首都医科大学学报 ›› 2019, Vol. 40 ›› Issue (3): 389-395.doi: 10.3969/j.issn.1006-7795.2019.03.013

• 心血管疾病临床研究 • 上一篇    下一篇

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

孙希鹏1, 诸国华1, 罗鸿宇2, 刘荣坤1, 杨峥1, 李静1, 徐津鹏3, 耿彤3, 张恺骅3, 华琦1   

  1. 1. 首都医科大学宣武医院心脏内科, 北京 100053;
    2. 首都医科大学宣武医院老年综合科, 北京 100053;
    3. 中新药业
  • 收稿日期:2019-03-15 出版日期:2019-05-21 发布日期:2019-06-13
  • 通讯作者: 华琦 E-mail:huaqi5371@sina.com

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

Sun Xipeng1, Zhu Guohua1, Luo Hongyu2, Liu Rongkun1, Yang Zheng1, Li Jing1, Xu Jinpeng3, Geng Tong3, Zhang Kaihua3, Hua Qi1   

  1. 1. Department of Cardiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China;
    2. Department of Geriatric Medicine, Xuanwu Hospital, Capital Medical University, Beijing 100053, China;
    3. Zhongxin Pharmaceuticals
  • Received:2019-03-15 Online:2019-05-21 Published:2019-06-13

摘要: 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。

关键词: 酒石酸美托洛尔片, 通脉养心丸, 室性早搏

Abstract: 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.

Key words: metoprolol tartrate tablets, tongmai yangxin pill, premature ventricular contraction

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