on.

2, matched group: QIJU DIHUANG WAN 1 ball, three times on the one (or oral liquid 2, three times on the one) is around serveing on.

In-test, two groups of cases were all avoided overwork, quitted smoking, give up alcohol, avoided and drink strong tea.

(3) observation index:

1, health giving quality observation index:

(1) related symptoms and sign: dizzy, headache, irritated insomnia, tinnitus, soreness of the waist and knees.

Cardinal symptom quantizes grade scale:

(2) blood pressure measurement

(3) chest X-ray

(4) Electrocardioscopy

(5) examination of ocular fundus

2, safety is observed:

(1) general health check-up project

(2) blood, urine, just conventional

(3) heart, liver, kidney function test

(4) curative effect is judged

1, efficacy of antihypertensive treatment evaluation criteria (standard of formulating with reference to national cardiovascular epidemiology in 1979 and crowd prevention and treatment forum)

(1) produce effects

1. diastolic pressure decline 1.3kpa (10mmHg) is above and reach normal range;

Though 2. diastolic pressure do not reduce to normally descended 2.7kpa (20mmHg) or more than.Need possess wherein 1.

(2) effective

1. diastolic pressure descends not as good as 1.3kpa (10mmHg), but has reached normal range;

2. decline 1.3-2.5kpa (10-19mmHg) before diastolic pressure is treated, but do not reach normal range;

3. systolic pressure is more than the preceding decline 4kpa (30mmHg) of treatment.Need possess wherein 1.

(3) invalid

Do not reach above standard person.

2, symptom efficacy assessment standard

Cardinal symptom: dizzy, headache, agitation, insomnia, tinnitus, soreness of the waist and knees

(1) produce effects: above-mentioned symptom disappears or reduces to one-level by three grades.

(2) effective: above-mentioned symptom alleviates or reduces to secondary by three grades, or reduces to one-level by secondary

(3) invalid: the above-mentioned symptom no change.

Data management and statistical analysis: all The data Excel software typings also manage.Group data is described with frequency or constituent ratio, adopts non parametric tests or X ²Check; Ranked data are described with frequency or constituent ratio, adopt non parametric tests; (x ± s) be described adopts t check or variance analysis or non parametric tests to measurement data with mean ± standard deviation.

Clinical trial one:

Test unit: Guizhou Prov. Traditional Chinese Medical Research Inst Affiliated Hospital

Test period: year October in March, 2002-2002

Therapeutic outcome:

(1) the preceding two groups of physical data analysis of comparable of treatment:

1, two groups of case source situations are relatively:

Table 1 liang group case source situation relatively

Group	The example number	The case source		X 2Statistic	P
						Outpatient service N	N is in hospital
		The treatment group	140					40	100	0.04	0.85
Matched group	50			15	35

Two groups of case source difference not statistically significants have comparability.

2, two groups of sex ratios are:

Table 2 liang group sex ratio

Group	The example number	Sex		X 2Statistic	P
						Man N	Woman N
		The treatment group	140					87	53	0.0003	0.99
Matched group	50			31	19

Two groups of sex comparing difference not statistically significants have comparability.

3, two groups of age ratios are:

The table 3 liang group age (year) relatively

Group	The example number	Age (x ± s)	The F statistic	P
					The treatment group	140	56.40±7.21	2.63	0.11
Matched group	50	54.48±7.23

Two groups of age comparing difference not statistically significants have comparability.

4, two groups of courses of disease are relatively:

The table 4 liang group course of disease (year) relatively

Group	The example number	The course of disease (x ± s)	The sum of ranks statistic	P
					The treatment group	140	1.60±158	-1.29	0.19
Matched group	50	1.44±159

Two groups of course of disease comparing difference not statistically significants have comparability.

5, two groups of preceding main clinic symptoms of treatment are relatively:

Main clinic symptoms relatively before the table 5 liang group treatment

Symptom	Group	The example number	Symptom quantizes classification (N)				The sum of ranks statistic	P
									Normally	The I level	The II level	The III level
			Dizzy	The treatment group	140	0							10	42	88	-0.54	0.59
	Matched group	50					0	6	14	30
			Headache	The treatment group	140	0					4	58	78	-0.21	0.82
	Matched group	50					0	6	15	29
			Irritated	The treatment group	140	2					22	74	42			-0.70	0.48
	Matched group	50					1	12	22	15
			Insomnia	The treatment group	140	15					39	59	27	1.50	0.10
	Matched group	50					2	12	16	20
			Tinnitus	The treatment group	140	22					40	50	28			0.67	0.50
	Matched group	50					8	11	19	12
			Soreness of the waist and knees	The treatment group	140	18					25	68	29	-1.13	0.25
	Matched group	50					8	15	16	11

Table 5 analysis result, two groups of above equal not statistically significants of clinical symptoms comparing difference have comparability.

6, two groups of preceding picture of the tongues of treatment, pulse conditions compare:

Table 6 liang group picture of the tongue relatively

Group	The example number	Picture of the tongue		X 2Statistic	P
						Normal N	Unusual N
		The treatment group	140					0	140	--	1.00
Matched group	50			0	50

Table 7 liang group pulse condition relatively

Group	The example number	Pulse condition		X 2Statistic	P
						Normal N (%)	Unusual N (%)
		The treatment group	140					8	132	--	0.11
Matched group	50			0	50

Table 6, table 7 analysis result show, two groups of picture of the tongues, pulse condition difference not statistically significant.

7, two groups of preceding blood pressures of treatment are relatively:

Blood pressure comparison before the table 8 liang group treatment (x ± s)

Blood pressure	Group	The example number	x±s	The F statistic	P
						Systolic pressure (mmHg)	The treatment group	140	158.92±10.74	3.38	0.07
Matched group	50	155.70±10.36
			Diastolic pressure (mmHg)	The treatment group	140		109.54±9.51	2.05	0.06
Matched group	50	101.12±9.38

Table 8 analysis result shows that two groups of equal not statistically significants of blood pressure comparing difference have comparability.

(2) therapeutic outcome

1, health giving quality analysis:

(1) two group of blood pressure lowering total effects comparative analysis:

Table 9 liang group blood pressure lowering total effects comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate	The sum of ranks statistic	P
								n(％)	n(％)	n (％)	(％)
		The treatment group	140	88(62.86)	41(29.29)							11(7.86)	92.14	-0.12	0.91
Matched group	50					34(68.00)	7(14.00)	9(18.00)	82.00

Table 9 analysis result, two groups of curative effect difference not statistically significants.

(2) two groups of main clinic symptoms curative effect comparative analysiss:

1. two groups of dizzy curative effect comparative analysiss:

The table 10 liang dizzy curative effect comparative analysis of group

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	140	76	47	17	87.86	-1.70	0.09
Matched group	50	22	16	12	76.00

Table 10 analysis result, two groups of dizzy curative effect difference not statistically significants.

