CN103272079A - Hui medicine compound for treating diabetic nephropathy and application thereof - Google Patents
Hui medicine compound for treating diabetic nephropathy and application thereof Download PDFInfo
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Abstract
The invention discloses a Hui medicine compound for treating diabetic nephropathy and an application thereof. The medical composition comprises the following raw materials in parts by weight: 100-500 parts of rhizoma nardostachyos, 160-600 parts of medlar, 200-1000 parts of aromatic medicine composition (Foeniculum vulgare: elecampane: Syzygium aromaticum: Agastache rugosus=4:3:2:1), 60-400 parts of pine mushroom, 160-580 parts of Semen Cuscutae, 40-240 parts of rheum officinale, 60-360 parts of aloe and 360-1000 parts of tonifying composition (ginseng: cistanche: flowers carthami=3:2:1). The compound provided by the invention has the advantages of exact curative effect and no remarkable toxic and side effects, and has the function of converting black hygroplasm in the body to red hygroplasm, yellow hygroplasm and white hygroplasm and has the effects of removing dampness by means of aromatics, eliminating phlegm and dredging collaterals and tonifying the kidney. The medicine compound is suitable for treating wet diabetic nephropathy with deficiency of the kidney and phlegm evil.
Description
Technical field
What the present invention relates to is a kind of time recurrence due to taking drug side and application thereof for the treatment of diabetic nephropathy.
Background technology
(Diabetes Mellitus DM) has become worldwide commonly encountered diseases, frequently-occurring disease to diabetes.Diabetic nephropathy (Diabetic Nephropathy, DN) be one of topmost microvascular complication of diabetes, and become global chronic kidney disease (CKD) and the main composition reason of the end stagerenaldisease (ESRD) that causes, the patient finally can only rely on dialysis or renal transplantation to earn a bare living, this has not only had a strong impact on existence and quality of life, brings heavy financial burden and stress more for family and society.
Find that according to China's extensive DM Epidemiological study several times the DM onset state of Ningxia Hui Autonomous Region presents two features: the first, the sickness rate height.1. the sickness rate in area, Ningxia occupies national higher level.The DM Epidemiological study of national maximum-norm in 1980 is found: area, Ningxia DM prevalence occupies second in the whole nation, is 12.41 ‰, is significantly higher than average national level (6.74 ‰).2. local Hui ethnic group sickness rate is higher than the crowd of Han nationality.According to investigations, the DM of Ningxia Hui ethnic group prevalence is 12.41 ‰, is significantly higher than local Han nationality (10.67 ‰), and is higher than national level.3. the incidence rate of diabetes merging kidney damage is higher than both at home and abroad.Lei Chen etc. have carried out investigation to the 2587 routine Ningxia 2 type DM patients of the Hui ethnic group and found: Ningxia Hui ethnic group inpatient DN prevalence is 46.3%, is higher than the domestic average level same period (33.6%).The second, hazardness is big.1. disable, fatality rate is higher.The DM chronic complicating diseases investigation of the calendar year 2001 whole nation is found: concerned by the restriction of its economic condition and religions belief, the DM patient's of the Hui ethnic group medical expense remains at low levels, and causes the disabling of the DM patient of the Hui ethnic group, fatality rate higher.2. overburden for medical economics.Reports such as Lei Chen: in a single day the DM of Ningxia Hui ethnic group inpatient merges complication, and its medical expense will increase by 125%, this DN patient wherein, in case entered the dialysis treatment phase, medical expense will increase by 500%.Therefore, select the method for an effective suitable Ningxia crowd prevention and treatment DN of the Hui ethnic group, most important.
Analyze its reason, we think relevant with multiple factors such as Special geography position, Ningxia Hui ethnic group area, diet structure, culture faith and life style.Wherein, geographical position " partially deficiency and coldness body constitution " of causing in the majority and " hyperlipidemia " that diet structure causes be topmost two reasons.
At present, modern medicine is at diabetic nephropathy (Diabetie Nephropathy, DN) the treatment measure is based on exercise therapy, Diet Therapy, control blood glucose, control blood pressure etc., but be subject to special religion and the life style of economic condition and the Hui ethnic group in area, Ningxia, undesirable to the control of blood glucose and complication.And Chinese medicine many be pathogenesis with " deficiency of spleen and stomach ", " blood stasis due to renal deficiency ", be the rule for the treatment of with " kidney and spleen invigorating ", " blood circulation promoting and blood stasis dispelling ", because " deficiency and coldness body constitution partially " in the majority and " hyperlipidemia " (suitable substantially with " phlegm-damp " of the traditional Chinese medical science), curative effect is also not satisfactory.Therefore, numerous in recent years researcheres have been invested sight " Hui ethnic group's medical science " this treasure-house, in the hope of therefrom haveing breakthrough.
Summary of the invention
Technical problem to be solved by this invention is based on Hui ethnic group's medical science " four sexology are said ", reports the rule for the treatment of of the kidney invigorating, eleminating phlegm and freeing channels according to benefit, provides a kind of recurrence due to taking drug side of going back to for the treatment of diabetic nephropathy at the deficiency of prior art and scheme.
