生脉注射液不良反应特征及影响因素

Adverse Reaction Characteristics and Influencing Factors of Shengmai Injections

目的:探讨生脉注射液不良反应特征,为临床安全用药提供参考。方法:查询全国8家药品生产企业药品说明书并进行比较分析;对在中国知网数据库检索的该药不良反应及生产工艺的文献进行分析。结果:8家企业的药品说明书载明的不良反应具有不可预测性、发生率不明确、死亡率未提及、不良反应多为速发型;该药发生不良反应与药物本身、患者自身因素及生产工艺等方面有关。结论:建议有关企业补充生脉注射液说明书安全性信息内容;开展上市后研究;完善生产工艺,提高药品质量。

Objective： To explore the general characteristics of adverse drug reactions induced byShengmai injections for safe and rational use. Methods： Adverse reactions and production process ofShengmai injections were analyzed through comparing instructions from eight drug manufacturers andsearching publications in the CNKI databases. Results： The adverse reactions of Shengmai injections wereunpredictable with unknown incidence and mortality, and happened quickly; Possible causes included drugitself, the patients＇ own factors, related production technology and so on. Conclusion： Drug manufacturersare suggested to update their instructions with safety information, conduct post -marketing studies andimprove their production process for higher quality of medicines.