注射用益气复脉(冻干)临床安全性集中监测研究

Clinical safety monitoring study of Yiqi Fumai Lyophilized Injection

目的考察注射用益气复脉(冻干)在临床广泛使用的安全性,进一步指导临床合理用药和完善说明书,并为企业制定风险管理计划提供依据。方法采用前瞻性、大样本、多中心集中监测的方法,纳入自2016年5月—2017年6月,共计44家医疗机构10 767例使用注射用益气复脉(冻干)的住院患者进行监测。记录患者基本情况、用药情况和不良反应发生情况,并进行数据统计和分析。结果本研究最终确定19例不良反应,发生率为0.176%;主要不良反应见于皮肤及其附属系统;其中不良反应组的滴注速度明显快于无不良反应组,差异具有统计学意义(P<0.05);所有不良反应最终均消失。结论注射用益气复脉(冻干)不良反应均属偶见,且不属于严重不良反应,临床应用相对安全,建议生产厂家应进行滴速方面的相关研究,进一步完善说明书信息、规范临床使用。

Objective To investigate the safety of Yiqi Fumai Lyophilized Injection in clinical use,including the type,incidence and risk factors of adverse events/adverse reactions,and to further guide the clinical rational use of drugs and improve the instructions.It also provides the basis for enterprises to formulate risk management plans.Methods The prospective,large sample,multi-center centralized monitoring method was used to include 10 767 inpatients in 44 medical institutions from May 2016 to June 2017.Record the patient’s basic condition,drug use,and adverse reactions,and conduct statistics and analysis.Results The total adverse reaction rate of Yiqi Fumai Lyophilized Injection was 0.176%,which was an occasional level,mainly found in the skin and its ancillary systems.Conclusion the adverse reaction of Yiqi Fumai Lyophilized Injection is rare,and the clinical application is relatively safe.It is recommended that the manufacturer should carry out the relevant research on the drop speed,further improve the instruction information and standardize the clinical use.