63例红花注射液的不良反应/事件分析及防治

Analysis and management of Honghua injection-induced adverse drug reactions/events in 63 patients

目的:分析红花注射液不良反应/事件发生的相关因素,探讨不良反应/事件发生的一般规律及特点,为红花注射液安全性再评价和红花注射液的二次开发提供依据,同时指导医生合理用药。方法:以"红花注射液"为关键词,利用中国期刊全文数据库(CNKI)、维普、万方等三大检索工具,检索2000年至2010年10月国内期刊发表的关于红花注射液不良反应/事件的临床文献,去除重复、报道不详细及综述文献,分析纳入研究中红花注射液的用药剂量、适应症、给药途径、方法、溶媒与不良反应/事件之间的关系。结果:红花注射液所引发的不良反应/事件主要为过敏性反应如过敏性休克、全身过敏反应和皮疹、喉头水肿及药物热和胸闷等。经治疗均好转,未见死亡病例报道。结论:临床医师药师应重视红花注射液的不良反应/事件,合理用药。注射时,在前30 min要加强监护,及早发现及早处理。

Objective： To explore the general pattern and characteristics of adverse drug reactions/events（ADR/ADE） induced by Honghua injection so as to establish safety assessment and the secondary development of Honghua injection,as well as to provide reference for clinical rational drug use.Methods： Honghua injection-induced ADR/ADEs reported in domestic medical journals during 2000-2010 were collected from CNKI,VIP and Wanfang Database with the keyword ＂Honghua injection＂.The relationship between the ADR/ADE and the dose,symptoms,route of administration,administration methods and solvent was analyzed.Results： The main type of Honghua injection-induced ADR/ADEs was allergic reaction,such as anaphylactic shock,systemic hypersensitivity reactions and skin rash,laryngeal edema,drug heat,and chest tightness.These reactions were attenuated after treatment.No death was reported.Conclusion： Clinical physicians and pharmaceutists should pay attention to Honghua injection-induced ADR/ADE and rational drug use.The use of Honghua injection should be under strict monitoring at the first 30 min,and the ADR/ADE should be observed and managed timely to reduce the occurrence of serious reactions.