生脉注射液不良反应回顾性分析

Retrospective Analysis on Adverse Drug Reaction of ShengMai Injection

目的:分析生脉注射液所致药品不良反应(ADR)的药物流行病学特点,为临床合理安全使用提供参考。方法:通过检索维普(VIP)与中国知网(CNKI)数据库,收集生脉注射液ADR案例,应用统计学方法对ADR信息进行回顾性分析。结果:各年龄组均有分布,主要临床表现有:发热伴全身性损害、皮肤及附件损害、心血管系统一般损害、胃肠系统损害,且以速发型过敏反应为主。结论:生脉注射液虽然比较安全但有必要引起临床重视,应加强对生脉注射液不良反应(ADR)的监测,不盲目扩大适应证,此外还应加强质量标准的研究,注重优化生产工艺以确保临床用药安全。

Objective： In order to provide reference for medication safety through analyzing drug epidemiolog- ical characteristics of adverse drug reaction （ADR） of ShengMai injection. Method： Cases ofADR of ShengMai in- jection were collected by retrieving the CNKI and VIP database, ADR information were analyzed retrospectively with statistical method. Result： ADR of ShengMai injection happened in all the ages, main manifestations included： fever complicated with systemic damage, damage of skin and accessories, general damage of cardiovascular system, damage of gastrointestinal system, mainly immediate allergic reactions. Conclusion： ShengMai injection in clinical use is safer, but it＇s necessary that we should pay attention to the issue, we should enhance the monitor of ADR of ShengMai injection, not expand the indications blind, strengthen the study on quality control and value on optimiza- tion of production process to ensure clinical safety.