2. two groups of headache curative effects comparative analysis:

Table 11 liang group headache curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	140	83	45	12	91.43	-0.87	0.39
Matched group	50	25	14	11	78.00

Table 11 analysis result, two groups of headache curative effect difference not statistically significants.

3. two groups of irritated curative effect comparative analysiss:

The table 12 liang irritated curative effect comparative analysis of group

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	138	66	60	12	91.30	-1.78	0.08
Matched group	49	17	24	8	83.67

Table 12 analysis result, two groups of irritated curative effect difference not statistically significants.

4. two groups of insomnia curative effects comparative analysis:

Table 13 liang group insomnia curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	125	52	61	12	90.40	-3.44	0.0006
Matched group	48	9	26	13	72.92

Table 13 analysis result, two groups of insomnia curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

5. two groups of tinnitus curative effects comparative analysis:

Table 14 liang group tinnitus curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	118	31	70	17	85.59	-2.49	0.01
Matched group	42	7	20	15	74.29

Table 14 analysis result, two groups of tinnitus curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

6. two groups of soreness of the waist and knees curative effects comparative analysis:

Table 15 liang group soreness of the waist and knees curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	122	58	48	16	86.89	-1.84	0.06
Matched group	42	140	18	10	76.19

Table 14 analysis result, two groups of soreness of the waist and knees curative effect difference not statistically significants.

7. two groups of treatment back picture of the tongues change comparative analysis:

Table 16 a liang group treatment back picture of the tongue changes comparative analysis

Group	The example number	Before the treatment (N)		Treatment back (N)		X 2Statistic	P
								Normally	Unusually	Normally	Unusually
		The treatment group	140	0	140							19	121	17.05	0.000
Matched group	50					0	50	8	42	6.13	0.01

The two groups of picture of the tongues in treatment back compare: X ²=0.17, P=0.67

Table 16 analysis result, picture of the tongue all has improvement before and after two groups of treatments, and difference has statistical significance.Two groups of treatment back picture of the tongues compare the difference not statistically significant.

8. two groups of treatment back pulse conditions change comparative analysis:

Table 17 a liang group treatment back pulse condition changes comparative analysis

Group	The example number	N (%) before the treatment		Treatment back N (%)		X 2Statistic	P
								Normally	Unusually	Normally	Unusually
		The treatment group	140	8	132							28	112	18.05	0.000
Matched group	50					0	50	7	43	5.14	0.02

Compare for two groups the treatment back: X ²=0.88, P=0.35

Table 17 analysis result, pulse condition difference all has statistical significance before and after two groups of treatments.Two groups of treatment back pulse conditions compare the difference not statistically significant.

Treat the bleeding from anus pressure ratios for (3) two groups:

Table 18 liang group treatment bleeding from anus pressure ratio is (x ± s)

Blood pressure	Group	The example number	Before the treatment	After the treatment	Front and back are poor	The t statistic	P
								Systolic pressure	The treatment group	140	158.92±10.74	144.78±7.63	14.14±8.95	18.69	0.000
(mmHg)	Matched group	50	155.70±10.36	143.44±9.64	12.26±11.07	7.83	0.000
Diastolic pressure	The treatment group	140	109.54±9.51	92.57±9.48	16.96±7.26	27.62	0.000
								(mmHg)	Matched group	50	101.12±9.38	88.08±9.77	13.04±8.02	11.49	0.000

Compare for two groups the treatment back: systolic pressure: F=0.99, P=0.32; Diastolic pressure: F=8.13, P=0.004.

Difference relatively before and after two groups of treatments: systolic pressure: F=1.42, P=0.23; Diastolic pressure: F=10.17, P=0.002.

Table 18 analysis result, blood pressure all has in various degree decline before and after two groups of treatments, and difference all has statistical significance before and after the treatment, shows that two medicines all have the effect of blood pressure lowering.By blood pressure difference before and after two groups of treatments is carried out than analyzing result, two groups of systolic pressure difference not statistically significants; The diastolic pressure difference has statistical significance, and the treatment group is better than matched group.

(4) treatment group sex, age and course of disease efficacy analysis:

1. treatment group sex and therapeutic effect relationship analysis:

Table 19 treatment group sex and therapeutic effect relationship analysis

Sex	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The man	87	56	23	8	90.80	0.27	0.79
The woman	53	32	18	3	94.37

Table 19 is the result show, the curative effect of treatment group different sexes is identical.

2. treatment group age and therapeutic effect relationship analysis:

Table 20 treatment group age and therapeutic effect relationship analysis

Age (year)	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								～50	34	25	7	2	94.12	3.87	0.14
～60	62	40	18	4	93.55
						～70	44	23	16	5	88.64

Table 20 is the result show, the curative effect of treatment group all ages and classes is identical.

3. the treatment group course of disease and therapeutic effect relationship analysis:

The table 21 treatment group course of disease and therapeutic effect relationship analysis

The course of disease (year)	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								～3	108	67	36	5	95.37	0.56	0.75
～6	28	19	4	5	82.14
						-12	4	2	1	1	75.00
＞12	0	--	--	--	--

Table 21 is the result show, the curative effect that the different courses of disease are organized in treatment is identical.

2, safety analysis:

(1) two group of laboratory safety check result is analyzed:

Table 22 a liang group laboratory safety check result is analyzed

Project	Group	The example number	Check result (treatment back before the treatment)
							Just/just	Just/different	Different/just	Different/different
			Routine blood test	The treatment group	140	140					0	0	0
Matched group	50	50					0	0	0
				Routine urinalysis	The treatment group	140				140	0	0	0
Matched group	50	50	0				0	0
					Stool routine examination	The treatment group			140	140	0	0	0
Matched group	50	50	0	0			0
						Liver function		The treatment group	140	140	0	0	0
Matched group	50	50	0	0	0
							Renal function	The treatment group	140	138	0	0	2
Matched group	50	47	0	0	3
						Electrocardiogram		The treatment group	140	140	0	0	0
Matched group	50	50	0	0	0

It is all unusual that treatment group and matched group have 5 routine renal function curings front and back, and 5 routine cases treatment front and back inosines all have higher slightly, surplus no significant change.

(2) analysis of adverse reactions: this research is totally 190 routine cases, all has no adverse reaction in the therapeutic process.

(3) safety analysis: this studies 190 routine cases, and lab testing has no side effect in the therapeutic process, and has no adverse reaction, and illustrates that the clinical use of two medicines is safe.

Discuss and conclusion:

(1) treatment last as the data analysis of comparable:

1, two groups of preceding case sources of treatment, sex, age and the equal not statistically significants of course of disease situation comparing difference have comparability.