Time recurrence due to taking drug side for the treatment of diabetic nephropathy of the present invention, comprise Radix Et Rhizoma Nardostachyos 100-500 weight portion, Fructus Lycii 160-600 weight portion, incense drug combination (the 200-1000 weight portion of Fructus Foeniculi, the Radix Aucklandiae, Flos Caryophylli, Herba Pogostemonis=4:3:2:1), armillaria Matsutake 60-400 weight portion, Semen Cuscutae 160-580 weight portion, Radix Et Rhizoma Rhei 40-240 weight portion, Aloe 60-360 weight portion, benefit are reported combination (the 360-1000 weight portion of Radix Ginseng, Herba Cistanches, Flos Carthami=3:2:1).
The compound medicine thing that returns of above-mentioned treatment diabetic nephropathy is preferably as follows the medicine composition: Radix Et Rhizoma Nardostachyos 180-380 weight portion, Fructus Lycii 280-500 weight portion, incense drug combination (the 380-620 weight portion of Fructus Foeniculi, the Radix Aucklandiae, Flos Caryophylli, Herba Pogostemonis=4:3:2:1), armillaria Matsutake 80-220 weight portion, Semen Cuscutae 180-380 weight portion, Radix Et Rhizoma Rhei 80-220 weight portion, Aloe 140-320 weight portion, benefit is reported combination (the 460-740 weight portion of Radix Ginseng, Herba Cistanches, Flos Carthami=3:2:1).
Best proportioning of the present invention is made up of following medicine: Radix Et Rhizoma Nardostachyos 200 weight portions, Fructus Lycii 300 weight portions, incense drug combination (600 weight portions of Fructus Foeniculi, the Radix Aucklandiae, Flos Caryophylli, Herba Pogostemonis=4:3:2:1), armillaria Matsutake 100 weight portions, Semen Cuscutae 200 weight portions, Radix Et Rhizoma Rhei 100 weight portions, Aloe 160 weight portions, benefit is reported combination (600 weight portions of Radix Ginseng, Herba Cistanches, Flos Carthami=3:2:1).
Time recurrence due to taking drug side of the present invention for 1 type and type 2 diabetes mellitus, at blood sugar lowering, improve the diabetic nephropathy patient renal function, alleviate aspects such as kidney pathological change good curative effect is all arranged, demonstrates the effect that it significantly improves diabetic nephropathy early metaphase symptom.
Many nature and flavor of the kinds of traditional Chinese medicines that this compound recipe is formed (returning medicine), return through determining the characteristic of its multipath, the effect of many target spots more.According to the Chinese medicine rationale, Radix Et Rhizoma Nardostachyos: acrid in the mouth, sweet, warm in nature, return spleen, stomach warp, have regulating QI to relieve pain, the effect of activating spleen and strengthening stomach; Fructus Lycii: sweet in the mouth, property is flat, returns liver, kidney, lung meridian, has nourishing the liver; Nourishing kidney; The effect of lung moistening; Incense drug combination (Fructus Foeniculi, the Radix Aucklandiae, Flos Caryophylli, Herba Pogostemonis) has in the accent of regulating the flow of vital energy, drying dampness to eliminate phlegm, the effect of warming middle-JIAO, warming the kidney, cold expelling; Armillaria Matsutake, sweet, flat, go into spleen, kidney, urinary bladder channel, the effect that the branch dampness removing is turbid, reinforce the kidney is arranged; Semen Cuscutae, sweet, temperature is returned the liver,kidney,spleen warp, and nourishing the liver and kidney is arranged, the effect of controlling nocturnal emission with astringent drugs reducing urination; Radix Et Rhizoma Rhei, hardship, cold, return stomach, large intestine, liver, spleen channel, the effect of attacking stagnant, clearing away damp-heat, pathogenic fire purging, removing heat from blood, blood stasis dispelling, detoxifcation is arranged; Aloe, bitter in the mouth, cold in nature, go into liver, the heart, spleen channel, have and rush down down liver heat removing, the effect of parasite killing.Benefit is reported combination, and (Radix Ginseng, Herba Cistanches, Flos Carthami=3:2:1) have inrigorating qi and promoting blood circulation, the effect of beneficial smart the kidney invigorating.According to Hui ethnic group's medical science " four sexology are said " theory, report the rule for the treatment of of the kidney invigorating, eleminating phlegm and freeing channels based on benefit, spread in the side tongue also Xin's (Radix Et Rhizoma Nardostachyos), horse breathe out perverse black put forward " incense drugs " such as (Flos Caryophylli), Herba Pogostemoniss of answering of our (Radix Aucklandiae), unexpected rival horse (Fructus Foeniculi), Ah we by the black liquor matter in the body being converted into red liquid matter (removing dampness by means of aromatics), remove the black liquor matter in the body; Luo Yina (Radix Et Rhizoma Rhei), A Songla we (Aloe) by the black liquor matter in the body is converted into yellow liquor matter (catharsis eliminates the phlegm); Ali's public affairs (armillaria Matsutake), neglect we then (Fructus Lycii), Ah husband make a mistake cover (Semen Cuscutae), benefit is reported combination (Radix Ginseng, Herba Cistanches, Flos Carthami) by the black liquor matter in the body being converted into white liquid matter (tonification kidney officials report), plays removing dampness by means of aromatics altogether, the effect of the collateral dredging that eliminates the phlegm, the kidney invigorating of benefit official report.
The specific embodiment
Below in conjunction with specific embodiment, the present invention is described in detail.
Embodiment 1
The glycometabolic influence research of type 1 diabetes mice that time recurrence due to taking drug side of the present invention induces alloxan.
70 of SPF level male mouse of kunming, body weight (20 ± 2) g purchases the Experimental Animal Center in Ningxia Medical University.
