CN104887949B - A kind of Chinese medicine preparation for the treatment of DCM (dilated cardiomyopathy) and preparation method thereof - Google Patents

A kind of Chinese medicine preparation for the treatment of DCM (dilated cardiomyopathy) and preparation method thereof Download PDF

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CN104887949B
CN104887949B CN201510364779.XA CN201510364779A CN104887949B CN 104887949 B CN104887949 B CN 104887949B CN 201510364779 A CN201510364779 A CN 201510364779A CN 104887949 B CN104887949 B CN 104887949B
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CN104887949A (en
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王正椋
李笑
吴栋
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Jiangsu love Biotechnology Co., Ltd.
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Zibo Kuake Pharmaceutical Technology Co Ltd
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Abstract

The invention belongs to medical art, be specifically related to a kind of Chinese medicine preparation for the treatment of DCM (dilated cardiomyopathy) and preparation method thereof, described Chinese medicine preparation is made up of following raw material medicaments: the Radix Astragali, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis, Chinese medicine preparation of the present invention for primary efficacy, has significant therapeutic effect to gas sun deficiency DCM (dilated cardiomyopathy) with benefiting qi and raising yang, dispersing cold for relieving pain, promoting diuresis to eliminate damp pathogen, nourishing YIN and benefiting blood, promoting blood circulation to remove obstruction in the collateral.

Description

A kind of Chinese medicine preparation for the treatment of DCM (dilated cardiomyopathy) and preparation method thereof
Technical field
The invention belongs to medical art, be specifically related to a kind of Chinese medicine preparation for the treatment of DCM (dilated cardiomyopathy) and preparation method thereof.
Background technology
Cardiomyopathy is that a kind of cause of disease is complicated, and basic lesion betides cardiac muscle and causes cardiac muscle can not the heart disease of normal contraction.With cardiac dilatation, out of breath after tired, orthopnea or paroxysmal nocturnal dyspnea, edema of lower limbs, cardiopalmus, uncomfortable in chest, angina pectoris etc. are clinical principal character.Primary disease is divided into primary cardiac myopathy and secondary cardiomyopathy two type by the cause of disease, and be divided into dilated cardiomyopathy, hypertrophic cardiomyopathy and restrictive cardiomyopathy three types by pathology, wherein DCM (dilated cardiomyopathy) is comparatively common, and restrictive cardiomyopathy is domestic rare.Cardiomyopathy onset is slow, but course of disease speed differs.All cardiac dilatation are obvious, and heart failure is lasting, or arrhythmia bigot, and prognosis is not good.The category such as " cardiopalmus ", " thoracic obstruction ", " the syndrome of dyspnea ", " edema " is belonged in theory of Chinese medical science center myopathy.Medicine typing is the weak disease of the motive, gentle positive two deficient syndromes of deficiency of both QI and YIN disease, and by determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, the treatment of reasonable formula to DCM (dilated cardiomyopathy) has the incomparable advantage of doctor trained in Western medicine, and toxic and side effects is little.Thus the more significant Chinese medicine preparation of discuss and study treatment DCM (dilated cardiomyopathy) curative effect has larger meaning.
Summary of the invention
The invention provides a kind of new Chinese medicine preparation for the treatment of DCM (dilated cardiomyopathy), this Chinese medicine preparation is rapid-action, good effect, toxic and side effects is little, and it only will be obtained by following 9 taste raw materials: the Radix Astragali, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis.
The technical scheme adopted for solving its technical problem is the Chinese medicine preparation of described treatment DCM (dilated cardiomyopathy), is made up of the medicine material of following weight: Radix Astragali 15-20g, Polyporus 10-15g, Cortex Cinnamomi 3-8g, Radix Aconiti Lateralis Preparata 8-12g, Radix Paeoniae Alba 5-10g, Poria 5-10g, Semen Plantaginis 10-15g, Radix Stephaniae Tetrandrae 5-10g, Radix Ophiopogonis 15-20g.