2, dizzy, the headache of main clinic symptoms before two groups of treatments, agitation, insomnia, tinnitus, soreness of the waist and knees, picture of the tongue and the equal not statistically significant of pulse condition comparing difference have comparability preferably.

3, treat preceding systolic pressure and the equal not statistically significant of diastolic pressure comparing difference for two groups, have comparability preferably.

(2) health giving quality analysis:

1, blood pressure lowering total effects interpretation of result: this research is totally 190 routine hyperpietics, adopts the method for parallel control, multi-center clinical trial design at random, and the patient is assigned randomly to treatment group and matched group.Therapeutic outcome: 140 examples are organized in treatment, and the blood pressure lowering total effective rate is 92.14%; Matched group 50 examples, blood pressure lowering total effective rate be 82.00%, two group of curative effect by statistics credit analyse difference not statistically significant, but clinical the treatment meaning arranged.

2, main clinic symptoms efficacy analysis: the curative effect that two groups of patient's main clinic symptoms is comprised dizzy, headache, agitation, insomnia, tinnitus and soreness of the waist and knees compares analysis result, treatment group and matched group insomnia, tinnitus curative effect difference have statistical significance, and treatment group curative effect is better than matched group; All the other symptom curative effect difference not statistically significants, therapeutic equivalence.

3, picture of the tongue, pulse condition result: picture of the tongue, the equal not statistically significant of pulse condition difference after two groups of treatments.

4, two groups of blood pressure testing results are analyzed: blood pressure all has decline in various degree before and after two groups of treatments, and difference all has statistical significance before and after the treatment, shows that two medicines all have the effect of blood pressure lowering.By blood pressure difference before and after two groups of treatments is carried out than analyzing result, two groups of systolic pressure difference not statistically significants; The diastolic pressure difference has statistical significance, and the treatment group is better than matched group.

5, treatment group sex, age and the course of disease and therapeutic effect relationship: through the curative effect of treatment group different sexes, all ages and classes and the different courses of disease is analyzed, the result shows the equal not statistically significant of curative effect difference of different sexes, all ages and classes and the different courses of disease, all has curative effect preferably.

6, health giving quality conclusion: this product compound eucommia bark sheet (eucommia bark depressor sheet) can improve the hyperpietic's of the liver-yang hyperactivity of suffering from a deficiency of the kidney clinical symptoms, comprises dizzy, headache, agitation, insomnia, tinnitus and soreness of the waist and knees etc., and has blood pressure lowering effect preferably.

(3) safety analysis:

1, laboratory safety check result: to blood, urine, just conventional before and after the 190 routine patient treatments, the heart, liver, renal function check that all no abnormal variation of result has no side effect.

2, untoward reaction result: all have no adverse reaction in the 190 routine patient treatment processes.

3, safety conclusion: two medicines are clinical safe in utilization, do not find toxic and side effects and untoward reaction.

Clinical trial two:

Test unit: communication hospital, Guizhou Province

Test period: year October in March, 2002-2002

Therapeutic outcome:

(1) the preceding two groups of physical data analysis of comparable of treatment

1, two groups of case source situations are relatively:

Table 23 liang group case source situation relatively

Group	The example number	The case source		X 2Statistic	P
						Outpatient service N	N is in hospital
		The treatment group	100					97	3	--	1.00
Matched group	30			30	0

Two groups of case source difference not statistically significants have comparability.

2, two groups of sex ratios are:

Table 24 liang group sex ratio

Group	The example number	Sex		X 2Statistic	P
						Man N	Woman N
		The treatment group	100					51	49	3.37	0.07
Matched group	30			21	9

Two groups of sex comparing difference not statistically significants have comparability.

3, two groups of age ratios are:

The table 25 liang group age (year) relatively

Group	The example number	Age (x ± s)	The F statistic	P
					The treatment group	100	56.68±6.89	2.00	0.16
Matched group	30	54.70±6.17

Two groups of age comparing difference not statistically significants have comparability.

4, two groups of courses of disease are relatively:

The table 26 liang group course of disease (year) relatively

Group	The example number	The course of disease (x ± s)	The sum of ranks statistic	P
					The treatment group	100	6.79±3.71	-0.02	0.98
Matched group	30	6.82±3.39

Two groups of course of disease comparing difference not statistically significants have comparability.

5, two groups of preceding main clinic symptoms of treatment are relatively:

Main clinic symptoms relatively before the table 27 liang group treatment

Symptom	Group	The example number	Symptom quantizes classification (N)				The sum of ranks statistic	P
									Normally	The I level	The II level	The III level
			Dizzy	The treatment group	100	0							0	26	74	0.66	0.51
	Matched group	30					0	0	6	24
			Headache	The treatment group	100	0					4	39	57	-0.61	0.54
	Matched group	30					0	1	14	15
			Irritated	The treatment group	100	0					3	48	49			-0.85	0.40
	Matched group	30					0	3	14	13
			Insomnia	The treatment group	100	0					18	34	48	-1.14	0.25
	Matched group	30					0	9	9	12
			Tinnitus	The treatment group	100	0					26	33	41			-0.01	0.99
	Matched group	30					0	5	15	10
			Soreness of the waist and knees	The treatment group	100	8					17	26	49	-0.99	0.32
	Matched group	30					1	7	12	10

Table 27 analysis result, two groups of above equal not statistically significants of clinical symptoms comparing difference have comparability.

6, two groups of preceding picture of the tongues of treatment, pulse conditions compare:

Table 28 liang group picture of the tongue relatively

Group	The example number	Picture of the tongue		X 2Statistic	P
						Normal N	Unusual N
		The treatment group	100					0	100	--	1.00
Matched group	30			0	30

Table 29 liang group pulse condition relatively

Group	The example number	Pulse condition		X 2Statistic	P
						Normal N (%)	Unusual N (%)
		The treatment group	100					1	99	--	1.00
Matched group	30			0	30

Table 28, table 29 analysis result show, two groups of picture of the tongues, the equal not statistically significant of pulse condition comparing difference have comparability.

7, two groups of preceding blood pressures of treatment are relatively:

Blood pressure comparison before the table 30 liang group treatment (x ± s)

Blood pressure	Group	The example number	x±s	The F statistic	P
						Systolic pressure (mmHg)	The treatment group	100	162.45±8.70	2.17	0.14
Matched group	30	165.30±11.10
			Diastolic pressure (mmHg)	The treatment group	100		102.18±6.62	2.08	0.15
Matched group	30	104.17±6.58

Table 30 analysis result shows that two groups of equal not statistically significants of blood pressure comparing difference have comparability.

