心安Ⅰ号治疗快速性心律失常的临床疗效研究

Clinical research on Xinan No. 1 in the treatment of rapid arrhythmic

目的探讨中药制剂心安Ⅰ号治疗快速心律失常的疗效及安全性。方法采用随机对照研究方法,将120例患者按照分层区组随机化法分为治疗组和对照组,治疗组采用心安Ⅰ号治疗,对照组采用稳心颗粒治疗;两组患者均治疗4周,收集统计患者24 h动态心电图及肝肾功能指标。结果经4周治疗后,治疗组63例中抗心律失常总有效率80.95%,对照组57例中抗心律失常总有效率61.39%,两组疗效比较,差异有统计学意义(P<0.05),且治疗组优于对照组。治疗前后早搏次数、ST段降低程度、总心率以及平均心率的降低幅度比较,治疗组和对照组组间差异有统计学意义(P<0.05),治疗组优于对照组。两组患者肝肾功能比较,差异无统计学意义(P>0.05)。结论心安Ⅰ号可有效治疗快速性心律失常,改善其临床症状,具有良好的安全性和耐受性。

Objective To explore the anti-rapid arrhythmia effect and safety of a Chinese herbal preparation Xinan No. 1 formula. Methods The randomized controlled double-blind trial was performed by using stratified blocked randomization method. 120 patients were divided into 2 groups. The treatment group（ n = 63） was treated with Xinan No. 1 formula,while the control group（ n = 57） was treated with Wenxin particle. Both groups were treated for 4 weeks. Liver and kidney function indexes and 24 h holter monitoring were gathered and analyzed. Results The effective rate of anti-rapid arrhythmia was 80. 95% in the treatment group and 61. 39% in the control group,which was significantly different（ P〈0. 05）. The therapeutic effects of number of premature beats,the level of reduced ST,and heart rate in treatment group were better than the ones in control group. The liver and kidney function has no significant differences（ P〉0. 05）. Conclusion Xinan No. 1 formula could control rapid arrhythmia effectively and stably and improve the clinical symptoms with good safety and tolerance.