Goal of the invention
The purpose of this invention is to provide the Chinese medicine composition that a kind of Qi-benefiting and heart-nourishing is calmed the nerves.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
Another purpose of the present invention provides the discrimination method of this Chinese medicine composition.
Summary of the invention
Medicine of the present invention is made up of effective ingredient and/or pharmaceutically acceptable excipient, and wherein said effective ingredient is to be made by the raw material of Chinese medicine of following consumption:
Radix Astragali 35-40 weight portion, Radix Ophiopogonis 15-20 weight portion, Radix Ginseng 5-10 weight portion, Poria 15-20 weight portion, Radix Rehmanniae 10-15 weight portion, Carapax et Plastrum Testudinis 5-10 weight portion, Fluoritum 25-30 weight portion, Ramulus Cinnamomi 10-15 weight portion, Herba Epimedii 15-20 weight portion, Flos Lonicerae 15-20 weight portion, Radix Salviae Miltiorrhizae 10-15 weight portion, Radix Curcumae 5-10 weight portion and Fructus Aurantii 5-10 weight portion.
Wherein the Radix Astragali and Radix Ophiopogonis are monarch drug, supplementing QI and nourishing YIN; Radix Ginseng, Poria, the Radix Rehmanniae, Carapax et Plastrum Testudinis are minister, assist monarch drug to strengthen the supplementing QI and nourishing YIN effect, and have calm the nerves only throb with fear, the spleen invigorating cardiotonic; Ramulus Cinnamomi activating YANG with pungent and warm drugs, Fluoritum are calmed the nerves and are only throbbed with fear; Radix Salviae Miltiorrhizae, Radix Curcumae, the blood stasis dispelling of Fructus Aurantii regulating qi and dredging collateral make tonify without causing stagnation, the Flos Lonicerae detoxifcation, and Herba Epimedii the lumbus strengthening and the kidney invigorating heart tonifying is the adjuvant thing.The combination of full side plays synergism jointly, have supplementing QI and nourishing YIN, calm the nerves only throb with fear, regulating the flow of QI to dissipate blood stasis, the cardiac stimulant effect of spleen invigorating.
In order to obtain optimum curative effect, more preferably the consumption of raw material of Chinese medicine is: the Radix Astragali 36 weight portions, Radix Ophiopogonis 18 weight portion, Radix Ginseng 9 weight portions, Poria 18 weight portions, Radix Rehmanniae 13 weight portions, Carapax et Plastrum Testudinis 9 weight portions, Fluoritum 26 weight portions, Ramulus Cinnamomi 13 weight portions, Herba Epimedii 18 weight portions, Flos Lonicerae 18 weight portions, Radix Salviae Miltiorrhizae 13 weight portions, Radix Curcumae 9 weight portions and Fructus Aurantii 9 weight portions.
The method of the effective ingredient of preparation medicine of the present invention can be the Radix Astragali, Radix Ophiopogonis, Radix Ginseng, Poria, Radix Rehmanniae, Carapax et Plastrum Testudinis, Fluoritum, Ramulus Cinnamomi, Herba Epimedii, Flos Lonicerae, Radix Salviae Miltiorrhizae, Radix Curcumae and the Fructus Aurantii that takes by weighing above-mentioned consumption, directly with the dry levigation of raw material of Chinese medicine difference, mixing is made powder.Also above-mentioned raw material of Chinese medicine can be extracted to make with extra care and carry or the 60-80% ethanol extraction, reclaim or concentrate, obtain as water.
The method of preferred for preparation effective ingredient of the present invention is that raw material is handled respectively: Flos Lonicerae decocts with water, filter, and filtrate for later use, Carapax et Plastrum Testudinis, Fluoritum, Radix Ginseng are smashed to pieces, decoct with water, and filter filtrate for later use; Medicinal residues and all the other Radixs Astragali etc. nine flavor decocts with water, and filters, and gained filtrate and above-mentioned filtrate are merged, and is concentrated into relative density and is 50 ℃ to survey 1.15-1.20, places room temperature, under agitation adds ethanol, makes to contain the alcohol amount and reach 65%, and cold preservation filters, and recovery ethanol obtains.
Effective ingredient of the present invention can also be made various dosage forms such as capsule, tablet, granule, oral liquid etc. with pharmaceutically acceptable excipient.
This medicine has the effect that Qi-benefiting and heart-nourishing is calmed the nerves, and can be used for treating viral myocarditis, also can treat coronary heart disease, angina pectoris or arrhythmia.Oral, a 20ml, three times on the one, 28 days is a course of treatment.
(wherein 350 examples are organized in treatment to medicine of the present invention through 500 examples, matched group 150 examples, the contrast medicine is a SHENGMAI YIN KOUFUYE, every day 3 times, each 20ml, the observation of clinical treatment viral myocarditis 4 weeks of the course of treatment), the result shows: the obvious effective rate to viral myocarditis is 40.8%, and total effective rate is 91.7%, to Electrocardiographic obvious effective rate is 25.0%, total effective rate is 66.0%, compares with matched group, and treatment group curative effect is better than matched group (P<0.01).
(wherein 100 examples are organized in treatment to medicine of the present invention, and matched group 60 examples contrast medicine and use beneficial heart oral liquid through 160 examples, every day 3 times, each 20ml, oral, around the course of treatment) clinical observation, the result shows that the total effective rate of Drug therapy coronary heart disease of the present invention is 96%, obvious effective rate is 58%, is 77% to the electrocardiogram total effective rate, and obvious effective rate is 37%, the total effective rate flavor normal to heart leak-off is 97.5%, and obvious effective rate is 80.4%.Compare with matched group, treatment group curative effect obviously is better than matched group (P<0.05).The drug effect time of the present invention is slow slightly than Western medicine coronary dilating medicine, but can effectively prevent the state of an illness repeatedly, and long-term efficacy is obvious, and has no adverse reaction.