(2) therapeutic outcome:

1, health giving quality analysis:

(1) two group of blood pressure lowering total effects comparative analysis

Table 31 liang group blood pressure lowering total effects comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate	The sum of ranks statistic	P
								n(％)	n(％)	n(％)	(％)
		The treatment group	100	66(66.00)	19(19.00)							15(15.00)	85.00	1.42	0.16
Matched group	30					16(53.33)	6(20.00)	8(26.67)	73.33

Table 31 analysis result, two groups of curative effect difference not statistically significants.

(2) two groups of main clinic symptoms curative effect comparative analysiss:

1. two groups of dizzy curative effect comparative analysiss:

The table 32 liang dizzy curative effect comparative analysis of group

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	100	77	19	4	96.00	-2.88	0.004
Matched group	30	14	9	7	7667

Table 32 analysis result, two groups of dizzy curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

2. two groups of headache curative effects comparative analysis:

Table 33 liang group headache curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	100	63	32	5	95.00	-2.55	0.01
Matched group	30	13	9	8	73.33

Table 33 analysis result, two groups of headache curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

3. two groups of irritated curative effect comparative analysiss:

The table 34 liang irritated curative effect comparative analysis of group

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	100	70	23	7	93.00	-3.22	0.001
Matched group	30	12	11	7	76.67

Table 34 analysis result, two groups of irritated curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

4. two groups of insomnia curative effects comparative analysis:

Table 35 liang group insomnia curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	100	60	32	8	92.00	-3.35	0.0008
Matched group	30	9	12	9	70.00

Table 35 analysis result, two groups of insomnia curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

5. two groups of tinnitus curative effects comparative analysis:

Table 36 liang group tinnitus curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	100	49	45	6	94.00	-2.59	0.009
Matched group	30	9	13	8	76.67

Table 36 analysis result, two groups of tinnitus curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

6. two groups of soreness of the waist and knees curative effects comparative analysis:

Table 37 liang group soreness of the waist and knees curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	92	51	32	9	90.22	-2.82	0.005
Matched group	29	8	14	7	75.86

Table 37 analysis result, two groups of soreness of the waist and knees curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

7. two groups of treatment back picture of the tongues change comparative analysis:

Table 38 a liang group treatment back picture of the tongue changes comparative analysis

Group	The example number	Before the treatment (N)		Treatment back (N)		X 2Statistic	P
								Normally	Unusually	Normally	Unusually
		The treatment group	100	0	100							0	100	--	1.00
Matched group	30					0	30	0	30	--	1.00

The two groups of picture of the tongues in treatment back compare: P=1.00

Table 38 analysis result, picture of the tongue does not all have improvement, the difference not statistically significant before and after two groups of treatments.Two groups of treatment back picture of the tongues compare the difference not statistically significant.

8. two groups of treatment back pulse conditions change comparative analysis:

Table 39 a liang group treatment back pulse condition changes comparative analysis

Group	The example number	N (%) before the treatment		Treatment back N (%)		X 2Statistic	P
								Normally	Unusually	Normally	Unusually
		The treatment group	100	1	99							12	88	9.09	0.003
Matched group	30					0	30	4	26	2.25	0.13

Compare for two groups the treatment back: X ²=0.03, P=0.85

Table 39 analysis result, pulse condition difference has statistical significance before and after the treatment of treatment group.Two groups of treatment back pulse conditions compare the difference not statistically significant.

Treat the bleeding from anus pressure ratios for (3) two groups:

Table 40 liang group treatment bleeding from anus pressure ratio is (x ± s)

Blood pressure	Group	The example number	Before the treatment	After the treatment	Front and back are poor	The t statistic	P
								Systolic pressure	The treatment group	100	162.45±8.70	137.04±8.88	25.41±10.36	24.53	0.000
(mmHg)	Matched group	30	165.30±11.10	14393±11.58	2137±13.88	8.43	0.000
Diastolic pressure	The treatment group	100	102.18±6.62	87.16±8.44	15.02±7.25	20.72	0.000
								(mmHg)	Matched group	30	104.17±6.58	90.40±8.22	13.77±8.54	8.83	0.000

Compare for two groups the treatment back: systolic pressure: F=11.99, P=0.0007; Diastolic pressure: F=3.44, P=0.07.

Difference relatively before and after two groups of treatments: systolic pressure: F=2.98, P=0.09; Diastolic pressure: F=0.63, P=0.42.

Table 40 analysis result, blood pressure all has in various degree decline before and after two groups of treatments, and difference all has statistical significance before and after the treatment, shows that two medicines all have the effect of blood pressure lowering.By blood pressure differences before and after two groups of treatments being carried out than analyzing the result, two groups of systolic pressures and the equal not statistically significant of diastolic pressure difference show that the effect of two medicine blood pressure lowerings is identical.

(4) treatment group sex, age and course of disease efficacy analysis:

1. treatment group sex and therapeutic effect relationship analysis:

Table 41 treatment group sex and therapeutic effect relationship analysis

Sex	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The man	51	30	13	8	84.31	-1.32	0.18
The woman	49	36	6	7	85.71

Table 41 is the result show, the curative effect of treatment group different sexes is identical.

2. treatment group age and therapeutic effect relationship analysis:

Table 42 treatment group age and therapeutic effect relationship analysis

Age (year)	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								～50	24	15	4	5	79.17	3.53	0.17
～60	47	35	8	4	91.49
						～70	29	16	7	6	79.31

Table 42 is the result show, the curative effect of treatment group all ages and classes is identical.

3. the treatment group course of disease and therapeutic effect relationship analysis:

The table 43 treatment group course of disease and therapeutic effect relationship analysis

The course of disease (year)	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								～3	10	9	1	0	100.00	7.73	0.053
～6	33	24	5	4	87.88
						～12	41	21	11	9	78.05
＞12	16	12	2	2	87.50

Table 43 is the result show, the curative effect that the different courses of disease are organized in treatment is identical.

2, safety analysis:

(1) two group of laboratory safety check result is analyzed:

Table 44 a liang group laboratory safety check result is analyzed

Project	Group	The example number	Check result (before the treatment/the treatment back)
							Just/just	Just/different	Different/just	Different/different
			Routine blood test	The treatment group	100	100					0	0	0
Matched group	30	30					0	0	0
				Routine urinalysis	The treatment group	100				100	0	0	0
Matched group	30	30	0				0	0
					Stool routine examination	The treatment group			100	100	0	0	0
Matched group	30	30	0	0			0
						Liver function		The treatment group	100	100	0	0	0
Matched group	30	30	0	0	0
							Renal function	The treatment group	100	100	0	0	0
Matched group	30	30	0	0	0
						Electrocardiogram		The treatment group	100	100	0	0	0
Matched group	30	30	0	0	0

Blood, urine, just conventional before and after treatment group and the matched group patient, the heart, liver, renal function are all normal, no obvious toxic-side effects.

(2) analysis of adverse reactions: this research is totally 130 routine cases, all has no adverse reaction in the therapeutic process.

