盐酸溴己新注射剂安全性风险的分析及思考

摘要

Obje ctive To analyze the risk of bromhexine hydrochloride injections in China, so as to provide reference for clinical rational drug use. Me thods The individual adverse drug reaction cases in WHO Vigilyze and China Adverse Drug Reaction Database, domestic literatures, and the domestic and foreign risk management measures were analyzed. Results The risk of serious allergic reaction and use of medicines in children should be concerned. Conclusion We should strengthen the clinical application monitoring of bromhexine hydrochloride injections, timely update the drug labeling and promote the rational application of medicine.%目的 分析盐酸溴己新注射剂的安全性风险,为临床合理用药提供参考.方法 对世界卫生组织药品不良反应监测数据库、我国药品不良反应监测数据库、国内文献数据库中的不良反应报告及国内外风险控制措施等相关资料进行整理与分析.结果 应关注盐酸溴己新注射剂严重过敏反应及儿童用药等相关风险.结论 须加强盐酸溴己新注射剂的临床应用监测,及时完善产品说明书,促进药品的合理使用.