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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 被引量:39

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
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摘要 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 10 3例 ,给予参松养心胶囊 (4粒 ,每日 3次 ) ,对照组 10 3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 6 9 0 % ,明显优于对照组显效率 18 4 %与总有效率 4 8 5 % (P =0 0 0 1)。治疗组中医证候显效率 4 1 8% ,总有效率 87 4 % ,明显优于对照组显效率 13 6 %与总有效率 6 7 0 % (P <0 0 0 1)。治疗组心电图显效率 12 0 % ,总有效率 5 6 0 % ,明显优于对照组显效率 3 9%与总有效率 38 1% (P =0 0 1)。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。 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.
出处 《中国中医基础医学杂志》 CAS CSCD 2003年第3期37-40,共4页 JOURNAL OF BASIC CHINESE MEDICINE
关键词 参松养心胶囊 冠心病 室性早搏 不良反应 中医药疗法 Shen Song Yang Xin Capsule premature ventricular beat (P.V.) coronary heart disease (CHD) adverse effects
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参考文献5

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