尹聪 陈鑫 涂星 袁丽君 佟智斌 孙辉

【摘 要】 目的：采用Meta分析初步评价灯盏细辛注射液临床应用的不良反应，分析其临床安全性，为临床应用提供参考。方法：计算机检索中国知网、万方、维普和PubMed数据库从建库至2018年1月公开发表的有灯盏细辛注射液的临床随机对照研究。采用RevMan5.3软件，对灯盏细辛注射液不良反应发生率进行Meta分析。同时对不同适应症、不同对照措施、不同疗程的不良反应发生率进行亚组分析。结果：最终符合纳入标准的文献共35篇。Meta分析显示，灯盏细辛注射液不良反应发生率与对照组相比[RR=0.83（0.51，1.34）]，两组间比较差异无统计学意义（P=0.44）。亚组分析显示，不同对照措施中硝酸甘油亚组中灯盏细辛注射液不良反应发生率显著低于对照组（P=0.02），复方丹参亚组中灯盏细辛注射液不良反应发生率显著高于对照组（P=0.08），而不同适应症亚组和不同疗程亚组灯盏细辛注射液的不良反应发生率与对照组相比差异无统计学意义（P≥0.10）。结论：灯盏细辛注射液与硝酸甘油注射液相比，临床不良反应发生率低，疗效好；与复方丹参注射液相比，不良反应发生率高，疗效相对较差。

【关键词】 灯盏细辛注射液；不良反应；Meta分析；亚组分析

【中图分类号】R287 【文献标志码】 A【文章编号】1007-8517（2018）15-0047-08

Abstract：Objective To evaluate the clinical application of Erigeron Breviscapus Injection by Meta-analysis， and to provide a reference for its clinical application. Methods A computerized randomized controlled clinical trial was conducted in CNKI， Wanfang， VIP and PubMed databases published from January， 2018 to the present. Using RevMan5.3 software Meta analysis of the incidence of adverse reactions Erigeron Injection. At the same time， different indications， different control measures， the incidence of adverse reactions in different courses for subgroup analysis. Results The 35 final articles meeting the inclusion criteria were included. Meta analysis showed that the incidence of adverse reactions of Dengzhanxixin injection compared with the control group [RR= 0.83 （0.51， 1.34）]， no significant difference between the two groups （P=0.44）. Subgroup analysis showed that the incidence of adverse reactions of Dengzhanxixin Injection in different control groups was significantly lower than that of the control group in the nitroglycerin subgroup （P=0.02）， and that in the compound Danshen subgroup （P=0.08） The incidence of reaction was significantly higher than that of the control group， while the incidence of adverse reactions of different indications subgroups and different courses of treatment were not significantly different from those of the control group. Conclusion Compared with nitroglycerin injection， Erigeron breviscapus injection has a low incidence of clinical adverse reactions and good curative effect. Compared with compound Danshen injection， the incidence of adverse reactions is high， and the curative effect is relatively poor.

Keywords：Erigeron Breviscapus Injection； Adverse Reactions； Meta Analysis； Subgroup Analysis

灯盏细辛注射液是云南道地药材灯盏细辛中提取酚酸类成分制成的灭菌水溶液（批准文号：国药准字Z53021569），主要含野黄芩苷（C21H18O12）和总咖啡酸酯（C25H24O12），具有活血袪瘀，通络止痛的功效，是用于缺血性中风、冠心病心绞痛治疗的常用中药注射剂。……