安迪尔胶囊治疗窦性心动过缓的临床观察

Clinical Observation of Andyer Capsule in Treatment of Sinus Bradycardia

目的观察安迪尔胶囊治疗窦性心动过缓的临床疗效。方法选取60例窦性心动过缓患者随机分为两组,安迪尔胶囊治疗组30例(口服安迪尔胶囊,每次4粒,每日3次);心宝丸对照组30例(口服心宝丸,每次5粒,每日3次)。两组治疗一个疗程(8周)。观察两组治疗前后临床症状改变、24h动态心电图及心率变异性分析的情况。结果中医证候疗效有效率、心率次数及心率变异性指标24h全部窦性心搏R-R间距标准差(SDNN),24h每5minR-R间距标准差(SDANN)、每5min正常R-R间期标准差的平均值(SDNNIndex),相邻窦性R-R间期差值均方根(r-MSSD)、相邻R-R间期之差大于50ms的心搏次数占心搏总数的百分比(PNN50)比较,治疗组与对照组比较差异均有统计学意义(P<0.05或P<0.01)。结论安迪尔胶囊能明显改善中医症候,治疗窦性心动过缓安全有效。

Objective To observe the effect of Andyer capsule in treatment of sinus bradycardia. Methods Sixty patients with sinus bradycardia were randomly assigned into two groups：Treatment group（n = 30）treated by Andyer capsule（oral, 4 pills each, 3 times a day） and control group（n = 30） treated by Xinbao pills （oral, 5 pills each, 3 times a day） for 8 weeks. The clinical symptoms, 24 hour Holter monitoring electrocardiogram（ECG） and the analysis of heart rate variability（HRV） were observed before and after treatment. Results There were statistically significant differences in the efficacy of traditional Chinese medicine（TCM）syndrome, heart rate and the ehanges of heart rate variability including parameter of SDNN,SDANN,SDNN Index, r - MSSD and PNN50 between treatment group and control group（P〈0.05 or P〈0.01 ）. Conclusion Andyer capsule was safe and effective in treatment of patients with sinus bradyeardia.