The discrimination method of Chinese medicine composition, it comprises the following steps:
A) get Chinese medicine composition 100ml, to water-bath, be concentrated into about 20ml, extract 2 times, each 30ml with the ether jolting, abandon or adopt ether solution, extract 3 times with water saturated n-butyl alcohol jolting, each 30ml merges n-butanol extracting liquid, put and be concentrated into about 30ml in the water-bath, extract 3 times with the 40% ammonia jolting that n-butyl alcohol is saturated, each 30ml abandons or adopts alkaline solution; N-butyl alcohol liquid is recycled to dried, and residue adds methanol 2ml makes dissolving, as need testing solution; Other gets ginsenoside Rg1, Re reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; Get Radix Ginseng reference substance medical material 1g again, add chloroform 40ml, heating and refluxing extraction 1 hour, discard chloroform solution, add water 0.5ml, stir make moistening after, add water saturated n-butyl alcohol 10ml, supersound process 30 minutes is drawn supernatant, the ammonia solution that adds 3 times of amounts, shake up, place and make layering, get upper strata liquid evaporate to dryness, residue adds methanol 1ml makes dissolving, in contrast medical material solution; Thin layer chromatography test according to an appendix VIB of Chinese Pharmacopoeia nineteen ninety-five version, draw need testing solution 4ul, each 3ul of each reference substance solution and control medicinal material, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water of 65: 36: 10 is that developing solvent was placed 30 minutes, take out, placed 10 minutes in room temperature, put in the chromatography cylinder saturated 20 minutes, and launched, take out, dry, spray is with 30% ethanol solution of sulfuric acid, 105 ℃ of bakings several minutes, in the test sample chromatograph, respectively with reference substance chromatograph and the corresponding position of control medicinal material chromatograph on, show identical aubergine speckle;
B) get Chinese medicine composition 50ml, put in the separatory bucket, the 50ml jolting that adds diethyl ether is extracted, leave standstill make layering after, discard ether solution, the water saturated n-butyl alcohol jolting of reuse is extracted 2 times, each 50ml, merge extractive liquid,, reclaim n-butyl alcohol to doing, residue is with methanol 1ml dissolving, as need testing solution; Other gets the icariine reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; Thin layer chromatography test according to an appendix VIB of Chinese Pharmacopoeia nineteen ninety-five version, draw need testing solution 4ul, each reference substance solution 2ul, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water of 13: 7: 2 is developing solvent, launch, take out, airing is put under the 365nm ultra-violet lamp and is inspected; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical kermesinus speckle; Spray with the aluminum chloride test solution after, speckle becomes orange red;
C) get Chinese medicine composition 50ml, put in the separatory bucket, use ethyl acetate extraction 3 times, each 50ml, merge extractive liquid, reclaims ethyl acetate to doing, and residue adds methanol 1ml makes dissolving, as need testing solution; Other gets the protocatechualdehyde reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the thin layer chromatography test of an appendix VIB of Chinese Pharmacopoeia nineteen ninety-five version, draw need testing solution 3ul, reference substance solution 2ul, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetates of 40: 25: 4-formic acid is developing solvent, take out, airing, spray is with 3% ferric chloride ethanol liquid; In the test sample chromatograph, with reference substance chromatograph and the corresponding position of reference substance chromatograph on, show identical blue spot;
D) the accurate Chinese medicine composition 10ml that draws, put in the separatory bucket, add water 10ml, extract 2 times with the ether jolting, each 20ml discards ether solution, and water layer extracts 5 times with water saturated 1: 3 n-butyl alcohol-ethyl acetate jolting, each 20ml, merge extractive liquid, is waved the solvent that looses to doing, and residue adds 20% ethanol 2ml makes dissolving, be added on the D101 type macroporous resin column of the 10g internal diameter 2cm that handled well in advance and column length 30cm, use 20% ethanol elution, collect eluent 150ml, put evaporate to dryness in the water-bath, residue is with the mixed liquor 2ml dissolving of 4: 1 methanol-water, as need testing solution; Precision takes by weighing chlorogenic acid reference substance 2.5mg, puts in the 5ml measuring bottle, with dissolve with methanol and be diluted to scale, makes solution that every 1ml contains 0.5mg product solution in contrast; Thin layer chromatography test according to an appendix VIB of Chinese Pharmacopoeia nineteen ninety-five version, accurate reference substance solution 2ul and 4ul, the need testing solution 1ul of drawing, put respectively on same silica gel g thin-layer plate, upper solution with butyl acetate-formic acid of 14: 5: 5-water is developing solvent, put in the chromatography cylinder saturated 30 minutes, and launched, take out, dry, put under the 365nm ultra-violet lamp and inspect the location; Thin layer chromatography scanning with an appendix VIB of Chinese Pharmacopoeia nineteen ninety-five version scans ,=330nm, and=210nm, the every 1ml of mensuration Chinese medicine composition contains chlorogenic acid and must not be less than 0.12mg.
Specific embodiment
Embodiment 1: the preparation of oral liquid
Take by weighing Radix Astragali 180g, Radix Ophiopogonis 90g, Radix Ginseng 45g, Poria 90g, Radix Rehmanniae 65g, Carapax et Plastrum Testudinis 45g, Fluoritum 130g, Ramulus Cinnamomi 65g, Herba Epimedii 90g, Flos Lonicerae 90g, Radix Salviae Miltiorrhizae 65g, Radix Curcumae 45g and Fructus Aurantii 45g, Flos Lonicerae decocts with water twice, each 40 minutes, filter merging filtrate, filtrate for later use, Carapax et Plastrum Testudinis, Fluoritum, Radix Ginseng are smashed to pieces, decoct with water 1.5 hours, filter filtrate for later use; Nine flavors such as medicinal residues and all the other Radixs Astragali decoct with water 3 times, and 1.5 hours for the first time, second and third time was 1 hour, filter, merging filtrate merges with above-mentioned filtrate, and being concentrated into relative density is 50 ℃ of survey 1.15-1.20, place room temperature, under agitation add ethanol, make to contain alcohol amount and reach 65%, cold preservation 48 hours, filter, reclaim ethanol, cold preservation 7 days filters, filtrate adds polyoxyethylene sorbitan monoleate 2.0g, potassium sorbate 1.5g, an amount of sweeting agent, adding distil water be to 1000ml, mixing, fill, trade name claim stilbene winter chin or cheek heart oral liquid again.
