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[摘要]
系统评价稳心颗粒与美托洛尔联用治疗室性早搏的疗效与安全性。计算机检索1995-2014 年中国知网全文数据库(CNKI)、万方数据库(WF)、维普中文科技期刊数据库(VIP)、江苏省工程技术文献信息中心、Co-chrane 图书馆临床对照试验资料库(CCRCT)、Medline、Sciencedirect 中的文献,并对最终数据采用RevMan 5.2 进行Meta 分析。共纳入20项研究(包含1 568 例患者)。Meta 分析结果显示,稳心颗粒与美托洛尔联用(治疗组)与单独使用美托洛尔(对照组)治疗室性早搏的临床症状改善的有效率 [RR=1.26,95% CI(1.17,1.36),P < 0.000 01]、室性早搏疗效的有效率 [RR=1.22,95% CI(1.16,1.29),P < 0.000 01]、总体不良反应发生率 [RR=0.70,95% CI(0.50,0.98),P=0.04] 的差异均具有统计学意义。针对相对较严重的不良反应进行亚组分析,两组间房室传导阻滞发生率的差异具有统计学意义 [RR=0.20,95% CI(0.04,0.89),P=0.04],但心动过缓的发生率并无统计学差异 [RR=0.54,95% CI(0.26,1.09),P=0.08]。进行敏感分析后,除了总体不良反应的发生率与基础分析的结果不一致,其余结局指标均与基础分析结果一致。稳心颗粒与美托洛尔联用治疗室性早搏比单用美托洛尔能够有效改善患者症状,显著减少室性早搏。但2 组间总体不良反应及心动过缓发生率的差异并未有统计学意义,房室传导阻滞发生率的差异也处在统计学意义的边缘,尚待扩大样本量后进一步分析。
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[Abstract]
To evaluate the clinical efficacy and safety of Wenxin Granule combined with metoprolol for treatment of ventricular premature. We searched CNKI, Wanfang Database, VIP, Jiangsu Engineering Technology Literature Information Center, CCRCT, Medline, and Sciencedirect from 1995 to 2014. Meta analysis was performed using Rev Man 5.2 software. Twenty trials were involved, including 1 568 cases. The results showed that there was significant difference in the clinical symptom effectiveness of Wenxin Granule combined with metoprolol and metoprolol alone in the treatment of ventricular premature [RR=1.26, 95% CI (1.17, 1.36), P < 0.000 01], as with the clinical effectiveness [RR=1.22, 95% CI (1.16, 1.29), P < 0.000 01] and the incidence of adverse drug reactions [RR=0.70, 95% CI (0.50, 0.98), P=0.04]. A subgroup analysis was done in the view of the severe adverse reaction. The results showed that there was significant difference in the incidence of atrioventricular block between the two groups [RR=0.20, 95% CI (0.04, 0.89), P=0.04], while no significant difference was found in the incidence of bradycardia [RR=0.54, 95% CI (0.26, 1.09), P=0.08]. The results of sensitivity analysis of final indicators were consistent with the fundamental analysis except the incidence of adverse drug reactions. Comparing with metoprolol alone, Wenxin Granule combined with metoprolol for treatment of ventricular premature can effectively improve the symptoms of patients, and significantly diminish the ventricular premature, while there is no significant difference in the incidence of total adverse drug reactions and bradycardia between the two groups. Also the difference in the incidence of atrioventricular block is with marginal significance. So the safety between the two groups may need further study after more samples be tested.
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