芪参胶囊治疗动脉粥样硬化性冠心病多中心临床研究总结

目的：系统评价经工艺提高及剂型改革后的芪参胶囊（1#胶囊）治疗动脉粥样硬化性冠心病的临床效应。方法：采用随机分组、原剂型药物（芪参胶囊0#胶囊）平行对照、双盲观察临床试验设计方案,观察受试病例219例,治疗组108例,对照组111例。结果：2组疾病疗效、中医证候疗效、心绞痛疗效及心电图疗效等组间比较差异均无统计学意义（P〈0.05）。TC、TG异常者治疗后具有明显的下降,与治疗前比较差异有统计学意义（P〈0.05）,但组间比较差异均无统计学意义（P〈0.05）。结论：经工艺提高及剂型改革后的芪参胶囊（1#胶囊）治疗动脉粥样硬化性冠心病具有较好的疗效,其作用与原剂型药物相似。

Multi-center Clinical Research of Qishen Capsule for Atherosclerosis of Coronary Heart Disease

Objective：To evaluate the efficacy of a new dosage form of Qishen medical formula for treatment of atherosclerosis of coro- nary heart disease. Methods：In a randomized, double-blind control clinical research, a comparison was made between the original form of Qishen （ 111 cases） and the present forms of Qishen （ 108 eases）. Results：The efficacy of the medicaments, measured as symptom alleviation, TCM pattern relief, ECG improvement were not significantly different between the two groups （P 〉 0.05 ） ; after treatment, abnormal levels of TC and TG were decreased significantly （ P 〈 0.05 ） for each group, with no statistically difference between groups （ P 〉 0.05）. Conclusion：The new dosage form of Qishen, processed with new technology, has a similar potency to the original dosage form.