参松养心胶囊治疗冠心病室性早搏随机双盲、阳性药对照、多中心临床研究

目的：观察参松养心胶囊对冠心病室性早搏的临床疗效和安全性，方法：采用随机双盲双模拟对照，按1：1比例随机分为治疗组103例，给予参松养心胶囊（4粒，每日3次），对照组103例，给予心律宁片（2片，每日3次）。4周后进行室性早搏，主要症状，心电图等疗效及毒副作用的评估。结果：治疗组室性早搏显效率35．0％，总有效率69．0％，明显优于对照组显效率18．4％与总有效率48．5％（P＝0．001）。治疗组中医证侯显效率41．8％，总有效率87．4％，明显优于对照组显效率13．6％与总有效率67．0％（P＜0．001）。治疗组心电图显效率12．0％，总有效率56．0％，明显优于对照组显效率3．9％与总有效率38．1％（P＝0．01）。结论：参松养心胶囊治疗冠心病室性早搏疗效确切，无毒性作用。

Clinical Study on Treatment of Premature Ventricular Beat(P.V.) of Coronary Heart Disease(CHD) with Shen Song Yang Xin Capsule:A Randomised,Double blind, Active controlled, Multi centre Trial

Objective: To assess the therapeutic effect and safty of Shen Song Yang Xin Capsule in treating premature ventricular beat (P.V.) of coronary heart disease (CHD). Method: Twenty hundrund and six patients with P.V. of CHD were randomly divided into treatment group treated with Shen Song Yang Xin Capsule and control group treated with Xin Lu Ning Tablet. The therapeutic course was 4 weeks. Main symptoms and signs, ECG, side and toxic reactions were observed before and after treatment. Result: In treatment group, the excellent effective rate of premature ventricular beat was 35.0%, general effective rate was 69.0%, respectively 18.4% and 48.5% in control group. The difference of effective rate between two groups was significant ( P =0.001). In treatment group, the excellent effective rate of TCM symptoms and signs was 41.8%, general effective rate was 87.4%, respectively 13.6% and 67.0% in control group. There was significant difference between the two groups( P <0.001). In treatment group, the excellent effective rate of ECG was 12.0%, general effective rate was 56.0%, respectively 3.9% and 38 1% in control group( P =0.01). Side and toxic reactions were not found in two groups. Conclusion:Shen Song Yang Xin Capsule can be used safely and effectively in patients with premature ventricular beat of coronary heart disease.