Embodiment 2: the preparation of tablet
Take by weighing Radix Astragali 180g, Radix Ophiopogonis 90g, Radix Ginseng 45g, Poria 90g, Radix Rehmanniae 65g, Carapax et Plastrum Testudinis 45g, Fluoritum 130g, Ramulus Cinnamomi 65g, Herba Epimedii 90g, Flos Lonicerae 90g, Radix Salviae Miltiorrhizae 65g, Radix Curcumae 45g and Fructus Aurantii 45g, Flos Lonicerae decocts with water twice, each 40 minutes, filter merging filtrate, filtrate for later use, Carapax et Plastrum Testudinis, Fluoritum, Radix Ginseng are smashed to pieces, decoct with water 1.5 hours, filter filtrate for later use; Nine flavors such as medicinal residues and all the other Radixs Astragali decoct with water 3 times, and 1.5 hours for the first time, second and third time was 1 hour, filter, merging filtrate merges with above-mentioned filtrate, being concentrated into relative density is 50 ℃ of survey 1.15-1.20, places room temperature, under agitation adds ethanol, make to contain alcohol amount and reach 65%, cold preservation 48 hours filters, reclaim ethanol, be condensed into thick paste, add starch and granulate, add magnesium stearate, tabletting, coating.
Embodiment 3: the preparation of powder
Take by weighing Radix Astragali 180g, Radix Ophiopogonis 90g, Radix Ginseng 45g, Poria 90g, Radix Rehmanniae 65g, Carapax et Plastrum Testudinis 45g, Fluoritum 130g, Ramulus Cinnamomi 65g, Herba Epimedii 90g, Flos Lonicerae 90g, Radix Salviae Miltiorrhizae 65g, Radix Curcumae 45g and Fructus Aurantii 45g, wherein Carapax et Plastrum Testudinis is scalded system, with the Fluoritum calcine, with the Fructus Aurantii parch, distinguish drying and crushing then, mix homogeneously is made powder.
The clinical treatment of test example 1 traditional Chinese medicine composition for treating viral myocarditis of the present invention is summed up
Case is selected
One, Western medicine diagnose standard:
(1) be foundation according to 1987 " national myocarditis cardiomyopathy symposium summary " about " adult's acute viral myocarditis diagnosis reference standard (draft) ", standard is as follows:
(1) in upper respiratory tract infection, 1-3 in week behind the viral infection such as diarrhoea, or heart performance (increasing pericardial friction rub, the phase galloping horse rate etc. that rises of relaxing as heart) appearred in acute stage;
(2) 1-3 in week after the above-mentioned infection, or morbidity various arrhythmia occur simultaneously with heart sympton, and following ECG change person does not appear obeying antiarrhythmic drug:
A. atrioventricular block, a left side or right bundle branch block fully;
B.2 the S-T section of leading more than is horizontal type or drops or the declivity type moves down>0.05mv, or a plurality of S-T of leading section is raised unusually or the person that has the abnormality Q wave;
C. take place frequently, multiform, multi-source, in pairs or concurrency premature beat, short battle array or paroxysmal supraventricular tachycardia or chamber speed, flutter or vibration etc.;
D.2 above with the R ripple be that the T ripple that leads of main ripple is inverted, smooth or reduction<R ripple 1/10;
E. take place frequently room morning or chamber morning (referring to per minute>6 time person).
Possess that any one can be diagnosed as viral myocarditis among the a.b.c.Possess d or e, or do not have obvious viral infection person, replenish one of following index person to help diagnosis: 1. left chamber function weaken (confirming) through noninvasive test 2. myocardial enzymes (CPK, I.OH, GOT) 2 raisings are arranged.
(3) with good conditionsily should carry out etiological examination;
Look into just, pharynx wipes away and isolates COxsackie or other virus.Several driving in the wrong direction can be measured by the serum neutralizing antibody, or the enzyme mark detects myocarditis serum I GC specific antibody titer mensuration, the homologous virus antibody titer raises 4 times (serum should be separated by more than 2 weeks) than first part of serum or titre>640 are positive first in all serum, and 300 is suspicious.
(2), children virus myocarditis Western medicine diagnose standard: (with reference to the standard of nineteen eighty-threes nine provinces and cities myocarditis cooperative groups modification).As follows:
(1) clinical diagnosis foundation:
Leading indicator:
A. acute and chronic cardiac insufficiency or cardio-cerebral syndrome;
B., the performance of gallop rhythm or pericarditis is arranged;
C. cardiac dilatation;
D. electrocardio illustrates tangible arrhythmia, or the S-T except that standard I II leads changes, for three days on end more than, or the exercise test positive etc.
Less important index
A. morbidity while or 1-3 had medical histories such as upper respiratory tract infection, diarrhoea before week;
B. obviously weak, pale, hyperhidrosis, cardiopalmus, breathe hard, symptom such as uncomfortable in chest, dizzy, precordial pain, hands and feet coolness and myalgia, at least two kinds.The baby can refuse milk, cyanosis, agitation, extremity cold, and eyes are stared etc.;
C. the apex first heart sound is low blunt, or tachycardia is arranged when quiet;
D. electrocardiogram mile abnormality;
E. the course of disease can have serum creatine phosphokinase (CPK) 100u or other isozyme (CPK-MB type) Su in early days, serum glutamic oxalacetic transaminase (AST)>100u, lactic acid dehydrogenase (LOH) 540u or isozyme (LOH1-5) or LOH1 increases or change such as LOH1: LOH2>1.Antimyocardial antibody+-++ and dynamic change is arranged.
(2) nosetiology is identified
A. go out virus from infant feces, throat swab or blood separation, and in the convalescent serum homologous virus neutralizing antibody (or hemagglutination inhibition antibody) titre raise than first part or descend 4 by more than.
B. from infant paracentesis pericardii liquid, pericardium, cardiac muscle or endocardium isolated viral, or specificity fluorescent antibody is checked positive.