Dosage is determined: basic, normal, high dosage group drug level is according to people and animal body surface area and the calculating of dosage scaling method.Basic, normal, high dosage group mice gives this compound recipe respectively and returns medicine 5g/kg, 10g/kg, 20g/kg.Medical material decocts 2 times according to traditional method after cultivar identification, is concentrated into respective sets dosage.
8 of picked at random are as the normal control group.All the other mices behind fasting 16h, the freshly prepared 2% alloxan normal saline solution of tail vein fast injection, 60m/kg.The normal control group gives the equal-volume normal saline.Above-mentioned mice is got blood and measures blood glucose value in the tail point through after the free diet of 72h, and blood glucose value is represented the modeling success greater than 16.7mmol/L.Get the mice of 40 modeling successes, be divided into 5 groups at random by blood glucose value, 8 every group, i.e. model group, metformin group, this time recurrence due to taking drug side (5g/kg) group, (10g/kg) group, (20g/kg) group.Each organizes equal ad lib, drinking-water.4d after the modeling, each organizes gastric infusion.The metformin group gives metformin 0.5g/kg; This time the basic, normal, high dosage group in recurrence due to taking drug side gives HGY5g/kg, 10g/kg, 20g/kg respectively; Blank group and model group give the equal-volume distilled water, every day 1 time, continuous 3 weeks.Each organizes mice respectively at 3rd day and 0th, 5,10,15 day of drug treatment of injection behind the alloxan, and afterbody is got blood, records the random blood sugar value of mice by blood glucose monitoring system.After administration finished, the mice broken end was got blood, and separation of serum is measured triglyceride (TG), T-CHOL (CHO), high density lipoprotein (HDL) and low density lipoprotein, LDL (LDL) in the serum with automatic biochemistry analyzer.Result: the 1. influence of the type 1 diabetes mouse blood sugar that alloxan is induced: with the blank group relatively, the blood glucose value of the model group mice (P＜0.0l) that significantly raises, and the blood glucose value of model group mice is trend of rising in time, shows that diabetes that alloxan induces are along with its state of an illness of development of time increases the weight of gradually.Compare with model group, metformin group and this time recurrence due to taking drug side (10g/kg) group, all can obviously reduce the blood glucose value of the diabetic mice that alloxan induces after (20g/kg) group 2 weeks of administration, HGY(10g/kg wherein) with, the blood sugar reducing function of metformin group is (seeing Table 1) quite.2. the influence of the type 1 diabetes mice blood fat that alloxan is induced: for the detection of blood lipids index, this experiment is only chosen back the optimal dose (10g/kg) of recurrence due to taking drug side as the experiment detected object.Compare with the blank group, model group mice serum TG, CHO and LDL level all obviously raise (P＜0.01), and HDL obviously reduces (P＜0.01).TG, CHO and the LDL level of returning recurrence due to taking drug side (10g/kg) group mice all are starkly lower than model group, and HDL is higher than model group (P＜0.01).The result shows: go back to recurrence due to taking drug side (10g/kg) and have tangible blood fat reducing effect (seeing Table 2) for the type 1 diabetes mice.
Table 1 the present invention goes back to recurrence due to taking drug side to the influence of type 1 diabetes mouse blood sugar
Compare with the normal control group,
*P＜0.01; Compare with model group,
▲P＜0.05,
▲ ▲P＜0.01.
Table 2 the present invention goes back to recurrence due to taking drug side to the influence of type 1 diabetes mice blood fat
Compare with the normal control group,
*P＜0.01; Compare with model group,
▲P＜0.05,
▲ ▲P＜0.01.
Embodiment 2
The glycometabolic influence of type 1 diabetes rat that time recurrence due to taking drug side of the present invention induces streptozotocin (STZ).
SPF level male Wistar rat, body weight 180～220g is provided by Ningxia Medical University's Experimental Animal Center.
Dosage is determined: basic, normal, high dosage group drug level is according to people and animal body surface area and the calculating of dosage scaling method.Basic, normal, high dosage group rat gives this compound recipe respectively and returns medicine 1g/kg, 2g/kg, 4g/kg.Medical material decocts 2 times according to traditional method after cultivar identification, is concentrated into respective sets dosage.
