中国药物警戒 ›› 2019, Vol. 16 ›› Issue (2): 94-100.

• 安全性评价与合理用药 • 上一篇    下一篇

西沙必利用药者心血管系统不良事件发生率的Meta分析

孙一鑫1, 孟康康2, 夏玉坤2, 熊玮仪2, 邓思危1, 董铎2, 詹思延1,*   

  1. 1 北京大学公共卫生学院流行病与卫生统计学系,北京100191;
    2 国家药品监督管理局药品评价中心,北京100022
  • 收稿日期:2019-03-12 修回日期:2019-03-12 出版日期:2019-02-25 发布日期:2019-03-12
  • 作者简介:孙一鑫,女,在读硕士,药物流行病学与循证医学。

Incidence of Cardiac Adverse Events of Cisapride: a Systematic Review and Meta-analysis

SUN Yixin1, MENG Kangkang2, XIA Yukun2, XIONG Weiyi2, DENG Siwei1, DONG Duo2, ZHAN Siyan1,*   

  1. 1 Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China;
    2 Center for Drug Reevaluation, NMPA, Beijing 100022, China
  • Received:2019-03-12 Revised:2019-03-12 Online:2019-02-25 Published:2019-03-12
  • Contact: *詹思延,女,博士,教授·博导,药物流行病学与循证医学。E-mail：siyan-zhan@bjmu.edu.cn

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摘要： 目的 系统评价西沙必利用药者心血管系统不良事件的发生情况。方法 根据检索策略,系统检索CNKI、维普、万方和SinoMed数据库,纳入1994~2018年公开发表的有关西沙必利引起心血管系统不良事件的文章。由两位研究者独立筛选文献、提取数据和质量评价,使用随机效应模型进行心血管不良事件发生率的Meta分析,并按照研究人群、用药方式、用药剂量与疗程进行亚组分析。结果 最终纳入53篇文献,包括57项研究。在38项小样本研究中进行Meta分析,计算心血管不良事件总体发生率为5.61%（95% CI: 3.49%,8.10%）,其中心慌/心悸、QT间期延长和心律失常的合并发生率分别为4.10%（95% CI: 2.84%,5.54%）、10.98%（95% CI: 5.13%,18.34%）和0.40% （95% CI: 0.00%,1.44%）。另外,研究检索到3项基于数据库开展的专门针对西沙必利与心律失常发生风险的大样本研究,报告的心律失常发生率范围在0.91~1.28/1 000人年。亚组分析结果显示,儿童用药者发生QT间期延长的风险可能较高。汇总个案报告结果,多为QT间期延长、尖端扭转型室性心动过速等严重事件报告,有3例合并其他疾病的患者死亡。结论 西沙必利可引起心血管系统不良事件,对于某些特殊人群可导致包括死亡在内的严重后果,应重视用药安全,严格遵循适应证、禁忌和注意事项用药。

关键词: 西沙必利, 心血管系统不良事件, 发生率, Meta分析

Abstract: Objective To systematically evaluate the incidence of cardiac adverse events of cisapride. Methods CNKI, VIP, WanFang and SinoMed databases were searched for eligible studies reporting the cardiac adverse events of cisapride from 1994 to 2018, using the chemical names or trade names of cisapride as keywords. Two researchers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the quality of included studies. Random-effects Meta-analysis was conducted to pool the incidence of cardiac adverse events, and subgroup analysis was performed based on the population, mode and dosage of medicine. Results A total of 53 articles were included, involving 57 researches. In 38 studies with small sample size, the results of Meta-analysis showed that the overall incidence of cardiac adverse events was 5.61% (95% CI: 3.49%, 8.10 %). The adverse event reported most was palpitation, followed by QT prolongation and arrhythmia, with the pooled incidence of 4.10% (95% CI: 2.84%, 5.54%), 10.98% (95% CI: 5.13%, 18.34%) and 0.40% (95% CI: 0.00%, 1.44%), respectively. Three database studies with large sample size, which focused on cisapride and the risk of arrhythmia, reported the incidence of arrhythmia ranging between 0.91 and 1.28/1 000 person-years. The subgroup analysis suggested that children had higher risks of QT prolongation. 16 case reports included 17 adverse events, most of which were severe adverse drug events, such as QT prolongation and torsade de pointes. Three cases with comorbidity died, which suggested the cardiac risk of cisapride may increase for some special patients. Conclusion Cisapride was associated with potential cardiac toxicity. Prescribers should strictly follow the indications and contraindications to ensure clinical medication safety.

Key words: cisapride, cardiac adverse events, incidence, Meta-analysis

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