(3) safety analysis: this studies 130 routine cases, and lab testing has no side effect in the therapeutic process, and has no adverse reaction, and illustrates that the clinical use of two medicines is safe.

Discuss and conclusion:

(1) treatment last as the data analysis of comparable:

1, two groups of preceding case sources of treatment, sex, age and the equal not statistically significants of course of disease situation comparing difference have comparability.

2, dizzy, the headache of main clinic symptoms before two groups of treatments, agitation, insomnia, tinnitus, soreness of the waist and knees, picture of the tongue and the equal not statistically significant of pulse condition comparing difference have comparability preferably.

3, treat preceding systolic pressure and the equal not statistically significant of diastolic pressure comparing difference for two groups, have comparability preferably.

(2) health giving quality analysis:

1, blood pressure lowering total effects interpretation of result: this research is totally 130 routine hyperpietics, adopts the method for parallel control, multi-center clinical trial design at random, and the patient is assigned randomly to treatment group and matched group.Therapeutic outcome: 100 examples are organized in treatment, and the blood pressure lowering total effective rate is 85.00%; Matched group 30 examples, blood pressure lowering total effective rate be 73.33%, two group of curative effect by statistics credit analyse difference not statistically significant, but clinical the treatment meaning arranged.

2, main clinic symptoms efficacy analysis: the curative effect that two groups of patient's main clinic symptoms is comprised dizzy, headache, agitation, insomnia, tinnitus and soreness of the waist and knees compares analysis result, above symptom curative effect difference all has statistical significance, and treatment group curative effect is better than matched group.

3, picture of the tongue, pulse condition result: picture of the tongue, the equal not statistically significant of pulse condition difference after two groups of treatments.

4, two groups of blood pressure testing results are analyzed: blood pressure all has decline in various degree before and after two groups of treatments, and difference all has statistical significance before and after the treatment, shows that two medicines all have the effect of blood pressure lowering.By blood pressure differences before and after two groups of treatments being carried out than analyzing the result, two groups of systolic pressures and the equal not statistically significant of diastolic pressure difference show that the effect of two medicine blood pressure lowerings is identical.

5, treatment group sex, age and the course of disease and therapeutic effect relationship: through the curative effect of treatment group different sexes, all ages and classes and the different courses of disease is analyzed, the result shows the equal not statistically significant of curative effect difference of different sexes, all ages and classes and the different courses of disease, all has curative effect preferably.

6, health giving quality conclusion: this product compound eucommia bark sheet (eucommia bark depressor sheet) can improve the hyperpietic's of the liver-yang hyperactivity of suffering from a deficiency of the kidney clinical symptoms, comprises dizzy, headache, agitation, insomnia, tinnitus and soreness of the waist and knees etc., and has blood pressure lowering effect preferably.

(3) safety analysis:

1, laboratory safety check result: to blood, urine, just conventional before and after the 130 routine patient treatments, the heart, liver, renal function check that all no abnormal variation of result has no side effect.

2, untoward reaction result: all have no adverse reaction in the 130 routine patient treatment processes.

3, safety conclusion: two medicines are clinical safe in utilization, do not find toxic and side effects and untoward reaction.

Clinical trial three:

Test unit: Hospital Attached to Guiyang Medical College

Test period: year October in March, 2002-2002

Therapeutic outcome:

(1) the preceding two groups of physical data analysis of comparable of treatment:

1, two groups of case source situations are relatively:

Table 45 liang group case source situation relatively

Group	The example number	The case source		X 2Statistic	P
						Outpatient service N	N is in hospital
		The treatment group	60					60	0	--	1.00
Matched group	20			20	0

Two groups of case source difference not statistically significants have comparability.

2, two groups of sex ratios are:

Table 46 liang group sex ratio

Group	The example number	Sex		X 2Statistic	P
						Man N	Woman N
		The treatment group	60					25	35	0.02	0.89
Matched group	20			8	12

Two groups of sex comparing difference not statistically significants have comparability.

3, two groups of age ratios are:

The table 47 liang group age (year) relatively

Group	The example number	Age (x ± s)	The F statistic	P
					The treatment group	60	58.33±9.18	0.58	0.45
Matched group	20	60.10±8.50

Two groups of age comparing difference not statistically significants have comparability.

4, two groups of courses of disease are relatively:

The table 48 liang group course of disease (year) relatively

Group	The example number	The course of disease (x ± s)	The sum of ranks statistic	P
					The treatment group	60	5.75±6.42	-0.98	0.33
Matched group	20	4.25±5.19

Two groups of course of disease comparing difference not statistically significants have comparability.

5, two groups of preceding main clinic symptoms of treatment are relatively:

Main clinic symptoms relatively before the table 49 liang group treatment

Symptom	Group	The example number	Symptom quantizes classification (N)				The sum of ranks statistic	P
									Normally	The I level	The II level	The III level
			Dizzy	The treatment group	60	16							6	25	13	-0.19	0.85
	Matched group	20					5	2	10	3
			Headache	The treatment group	60	11					6	25	18	-0.55	0.58
	Matched group	20					5	3	6	6
			Irritated	The treatment group	60	22					13	19	6			0.27	0.78
	Matched group	20					8	3	5	4
			Insomnia	The treatment group	60	16					11	24	9	1.01	0.31
	Matched group	20					4	2	10	4
			Tinnitus	The treatment group	60	33					10	8	9			-0.17	0.86
	Matched group	20					11	5	1	3
			Soreness of the waist and knees	The treatment group	60	28					12	15	5	0.79	0.43
	Matched group	20					7	5	6	2

Table 49 analysis result, two groups of above equal not statistically significants of clinical symptoms comparing difference have comparability.

6, two groups of preceding picture of the tongues of treatment, pulse conditions compare:

Table 50 liang group picture of the tongue relatively

Group	The example number	Picture of the tongue		X 2Statistic	P
						Normal N	Unusual N
		The treatment group	60					4	56	2.96	0.09
Matched group	20			4	16

Table 51 liang group pulse condition relatively

Group	The example number	Pulse condition		X 2Statistic	P
						Normal N (%)	Unusual N (%)
		The treatment group	60					3	57	6.67	0.009
Matched group	20			5	15

Table 50, table 51 analysis result show, two groups of picture of the tongue difference not statistically significants, and the pulse condition diversity ratio has statistical significance, but efficacy determination is not had obvious influence.

7, two groups of preceding blood pressures of treatment are relatively:

Blood pressure comparison before the table 52 liang group treatment (x ± s)

Blood pressure	Group	The example number	x±s	The F statistic	P
						Systolic pressure (mmHg)	The treatment group	60	160.92±20.68	0.55	0.46
Matched group	20	165.50±32.07
			Diastolic pressure (mmHg)	The treatment group	60		101.62±1120	3.85	0.053
Matched group	20	108.50±19.20

Table 52 analysis result shows that two groups of equal not statistically significants of blood pressure comparing difference have comparability.