(3) make a definite diagnosis condition
A. have two of 1 of two of clinical leading indicators or clinical leading indicator and less important indexs (all requiring to have the electrocardiogram index), but clinical diagnosis is a myocarditis;
B. possess nosetiology simultaneously and find that one of (a) and (b) bar person is diagnosable for viral myocarditis.The myocarditic while is taking place, and there is obvious viral infection in other system of health but unconditionally does viral segregator, can consider to be diagnosed as viral myocarditis in conjunction with medical history.
C. all do not possess above condition clinically, but suspect to be myocarditis clinically, and can be used as " dubiety myocarditis " carries out long term follow-up;
D. other cardiovascular disease except.
Two, tcm diagnosis, dialectical standard
(1) traditional Chinese medical science medical diagnosis on disease standard
According to the high traditional Chinese medical science in whole nation universities and colleges current teaching materials internal medicine (version in 1985) clear and definite tcm diagnosis and dialectical.Press new drug (Chinese medicine) treatment viral myocarditis clinical research guideline, can be divided into: evil poison is invaded heart card, evil sad YIN syndrome, syndrome of deficiency of both qi and yin, deficiency syndrome of both YIN and YANG.
(2) function of Chinese medicine composition cures mainly according to the present invention, selects following patient:
1. tcm diagnosis: all to have cardiopalmus be primary symptom, and have tired, breathe hard, uncomfortable in chest, pained, vexed, hectic fever, spontaneous perspiration or night sweat, light red tongue, few tongue, thready and rapid pulse without strength or knot for the person, can be diagnosed as severe palpitation---syndrome of deficiency of both qi and yin.
2. select:
(1) the inclined to one side syndrome of deficiency of QI of deficiency of both QI and YIN: disease see cardiopalmus, tired, breathe hard, uncomfortable in chest, heat in the hands and feet, indigestion and loss of appetite, spontaneous perspiration, shallow complexion, light red tongue, deep-thready pulse, deep and slow or knot, generation, puckery person;
(2) the inclined to one side yin deficiency syndrome of deficiency of both QI and YIN: disease see cardiopalmus, tired, breathe hard, uncomfortable in chest, insomnia, dreaminess, hectic fever, night sweat, vexed, pale complexion, red tongue or light red, thready and rapid pulse or short person.
(3) the deficiency of both QI and YIN blood stasis syndrome of holding concurrently: see cardiopalmus, tired, breathe hard, uncomfortable in chest or pained, hectic fever, dim complexion or two eyelets are dark, or skin is dry and astringent, light red tongue is latent blue or green or ecchymosis arranged, weak pulse, puckery, dazzle, tie, for etc.
Three, clinical stages and typing:
(1) clinical stages
A. acute stage: New Development disease person, clinical symptoms is obviously changeable, and the course of disease is more than 6 months;
B. convalescent period: clinical symptoms and electrocardiogram can take a turn for the better gradually, but recovery from illness as yet, the course of disease is generally more than 6 months;
C. lag phase: clinical symptoms occurs repeatedly, and electrocardiogram and X line change protracted course of disease, and lab testing has the active performance of the state of an illness, and the course of disease is more than 1 year;
D. chronic phase: carrying out property cardiac enlargement or heart failure repeatedly, the course of disease is more than 1 year.
E. sequela: clinical non-evident sympton, but leave more stable electrocardiographic abnormality, as a chamber or the conduction block of bundle branch, the premature beat and the boundary property rhythm of the heart etc.
(2) Clinical typing:
A. light-duty: as can not have tangible subjective symptoms, after flu, chance on premature beat, or have the several ST-T that lead of the property a crossed electrocardiogram to change.Have the symptom to show based on weak, secondly for hyperhidrosis, pale, cardiopalmus, breathe hard, dizziness, inappetence etc.Check visible pale complexion, the lip pastiness, apex first bass is low blunt, occurs I level or II level blowing systolic murmur sometimes, can change with preceding contraction or I °, II ° atrioventricular block or slight ST-T.
B. medium-sized: light-dutyer person is few, and onset is more anxious, and is weak more outstanding except that aforementioned symptom is heavier, and precordial pain can be arranged.That the hurried person of onset can accompany is nauseating, vomiting, refusing to eat.Check common heart rate soon or slow excessively, or uneven, the tachypnea that has, agitation is heavier, lip green grass or young crops, hear sounds is low, and wind sample systolic murmur appears in apex, and gallop rhythm and various arrhythmia can be arranged.Blood pressure is low, and pulse pressure difference lowers, and rale appears in the pulmonary that has, and liver has increase in various degree.
C. heavy: still less.Be fulminant type.Onset is hurried, and functional defect appears in a few hours to 1,2 hours, or very fast generation cardiogenic shock.The patient feels that extreme is weak, dizzy, irritated, suffers from abdominal pain, vomits, the dyspnea that has, and precordial pain, or constriction, the big fellow is dripping, and skin is clammy.Then refusing to eat of baby, cry and scream, brothers' cold, weakness, dyspnea.Greyish white, the lip cyanosis of infant complexion is seen in inspection, extremity cold, the finger toe cyanosis that has, thready and weak pulse in addition touch less than, blood pressure is low, and pulse pressure is low, or does not detect blood pressure, hear sounds is extremely blunt, first heart sound almost be can't hear, and blowing systolic murmur appears in apex, audible and gallop rhythm, tachycardia is crossed slow or uneven.How heart does not increase in a short time, severe arrhythmia may occur, and rale appears in the pulmonary that has, and liver increases rapidly, tenderness can be arranged, the generation acute left heart failure that has, pulmonary edema, the state of an illness develops rapidly, can die from severe arrhythmia in a few hours or a few days, shock or pulmonary edema.As rescue in time, correct, many infants can comparatively fast take a turn for the better, escape danger after a few days to several months, and part recovery from illness later on, arrhythmia takes place in a part often, and a part transfers to chronic or stays sequela.
Four, include in exclusion standard
Include standard in:
(1) case select to meet above-mentioned in, the Western medicine diagnose standard.All viral myocarditis that is diagnosed as, with the part patient with slight symptoms of acute stage, and to meet Chinese medical discrimination be that deficiency of both QI and YIN is main case convalescent period, lag phase, chronic phase, sequela kind, and the part disease person that holds concurrently, and all can include in as observing case.
