清开灵注射剂致82例不良反应/不良事件文献分析

目的:搜集清开灵注射剂临床使用中的药品不良反应/事件(ADR/ADE)文献报道,分析导致ADR/ADE的风险因素,为临床安全用药提供依据。方法:检索中国期刊全文数据库(CNKI)(1979-2010)、万方数据库(1982-2010),以"清开灵and(注射液or注射剂or粉针剂or冻干粉)and(不良反应or不良事件or病例报告)"为检索式,共收录来自35种期刊的82篇文献。结果:清开灵注射剂ADR/ADE可累及多个器官和系统,以过敏性休克导致的呼吸系统损害最为常见,其次是皮肤及其附件损害和全身性损害;以速发型为主,兼有迟发型,严重者可致死亡。结论:应加强清开灵注射剂的ADR/ADE监测,促进临床合理用药。

Literature Analysis of 82 Cases of Adverse Reactions/Events Caused by Qingkailing Injection

Objective： To investigate the situation of adverse drug reactions/events （ADRs/ADEs） in the clinical appli- cation of qingkailing injection and analyze the risk factors leading to the ADRs/ADEs so as to provide a reference for the safety of clinical medication. Methods： About 82 literatures of 35 journals were retrieved from CNKI （1979 - 2010） and Wanfang Database （ 1982 - 2010） by taking ＂qingkailing and （injection or powder-injection or freeze-dried powder） and （adverse reaction or adverse event or case-reporting）＂as the retrieval strategy. Results： The adverse drug reactions~events caused by qingkailing injection may implicate multiple organ systems. Respiratory damage caused by anaphylactic shock was the most common, followed by the skin and its appendages and systemic damages, mainly occurred as the rapid reac- tion and sometime as the late onset and severe cases can cause death. Conclusion： The monitoring of ADRs/ADEs caused by qingkailing injection should be strengthened so as to promote the rational drug use.