(2) therapeutic outcome:

1, health giving quality analysis:

(1) two group of blood pressure lowering total effects comparative analysis:

Table 53 liang group blood pressure lowering total effects comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate	The sum of ranks statistic	P
								n (％)	N(％)	n(％)	(％)
		The treatment group	60	27(45.00)	31(5167)							2(3.33)	96.67	3.44	0.0006
Matched group	20					2(10.00)	13(6500)	5(25.00)	75.00

Table 53 analysis result, two groups of curative effect differences have statistical significance, and treatment group curative effect is better than matched group.

(2) two groups of main clinic symptoms curative effect comparative analysiss:

1. two groups of dizzy curative effect comparative analysiss:

The table 54 liang dizzy curative effect comparative analysis of group

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	44	17	26	1	97.73	-2.81	0.005
Matched group	15	0	14	1	93.33

Table 54 analysis result, two groups of dizzy curative effect differences have statistical significance.

2. two groups of headache curative effects comparative analysis:

Table 55 liang group headache curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	49	20	23	6	87.76	0.67	0.50
Matched group	15	6	7	2	86.67

Table 55 analysis result, two groups of headache curative effect difference not statistically significants.

3. two groups of irritated curative effect comparative analysiss:

The table 56 liang irritated curative effect comparative analysis of group

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	38	17	9	12	68.42	0.82	0.41
Matched group	12	4	6	2	83.33

Table 56 analysis result, two groups of irritated curative effect difference not statistically significants.

4. two groups of insomnia curative effects comparative analysis:

Table 57 liang group insomnia curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	44	13	20	11	75.00	2.44	0.02
Matched group	16	10	4	2	87.50

Table 57 analysis result, two groups of insomnia curative effect differences have statistical significance.

5. two groups of tinnitus curative effects comparative analysis:

Table 58 liang group tinnitus curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	27	10	8	9	66.67	-1.14	0.25
Matched group	9	0	6	3	66.67

Table 58 analysis result, two groups of tinnitus curative effect difference not statistically significants.

6. two groups of soreness of the waist and knees curative effects comparative analysis:

Table 59 liang group soreness of the waist and knees curative effect comparative analysis

Group	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The treatment group	32	11	12	9	71.87	-0.91	0.36
Matched group	13	0	11	2	84.62

Table 59 analysis result, two groups of soreness of the waist and knees curative effect difference not statistically significants.

7. two groups of treatment back picture of the tongues change comparative analysis:

Table 60 a liang group treatment back picture of the tongue changes comparative analysis

Group	The example number	Before the treatment (N)		Treatment back (N)		X 2Statistic	P
								Normally	Unusually	Normally	Unusually
		The treatment group	60	4	56							15	45	9.09	0.003
Matched group	20					4	16	14	6	8.10	0.004

The two groups of picture of the tongues in treatment back compare: X ²=13.14, P=0.0003

Table 60 analysis result, picture of the tongue all has improvement before and after two groups of treatments, and difference has statistical significance.Two groups of treatment back picture of the tongues compare, and difference has statistical significance.

8. two groups of treatment back pulse conditions change comparative analysis:

Table 61 a liang group treatment back pulse condition changes comparative analysis

Group	The example number	N (%) before the treatment		Treatment back N (%)		X 2Statistic	P
								Normally	Unusually	Normally	Unusually
		The treatment group	60	3	57							16	44	11.08	0.0009
Matched group	20					5	15	14	6	7.11	0.005

Compare for two groups the treatment back: X ²=12.01, P=0.0005

Table 61 analysis result, pulse condition difference all has statistical significance before and after two groups of treatments.Two groups of treatment back pulse conditions compare, and difference has statistical significance.

Treat the bleeding from anus pressure ratios for (3) two groups:

Table 62 liang group treatment bleeding from anus pressure ratio is (x ± s)

Blood pressure	Group	The example number	Before the treatment	After the treatment	Front and back are poor	The t statistic	P
								Systolic pressure	The treatment group	60	160.92± 20.68	145.43± 21.10	15.48± 7.70	15.57	0.000
(mmHg)	Matched group	20	165.50± 32.07	153.00± 21.24	1250± 2.93	3.60	0.002
Diastolic pressure	The treatment group	60	101.62± 11.20	91.43± 11.27	10.18± 6.84	11.53	0.000
								(mmHg)	Matched group	20	108.50± 19.20	98.95± 11.14	9.55± 1189	3.59	0.002

Compare for two groups the treatment back: systolic pressure: F=1.92, P=0.17; Diastolic pressure: F=6.71, P=0.01.

Difference relatively before and after two groups of treatments: systolic pressure: F=1.29, P=0.26; Diastolic pressure: F=0.09, P=0.77.

Table 62 analysis result, blood pressure all has in various degree decline before and after two groups of treatments, and difference all has statistical significance before and after the treatment, shows that two medicines all have the effect of blood pressure lowering.By blood pressure differences before and after two groups of treatments being carried out than analyzing the result, two groups of systolic pressures and the equal not statistically significant of diastolic pressure difference show that the effect of two medicine blood pressure lowerings is identical.

(4) treatment group sex, age and course of disease efficacy analysis:

1. treatment group sex and therapeutic effect relationship analysis:

Table 63 treatment group sex and therapeutic effect relationship analysis

Sex	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								The man	25	12	12	1	96.00	-0.32	0.75
The woman	35	15	19	1	97.14

Table 63 is the result show, the curative effect of treatment group different sexes is identical.

2. treatment group age and therapeutic effect relationship analysis:

Table 64 treatment group age and therapeutic effect relationship analysis

Age (year)	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								～50	14	6	7	1	92.86	3.02	0.22
～60	19	6	12	1	94.74
						～70	27	15	12	0	100.00

Table 64 is the result show, the curative effect of treatment group all ages and classes is identical.

3. the treatment group course of disease and therapeutic effect relationship analysis:

The table 65 treatment group course of disease and therapeutic effect relationship analysis

The course of disease (year)	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)	The sum of ranks statistic	P
								～3	34	12	20	2	94.12	6.74	0.08
～6	2	0	2	0	100.00
						～12	16	11	5	0	100.00
＞12	8	4	4	0	100.00

Table 65 is the result show, the curative effect that the different courses of disease are organized in treatment is identical.