(2) exclusion standard: all increased in acute viral myocarditis are heart failure, severe arrhythmia, companion's hyperpyrexia person again.Hyperthyroidism, the B function of receptors is hyperfunction and rheumatic myocarditis, toxic myocarditis, coronary heart disease, connective tissue disease in other disease of influence cardiac muscles such as metabolic disease, all merging are serious protopathy person such as cerebrovascular, liver, kidney, hemopoietic system again; All not medications in accordance with regulations can't be judged that curative effect and data are not congruent to affect the treatment, or safety judgement person; All babies, gestation or women breast-feeding their children person all do not classify the object of observation as.
According to above standard, this group case all meets the diagnosis of viral myocarditis in the adaptation disease of this clearly demarcated Chinese medicine composition.
Physical data
This group case, outpatient service 118 examples, inpatient's 385 examples.Xiyuan hospital 60 examples wherein, Jilin Prov. Inst. of Chinese Medicine and Chinese Medical Science 110 examples, Changchun institute of traditional Chinese medicine 120 examples, Bethune medical university internal medicine 120 examples, department of pediatrics 60 examples, Jilin Hospital, Air Force, P.L.A.'s 30 examples amount to 500 examples.
1. sex
Table 1
| Add up to | The man | The woman | Man: woman | X
2 | P |
Treatment group matched group | 350 150 | 133 71 | 217 79 | 1∶1.63 1∶1.11 | 3.79 | >0.05 |
As can be seen from Table 1: no significant difference between two groups of sexes (P>0.05).Illustrate that it all is isostatic that treatment is organized in the matched group sex.
2. age
Table 2 age distribution (example)
P | Add up to | <5 years old | 5-9 year | 10-19 year | 20-29 year | More than 30 years old | X
2 |
The treatment group | 350 | 3 | 25 | 58 | 82 | 182 | |
Matched group | 150 | 2 | 16 | 34 | 31 | 67 | 5.43 | >0.05 |
As can be seen from Table 2: age distribution equilibrium between two groups (P>0.05).Treatment group minimal ages 2 years old, maximum 70 years old age, 23.9 years old mean age; Matched group age minimal ages 4 years old, maximum 65 years old age, 26.6 years old mean age.
3. Clinical typing
Table 3 state of an illness clinical distribution (example)
| Add up to | Gently | In | Heavy | X
2 | P |
1 matched group is organized in treatment | 350 150 | 195 87 | 121 52 | 34 11 | 0.76 | >0.1 |
As can be seen from Table 3: no significant difference (P>0.1) on the severity extent between two groups illustrates that severity extent is isostatic between two groups.
4. clinical stages
Table 4 clinical stages distribution
| Add up to | Acute stage | Convalescent period | Lag phase | Chronic phase | Sequela | X
2 | P |
5 matched groups are organized in treatment | 350 150 | 125 70 | 103 38 | 80 29 | 34 8 | 8 5 | 7.31 | >0.0 |
As can be seen from Table 4: do not have explicitly difference (P>0.05) between two groups by stages, illustrate between two groups to be isostatic on clinical stages.
5. Chinese medical discrimination:
The table 5 liang group dialectical comparison of traditional Chinese medical science deficiency of both QI and YIN (example)
| Add up to | The inclined to one side deficiency of vital energy | The inclined to one side deficiency of YIN | The double stasis of blood | X
2 | P |
The treatment group | 350 | 178 | 98 | 74 | 4.55 | >0.1 |
Matched group | 150 | 74 | 54 | 22 | | |
As can be seen from Table 5: there was no significant difference (P>0.1) between Chinese medical discrimination between two groups illustrates that the disease distribution between two groups is isostatic
6. the course of disease
Table 6 course of disease distribution (example)
| Add up to | <January | The 1-6 month | June-1 year | 1-2 | >2 years | X
2 | P |
Treatment group matched group | 350 150 | 69 29 | 56 41 | 103 38 | 65 22 | 57 20 | 8.99 | >0.05 |
As can be seen from Table 6: the traditional Chinese medical science course of disease compares there was no significant difference (P>0.05) between two groups, illustrates that the course of disease distribution between two groups is isostatic substantially.
Therapeutic Method
This organizes 500 examples, is divided into treatment group 350 example and matched group 150 examples at random, all uses oral liquid treatment for two groups, and its packing stasis of blood outward appearance is all consistent.With blind method drug treatment.
One, treatment group: 350 examples, oral Chinese medicine composition oral liquid of the present invention (Tonghua, Jilin Bai Shan pharmaceutical factory produces, lot number 9212101), 20ml, every day 3 times, 4 weeks of the course of treatment.
Two, matched group: 150 examples, oral SHENGMAI YIN KOUFUYE, (pharmacy two factories in Changbai produce, lot number 9221002), 20ml, every day 3 times, 4 weeks of the course of treatment.
According to clinical experiment plan requirement, fill in summary sheet in detail, recording ecg, blood, urine is index inspections such as routine, blood pressure, erythrocyte sedimentation rate, CPK, LOH, GOT, cardiac function, liver function, renal function, Chest X-rays, Color Sonography just, and some cases is done the serum-virus antigen titration.
Therapeutic outcome
One, efficacy assessment standard:
Reference<new Chinese medicine clinical research guideline〉evaluate curative effect.
(1) comprehensive therapeutic effect evaluation criteria
1. clinical recovery: clinical symptoms and sign disappear, and the X line shows that heart does not have expansion, and color ultrasound is shown each chamber of heart all in normal range, and ECC shows normal ECG, and other experimental check is no abnormal.
2. produce effects: clinical symptoms and sign are clearly better, and the premature beat of electrocardio diagram disappears in more than 80%.
3. effective: clinical symptoms and sign take a turn for the better, and the premature beat of electrocardio diagram disappears between the 50-80%.
4. invalid: clinical symptoms and sign do not have improvement, and the premature beat of electrocardio diagram disappears in below 50% for a short time or in the more preceding increase by 30%, other physics and chemistry and experimental check do not have significant change.
