| Objectives:ShenMaiShu Xin for participation dropping treatment of coronary heart disease, angina (qi and Yin deficiency syndrome) two of clinical application and effectiveness of safety, and explores the preliminary evaluation of clinical dosage.Method:1. According to the center, controlled, repeat, randomized, double-blind, clinical trials in MaiShu hin principle, parameter for comparison, dropping blank agent into groups meet the conditions of the 216 cases of patients with five clinical trials, distribution center, I center into groups of patients per bed. it 60 cases, fall off in 2 cases. One group by group found 2-1 distribution. Namely 40 cases were randomly.divided into trial group (give MaiShu hin and 15 pills/times dropping,3 times a day), the control group 20 cases (give placebo 15 pills/times,3 times a day). I center into the group cases women 35 patients, male, age 25 cases of 40 to 65 years old. Two groups of patients in the gender, age, with basic diseases, angina pectoris grading, weekly attack angina between times (see table 1-5) there are no significant difference (P> 0.05), have balanced comparability; Clinical observation around, its early for a week.2. Two groups of patients observe syndromes curative effect, angina pectoris curative effect, give statistics processing comparative efficacy (see table 6-9).3. The two groups of patients "TCM observed in" single disease hou "bosom frowsty, chest pain" comparative efficacy (see table 1).4. Observe two groups were promising effect time is medicine (see table 12).5. Observation and safety related laboratory index (including routine blood, urine, electrocardiogram, liver, kidney, and clotting four examination, this paper discusses MaiShu hin) and dropping the safety of clinical applications.6. All data analyzed by SAS9.1.3 statistical software. Measurement data to+S said, using t-test analysis; Counting material use X2 inspection.Results:1. The two groups of patients TCM syndrome curative effect, angina pectoris syndrome comparative (such as table 6 curative effect,8): syndromes curative effect for the total effective rate in treatment group and control joys for 25%; Angina total effective syndrome curative effect in treatment group and control for 68.3%87.5%for. No significant differences between groups compare sexual statistically significant (P> 0.05).2. The two groups of TCM syndrome patients with total score, angina total score syndrome (see chart 7,9) were significantly lower than before treatment, there is a significant difference statistically significant (P< 0.05). Before and after the treatment of TCM syndrome in two total score, angina pectoris syndrome total credit, no significant comparative differences between groups of statistically significant (P> 0.05).3. Two groups of patients "in" TCM single symptoms "chest pain, bosom is frowsty" comparative efficacy (see table 1):treatment group and control group than the "chest pain, bosom frowsty" curative effect between-group differences more statistically significant (P< 0.05), when the drug treatment group than controls are chest pain, bosom is frowsty reduce; Other index, between-group differences comparison was statistically significant (P> 0.05).4. The two groups of patients electrocardiogram curative effect (such as table comparing total effective 11):treatment group and control group 57.5%comparative differences between 50%was not statistically significant (P> 0.05).5. The two groups of patients drug effect-acting period comparison (such as table 12):in "drugs, " the effect-acting period between treatment group and control qol diff are statistically significant (P< 0.01), the treatment group than controls drug effect-acting period shorter.6. The two groups of patients compared blood lipid curative effect (see table 13):when the drug treatment group can markedly reduce the TC, compared with controls difference was statistically significant (P< 0.05). When the drug treatment group and control group are TG, LDL-C no decrease effect, between-group differences comparison was statistically significant (P> 0.05).7. The two groups of patients before and after the treatment of routine blood, urine and blood coagulation four, liver function, kidney of that there are no exception, check in clinical drug is safe.Conclusion:And dropping MaiShu Xin a safe and effective in the treatment of coronary heart disease, angina (qi and Yin deficiency syndrome) two of proprietary Chinese medicine. It to improve patients'symptoms, signs, obvious effects to clinical application. Its action mechanisms may MaiShu Xin with participation dropping significantly increased blood flow in the coronary artery and weaker influence on myocardial shrinkage performance. |
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