一项多中心、随机、双盲、平行对照临床研究——评价酒石酸美托洛尔片联合通脉养心丸治疗室性早搏的有效性和安全性

A multicenter, randomized, double-blind, parallel controlled clinical study:evaluate the efficacy and safety of metoprolol tartrate tablets combined with tongmai yangxin pill on premature ventricular contraction

目的研究酒石酸美托洛尔片联合通脉养心丸对室性早搏的治疗作用。方法584例室性早搏患者采用数字表法随机分成两组:试验组(n=292):酒石酸美托洛尔片(1片/次,2次/d)联合通脉养心丸(40丸/次,2次/d);对照组(n=292):酒石酸美托洛尔片(1片/次,2次/d)联合通脉养心丸模拟剂(40丸/次,2次/d);疗程均为8周。结果经过8周治疗后,试验组早搏次数下降4 537次,下降率为(63±53)%,治疗总有效率为76.4%,对照组早搏次数下降3 013次,下降率为(42±64)%,治疗总有效率为51.4%,两组患者室性早搏次数比较,差异有统计学意义(P<0.05)。两组患者不良事件和不良反应发生率比较,差异无统计学意义(P>0.05)。结论酒石酸美托洛尔片联合通脉养心丸对室性早搏的治疗作用显著,能明显减少患者的室性早搏次数。

Objective To investigated the effects of metoprolol tartrate tablets combined with tongmai yangxin pill(TMYXP)on premature ventricular contraction(PVC).Methods The 584 patients with PVC were randomly assigned at a 1∶1 ratio into 2 groups:the treatment group(n=292,metoprolol tartrate tablets 2 tablets/d combined with TMYXP 80 pills/d)and the control group(n=292,metoprolol tartrate tablets 2 tablets/d combined with simulant TMYXP 80 pills/d).The total study period was 8 weeks.Results After treatment,the number of PVC in the treatment group decreased by 4 537 times,with a decrease rate of(63±53)%,and the total effective rate was 76.4%.The number of PVC in the control group decreased by 3 013 times,with a decrease rate of(42±64)%,and the total effective rate was 51.4%.The difference between the two groups was statistically significant(P<0.05).There was no significant difference in the incidence of adverse events and adverse reactions between the two groups(P>0.05).Conclusion Metoprolol tartrate tablets combined with TMYXP could effectively reduce the number of PVC.