5. increase the weight of: symptom, sign and physico-chemical examination, before increase the weight of.
(2) ECG curative effect criterion:
1. produce effects: electrocardiogram returns to " roughly normal " (i.e. " normal range ") or reaches " normal ECG ".Or premature beat reduces more than 80%.
2. effective: the reduction of S-T section, more than the treatment back rise 0.05mv, but do not reach normal level, shoal at the negative T wave that mainly leads (reaching 25% above person) or T ripple become uprightly chamber or intraventricular block improver by smooth.Or premature beat disappears between the 50-80%.
3. do not have change: electrocardiogram is preceding identical with treatment substantially.Or premature beat disappears in below 50%.
4. increase the weight of: the ST section reduces more than the 0.05mv before the treatment, deepens (reaching more than 25%) at the negative T wave that mainly leads, or ectopic cardiac rhythm, atrioventricular block or intraventricular block, or the more preceding increase of premature beat is more than 30%.
According to difference tracing study June-1 year by stages.
(3) clinical therapeutic effect of syndrome criterion
According to: " integration method of Syndrome in TCM " puts question to unified statement, the symptom that all patients initiatively say, and again obviously or continued to occur being designated as (++ ++) 9 minutes; The symptom that the doctor gets by symptom significantly or continue to occur was designated as (+++) 6 minutes; Heavy or be interrupted and occur when light during symptom, be designated as (++) 3 minutes; Mild symptoms or appearance once in a while were designated as (+) 1 minute; Asymptomatic, be designated as (-) 0 minute.Inspection and pulse-taking heavily have any one and are designated as 6 fens.
1. clinical recovery: treatment back symptom and sign disappearance.
2. produce effects: treatment back symptom integral value descends 2/3.
3. effective: between the treatment back symptom integral value decline 1/3-2/3.
4. invalid: treatment back symptom integral value descends<1/3.
(4) statistical procedures as a result:
The above criterion of therapeutical effect of a tree name, the analytical test result to continuous data, carries out the t check, to enumeration data, carries out the X check, rank test, earlier with the Ridit check, the significance test of reuse rate is checked with u-test to clinical observation on the therapeutic effect.Draw the final conclusion of clinical observation then.
Two, result of the test
(1) clinical observation curative effect sees table 7-17 for details.
Table 7 liang group general curative effect is (example) relatively
| Add up to | Produce effects (%) | Effectively (%) | Invalid (%) | Increase the weight of (%) | Total effective rate % | u | P |
Treatment group matched group | 350 150 | 143(40.8) 26(17.3) | 178(50.9) 74(49.3) | 29(8.3) 49(32.7) | 0 1(0.7) | 91.7 66.7 | 6.46 | <0.01 |
As can be seen from Table 7: analyze through Ridit, get curative effect between two groups relatively by utmost point significant difference P<0.01.Illustrate that treatment group curative effect obviously is better than matched group.
Table 8 liang group Chinese medical discrimination curative effect relatively
Dialectical | Group | Add up to | Produce effects | Effectively | Invalid | Increase the weight of | Total effective rate | U | P |
The inclined to one side deficiency of vital energy | Treatment group matched group | 178 74 | 77 12 | 86 38 | 15 24 | 0 0 | 91.5 67.5 | 4.80 | <0.01 |
The inclined to one side deficiency of YIN | Treatment group matched group | 98 54 | 45 13 | 44 23 | 9 18 | 0 0 | 90.8 66.7 | 3.36 | <0.01 |
The double stasis of blood | Treatment group matched group | 74 22 | 21 1 | 48 13 | 5 7 | 0 1 | 93.2 63.6 | 2.93 | <0.01 |
As can be seen from Table 8: analyze: utmost point significant difference (p<0.01) is arranged between the Chinese medical discrimination curative effect between two groups through Ridit.On traditional Chinese medical science deficiency of both QI and YIN is dialectical, get curative effect in conjunction with clinical statement treatment group and all be better than matched group.
Table 9 liang group symptoms and therapeutic effect relatively
| Curative effect | Cardiopalmus | Uncomfortable in chest | Breathe hard | Weak | Dizzy | Pharyngalgia | Perspire | Cyanosis | Poor appetite | Pained | Vexed | Heating |
Treatment group n=350 | Total routine digital display effect enabledisable total effective rate (%) | 331 195 119 17 94.9 | 334 229 90 15 95.5 | 330 215 96 19 94.2 | 343 215 105 23 93.3 | 169 118 41 10 94.12 | 164 118 28 18 89.0 | 184 128 44 12 93.5 | 26 16 6 4 84.6 | 201 129 51 21 89.6 | 207 146 43 18 91.3 | 208 154 39 15 92.8 | 50 43 6 1 98.0 |
Matched group n=150 | Total routine digital display effect enabledisable total effective rate (%) | 131 41 61 29 81.6 | 136 58 50 28 79.4 | 132 58 48 26 80.3 | 141 72 45 24 83.0 | 61 39 12 10 83.6 | 54 39 8 7 87.0 | 59 47 6 6 89.8 | 9 6 0 3 66.7 | 76 40 22 14 81.6 | 84 54 8 22 73.8 | 65 38 15 9 81.1 | 29 27 1 1 96.6 |
| U p | 5.56 <0.0 1 | 6.28 <0.0 1 | 4.17 <0.01 | 2.54 <0.05 | 1.01 >0.05 | 0.03 >0.05 | 0.96 >0.05 | 0.11 >0.05 | 1.69 >0.05 | 1.45 >0.05 | 2.54 <0.05 | 0.51 >0.05 |
As can be seen from Table 9: analyze and u-test through Ridit, between two groups to cardiopalmus, uncomfortable in chest, breathe hard, weak, vexed there were significant differences (p<0.05, bright in conjunction with clinical theory+9-, the treatment group to cardiopalmus, uncomfortable in chest, breathe hard, weak, vexed doing well,improving is better than matched group.