2, safety analysis:

(1) two group of laboratory safety check result is analyzed:

Table 66 a liang group laboratory safety check result is analyzed

Project	Group	The example number	Check result (before the treatment/the treatment back)
							Just/just	Just/different	Different/just	Different/different
			Routine blood test	The treatment group	60	60					0	0	0
Matched group	20	20					0	0	0
				Routine urinalysis	The treatment group	60				60	0	0	0
Matched group	20	20	0				0	0
					Stool routine examination	The treatment group			60	60	0	0	0
Matched group	20	20	0	0			0
						Liver function		The treatment group	60	60	0	0	0
Matched group	20	20	0	0	0
							Renal function	The treatment group	60	60	0	0	0
Matched group	20	20	0	0	0
						Electrocardiogram		The treatment group	60	58	0	0	1
Matched group	20	17	0	0	1

Electrocardioscopy is unusual:

1 example is organized in treatment: Du * *, the man is myocardial ischemia before and after the treatment, and locular wall thickens, surplus no significant change.

Matched group 1 example: poplar * *, the man is myocardial ischemia, arrhythmia, surplus no significant change before and after the treatment.

(2) analysis of adverse reactions: this research is totally 80 routine cases, all has no adverse reaction in the therapeutic process.

(3) safety analysis: this studies 80 routine cases, and lab testing has no side effect in the therapeutic process, and has no adverse reaction, and illustrates that the clinical use of two medicines is safe.

Discuss and conclusion:

(1) treatment last as the data analysis of comparable:

1, two groups of preceding case sources of treatment, sex, age and the equal not statistically significants of course of disease situation comparing difference have comparability.

2, dizzy, the headache of main clinic symptoms before two groups of treatments, agitation, insomnia, tinnitus, soreness of the waist and knees, picture of the tongue and the equal not statistically significant of pulse condition comparing difference have comparability preferably.

3, treat preceding systolic pressure and the equal not statistically significant of diastolic pressure comparing difference for two groups, have comparability preferably.

(2) health giving quality analysis:

1, blood pressure lowering total effects interpretation of result: this research is totally 80 routine hyperpietics, adopts the method for parallel control, multi-center clinical trial design at random, and the patient is assigned randomly to treatment group and matched group.Therapeutic outcome: 60 examples are organized in treatment, and the blood pressure lowering total effective rate is 96.67%; Matched group 20 examples, blood pressure lowering total effective rate be 75.00%, two group of curative effect by statistics credit analyse, difference has statistical significance, treatment group curative effect is better than matched group.

2, main clinic symptoms efficacy analysis: the curative effect that two groups of patient's main clinic symptoms is comprised dizzy, headache, agitation, insomnia, tinnitus and soreness of the waist and knees compares analysis result, treatment group and matched group are dizzy, insomnia curative effect difference has statistical significance, all the other symptom curative effect difference not statistically significants.

3, picture of the tongue, pulse condition result: two groups of treatment back picture of the tongues, pulse condition differences all have statistical significance.

4, two groups of blood pressure testing results are analyzed: blood pressure all has decline in various degree before and after two groups of treatments, and difference all has statistical significance before and after the treatment, shows that two medicines all have the effect of blood pressure lowering.By blood pressure differences before and after two groups of treatments being carried out than analyzing the result, two groups of systolic pressures and the equal not statistically significant of diastolic pressure difference show that the effect of two medicine blood pressure lowerings is identical.

5, treatment group sex, age and the course of disease and therapeutic effect relationship: through the curative effect of treatment group different sexes, all ages and classes and the different courses of disease is analyzed, the result shows the equal not statistically significant of curative effect difference of different sexes, all ages and classes and the different courses of disease, all has curative effect preferably.

6, health giving quality conclusion: this product compound eucommia bark sheet (eucommia bark depressor sheet) can improve the hyperpietic's of the liver-yang hyperactivity of suffering from a deficiency of the kidney clinical symptoms, comprises dizzy, headache, agitation, insomnia, tinnitus and soreness of the waist and knees etc., and has blood pressure lowering effect preferably.

(3) safety analysis:

1, laboratory safety check result: to blood, urine, just conventional before and after the 80 routine patient treatments, the heart, liver, renal function check that all no abnormal variation of result has no side effect.

2, untoward reaction result: all have no adverse reaction in the 80 routine patient treatment processes.

3, safety conclusion: two medicines are clinical safe in utilization, do not find toxic and side effects and untoward reaction.

Clinical trial is summed up:

Be set forth in the III clinical trial phase research of carrying out this medicine treatment hypertension (liver-yang hyperactivity of suffering from a deficiency of the kidney card) year October in March, 2002-2002 in Hospital Attached to Guiyang Medical College, Guizhou Prov. Traditional Chinese Medical Research Inst Affiliated Hospital and communication hospital, Guizhou Province on comprehensive, the result shows: 300 examples are organized in the treatment of this product compound eucommia bark sheet, and total effective rate is 90.67%; QIJU DIHUANG WAN matched group 100 examples, total effective rate be 78.00%, two group of clinical efficacy by statistics credit analyse difference statistical significance arranged, treatment group curative effect is better than matched group.

The specific embodiment:

Embodiments of the invention 1: weighting raw materials material Cortex Eucommiae (parched) 781.67g, Herba Leonuri 781.67g, Spica Prunellae 468.33g, Radix Scutellariae 468.33g and Ramulus Uncariae Cum Uncis 468.33g, hook taking rattan 250g adds alcohol reflux 2 times, 1.5 hours for the first time, 1 hour for the second time, filter merge extractive liquid,, reclaim ethanol and be concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and all the other Ramulus Uncariae Cum Uncis, Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 3 times, and each 1 hour, collecting decoction, filter, filtrate was left standstill 24 hours, drew supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis extract fine powder, mixing, dry, pulverize, make granule, encapsulated, make 1000, promptly get capsule of the present invention.Wherein content is tan granule or powder; Feeble QI, puckery, little hardship.This product is oral, and 3 times on the one, each 3.Every dress 0.48g.

Embodiments of the invention 2: weighting raw materials material Cortex Eucommiae (parched) 600g, Herba Leonuri 600g, Spica Prunellae 200g, Radix Scutellariae 200g and Ramulus Uncariae Cum Uncis 280g, hook taking rattan 150g adds alcohol reflux 1 time, each 3 hours, filter, merge extractive liquid, reclaims ethanol and is concentrated into thick paste shape, drying, be ground into fine powder, standby; Filtering residue and all the other Ramulus Uncariae Cum Uncis, Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction filters, and filtrate was left standstill 12 hours, draw supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis extract fine powder, mixing, drying is pulverized, add an amount of alcohol granulation, drying is pressed into 1000, promptly gets tablet of the present invention.

Embodiments of the invention 3: weighting raw materials material Cortex Eucommiae (parched) 900g, Herba Leonuri 900g, Spica Prunellae 500g, Radix Scutellariae 500g and Ramulus Uncariae Cum Uncis 500g, the hook taking rattan adds alcohol reflux 4 times, each 1 hour, filter, merge extractive liquid, reclaims ethanol and is concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 4 times, and each 0.5 hour, collecting decoction, filter, filtrate was left standstill 36 hours, drew supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis fine powder, mixing, dry, pulverize, add tween 80 and propylene glycol then, mixing, with being pressed into soft capsule after the colloid mill grinding, promptly obtain soft capsule of the present invention.