8 rats of picked at random are as the normal control group; All the other rats are behind fasting 12h, every tail vein injection is helped rhzomorph (STZ with the chain arteries and veins of 0.1M sodium citrate buffer solution (pH=4.5) preparation, 60mg/kg), the 3rd day detection blood sugar concentration behind injection STZ, to determine whether diabetes animal model successfully copies, being higher than 16.7mmol/L person with random blood sugar is the modeling success.Rat with the modeling success is divided into model control group at random again, glimepiride group, this time recurrence due to taking drug side (1g/kg) group, (2g/kg) group, (5g/kg) group.Give the normal rat forage feed, the feed of freely drinking water, every mouse cage is raised 4 rats, gives sufficient room, illumination every day 12h, 18～23 ℃ of room temperatures.4d after the modeling, each group is carried out gastric infusion.The glimepiride group gives glimepiride, 200mg/kg; Return the basic, normal, high dosage group in recurrence due to taking drug side and give this time recurrence due to taking drug side 1g/kg, 2g/kg, 4g/kg respectively; Give the equal-volume distilled water, every day 1 time, continuous 3 weeks to normal according to group and model group.Each organizes the rat Mus respectively at 3rd day and 0th, 5,10,15 day of drug treatment of injection behind the STZ, and afterbody is got blood, records the random blood sugar value of rat by blood glucose monitoring system.After administration finished, the rat broken end was got blood, and separation of serum is measured triglyceride (TG), T-CHOL (CHO), high density lipoprotein (HDL) and low density lipoprotein, LDL (LDL) in the serum with automatic biochemistry analyzer.Result: the 1. influence of the type 1 diabetes rat blood sugar that STZ is induced: with the normal control group relatively, the blood glucose value of model group rat significantly raises (P＜0.01), illustrate that modeling is successfully.And the blood glucose value of model group rat is trend of rising in time, shows that diabetes that STZ induces are along with its state of an illness of development of time increases the weight of gradually.With model group relatively, glimepiride group and this time recurrence due to taking drug side (2g/kg) group, all can obviously reduce the blood glucose value of diabetes rat after (4g/kg) group 2 weeks of administration, the blood sugar reducing function that wherein returns recurrence due to taking drug side (2g/kg) group and glimepiride group is (seeing Table 3) quite.2. the influence of the type 1 diabetes rat fat that STZ is induced: for the detection of blood lipids index, only select this time recurrence due to taking drug side optimal dose (2g/kg) group as the experiment detected object.Model group rat blood serum TG, CHO compare with the normal control group all with the LDL level and obviously raise (P＜0.01), and the HDL level obviously reduces (P＜0.01).TG, CHO and the LDL level of this time recurrence due to taking drug side (2g/kg) group rat all are starkly lower than model group, and the HDL level is higher than model group (P＜0.01).The result shows: this time recurrence due to taking drug side (2g/kg) has tangible blood fat reducing effect (seeing Table 4) to the type 1 diabetes rat.
Table 3 the present invention goes back to recurrence due to taking drug side to the influence of type 1 diabetes rat blood sugar
Compare with the normal control group,
*P＜0.01; Compare with model group,
▲P＜0.05,
▲ ▲P＜0.01.
Table 4 the present invention goes back to recurrence due to taking drug side to the influence of type 1 diabetes rat fat
Compare with the normal control group,
*P＜0.01; Compare with model group,
▲ ▲P＜0.01.
Embodiment 3
During year October in October, 2008 to 2009, choose patient's 224 examples that the diabetes that meet the Western medicine diagnose standard and include standard in merge urinary tract infection, use go back to recurrence due to taking drug side of the present invention and observe 3 courses for the treatment of continuously, and followed up a case by regular visits to 3 months, carry out baseline analysis, tcm syndrome therapeutic evaluation.
1 object of study:
Case derives from goes to a doctor in the type 2 diabetes mellitus patient of Yinchuan City institute of traditional Chinese medicine department of endocrinology outpatient service year January in January, 2006 to 2008, chooses the patient that the diabetes of clarifying a diagnosis merge urinary tract infection, male or female, age 45-75 year.
1.1 diagnostic criteria:
A. the Western medicine diagnose standard of diabetes: with reference to the standard that in November, 2003, international diabetologist committee formulated.
B. the Western medicine diagnose standard of urinary tract infection: dye diagnostic criteria with reference to the urinary tract togetherness that the academic meeting of second national nephropathy in 1985 is formulated.
1.2 include in and get rid of the case standard:
Type 2 diabetes mellitus; The outpatient service and the inpatient that meet the Western medicine diagnose standard; Age is at 45-75 between year; Conscious, the normal person of thinking and language competence; The person that is signed with the Informed Consent Form.Get rid of gestation or women breast-feeding their children; Be unwilling the partner (refer to cooperate diet control or in accordance with regulations medication and affect the treatment and safety judgement person) and psychotic; Be associated with the patient of serious primary disease such as cardiovascular, liver, kidney and hemopoietic system; Acute metabolism disorder and concurrent infection persons such as diabetic ketoacidosis were arranged in nearly January.
1.3 therapeutic evaluation standard
Carry out the evaluation of Syndrome in TCM marquis curative effect with reference to " the clinical research guideline of new Chinese medicine treatment urinary tract infection " in " the clinical research guidelines of new Chinese medicine treatment diabetes " in 2002 Ministry of Public Health " new Chinese medicine clinical research guideline " and 1993 Ministry of Public Health " new Chinese medicine clinical research guideline ".
2 research methoies
2.1 therapeutic scheme and management procedure
2.1.1 Primary Care
Diet control, exercise therapy and suitable additional heat.
2.1.2 glucose-lowering treatment
1. oral antidiabetic drug treatment: first-selected gliquidone cooperates acarbose in case of necessity.
2. insulinize: give insulinize according to the blood glucose situation.Requirement make the patient before the meal the blood glucose basic controlling in the control of 3.9-6.7mmol/L, post-prandial glycemia in 7.2-10.0mmol/L and glycolated hemoglobin control in 7.0% following level.
2.1.3 GP TH
A organizes conventional Coryza Treated by Syndrome Differentiation: on Primary Care+glucose-lowering treatment basis, carry out treatment by Chinese herbs with reference to " stranguria differentiation of symptoms and signs for classification of syndrome " in the higher medical universities and colleges teaching material " Chinese Internal Medicine " on probation in 1993, be that main formula is added and subtracted with Xiaoji Yinzi, BUZHONG YIQI TANG, ZHIBAI DIHUANG WAN, incomparable Rhizoma Dioscoreae ball etc., get medicine-feeding and go into that to add water in the earth pot an amount of, 20 minutes at a simmer of the boiled back of intense fire, extracting juice 400ml divides after morning, noon, the supper and to take for 3 times, day potion.