The preferred technical solution of the present invention is that described Chinese medicine preparation of the present invention is obtained by the crude drug of following weight portion: Radix Astragali 18g, Polyporus 12g, Cortex Cinnamomi 5g, Radix Aconiti Lateralis Preparata 10g, Radix Paeoniae Alba 7g, Poria 8g, Semen Plantaginis 12g, Radix Stephaniae Tetrandrae 8g, Radix Ophiopogonis 18g.
Present invention also offers the preparation method of described Chinese medicine preparation, specifically comprise the steps: the crude drug Radix Astragali of above-mentioned weight portion, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis pulverized 80-120 mesh sieve respectively, mix homogeneously, add the soak by water 2 times of medical material gross mass 5-8 times amount, each 2 hours, filter cleaner extracting juice merges, and the filtrate after merging is concentrated, the alcoholic solution that volumetric concentration is 60% ~ 80% is doubly added again according to the 3-5 of filtrate gross weight, reflux, extract, three times, return time is 2-3h, filter, filtrate recycling ethanol, cold filtration, wash with water, namely Chinese medical concrete is obtained after drying.
Those skilled in the art directly can be used as medicine on obtained active constituents of medicine basis of the present invention to use or add on pharmaceutics acceptable adjuvant routinely technique be prepared into required preparation.As the oral drugs of the solid dosage form such as conventional tablet (dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet, effervescent tablet), capsule (hard capsule, soft capsule), granule, pill (drop pill), powder can be made, the oral drugs of the liquid forms such as syrup, oral liquid, water preparation, mixture, decoction also can be made.Therefore, in this Chinese medicine preparation except effective ingredient, pharmaceutically acceptable adjuvant can also be contained.Preferably, Chinese medicine preparation of the present invention conveniently preparation technology be prepared into granule, tablet, capsule, electuary or powder etc.Most preferably, Chinese medicine preparation of the present invention conveniently preparation technology be prepared into granule.
The present invention also asks to protect above-mentioned Chinese medicine preparation in the purposes of preparation treatment DCM (dilated cardiomyopathy) particularly in preparation treatment gas sun deficiency DCM (dilated cardiomyopathy) medicine.Known by clinical trial, after treating 1 course for the treatment of, treatment group and the clinical obvious effective rate of matched group symptom curative effect are respectively 66.7%, 40.0%, and treatment group and matched group symptom curative effect total effective rate are respectively 95.6%, 73.3%.Treatment group symptom obvious effective rate, total effective rate are obviously better than matched group as can be seen from Table 1, through statistical procedures there were significant differences P < 0.05.LVED (Left Ventricular End Systolic Dimension) (LVEDD) and ejection fraction (EF) situation of change as can be seen from Table 2.Before and after two groups of treatments, LVEFD and EF self more all have clear improvement (P < 0.05, P < 0.01), between group, comparison therapy group is all better than matched group (P < 0.05, P < 0.01), and treatment group LVEFD and EF improvement is better than matched group.In safety evaluatio, the routine blood test before and after treatment group patient consumes, routine urinalysis etc. inspections do not find obvious exception.Illustrate that using Chinese medicine preparation of the present invention treatment DCM (dilated cardiomyopathy) particularly to treat belongs to gas sun two deficiency syndrome DCM (dilated cardiomyopathy) determined curative effects thus, serve the remarkable result for the treatment of both the principal and secondary aspects of a disease, safe and reliable, can be used as the effective ways for the treatment of gas sun two deficiency syndrome DCM (dilated cardiomyopathy) diseases, be worth of widely use in clinical.
In Chinese medicine preparation of the present invention, functional effect and the side of each Chinese medicine component separate as follows:
The Radix Astragali, warm in nature, sweet in the mouth.Invigorating QI to consolidate the body surface resistance, expelling pus and toxin by strengthening QI, diuresis, granulation promoting., chronic diarrhea proctoptosis, spontaneous perspiration, edema weak for the deficiency of vital energy, sub-official prolapsus, chronic nephritis proteinuria, diabetes, open sore part disunion of a specified duration.。
Polyporus, sweet, light, flat.Return kidney, urinary bladder channel.Promoting diuresis to eliminate damp pathogen.For dysuria, edema, has loose bowels, stranguria with turbid discharge, leukorrhagia.
