中药参松养心胶囊改善冠心病患者异位心律的随机双盲、阳性药对照、多中心临床研究

目的探讨参松养心胶囊对冠心病室性期前收缩的临床疗效和安全性.方法对符合纳入标准的 206例门诊或住院患者,采用随机双盲双模拟对照,按11随机分为治疗组 103例,给予参松养心胶囊( 4粒, 3次 /d),对照组 103例给予心律宁片(2片, 3次 /d). 4周后进行室性期前收缩、主要症状、心电图等疗效及毒副作用的评估.结果治疗组室性期前收缩显效率 35.0%( 36/103),总有效率 69.0%( 71/103),明显优于对照组显效率18.4%( 19/103)与总有效率 48.5%( 50/103)( Z=- 3.261, P=0.001). 结论参松养心胶囊治疗冠心病室性期早搏明显优于心律宁片,未见对血、尿、便常规,肝、肾功能等的不良影响.

A random double blind,positive medication control and multi-centre clinical study on the effects of traditional Chinese medicine Shensong Yangxin capsule in improving ectopic cardiac rhythm in coronary heart disease patients

OBJECTIVE: To discuss the clinical therapeutic effectiveness and safety of Ginseng-spikenard heart nourishing capsule to ventricular extrasystole in coronary heart disease. METHODS:206 cases of patients accorded with inclusive criteria from outpatient or inpatient department were randomly allocated with randomly double blind double analogue into therapy group with 103 cases and treated with the capsule(4 capsules,3 times a day). 103 cases were allocated into control group and treated with Xinluning(2 tablets,3 times a day). Therapeutic effectiveness and toxic side effects on ventricular extrasystole,main symptoms,and electrocardiogram were assessed after 4 weeks. RESULTS:The effective rate of ventricular extrasystole in the therapy group was 35.0% (36/103) and the total effective rate was 69.0% (71/103), which were markedly higher than those of the control group[18.4% (19/103) and 48.5% (50/103) respectively](Z=3.261,P=0.001). CONCLUSION:The therapeutic effectiveness of the capsule in the treatment of ventricular extrasystole in coronary heart disease was obviously better than that of Xinluning,and the side effects was not found in the routine test of blood,urine,stool and liver,and kidney functions.