参松养心胶囊治疗室性早搏的多中心随机对照研究

Clinical study on ventricular premature beat treated by Shensongyangxin capsule:a randomized,controlled,multicenter trial

目的观察参松养心胶囊治疗不同病因室性早搏(VPB)的疗效与安全性。方法选择心功能NYHAI^III级的VPB患者164例,采用多中心随机对照,按2∶1分为治疗组(108例)和对照组(56例),治疗组口服参松养心胶囊4粒,每日3次;对照组口服慢心律150mg,每日3次,疗程4周。观察2组患者室性早搏的总有效率、症状改善率及安全性。并分析比较有器质性病因VPB亚组和无器质性病因VPB亚组的治疗效果。结果治疗组总有效率为88.9%,症状改善率为93.5%;对照组总有效率为71.4%,症状改善率55.3%,2组比较差异有显著意义(P<0.01)。对无器质性病因的VPB,治疗组对症状改善和早搏次数的控制均优于对照组(分别为91.2%对47.6%,P<0.05;85.3%对57.1%,P<0.05);对有器质性病因的VPB,治疗组对症状的改善优于对照组(94.6%对60.0%,P<0.05)。结论参松养心胶囊对不同病因的室性早搏有明显疗效,且无严重不良反应。

Objective To investigate the efficacy and safety of Shensongyangxin capsule in the treatment of ventricular premature beat （VPB）. Methods 164 patients with frequent VPB were enrolled and randomly assigned by 2 to 1 ratio into two groups. 108 patients in treatment group were treated with Shensongyangxin capsule （4 capsules, three times a day）;56 patients in control group were treated with mexilitine （150 mg, three times a day）, with a treatment course of 4 weeks for both groups. The effect on VPB, improvement of main chnical symptoms and safety were observed in both groups. Sub-study analysis was performed to evaluate the efficacy on VPB with or without any cause treated with Shensongyangxin capsule or mexihtine. Results The general effective rate in treatment group was significantly higher than that in control group （88.9% vs 71.4%, P 〈 0.01） ;The effective rate of improving the main clinical symptoms in treatment and control group was 93.5% and 55.3% respectively.The efficacy on VPB and improvement of clinical symptoms in treatment group were statistically higher than those in control group for the VPB without any cause （91.2% vs 47.6%, P 〈 0. 05; 85.3 % vs 57.1%, P 〈 0. 05, respectively）. The efficacy on VPB in treatment group had no difference, as compared with that in control group for the VPB with any cause （90.5 % vs 80.0%, P 〉 0.05） ,however,the effective rate of improving the clinical symptoms in treatmefit group and control group was 94.6% and 60.0% ,respectively,there was a significant difference between the two groups （ P 〈 0.05）. Conclusion Shensongyangxin capsule has obvious efficacy in treatment of VPB, without serious side effects.