The comparison of table 10 liang group sign curative effect
Group | The treatment group | Matched group | u | p |
Sign | The example number | Produce effects | Effectively | Invalid | Increase the weight of | Total effective rate (%) | The example number | Produce effects | Effectively | Invalid | Increase the weight of | Total effective rate (%) | | |
Hole | 69 | 38 | 28 | 3 | 0 | 95.4 | 38 | 15 | 9 | 8 | 6 | 68.4 | 2.66 | < |
Tachycardia | | | | | | | | | | | | | 0.01 |
Sinus bradycardia | 19 | 10 | 9 | 0 | 0 | 100.0 | 11 | 4 | 4 | 3 | 0 | 72.7 | 1.33> 0.05 |
Gallop rhythm | 12 | 9 | 1 | 2 | 0 | 83.3 | 7 | 3 | 4 | 0 | 0 | 100.0 | 0.82> 0.05 |
Pericardial friction rub | 7 | 6 | 1 | 0 | 0 | 100.0 | 2 | 1 | 0 | 1 | 0 | 50.0 | 0.44> 0.05 |
Pharyngeal hyperemia | 202 | 174 | 22 | 6 | 0 | 92.1 | 60 | 21 | 29 | 10 | 0 | 88.8 | 6.06< 0.01 |
Tonsillitis | 80 | 70 | 9 | 1 | 0 | 98.8 | 19 | 15 | 2 | 2 | 0 | 89.5 | 0.65> 0.05 |
Pale complexion | 106 | 81 | 10 | 13 | 1 | 86.7 | 38 | 7 | 19 | 12 | 0 | 68.4 | 5.07> 0.05 |
Acra is sent out cold | 53 | 40 | 10 | 3 | 0 | 94.3 | 16 | 4 | 5 | 6 | 1 | 56.2 | 3.48< 0.01 |
Hypotension | 41 | 33 | 6 | 2 | 0 | 95.1 | 8 | 5 | 1 | 2 | 0 | 75.0 | 0.94> 0.05 |
{<90/ 60MH g} | | | | | | | | | | | 0 | | |
The lip dark purple | 21 | 15 | 5 | 1 | 0 | 95.2 | 9 | 6 | 0 | 3 | 0 | 66.7 | 0.55>0 .05 |
Shallow complexion | 76 | 51 | 11 | 14 | 0 | 84.2 | 17 | 11 | 3 | 3 | 0 | 82.4 | 0.11>0 .05 |
Dim complexion | 32 | 18 | 10 | 4 | 0 | 87.5 | 16 | 6 | 5 | 5 | 0 | 68.8 | 1.17>0 .05 |
Skin is dry and astringent | 48 | 30 | 8 | 10 | 0 | 79.2 | 12 | 5 | 4 | 3 | 0 | 75.0 | 0.96>0 .05 |
Ventricular premature contraction | 115 | 76 | 33 | 6 | 0 | 91.8 | 48 | 22 | 10 | 15 | 1 | 66.7 | 2.68<0 .01 |
Artrial premature beat | 12 | 6 | 5 | 1 | 0 | 91.7 | 5 | 1 | 2 | 2 | 0 | 60.0 | 5.27<0 .01 |
As can be seen from Table 10: analyze and u-test through Ridit, between two groups in sinus tachycardia, pharyngeal hyperemia, acra are sent out cold, there were significant differences in the ventricular premature contraction aspect (p<0.01), improving sinus tachycardia in conjunction with clinical statement treatment group, pharyngeal hyperemia, acra are sent out cold, ventricular premature contraction aspect curative effect is better than matched group.
Table 12 a liang group electrocardiogram improves curative effect relatively (example)
| Add up to | Produce effects (%) | Effectively (%) | Invalid (%) | Increase the weight of (%) | Total effective rate % | U | p |
Treatment group matched group | 312 143 | 78(25.0) 23(16.0) | 12(41.0) 49(34.3) | 95(30.4) 63(44.1) | 11(3.5) 8(5.6) | 66.0 50.3 | 3.05 | <0.01 |
350 examples are organized in treatment, wherein normal person's 38 examples, matched group 150 examples, wherein normal person's 7 examples.As can be seen from Table 12: analyze and u-test through Ridit, ECG curative effect has utmost point significant difference (p<0.01) between two groups, illustrates that it is excellent that the treatment group is improved treatment than the matched group electrocardiogram.
Table 13 liang group electrocardiogram I atrioventricular block curative effect relatively
| Add up to | Cure | Effectively (%) | Invalid (%) | Total effective rate (%) | U | p |
Treatment group matched group | 32 7 | 19(59.4) 3(42.9) | 3(9.4) 1(14.2) | 10(31.2) 3(42.9) | 68.8 57.1 | 0.667 | >0.05 |
As can be seen from Table 13: analyze and u-test through Ridit, two groups to electrocardiogram I atrioventricular block curative effect thing significant difference p>0.05.
The variation of table 14 liang group special examined index
Group | | Routine number is increased in white score | Antiviral antibody increases routine number | Myocardium enzyme changes routine number | Chest X-rays cardiac enlargement example number |
The treatment group | Treatment back total effective rate (%) before the treatment | 50 16 68.0 | 99 25 74.7 | 130 20 84.6 | 21 0 100 |
Matched group | Treatment back total effective rate (%) X P before the treatment | 30 5 88.1 3.44 >0.05 | 16 10 37.5 22.96 <0.01 | 54 19 64.8 3.34 >0.05 | 9 4 55.6 1.51 >0.05 |
As can be seen from Table 14: credit is analysed by statistics, the changing matter significant difference (p>0.05) of score in vain between two groups, myocardium enzyme, cardiac enlargement example number, but the variation of antiviral antibody has utmost point significant difference (p<0.01), illustrate the treatment group than matched group improve antiviral antibody increase aspect curative effect for well.