Embodiments of the invention 4: weighting raw materials material Cortex Eucommiae (parched) 800g, Herba Leonuri 800g, Spica Prunellae 400g, Radix Scutellariae 400g and Ramulus Uncariae Cum Uncis 400g, the hook taking rattan adds alcohol reflux 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, filter, merge extractive liquid, reclaims ethanol and is concentrated into thick paste shape, drying, be ground into fine powder, standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 3 times, and each 1 hour, collecting decoction, filter, filtrate was left standstill 30 hours, drew supernatant, and the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, add above-mentioned Ramulus Uncariae Cum Uncis fine powder, mixing, drying is pulverized, add aspartame then and lactose is an amount of, dry-pressing is granulated and is promptly got granule of the present invention.

Embodiments of the invention 5: weighting raw materials material Cortex Eucommiae (parched) 700g, Herba Leonuri 700g, Spica Prunellae 250g, Radix Scutellariae 250g and Ramulus Uncariae Cum Uncis 250g, the hook taking rattan adds alcohol reflux 2 times, 1 hour for the first time, 0.5 hour for the second time, filter merge extractive liquid,, reclaim ethanol and be concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 2 times, and each 1 hour, collecting decoction, filter, filtrate was left standstill 24 hours, drew supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, add above-mentioned Ramulus Uncariae Cum Uncis fine powder, mixing, drying, pulverize, add vegetable oil substrate, pill promptly gets drop pill of the present invention.

Embodiments of the invention 6: weighting raw materials material Cortex Eucommiae (parched) 600g, Herba Leonuri 600g, Spica Prunellae 200g, Radix Scutellariae 200g and Ramulus Uncariae Cum Uncis 200g, the hook taking rattan adds alcohol reflux 4 times, each 1 hour, filter, merge extractive liquid, reclaims ethanol and is concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 4 times, and each 0.5 hour, collecting decoction, filter, filtrate was left standstill 36 hours, drew supernatant, and the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, add above-mentioned Ramulus Uncariae Cum Uncis fine powder, mixing, drying is pulverized, add solvent and proper honey and sorbic acid, promptly get oral liquid formulations of the present invention.

Embodiments of the invention 7: weighting raw materials material Cortex Eucommiae (parched) 900g, Herba Leonuri 900g, Spica Prunellae 500g, Radix Scutellariae 500g and Ramulus Uncariae Cum Uncis 500g, the hook taking rattan adds alcohol reflux 1 time, each 3 hours, filter, merge extractive liquid, reclaims ethanol and is concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction filters, and filtrate was left standstill 12 hours, draw supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis fine powder, mixing, dry, pulverize, add glycerol then and grind well back adding syrup, promptly get syrup of the present invention.

Claims (6)

1. pharmaceutical preparation for the treatment of vascular hypertension is characterized in that: according to listed as parts by weight, it is prepared from for 200～500 parts with 600～900 parts of Cortex Eucommiae (parched), 600～900 parts of Herba Leonuris, 200～500 parts of Spica Prunellaes, 200～500 parts of Radix Scutellariaes and Ramulus Uncariae Cum Uncis.

2. according to the pharmaceutical preparation of the described treatment vascular hypertension of claim 1, it is characterized in that: calculate according to weight, it is prepared from Cortex Eucommiae (parched) 781.67g, Herba Leonuri 781.67g, Spica Prunellae 468.33g, Radix Scutellariae 468.33g and Ramulus Uncariae Cum Uncis 468.33g.

3. according to the pharmaceutical preparation of claim 1 or 2 described treatment vascular hypertensions, it is characterized in that: described pharmaceutical preparation is tablet, capsule, soft capsule, granule, drop pill, oral liquid or syrup.

4. as the preparation method of the pharmaceutical preparation of treatment vascular hypertension as described in the claim 1～3 any, it is characterized in that: weighting raw materials material Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae, Radix Scutellariae and Ramulus Uncariae Cum Uncis, hook taking rattan 250g adds alcohol reflux 1～4 time, each 1～3 hour, filter merge extractive liquid,, reclaim ethanol and be concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and all the other Ramulus Uncariae Cum Uncis, Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 2～4 times, and each 0.5～2 hour, collecting decoction, filter, filtrate was left standstill 12～36 hours, drew supernatant, and the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, add above-mentioned Ramulus Uncariae Cum Uncis fine powder, mixing, drying is pulverized, promptly get the effective ingredient of medicine of the present invention, the effective ingredient that obtains is added the adjuvant that needs, is prepared into required preparation according to conventional method.

5. according to the preparation method of the pharmaceutical preparation of the described treatment vascular hypertension of claim 4, it is characterized in that: weighting raw materials material Cortex Eucommiae (parched) 600g, Herba Leonuri 600g, Spica Prunellae 200g, Radix Scutellariae 200g and Ramulus Uncariae Cum Uncis 280g, hook taking rattan 150g adds alcohol reflux 1 time, each 3 hours, filter merge extractive liquid,, reclaim ethanol and be concentrated into the thick paste shape, drying is ground into fine powder, and is standby; Filtering residue and Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction filters, and filtrate was left standstill 12 hours, draw supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis extract fine powder, mixing, drying is pulverized, add an amount of alcohol granulation, drying is pressed into 1000, promptly gets tablet of the present invention.

6. according to the preparation method of the pharmaceutical preparation of claim 2 or 4 described treatment vascular hypertensions, it is characterized in that: weighting raw materials material Cortex Eucommiae (parched) 781.67g, Herba Leonuri 781.67g, Spica Prunellae 468.33g, Radix Scutellariae 468.33g and Ramulus Uncariae Cum Uncis 468.33g, hook taking rattan 250g adds alcohol reflux 2 times, and 1.5 hours for the first time, 1 hour for the second time, filter, merge extractive liquid, reclaims ethanol and is concentrated into thick paste shape, drying, be ground into fine powder, standby; Filtering residue and all the other Ramulus Uncariae Cum Uncis, Cortex Eucommiae (parched), Herba Leonuri, Spica Prunellae and Radix Scutellariae decoct with water 3 times, and each 1 hour, collecting decoction, filter, filtrate was left standstill 24 hours, drew supernatant, the survey relative density is 1.35～1.38 thick paste when being evaporated to 80 ℃, adds above-mentioned Ramulus Uncariae Cum Uncis extract fine powder, mixing, dry, pulverize, make granule, encapsulated, make 1000, promptly get capsule of the present invention.