It is the main formula treatment that the present invention of B group goes back to recurrence due to taking drug side: on Primary Care+glucose-lowering treatment basis, Radix Et Rhizoma Nardostachyos 20g, Fructus Lycii 30g, incense drug combination (the 60g of Fructus Foeniculi, the Radix Aucklandiae, Flos Caryophylli, Herba Pogostemonis=4:3:2:1), armillaria Matsutake 10g, Semen Cuscutae 20g, Radix Et Rhizoma Rhei 10g, Aloe 16g, benefit is reported the combination (60g of Radix Ginseng, Herba Cistanches, Flos Carthami=3:2:1); Get medicine-feeding and go into that to add water in the earth pot an amount of, 20 minutes at a simmer of the boiled back of intense fire, extracting juice 400ml divides after morning, noon, the supper and to take for 3 times, day potion.
C organizes antibiotic therapy: on Primary Care+glucose-lowering treatment basis, before the drug sensitive test result report, select the little and high antibiotic of concentration in the kidney of nephrotoxicity according to clinical experience; After the drug sensitive test result report, adjust according to urine cultivation and drug sensitive test result.
2.1.4 the course for the treatment of
With 2 weeks be a course for the treatment of, observe 3 courses for the treatment of continuously, and followed up a case by regular visits to 3 months.At viewing duration, all cases must not be used the Chinese and western drugs of other blood sugar lowering and treatment urine sense except above treatment, and clinical research person and patient sign Informed Consent Form.
2.2 observation index
2.2.1 safety observation index
1. general health check-up project: pulse, breathing, heart rate, blood pressure, body temperature;
2. blood, urine, just routine test;
3. electrocardiogram, liver, kidney function test.
2.2.2 tcm syndrome index
The design diabetes merge the urinary tract infection syndrome investigation table of integrals (with reference to " the practical Chinese Internal Medicine " of " diabetic symptom scalar quantization table ", Ministry of Public Health " new Chinese medicine clinical research guideline " " the clinical research guideline of new Chinese medicine treatment urinary tract infection " in 1993 and the medium chief editor of square medicine in 1994 in 2002 Ministry of Public Health " new Chinese medicine clinical research guideline " " the clinical research guidelines of new Chinese medicine treatment diabetes ", and in conjunction with clinical report), gathered by the investigator, fill in strictly according to the facts by project and the content of application form.Its main contents are 0 week (being the first visit same day), 2 weeks, 4 weeks, 6 weeks and natural situation and the cardinal symptom sign thereof of following up a case by regular visits to 3 months respondents.
2.2.3 statistical method
Statistics is used the SPSS15.0 statistical analysis software.Because the data of this research are the orderly qualitative data of individual event, thus common X 2 test do not adopted, and adopted the Wilcoxon check of nonparametric statistics.
3. result of study
3.1 baseline analysis
Be total to MethodsThe cases enrolled 242 examples, 18 examples come off.A organizes 6 examples that come off, and B organizes 4 examples that come off, and C organizes 8 examples that come off.Include analysis totally 224 examples in, male's 54 examples, women's 170 examples.Sex composition, age distribution, body weight distribute, Syndrome in TCM marquis's integral mean value, and through X 2 test, P〉0.05, there was no significant difference has comparability.
3.2 tcm syndrome therapeutic evaluation
3.2.1 Syndrome in TCM marquis's curative effect relatively
The obvious effective rate of tcm syndrome is through X 2 test, P＜0.05, and illustrating between 3 groups has significant difference.The A group compares P＜0.01 with the B group; The C group compares P＜0.01 with the B group; The A group compares P with the C group〉0.05.Illustrate: the present invention returns recurrence due to taking drug side's group tcm syndrome obvious effective rate and other two groups comparisons, and significant difference is arranged.Total effective rate is through X 2 test, P〉0.05, there was no significant difference between 3 groups is described.See Table 5, table 6 and table 7.
Table 5 tcm syndrome curative effect is (%) relatively
Table 6 tcm syndrome obvious effective rate is (%) relatively
Table 7 tcm syndrome total effective rate is (%) relatively
3.2.2 the distribution situation (through frequency statistics) of main tcm symptom
Diabetes merge the main tcm symptom of urinary tract infection and are positioned at preceding 12 symptom of frequency distribution and are successively: urgent micturition dysurea, urine is many, nocturia, urethra scorching hot, vexed, the lazy speech of breathing hard, polyorexia, soreness of the waist and knees, headache, lumbago and backache, chest and hypochondrium, forgetful frequently.Substantially conform to the characteristics of primary disease " the evil poison of diseases caused by exogenous pathogenic factor on the internal injury basis ".