Cortex Cinnamomi, pungent, sweet, hot greatly.Return kidney, spleen, the heart, Liver Channel.Mend fire supporing yang, let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow.For sexual impotence, cold womb, chills and pain of the waist and kness, suffers from a deficiency of the kidney and breathes heavily, dizziness due to yang deficiency, conjunctival congestion pharyngalgia, trusted subordinate's cold type of pain, and deficiency and coldness is vomited and diarrhoea, colic of cold type, renal mass, amenorrhea, dysmenorrhea.
Radix Aconiti Lateralis Preparata, pungent, sweet, hot greatly; Poisonous.GUIXIN, kidney, spleen channel.Recuperating depleted YANG and rescuing the patient from collapse, mends fire supporing yang, by wind-cold damp pathogen.For YANG-depletion collapse, cold extremities faint pulse, sexual impotence, cold womb, trusted subordinate's cold type of pain, deficiency and coldness is vomited and diarrhoea, YIN-cold edema, yang deficiency diseases caused by exogenous pathogenic factor, arthralgia due to cold-dampnes.
The Radix Paeoniae Alba, bitter, sour, be slightly cold.Return liver, spleen channel.Suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Dizzy for having a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.
Poria is sweet, light, flat.GUIXIN, lung, spleen, kidney channel.Promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Semen Plantaginis, sweet, be slightly cold.Return liver, kidney, lung, small intestine meridian.Clearing away heat and promoting diuresis, eliminating dampness by diuresis is treating stranguria, improving eyesight, eliminates the phlegm.For edema distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, phlegm-heat cough.
Radix Stephaniae Tetrandrae is bitter, cold.Return bladder, lung meridian.Inducing diuresis to remove edema, wind-expelling pain-stopping.For edema beriberi, dysuria, eczema sore, rheumatic arthralgia; Hypertension.
Radix Ophiopogonis, sweet, micro-hardship, is slightly cold.GUIXIN, lung, stomach warp.YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.For dryness of the lung dry cough.Chronic consumptive disease is coughed, and Tianjin wound is thirsty, vexed insomnia, and interior-heat is quenched one's thirst, dryness of the intestine constipation; Pharyngeal diphtheria.
QI-deficiency of the heart and lung, hypofunction of YANG QI in chest, painstaking effort lose fortune, blockage of the cardiac vessels, therefore see chest distress, or chest pain, dark complexion, cyanotic lips; Deficiency of heart-YANG and kidney-YANG, disturbance in functioning of QI, fluid-retention stagnating in the interior, upper icepro cardiopulmonary thought-read is throbbed with fear asthma, can not put down sleeping, night weakened YANG QI, therefore asthma aggravation; Hinder in diseases caused by retention of fluid, insufficiency of the spleen mistake be good for, then distension and fullness of the chest and abdomen, Na Gu not under; Diseases caused by retention of fluid dysentery, then oliguria, lower limb foot edema; Yang-energy is on the decline, loses in warm survey aversion to cold and cold limbs; Light red tongue is fat and purple, white, slippery and moist fur, deep-thready pulse knot generation, is gas sun two empty, and what blood stasis drink stopped levies.The present invention is from the cogitive theory of the traditional Chinese medical science to gas sun deficiency DCM (dilated cardiomyopathy), for the purpose of benefiting qi and raising yang, dispersing cold for relieving pain, promoting diuresis to eliminate damp pathogen, nourishing YIN and benefiting blood, promoting blood circulation to remove obstruction in the collateral, carry out scientific composition, its various crude drug mild in medicine property selected and, nontoxic, safe and reliable, prepare easy, cost is low, and curative effect is fast, the Radix Astragali, Radix Stephaniae Tetrandrae in side, benefiting QI for strengthening the superficies, menstruction regulating and pain relieving, inducing diuresis to remove edema, wind-expelling pain-stopping; Polyporus, Poria, Semen