| Objective:Evaluation of Xue Tong Dan pill treatment of coronary heart disease angina pectoris(syndrome of blood stasis resistance) of the efficacy and safety.Method:1. This is a multi-center clinical trial, the entire trial enrolled a total of 144 cases of subjects, which were distributed in eight clinical testing center, the center is the number of subjects enrolled in 24 cases, loss 0 cases. According to a randomized, double-blind, placebo-controlled and principles, the experimental group and the control group the number of cases by 1: 1 allocation. That group of 12 patients were randomly divided into experimental(given Xue Tong Dan pills, 15 pills each time, 3 times/day), a control group of 12 patients(given Xue Tong Dan pills mimetic, 15 pills each time, 3 times/day); 2. Before the experiment subjects were compared by sex, age, degree of pain, angina pain, weekly seizure frequency, associated with underlying diseases and concomitant medications, etc.(see Table 1-6), the statistical analysis, no significant difference(See all P>0.05), prompted two subjects comparable; import of two weeks, the treatment of eight weeks; after treatment, recording two groups of patients before and after treatment symptom score, angina pectoris and give statisticalprocess integration, and the efficacy of contrast(see Table 7 to Table 10); 3. ECG recording two subjects efficacy, efficacy assessment(Table 11), as well as exercise duration compare two groups of patients(Table 12); 4. Clinical examination subjects were observed vital signs, blood, urine, feces three conventional, electrocardiogram, liver and kidney function, blood coagulation, urine pregnancy tests and adverse events(including drug side effects), to assess the safety of drugs; 5. All data were analyzed using the SAS 9.13 software. Clinical indicators were based on the full analysis set and the per protocol for analysis, security index Safety data set for analysis.Result:1. The contrast between the treatment groups: ⑴ two subjects TCM syndromes(see Table 7): The total effective rate was 91.7% in the experimental group than the control group was 50%; syndrome effect ⑵ two subjects angina pectoris effect(see Table 9): The total efficiency was 75.0% in the experimental group than the control group, 33.3%; ⑶ two subjects ECG efficacy(see Table 11): The total efficiency of 66.7% in the experimental group than the control group and 16.7%; ⑷ two treadmill exercise duration(see Table 12): the experimental group was significantly longer than the control group; ⑸ groups and angina symptom score Integra: the experimental group were lower than the control group. Six were on the statistical analysis, the difference was significant statistically significant(P<O.05), prompted the experimental group than the control group. 2. Comparison before and after treatment: ⑴ experimental group after treatment symptom score and efficacy, angina scores and efficacy, the efficacy of ECG, exercise duration are better than before treatment, the difference wassignificant by statistical analysis statistical significance(P<0.05); ⑵ after treatment compared with the control group before treatment, the six comparative statistical analysis showed no significant difference(P>0.05); Above comparison, indicating that Xue Tong Dan pills could improve the patients symptoms and further show that the drug on coronary heart disease angina pectoris(blood stasis) effective3 from the adverse effects in terms of before and after treatment two subjects of vital signs, blood, urine, feces three conventional, electrocardiogram, liver and kidney function, blood clotting function, adverse events were all without exception, said Ming medicine for clinical bed is safe.Conclusion:Xue Tong Dan pills treatment of coronary heart disease angina pectoris(syndrome of blood stasis resistance) safe and effective. Its mechanism may be related to reduce coronary resistance and increase coronary blood flow, inhibit platelet aggregation, improve blood rheology and resisting thrombosis, etc. |
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