芪苈强心胶囊治疗慢性收缩性心力衰竭的临床研究

目的评价芪苈强心胶囊治疗慢性收缩性心力衰竭的疗效及安全性。方法采用随机双盲、阳性药对照、多中心临床研究,治疗组326例口服芪苈强心胶囊,每次4粒,每日3次;对照组162例口服心宝丸,心功能II级每次2粒,每日3次;心功能III级每次4粒,每日3次。疗程均4周。4周后进行心功能疗效、中医证候疗效、Lee氏心力衰竭计分等疗效性指标及血、尿、便常规,心电图,肝、肾功能,血K+、Na+、Cl-及不良反应等安全性指标评价。结果心功能疗效:冠心病心力衰竭或高血压心力衰竭治疗组与对照组疗效相近(P>0.05)。中医证候疗效治疗组均优于对照组(P<0.05或P<0.01)。Lee氏心力衰竭计分冠心病心力衰竭治疗组优于对照组(P<0.05),高血压心力衰竭治疗组与对照组相近(P>0.05)。安全性指标方面2组均未见异常变化。结论芪苈强心胶囊治疗慢性收缩性心力衰竭疗效满意,且能明显改善中医证候,未见不良反应。

Qiliqiangxin capsule in treating chronic systolic heart failure

Objective To evaluate the efficacy and safety of the Qiliqiangxin capsule in treating chronic systolic heart failure patients. Methods A randomized, double blinded, positive controlled, multicenter trial was conducted for 4 weeks. 326 patients （the treatment group） received Qifiqiangxin capsule, 4 pills tid. And 126 patients （the control group） were given Xinbao pill according to heart function. The patients who were classified in grade II were taken 2 pills tid while grade III with 4 pills tid. Four weeks later, the efficacy and safety indexes were evaluated. The effective indexes included heart function, traditional Chinese medicine symptoms improvement, Lee＇ s score and the safety indexes （ including routine test of blood, urine, and stool, ECG, ALT, BUN, Cr, K^＋ , Na^＋ , Cl^- ）. Results The treatment groups （including coronary heart disease group and hypertension group）were similar to the control group in heart function and no statistical significant difference existed（ P 〉 0.05 ）. The two treatment groups were better than the control group in traditional Chinese medicine symptoms（ P 〈 0.05 or P 〈 0.01 ）. The coronary heart disease group was better than, while the hypertension group was similar to the control group in the Lee＇ s scoring. No abnormal changes in safety indexes were detected in both groups. Conclusion Traditional Chinese medicine symptoms were obviously improved and there were no adverse effects existed. Therefore, the effect of Qiliqiangxin capsule in treating chronic heart failure was satisfied.