Plantaginis, promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming; Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, YANG invigorating is dispeled cold, promoting blood circulation and stopping pain; The Radix Paeoniae Alba, Radix Ophiopogonis, suppressing the hyperactive liver lung moistening, nourishing YIN and benefiting blood, mind calming pain relieving.All medicines are harmonious, and effectively can treat DCM (dilated cardiomyopathy) particularly gas sun two deficiency syndrome DCM (dilated cardiomyopathy).Verify through clinical practice, take Chinese medicine preparation of the present invention treatment gas sun two deficiency syndrome DCM (dilated cardiomyopathy), determined curative effect, mild in medicine property and, side effect is low, and safety coefficient is high, clinical observation cure rate, total effective rate are high, LVEFD and EF all has clear improvement, and dosage form medication prepared by the present invention is simultaneously convenient, improves the compliance of dilated cardiomyopathy patients.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following specific embodiment.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 granule/electuary
Take each raw material of the present invention by following weight portion: Radix Astragali 18g, Polyporus 12g, Cortex Cinnamomi 5g, Radix Aconiti Lateralis Preparata 10g, Radix Paeoniae Alba 7g, Poria 8g, Semen Plantaginis 12g, Radix Stephaniae Tetrandrae 8g, Radix Ophiopogonis 18g.
Preparation technology is as follows: the Radix Astragali of above-mentioned weight portion, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis were pulverized 80-120 mesh sieve respectively, mix homogeneously, add the soak by water 2 times of medical material gross mass 7 times amount, each 2 hours, filter cleaner extracting juice merges, and the filtrate after merging is concentrated, the alcoholic solution that volumetric concentration is 70% is added again according to 4 times of filtrate gross weight, reflux, extract, three times, return time is 3h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying.Those skilled in the art directly can be used as medicine on this basis to use or add adjuvant conventional formulation technique and be obtained granule.
When using Chinese medicine preparation of the present invention to treat DCM (dilated cardiomyopathy) card, when taking prepared granule, every bag contains crude drug amount 1g, every day 3 times, each 1 bag.
Embodiment 2 tablet
Take each raw material of the present invention by following weight portion: Radix Astragali 18g, Polyporus 12g, Cortex Cinnamomi 5g, Radix Aconiti Lateralis Preparata 10g, Radix Paeoniae Alba 7g, Poria 8g, Semen Plantaginis 12g, Radix Stephaniae Tetrandrae 8g, Radix Ophiopogonis 18g.
Preparation technology is as follows: the crude drug Radix Astragali of above-mentioned weight portion, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis were pulverized 80-120 mesh sieve respectively, mix homogeneously, add the soak by water 2 times of medical material gross mass 7 times amount, each 2 hours, filter cleaner extracting juice merges, and the filtrate after merging is concentrated, the alcoholic solution that volumetric concentration is 70% is added again according to 4 times of filtrate gross weight, reflux, extract, three times, return time is 2h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying.Those skilled in the art directly can be used as medicine on this basis to use or add adjuvant conventional formulation technique and be obtained tablet.
When using Chinese medicine preparation of the present invention to treat DCM (dilated cardiomyopathy) card, when taking prepared tablet, every sheet contains crude drug amount 0.15g, every day 3 times, each 4.
Embodiment 3 capsule
Take each raw material of the present invention by following weight portion: Radix Astragali 18g, Polyporus 12g, Cortex Cinnamomi 5g, Radix Aconiti Lateralis Preparata 10g, Radix Paeoniae Alba 7g, Poria 8g, Semen Plantaginis 12g, Radix Stephaniae Tetrandrae 8g, Radix Ophiopogonis 18g.
