二参复脉胶囊对比心宝丸干预老年窦性心动过缓优效性及安全性随机对照双盲试验  

The Superiority and Safety of Ershen Fumai Capsules(二参复脉胶囊)versus Xinbao Pills(心宝丸)for Senile Sinus Bradycardia:a Randomized Double-Blinded Clinical Trial

作　　者：郭建丽[1] 牛天福[1] 杨小燕[1] 耿强[1] 祁慧霞[1] 王建萍[1] 李娟[1] 曲润波[1] GUO Jianli;NIU Tianfu;YANG Xiaoyan;GENG Qiang;QI Huixia;WANG Jianping;LI Juan;QYU Runbo(Shanxi Province Hospital of Traditional Chinese Medicine,Taiyuan,030012)

机构地区：[1]山西省中医院,山西省030012

出　　处：《中医杂志》2021年第3期224-228,共5页Journal of Traditional Chinese Medicine

摘　　要：目的观察二参复脉胶囊对比心宝丸治疗老年窦性心动过缓的优效性及安全性。方法将120例老年窦性心动过缓患者随机分为治疗组与对照组各60例,两组均予常规原发病对症治疗,在此基础上治疗组口服二参复脉胶囊(每粒0.5g,每次4粒)+心宝丸安慰剂(每次5丸),对照组口服心宝丸(每丸60mg,每次5丸)+二参复脉胶囊安慰剂(每次4粒),两组服药均每日3次,连续8周。治疗前后两组患者分别进行24小时动态心电图、心率变异性、血脂、血流动力学各指标检测及血常规、尿常规、便常规、肝功能、肾功能、电解质等安全性指标检测,治疗后评价两组患者中医证候疗效及动态心电图疗效。结果治疗组中医证候疗效总有效率85.0%,动态心电图疗效总有效率88.3%,对照组分别为68.3%、70.0%,两组比较差异均有统计学意义(P<0.05)。两组治疗后动态心电图最快心率、最慢心率、平均心率、总心率及心率变异性时域分析各指标均有明显提高(P<0.05);与对照组比较,除心率变异性时域分析指标相邻NN间期差值的均方根外,治疗后治疗组上述各指标均提高更明显(P<0.05)。两组治疗后血脂水平包括总胆固醇、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇,血流动力学指标包括左室射血分数、每搏射血量、心排血量、心排血指数均较本组治疗前改善(P<0.05)。安全性分析方面,治疗组与对照组随访不良事件发生率及治疗前后各安全性指标差异均无统计学意义(P>0.05)。结论二参复脉胶囊治疗老年窦性心动过缓疗效优于心宝丸,二者安全性相当。Objective To explore the superiority and safety of Ershen Fumai Capsules(二参复脉胶囊)versus Xinbao Pills(心宝丸)for the treatment of senile sinus bradycardia.Methods Totally 120 elderly patients with sinus bradycardia were randomly divided into a treatment group and a control group with 60 patients in each group.Besides the conventional treatment for the primary diseases,Ershen Fumai Capsules(0.5 g each capsule,4 capsules per time)plus Xinbao Pills placebo(5 pills per time)were given in the treatment group,while Ershen Fumai Capsules placebo(4 capsules per time)plus Xinbao Pills(60 mg each pill,5 pills per time)were given in the control group,all medication three times daily,for eight weeks.The 24-hour dynamic electrocardiogram,heart rate variability(HRV),blood lipids,hemodynamic indicators,as well as safety indicators including blood routine,urine routine,stool routine,liver function,kidney function,and electrolytes were measured before and after treatment.The effects on traditional Chinese medicine(TCM)syndromes and dynamic electrocardiogram were evaluated.Results In the treatment group,the total effective rate by TCM syndromes was 85.0%,and the total effective rate by dynamic electrocardiogram was 88.3%,while those in the control group were 68.3%and 70.0%,respectively(P<0.05).The fastest heart rate,slowest heart rate,average heart rate,total heart rate,and HRV at different time-domain measurements were significantly improved in both groups after treatment(P<0.05),with more improvements in treatment group than control group in all above indicators except for the root mean square of differences between adjacent or neighboring NN intervals(P<0.05).The blood lipid indicators including total cholesterol,triglycerides,high-density lipoprotein cholesterol,low-density lipoprotein cholesterol,as well as the hemodynamic indicators including left ventricular ejection fraction,stroke volume,cardiac output and cardiac index were all improved in both groups after treatment(P<0.05).There were no significant differe

关 键 词：老年窦性心动过缓 心律失常 二参复脉胶囊 心宝丸 心率变异性 

分 类 号：R259[医药卫生—中西医结合]