崔瑞昭+谢雁鸣+廖星+王冀东

[摘要] 系统评价苦碟子注射液用药安全性。计算机检索Cochrane图书馆、Medline、EMbase、Web of Science、Clinical Trials、CBM、CNKI、VIP、万方数据库和中国临床试验注册中心，收集关于苦碟子注射液所有研究类型文献。根据纳入排除标准筛选文献、提取资料。所有纳入研究均按目前国际上公认的方法学质量评价工具或报告质量评价标准进行评估；采用Stata 12.0软件对苦碟子注射液的不良反应（ADR）进行Meta分析。该系统评价共纳入411个研究，最终分析315个研究，使用苦碟子注射液的患者共18 072例，累计发生330例ADRs和13例AEs。最常见的ADR为中枢及外周神经系统损害，加权合并发生率为2.9%[95%CI（0.022，0.036）]。该研究分析发现苦碟子注射液总体安全性可接受，现虽系统分析了关于该药安全性病例报告的直接证据，但缺少针对该药上市后安全性的机制研究或前瞻性长期的临床观察性研究，因此关于其安全性研究还需进一步深入；同时苦碟子注射液在适应症方面，存在严重超说明书使用范围，迫切需要相关部门制定用药规范，给临床用药提供更好的指导。

[关键词] 苦碟子注射液； 安全性； 不良反应/事件； 系统评价； Meta分析

[Abstract] To systematically evaluate the safety of Kudiezi injection. Databases such as Cochrane library， Medline， EMbase， Web of Science， Clinical Trials， CBM， CNKI， VIP， Wanfang and Chinese Clinical Trial Register were searched to collect the literature on all the study types of Kudiezi injection. Two researchers screened literature， assessed quality and extracted data according to inclusion and exclusion criteria. All studies were assessed by using internationally recognized methodological quality assessment tools or reporting quality evaluation criteria； Meta-analysis of adverse drug reaction/adverse events （ADR/AE） of Kudiezi injection was performed by using Stata 12.0 software. There were 411 clinical studies included， out of which 315 studies were analyzed finally. 18 072 patients in total used kudiezi injection， and there were 330 cases with ADRs and 13 cases with AEs. The most common ADR related system was the central and peripheral nervous system， with a weighted incidence of 2.9% [95%CI（0.022， 0.036）]. From the current evidence， the overall safety of Kudiezi injection was acceptable. Although data could be collected from all kinds of published reports， there are lack of mechanism experiments or observational studies with large samples of Kudiezi injection. Therefore， it is necessary to carry out further research on the safety of Kudiezi injection. Meanwhile， off label use of Kudiezi injection is common， so it is urgent for relevant governmental departments to formulate drug use specifications and provide better guidance for clinical drug use.

[Key words] Kudiezi injection； safety； adverse drug reaction/adverse events； systematic review； Meta-analysis

苦碟子異名满天星，药用原植物为抱茎苦荬菜Ixeris sonchifolia （Bunge） Hance，是菊科苦荬菜属二年生草本植物，以干燥全草入药。该药材目前尚未收入到《中国药典》，只在《内蒙古中草药》中记载，有清热解毒，活血止痛，排脓等功效[1-2]。苦碟子注射液是以苦碟子为原料提取精制而成的中药注射液。从国家食品药品监督管理总局（CFDA）的网站查询到，目前国内有2家公司生产苦碟子注射液，分别是通化华夏药业有限责任公司生产的碟脉灵注射液（国药准字Z20025450）和沈阳双鼎制药有限公司生产的悦安欣注射液（国药准字Z20025449）。……