Preparation technology is as follows: the crude drug Radix Astragali of above-mentioned weight portion, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis were pulverized 80-120 mesh sieve respectively, mix homogeneously, add the soak by water 2 times of medical material gross mass 7 times amount, each 2 hours, filter cleaner extracting juice merges, and the filtrate after merging is concentrated, the alcoholic solution that volumetric concentration is 70% is added again according to 4 times of filtrate gross weight, reflux, extract, three times, return time is 2h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying.Those skilled in the art directly can be used as medicine on this basis to use or add adjuvant conventional formulation technique and be obtained capsule.
When using Chinese medicine preparation of the present invention to treat DCM (dilated cardiomyopathy) card, when taking prepared capsule, every contains crude drug amount 0.15g, every day 3 times, each 4.
Embodiment 4 granule
Take each raw material of the present invention by following weight portion: Radix Astragali 15g, Polyporus 10g, Cortex Cinnamomi 3g, Radix Aconiti Lateralis Preparata 8g, Radix Paeoniae Alba 5g, Poria 5g, Semen Plantaginis 10g, Radix Stephaniae Tetrandrae 5g, Radix Ophiopogonis 15g.
Preparation technology is as follows: the crude drug Radix Astragali of above-mentioned weight portion, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis were pulverized 80-120 mesh sieve respectively, mix homogeneously, add the soak by water 2 times of medical material gross mass 5 times amount, each 2 hours, filter cleaner extracting juice merges, and the filtrate after merging is concentrated, the alcoholic solution that volumetric concentration is 60% is added again according to 3 times of filtrate gross weight, reflux, extract, three times, return time is 2h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying.Those skilled in the art directly can be used as medicine on this basis to use or add adjuvant conventional formulation technique and be obtained granule.
When using Chinese medicine preparation of the present invention to treat DCM (dilated cardiomyopathy) card, when taking prepared granule, every bag contains crude drug amount 1g, every day 3 times, each 1 bag.
Embodiment 5 granule
Take each raw material of the present invention by following weight portion: Radix Astragali 20g, Polyporus 15g, Cortex Cinnamomi 8g, Radix Aconiti Lateralis Preparata 12g, Radix Paeoniae Alba 10g, Poria 10g, Semen Plantaginis 15g, Radix Stephaniae Tetrandrae 10g, Radix Ophiopogonis 20g.
Preparation technology is as follows: the crude drug Radix Astragali of above-mentioned weight portion, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis were pulverized 80-120 mesh sieve respectively, mix homogeneously, add the soak by water 2 times of medical material gross mass 8 times amount, each 2 hours, filter cleaner extracting juice merges, and the filtrate after merging is concentrated, the alcoholic solution that volumetric concentration is 80% is added again according to 5 times of filtrate gross weight, reflux, extract, three times, return time is 3h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying.Those skilled in the art directly can be used as medicine on this basis to use or add adjuvant conventional formulation technique and be obtained granule.
When using Chinese medicine preparation of the present invention to treat DCM (dilated cardiomyopathy) card, when taking prepared granule, every bag contains crude drug amount 1g, every day 3 times, each 1 bag.
The clinical observation of embodiment 6 Chinese medicine preparation treatment of the present invention DCM (dilated cardiomyopathy)
1, case-data:
Outpatient service and ward are diagnosed as patient 90 example of gas sun deficiency DCM (dilated cardiomyopathy), are divided into treatment group, matched group at random.Wherein treatment group 45 example, man 26 example, female 19 example; The oldest person 60 years old, reckling 19 years old, 35.9 ± 3.52 years old mean age, its center function is II grade of patient 10 example, and cardiac function is III grade of patient 26 example, and cardiac function is IV grade of patient 9 example.Matched group 45 example, man 25 example, female 20 example; The oldest person 58 years old, reckling 18 years old, 36.2 ± 3.68 years old mean age, its center function is II grade of patient 11 example, and cardiac function is III grade of patient 25 example, and cardiac function is IV grade of patient 9 example.Two groups of patients there was no significant difference (P > 0.05) in sex, age, the course of disease, the state of an illness etc., has comparability.