3.2.3 main tcm symptom subtracts branch efficacy analysis (through the Wilcoxon check)
The present invention returns recurrence due to taking drug side's group and the curative effect of heating, headache, nausea and vomiting all is better than routine in 2 weeks, 4 weeks, 6 weeks, when following up a case by regular visits to distinguishes and control group and western medicine group that significant difference is arranged; To urine frequently many, numb limbs and tense tendons, urgent micturition dysurea, urethra scorching hot, the urine yellow skin is red, stool is not well, the curative effect of insomnia is compared no significant difference with other two groups 2 when all, all is better than other two groups in 4 weeks, 6 weeks, when following up a case by regular visits to, and significant difference is arranged; Be better than other two groups during to 2 weeks of curative effect of thirsty polydipsia, 4 weeks, significant difference is arranged; In 6 weeks, when following up a case by regular visits to, compared no significant difference with other two groups; In 2 weeks of vexed curative effect, when following up a case by regular visits to, compared no significant difference with other two groups, be better than other two groups when 4 weeks, 6 weeks, significant difference is arranged; Compare no significant difference with other two groups during to 2 weeks of curative effect of limbs pain, 4 weeks, in 6 weeks, when following up a case by regular visits to, are better than other two groups, and significant difference is arranged; The curative effect of ureter tenderness is better than other two groups when 2 weeks, significant difference is arranged; To the curative effect of feverish sensation in the palms and soles, be better than other two groups when following up a case by regular visits to, significant difference is arranged; The curative effect of hyperhidrosis, nocturia is better than other two groups when 6 weeks, significant difference is arranged; Curative effect to soreness of the waist and knees is not so good as the western medicine group in 6 weeks, when following up a case by regular visits to.(annotate: symptom unlisted in the table is many because the baseline score value between three groups is unbalanced.）
Embodiment 4
During year August in January, 2009 to 2009, choose the type 2 diabetes mellitus nephrotic of the Ningxia Hui ethnic group 158 examples that meet the Western medicine diagnose standard and include standard in, use go back to recurrence due to taking drug side of the present invention and observed 3 months continuously, carry out baseline analysis, the relevant physico-chemical examination analysis of diabetes, tcm syndrome therapeutic evaluation.
1. object of study:
Case derives from goes to a doctor in attached Yinchuan City institute of traditional Chinese medicine of Ningxia Medical University and First People's Hospital, Yinchuan City a year August in January, 2009 to 2009, meets the Western medicine diagnose standard and includes the type 2 diabetes mellitus patient of the Ningxia Hui ethnic group of standard in, male or female, age 45-75 year.
1.1 diagnostic criteria:
A. diagnosis of diabetes is with reference to the standard of in November, 2003 international diabetologist committee formulation.That is: 1. diabetic symptom+random time plasma glucose levels 〉=11.1mmol/L; 2. fasting blood glucose level 〉=7.0mmol/L; 3. during OGTT tests, 2h blood sugar level 〉=11.1mmol/L.The patient who meets one of above-mentioned standard repeats above-mentioned inspection in another sky, namely is diagnosed as diabetes if still meet one of 3 standards person.
B. the standard drafted in 1993 with reference to CHINESE JOURNAL OF INTERNAL MEDICINE editorial board nephropathy special interest group of the diagnosis of chronic renal failure.That is: 1. endogenous creatinine clearance rate (Ccr)＜80ml/min; 2. serum creatinine (Scr)〉133 μ mol/L; The systemic disease medical history that 3. the chronic renal disease history is arranged or involve kidney.
1.2 include the case standard in:
1. all the patient is type 2 diabetes mellitus; 2. all the patient is the Hui ethnic group; 3. the outpatient service and the inpatient that meet the Western medicine diagnose standard; 4. the age is at 45-75 between year; 5. conscious, the normal person of thinking and language competence; 6. the person that is signed with the Informed Consent Form.
1.3 get rid of the case standard:
1. the age is less than 45 years old or greater than 75 years old case; 2. gestation or women breast-feeding their children; 3. be unwilling the partner (refer to cooperate diet control or in accordance with regulations medication and affect the treatment and safety judgement person) and psychotic; 4. be associated with the patient of serious primary disease such as cardiovascular, liver, kidney and hemopoietic system; 5. acute metabolism disorder and concurrent infection persons such as diabetic ketoacidosis are arranged in nearly January.
1.4 the rejecting of case and coming off
1. all cases of respectively including standard in and being included in by mistake that do not meet, though and meet the standard of including in and the case of medication not after including in, to this observation related drugs allergy sufferers, need give rejecting.2. experimenter's compliance poor, serious adverse events takes place, severe complication or special physiological variation etc. take place should not continue reception test, the case of medication etc. in accordance with regulations is not the case that comes off.Should handle in conjunction with practical situation during statistical analysis, as untoward reaction person is taken place, should add up by untoward reaction; Finished 1/2 the course for the treatment of, should add up curative effect.3. reject and expulsion rate＜20%.
1.5 termination test standard
The serious adverse reaction person is taken place in the test, should in time end test.
1.6 therapeutic evaluation standard
Reach " the clinical research guideline that new Chinese medicine is treated chronic renal failure " with reference to " the clinical research guidelines of new Chinese medicine treatment diabetes " in 2002 Ministry of Public Health " new Chinese medicine clinical research guideline " and carry out therapeutic evaluation.
2 research methoies
2.1 therapeutic scheme and management procedure
2.1.1 Primary Care
Diet control, exercise therapy and suitable additional heat.
2.1.2 glucose-lowering treatment
1. oral antidiabetic drug treatment: lotensin sheet (10mg every day 1 time oral).
2. insulinize: give insulinize according to the blood glucose situation.Requirement make the patient before the meal the blood glucose basic controlling in the control of 3.9-6.7mmol/L, post-prandial glycemia in 7.2-10.0mmol/L and glycolated hemoglobin control in 6.5% following level.
