63例红花注射液的不良反应/事件分析及防治

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。

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

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.