中西医联合治疗对室性期前收缩患者心脏功能影响的多中心、随机、双盲、平行对照临床研究

Effect of combination of Chinese traditional medicine and western medicine on cardiac function in patients with premature ventricular contraction: a multi-center, randomized, double-blind, parallel controlled clinical study

目的研究酒石酸美托洛尔片联合通脉养心丸对室性期前收缩患者心功能的影响。方法采用随机数字表按1∶1的比例,将584例室性期前收缩患者随机分成试验组(292例)和对照组(292例),试验组患者给予酒石酸美托洛尔片(1片/次,2次/d)联合通脉养心丸(40丸/次,2次/d),对照组给予酒石酸美托洛尔片(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,比较两组的心功能治疗有效率。结果两组的一般情况、基线心功能分级(NYHA分级)和超声心动图指标相似(均为P>0.05)。经过8周治疗后,试验组心功能总有效率为21.9%,对照组为12.4%,差异有统计学意义(χ^2=8.403,P=0.004)。同时,试验组与对照组对超声心动图指标均有一定改善作用,且试验组的左室射血分数提高值明显优于对照组[1.00(-6.00,9.00)比0.00(-9.00,7.00),Z=1.987,P=0.047]。结论酒石酸美托洛尔片联合通脉养心丸可提高室性期前收缩患者的左室射血分数。

Objective To investigate the effect of metoprolol tartrate tablets combined with Tongmai Yangxin Pills(TMYXP)on cardiac function in patients with premature ventricular contraction(PVC).Methods According to the random number table,584 patients with PVC were randomly assigned into two groups by 1∶1 ratio.The 292 patients in the treatment group were given metoprolol tartrate tablets,50 mg twice a day combined with TMYXP,40 pills twice a day,while 292 patients in the control group were given metoprolol tartrate tablets,50 mg twice a day combined with TMYXP placebo,40 pills twice a day for 8 weeks.The heart function was compared between the 2 groups.Results The general condition,baseline heart function grading(NYHA grading)and echocardiographic parameters were similar in the two groups(all P>0.05).After 8-week treatment,the effective rate was 21.9%in the treatment group and 12.4%in the control group with statistically significant difference(χ^2=8.403,P=0.004).Echocardiographic parameters showed some improved in both groups.Compared with control group,left ventricular ejection fraction(LVEF)was significant improved in the treatment group[1.00(-6.00,9.00)vs.0.00(-9.00,7.00),Z=1.987,P=0.047].Conclusions Metoprolol tartrate tablets combined with TMYXP may be helpful for improvement of LVEF in patients with PVC.