The course of disease | | Total routine number | Produce effects (%) | Effectively (%) | Invalid (%) | Increase the weight of (%) | U | p |
January | Treatment group matched group | 69 29 | 41(59.4) 5(17.2) | 24(31.8) 14(48.3) | 4(5.8) 9(31.0) | 0 1(3.5) | 4.03 | <0.01 |
The 1-6 month | Treatment group matched group | 56 41 | 33(58.9) 11(26.8) | 18(32.2) 17(41.5) | 5(8.9) 13(31.7) | 0 0 | 3.25 | <0.01 |
June-1 year | Treatment group matched group | 103 38 | 27(26.2) 7(18.4) | 69(61.0) 20(52.6) | 7(6.8) 11(29.0) | 0 0 | 2.15 | <0.05 |
1-2 | Treatment group matched group | 65 22 | 19(29.2) 1(4.54) | 43(66.2) 12(54.54) | 3(4.6) 9(40.90) | 0 0 | 3.45 | <0.01 |
>2 years | Treatment group matched group | 57 20 | 23(40.4) 2(10.0) | 24(42.1) 11(55.0) | 10(17.5) 7(35.0) | 0 0 | 1.12 | >0.05 |
As can be seen from Table 15: analyze and u-test through Ridit, remove the course of disease greater than 2 years groups, treat outside contrast curative effect zero difference (p>0.05), the course of disease and curative effect relatively have utmost point significant difference (p<0.01) between surplus group.In conjunction with clinical statement, the curative effect that each course of disease is organized in treatment is better than matched group.
The table 16 liang group age is in the comparison of curative effect
Age | | Total routine number | Produce effects (%) | Effectively (%) | Invalid (%) | Increase the weight of (%) | U | p |
<5 years old | Treatment group matched group | 3 2 | 2(66.7) 1(50.0) | 1(33.3) 0 | 0 0 | 0 (50.5) | 0.63 | 0.05 |
5-9 year | Treatment group matched group | 25 16 | 11(44.0) 4(25.0) | 12(48.0) 7(43.8) | 2(8.0) 5(31.2) | 0 0 | 1.65 | >0.05 |
10-19 year | Treatment group matched group | 58 34 | 20(35.6) 8(23.5) | 34(57.6) 14(41.2) | 4(6.8) 12(35.3) | 0 0 | 2.31 | <0.05 |
20-29 year | Treatment group matched group | 82 31 | 35(42.7) 5(16.1) | 39(47.6) 18(58.1) | 3(9.8) 8(25.8) | 0 0 | 3.07 | <0.01 |
More than 30 years old | Treatment group matched group | 182 67 | 75(41.2) 9(13.4) | 92(50.5) 35(52.2) | 15(8.3) 23(34.4) | 0 0 | 4.94 | <0.01 |
As can be seen from Table 16: analyze and u-test through Ridit, remove between the age between two groups less than 5 years old group, 5-9 year group there was no significant difference (p>0.05), significant difference (p<0.05) is all arranged between all the other each age group, in conjunction with clinical statement, the age is better than matched group in the patient group curative effect more than 10 years old.
Table 17 a liang group severity extent compares in the analysis of curative effect
Group | Degree | Add up to | Produce effects | Effectively | Invalid | Increase the weight of | Total effective rate | In the group |
The treatment group | Light-duty medium-sized heavy type | 195 121 34 | 84 50 9 | 96 62 20 | 15 9 5 | 0 0 0 | 92.3% 92.5% 85.3% | H | P |
3.29 | >0.05 |
Matched group | Light-duty medium-sized heavy type | 87 52 11 | 19 6 1 | 44 26 4 | 24 20 5 | 0 0 1 | 72.4% 61.5% 45.4% | 7.01 | <0.05 |
Between group | Light-duty medium-sized heavy type | u=4.15 u=4.78 u=2.26 | p<0.01 p<0.01 p<0.05 | | | | | | |
Can see from table 17 and to remove, analyze by statistics, treatment group severity extent is in the comparison there was no significant difference (P>0.05) of curative effect, and the matched group state of an illness is in curative effect more variant (p<0.05), the light more curative effect of the state of an illness is good more, and the curative effect that treatment is organized between each state of an illness group all is better than matched group p<0.05.Illustrate that treatment group curative effect is better than matched group, wherein light, medium-sized more obvious.
Untoward reaction:
By treatment being organized 350 routine patients' clinical observation, untoward reaction does not take place.After having only 6 routine patients to take medicine the stomach discomfort sense is arranged, ANOMALOUS VARIATIONS to blood pressure, liver function, kidney function test, does not all take place in transference cure behind the one after each meal.
Other: 350 examples are organized in treatment, and in 4 weeks of administration time, the gas effect time is 1 week not, and 4 weeks reached stable curative effect.Finish back follow-up observation totally 60 examples the course of treatment, wherein follow up a case by regular visits to 6 months person's 40 examples, follow up a case by regular visits to 1 year person's 20 example, curative effect is not still consolidated the person and is reached 55 examples (91.6%).
Table 18 a liang group curative effect is followed the trail of
| Example | The treatment group | Example | Matched group | P |
| | Recurrence | Not recurrence | Efficacy consolidation rate (%) | | Recurrence | Not recurrence | Efficacy consolidation rate (%) | |
Cardiopalmus | 55 | 6 | 49 | 89.0 | 29 | 3 | 26 | 89.6 | p>0.05 |
Uncomfortable in chest | 53 | 2 | 51 | 96.2 | 25 | 2 | 23 | 92.0 | p>0.05 |
Breathe hard | 55 | 1 | 54 | 98.1 | 27 | 2 | 25 | 92.5 | p>0.05 |
Weak | 56 | 4 | 52 | 92.8 | 28 | 3 | 25 | 89.2 | p>0.05 |
Vexed | 47 | 4 | 43 | 91.4 | 27 | 3 | 24 | 88.8 | p>0.05 |
Sinus tachycardia | 50 | 1 | 49 | 98.0 | 22 | 2 | 20 | 90.9 | p>0.05 |
Pharyngeal hyperemia | 55 | 3 | 52 | 94.5 | 28 | 3 | 25 | 89.2 | p>0.05 |
Ventricular premature contraction | 54 | 5 | 49 | 90.7 | 28 | 3 | 25 | 89.2 | p>0.05 |
1 degree atrioventricular block | 7 | 0 | 7 | 100.0 | 5 | 1 | 4 | 80 | p>0.05 |
Through X check, two groups of there was no significant differences aspect efficacy consolidation (P>0.05).