Objective: Evaluation of bee yellow dropping pill treatment of coronary heart disease angina pectoris(obstruction of qi deficiency and blood stasis) the clinical curative effect and security, and to explore the clinical suitable dose.Methods: 1.This test follow the parallel randomized, double blind, placebo controlled, multicenter clinical trial, subjects: coronary heart disease angina pectoris ?, ?, ? level, for qi deficiency blood stasis syndrome differentiation of traditional Chinese medicine subjects. Selected 480 cases, two weeks after the period were randomly divided into experimental group 360 cases, control group 120 cases, after 12 weeks of treatment, respectively, in the 15 to study the clinical trial center, the center, a total of 36 patients selected subjects randomly divided into three groups, respectively is: group 1, a total of 12 cases(yellow bee dropping pill 20 / time, 3 times/day, oral), group 2, a total of 12 cases(yellow bee dropping pill 30 / time, 3 times/day, oral), the control group,12 cases(bee yellow dropping simulation agent(1 bag/time, 3 times/day, oral)).2. By observing the subjects before and after the treatment of angina pectoris(episodes, the degree of pain, duration) and integral, nitroglycerin and stop to reduce dose rates, syndromes and integral, electrocardiogram, athletic flat test, evaluation of bee yellow dropping pill treatment of coronary heart disease angina pectoris(qi deficiency and blood stasis syndrome) is effective.3. By observing vital signs before and after the treatment, blood, urine, dung routine, liver function, renal function examination and the subjects of adverse events and evaluate its safety.4. The test data are all using SAS 9.1.3 software for analysis.Result: 1.The three groups of patients in gender, age, with basic diseases, angina, grading, attack frequency of angina pectoris, etc, there was no significant difference statistically significant(P > 0.05), comparable.2. Syndromes curative effect: efficient: experimental group 1(75.0%), group 2 is 83.3%, the control group is 41.7%; Group 1, group 2, respectively, compared with control group differences significant statistical significance.3. Angina pectoris curative effect: efficient: experimental group 1(66.7%), group 2 is 75.0%, the control group is 25.0%; Group 1, group 2, respectively, compared with control group differences significant statistical significance.4.TCM syndrome integral, angina, integral: three groups of patients before treatment of traditional Chinese medicine syndrome scores and angina pectoris was no significant statistical difference(P > 0.05), comparable. Three groups of patients after treatment of TCM syndrome integral and angina pectoris integral are lower than before the treatment, and a significant statistical significance; After treatment of TCM syndrome integral test group 1, group 2, respectively, compared with control group to reduce more apparent, comparative differences significant statistical significance. After treatment angina pectoris integral test group 1, group 2 more obviously than the control group to reduce, comparative differences significant statistical significance.5.Ecg curative effect: efficient experimental group 1(41.7%), group 2 is 66.7%, the control group is 8.3%; Group 1, group 2, respectively, compared with control group differences significant statistical significance.6. Athletic flat test: athletic flat test movement began in the time required to achieve positive standard/suspended, comparison between the three groups before test, there was no significant difference, P > 0.05, no statistical significance, test after comparison between the three groups, experiment group 1 and 2 group than the control group, P < 0.05, the difference was statistically significant.7. Before and after the experiment of three groups of subjects were vital signs, blood routine, routine urine, dung routine, blood coagulation four, there were no obvious abnormal liver function, renal function; In the whole test process, and adverse events were three groups of subjects.Conclusion:Bees yellow dropping pill treatment of coronary heart disease angina pectoris(obstruction of qi deficiency and blood stasis syndrome) safe, effective, according to the result of ? phase of clinical trial, suggested dosage phase ? clinical trials for 3 times a day, 30 pills at a time. |