2.1.3 GP TH
A organizes (treatment group): Radix Et Rhizoma Nardostachyos 20g, and Fructus Lycii 30g, incense drug combination (60g of Fructus Foeniculi, the Radix Aucklandiae, Flos Caryophylli, Herba Pogostemonis=4:3:2:1), armillaria Matsutake 10g, Semen Cuscutae 20g, Radix Et Rhizoma Rhei 10g, Aloe 16g, benefit is reported the combination (60g of Radix Ginseng, Herba Cistanches, Flos Carthami=3:2:1); Get medicine-feeding and go into that to add water in the earth pot an amount of, 20 minutes at a simmer of the boiled back of intense fire, extracting juice 400ml divides after morning, noon, the supper and sleeps and take for preceding four times, day potion.Simultaneously oral lotensin sheet 10mg every day 1 time is oral.
B organizes (matched group): it is oral only to give lotensin sheet 10mg every day 1 time.
2.1.4 the course for the treatment of
With 4 weeks be a course for the treatment of, observe 3 courses for the treatment of continuously.At viewing duration, all cases must not use the Chinese and western drugs of other blood sugar lowering and treatment chronic renal failure, and clinical research person and patient person are signed Informed Consent Form except above treatment.
2.2 observation index
2.2.1 safety observation index
1. general health check-up project: pulse, breathing, heart rate, blood pressure, body temperature;
2. blood, urine, just routine test;
3. electrocardiogram, liver, kidney function test.
2.2.2 mainly detect index
A. on an empty stomach 2 hours after the meal blood glucose (employing glucose oxidase method), glycolated hemoglobin (adopting immune colorimetry), cholesterol (adopting the alcohol oxidase method), triglyceride (the dissociative glycerin method is gone in employing), LDL-C (adopting direct one-step method);
B. renal function detects: comprise serum creatinine, blood urea nitrogen (Hitachi's 7150 type automatic clinical chemistry analyzers are measured).
2.2.3 Syndrome in TCM marquis's index
The design diabetes merge the urinary system infection syndrome investigation table of integrals (with reference to " diabetic symptom scalar quantization table " in 2002 Ministry of Public Health " new Chinese medicine clinical research guideline " " the clinical research guidelines of new Chinese medicine treatment diabetes " and " the clinical research guideline of new Chinese medicine treatment chronic renal failure " and the medium chief editor of square medicine in 1994 " practical Chinese Internal Medicine ", chief of the Xiongnu in Acient China's moral in 2005 etc. " Hui ethnic group's medical science profound meaning " of editing, and in conjunction with clinical report), gathered by the investigator, fill in strictly according to the facts by project and the content of application form.Its main contents are 0 week (being the first visit same day), 4 weeks, 8 weeks, 12 all respondents' natural situation and cardinal symptom sign thereof.
2.3 statistical method
Statistics is used the SPSS15.0 analysis software.1. the analysis of quantitative data: meet normal distribution: variance is checked with t together; Heterogeneity of variance t ' check.Skewness distributes: data transaction or directly use nonparametric statistics.2. the comparison of rate: adopt X 2 test, accurately probabilistic method check.3. the comparison of individual event ordinal data: adopt Wilcoxon or Logistic regression analysis.
3 results of study
3.1 baseline analysis
Be total to MethodsThe cases enrolled 167 examples, 9 examples come off.A organizes 6 examples that come off, and B organizes 3 examples that come off.Include analysis totally 158 examples in, male's 73 examples, women's 85 examples.Sex composition, age distribution, body weight distribute, through X 2 test, and P〉0.05, there was no significant difference has comparability.
The physico-chemical examination therapeutic evaluation 3.2 diabetes are correlated with
3.2.1 fasting glucose (FPG), 2 hours after the meal blood glucose (2HPG) and glycolated hemoglobin (HbA1c) be (table 8) relatively:
1. result: two groups all when 12 weeks FPG descend A group: P＜0.01; B group: P＜0.05.And compare P＜0.01 between group.Illustrate: two groups all effective in cure to FPG in 12 weeks, but the curative effect for the treatment of group is better than matched group, and utmost point significant difference is arranged.
2. result: two groups of all 2HPG declines when 4 weeks and 8 weeks, and two groups equal: P＜0.05; During 12 weeks, the A group is equal with the B group: P＜0.01.Illustrate: two groups are all effective in cure to 2HPG in 4,8 and 12 weeks, but 12 when week better efficacy (P＜0.01); Curative effect compares there was no significant difference between group.
3. result: two groups all at 8 weeks and 12 HbA when all
1C descends, during 8 weeks: P＜0.05; During 12 weeks: P＜0.01.During 12 weeks, two groups are compared P＜0.01.Illustrate: two groups when 8 weeks and 12 weeks, all to HbA
1C is effective in cure, but 12 whens week better (P＜0.01); Relatively, the A group is better than B group P＜0.01 between group.
Table 8FPG, 2HPG(
Mmol/L) and HbA
1C(%) relatively
Compare with 0 week (before the treatment),
*P＜0.01; Compare between the treatment group (4 weeks, 8 weeks, 12 weeks),
▲P＜0.05,
▲ ▲P＜0.01.
3.2.2 blood fat is relatively:
The result: two groups of each time points for the treatment of back relatively reach each time point with 0 week (before the treatment) and compare for two groups, are P〉0.05.Illustrate: no matter the treatment group is self cross-reference to the curative effect of blood fat, still contrast between group, difference that there are no significant.See Table 9.