2, diagnosis basis
All meet nineteen ninety-five WHO/ISFC diagnostic criteria.
Syndrome Differentiation of Traditional Chinese Medicine is gas sun two deficient syndrome shapes: chest distress, or have chest pain, and cardiopalmus is panted, and can not put down sleeping, and night aggravates, distension and fullness of the chest and abdomen, Na Gu not under, oliguria, lower limb foot edema, aversion to cold and cold limbs, dark complexion, cyanotic lips.Light red tongue is fat and purple, white, slippery and moist fur, deep-thready pulse knot generation.This type sees the cardiomyopathy heart failure serious phase.
3, inclusive criteria:
(1) diagnosis basis is met;
(2) meet Chinese medical discrimination diagnostic criteria and belong to gas sun deficiency DCM (dilated cardiomyopathy) person;
(3) age 18-60 year, male or female;
(4) clinical research " Informed Consent Form " is signed.
4, Excluded cases standard:
(1) due to heart failure person that liver and kidney failure causes;
(2) gestation or women breast-feeding their children;
(3) Liver and kidney and the severe primary such as endocrine, hemopoietic system disease and psychotic patient is merged;
(4) to the known composition allergy sufferers of this medicine.
5, to reject and the standard that comes off:
(1), after case is selected in, find not meet inclusive criteria or meet exclusion standard person;
(2) there is serious adverse events, judge to stop this case clinical trial person according to doctor;
(3) case selected after data not entirely or not by specifying medication person;
(4) in process of the test, experimenter's compliance is poor, and affect the treatment estimator.
6, usage and dosage:
Matched group: give SHENGMAI ZHUSHEYE 40mL+5% Glucose Liquid 250mL, quiet, 15 ~ 30/min, continuous 14 days, rear continuation used each 2 of SHENGMAI JIAONANG, oral, 3 times on the 1st, digoxin 0.125g, captopril 0.125g are oral, 2 times on the 1st, 2 months courses for the treatment of.。
Treatment group: give Drug therapy of the present invention, granule prepared by Example 1, containing crude drug amount 1g, every day 3 times, each 1 bag, takes for every bag after the meal half an hour.
Two groups of patients, at treatments period, except above-mentioned treatment, must not use other therapies.February is 1 course for the treatment of, after treating 1 course for the treatment of, and statistical observation record.
7, criterion of therapeutical effect: effective in cure judging quota all meet curative effect determinate standard in " new Chinese medicine guideline of clinical investigations ".
Effective: all symptoms, sign and decentraction function are all significantly improved, and cardiac function is improved to more than II grade;
Effective: symptom, sign and cardiac function all make moderate progress, cardiac function is improved to more than I level;
Invalid: the various clinical symptoms of patient all do not obtain any improvement, the phenomenon increased the weight of even in addition.
Total effective rate=obvious effective rate+effective percentage.
8, therapeutic outcome:
In therapeutic process, nothing exits, come off case, all completes clinical observation.
After treating 1 course for the treatment of, treatment group and the clinical obvious effective rate of matched group symptom curative effect are respectively 66.7%, 40.0%, and treatment group and matched group symptom curative effect total effective rate are respectively 95.6%, 73.3%.Treatment group symptom obvious effective rate, total effective rate are obviously better than matched group as can be seen from Table 1, have pole significant difference P < 0.05 through statistical procedures.LVED (Left Ventricular End Systolic Dimension) (LVEDD) and ejection fraction (EF) situation of change as can be seen from Table 2.Before and after two groups of treatments, LVEFD and EF self more all have clear improvement (P < 0.05, P < 0.01), between group, comparison therapy group is all better than matched group (P < 0.05, P < 0.01), and treatment group LVEFD and EF improvement is better than matched group.
Table 1. liang group symptom comparitive study
Group n Effective Effectively Invalid Total effective rate (%)
Treatment group 45 30 13 2 43(95.6%)
Matched group 45 18 15 12 33(73.3%)
Before and after table 2. liang group treatment, cardiac function compares
Note: compare with before treatment p < 0.05, ☆ ☆p < 0.01; Compare with matched group p < 0.05, △ △p < 0.01.
From clinical observation result, treatment group symptom obvious effective rate, total effective rate, cardiac function improve situation and are all obviously better than matched group, and this Chinese medicine preparation improves obviously DCM (dilated cardiomyopathy) clinical symptoms as seen.Simultaneously in safety evaluatio, the routine blood test before and after treatment group patient consumes, routine urinalysis etc. inspections do not find obvious exception.Illustrate that using Chinese medicine preparation of the present invention treatment DCM (dilated cardiomyopathy) particularly to treat belongs to gas sun two deficiency syndrome DCM (dilated cardiomyopathy) determined curative effects thus, safe and reliable, can be used as the effective ways for the treatment of gas sun two deficiency syndrome DCM (dilated cardiomyopathy), be worth of widely use in clinical.

Claims (8)

1. treat the Chinese medicine preparation of DCM (dilated cardiomyopathy) for one kind, it is characterized in that, it is obtained by the crude drug of following weight portion: Radix Astragali 15-20g, Polyporus 10-15g, Cortex Cinnamomi 3-8g, Radix Aconiti Lateralis Preparata 8-12g, Radix Paeoniae Alba 5-10g, Poria 5-10g, Semen Plantaginis 10-15g, Radix Stephaniae Tetrandrae 5-10g, Radix Ophiopogonis 15-20g.
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that, it is obtained by the crude drug of following weight portion: Radix Astragali 18g, Polyporus 12g, Cortex Cinnamomi 5g, Radix Aconiti Lateralis Preparata 10g, Radix Paeoniae Alba 7g, Poria 8g, Semen Plantaginis 12g, Radix Stephaniae Tetrandrae 8g, Radix Ophiopogonis 18g.
3. Chinese medicine preparation as claimed in claim 1 or 2, it is characterized in that, described Chinese medicine preparation is oral formulations.
4. Chinese medicine preparation as claimed in claim 3, it is characterized in that, described oral formulations is tablet, electuary, capsule or granule.
5. Chinese medicine preparation as claimed in claim 4, it is characterized in that, described oral formulations is granule.
6. prepare the method for Chinese medicine preparation as claimed in claim 1 or 2 for one kind, it is characterized in that, comprise the steps: the crude drug Radix Astragali of above-mentioned weight portion, Polyporus, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, the Radix Paeoniae Alba, Poria, Semen Plantaginis, Radix Stephaniae Tetrandrae, Radix Ophiopogonis pulverized 80-120 mesh sieve respectively, mix homogeneously, add the soak by water 2 times of medical material gross mass 5-8 times amount, each 2 hours, filter cleaner extracting juice merges, and the filtrate after merging is concentrated, the alcoholic solution that volumetric concentration is 60% ~ 80% is doubly added again according to the 3-5 of filtrate gross weight, reflux, extract, three times, return time is 2-3h, filter, filtrate recycling ethanol, cold filtration, wash with water, namely Chinese medical concrete is obtained after drying.
7. the purposes of Chinese medicine preparation as claimed in claim 1 or 2 in preparation treatment DCM (dilated cardiomyopathy) medicine.
8. the purposes of Chinese medicine preparation as claimed in claim 1 or 2 in preparation treatment gas sun two deficiency syndrome DCM (dilated cardiomyopathy) medicines.
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CN101322801A (en) * 2007-06-15 2008-12-17 河北以岭医药研究院有限公司 Use of Chinese medicinal composition in preparing medicament for treating dilated cardiomyopathy

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Publication number Priority date Publication date Assignee Title
CN101322801A (en) * 2007-06-15 2008-12-17 河北以岭医药研究院有限公司 Use of Chinese medicinal composition in preparing medicament for treating dilated cardiomyopathy

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