Table 9 cholesterol, triglyceride, ldl ratio (
Mmol/L)
3.2.3 serum creatinine (Scr), blood urea nitrogen (Bun) are relatively:
1. result: A group Scr when 4,8,12 weeks descends, in 4 weeks: P＜0.05, in 8 week and 12 weeks: P＜0.01; The B group is in 12 weeks: P＜0.05.And compare between group, in 8 week and 12 weeks: P＜0.01.Illustrate: the treatment group is better than matched group in the curative effect in 4,8,12 weeks, and when 8 weeks and 12 weeks utmost point significant difference is arranged.
2. result: A group is when 8 weeks and 12 weeks, and the B group descends at 12 all Bun, and A organizes in 8 weeks, and B organizes in 12 weeks: P＜0.05, and A organizes in 12 weeks: P＜0.01; During 12 weeks, the A group is equal with the B group: P＜0.01.Illustrate: A group is all effective in cure to Bun in 8 and 12 weeks, but better efficacy (P＜0.01) during 12 weeks, the B group when 12 weeks to Bun effective in cure (P＜0.01); Curative effect comparison A group is better than the B group between group.
Table 10 serum creatinine (Scr), blood urea nitrogen (Bun) relatively (
Mmol/L)
Compare with 0 week (before the treatment),
*P＜0.01; Compare between the treatment group (4 weeks, 8 weeks, 12 weeks),
▲P＜0.05,
▲ ▲P＜0.01.
3.3 tcm syndrome therapeutic evaluation:
3.3.1 the comparison of tcm syndrome total effective rate
Table 11 tcm syndrome total effective rate is (%) relatively
3.3.2 main tcm symptom subtracts branch efficacy analysis (through the Wilcoxon check)
The treatment group is better than matched group to the curative effect of heating, headache, nausea and vomiting at 4 weeks, 8 weeks, 12 Zhou Shijun, and significant difference is arranged; To urine frequently many, numb limbs and tense tendons, urgent micturition dysurea, urethra scorching hot, the urine yellow skin is red, stool is not well, the curative effect of insomnia is compared no significant difference with matched group 8 when all, is better than matched group at 8 weeks, 12 Zhou Shijun, and significant difference is arranged; Be better than matched group during to 4 weeks of curative effect of thirsty polydipsia, 8 weeks, significant difference is arranged; Compare no significant difference with matched group during 12 weeks; Vexed curative effect is compared no significant difference with matched group during 4 weeks, be better than matched group when 8 weeks, 12 weeks, significant difference is arranged; Compare no significant difference with matched group during to 4 weeks of curative effect of limbs pain, 8 weeks, 8 weeks, 12 o'clock are better than matched group, and significant difference is arranged; The curative effect of ureter tenderness is better than matched group when 4 weeks, significant difference is arranged; To the curative effect of feverish sensation in the palms and soles, be better than matched group during 12 weeks, significant difference is arranged; The curative effect of hyperhidrosis, nocturia is better than matched group when 8 weeks, significant difference is arranged; Curative effect to soreness of the waist and knees is not so good as matched group at 12 o'clock in 8 weeks.(annotate: symptom unlisted in the table is many because the baseline score value between two groups is unbalanced.）
Should be understood that, for those of ordinary skills, can be improved according to the above description or conversion, and all these improvement and conversion all should belong to the protection domain of claims of the present invention.
Claims (5)
1. recurrence due to taking drug side of returning for the treatment of diabetic nephropathy, it is characterized in that, this medicine is made by following materials of weight proportions: Radix Et Rhizoma Nardostachyos 100-500 weight portion, Fructus Lycii 160-600 weight portion, incense drug combination 200-1000 weight portion, armillaria Matsutake 60-400 weight portion, Semen Cuscutae 160-580 weight portion, Radix Et Rhizoma Rhei 40-240 weight portion, Aloe 60-360 weight portion, benefit is reported combination 360-1000 weight portion; The incense drug combination: Fructus Foeniculi, the Radix Aucklandiae, Flos Caryophylli, Herba Pogostemonis weight ratio are 4:3:2:1; Benefit is reported combination: Radix Ginseng, Herba Cistanches, Flos Carthami weight ratio are 3:2:1.
2. time recurrence due to taking drug side according to claim 1, it is characterized in that, the weight proportion of its raw material is Radix Et Rhizoma Nardostachyos 180-380 weight portion, Fructus Lycii 280-500 weight portion, incense drug combination 380-620 weight portion, armillaria Matsutake 80-220 weight portion, Semen Cuscutae 180-380 weight portion, Radix Et Rhizoma Rhei 80-220 weight portion, Aloe 140-320 weight portion, benefit is reported combination 460-740 weight portion.
3. time recurrence due to taking drug side according to claim 1 and 2, it is characterized in that, the weight proportion of its raw material is Radix Et Rhizoma Nardostachyos 200 weight portions, Fructus Lycii 300 weight portions, incense drug makes up 600 weight portions, armillaria Matsutake 100 weight portions, Semen Cuscutae 200 weight portions, Radix Et Rhizoma Rhei 100 weight portions, Aloe 160 weight portions, benefit reports combination 600 weight portions.
4. according to the application of the arbitrary described time recurrence due to taking drug side of claim 1-3 in preparation treatment medicine for treating diabetic nephropathy.
5. application as claimed in claim 4 is characterized in that diabetes are 1 type or type 2 diabetes mellitus.
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