目的 考察注射用益氣復脈（凍干）在臨床廣泛使用的安全性，進一步指導臨床合理用藥和完善說明書，并為企業(yè)制定風險管理計劃提供依據(jù)。方法 采用前瞻性、大樣本、多中心集中監(jiān)測的方法，納入自2016年5月-2017年6月，共計44家醫(yī)療機構10 767例使用注射用益氣復脈（凍干）的住院患者進行監(jiān)測。記錄患者基本情況、用藥情況和不良反應發(fā)生情況，并進行數(shù)據(jù)統(tǒng)計和分析。結(jié)果 本研究最終確定19例不良反應，發(fā)生率為0.176%；主要不良反應見于皮膚及其附屬系統(tǒng)；其中不良反應組的滴注速度明顯快于無不良反應組，差異具有統(tǒng)計學意義（P<0.05）；所有不良反應最終均消失。結(jié)論 注射用益氣復脈（凍干）不良反應均屬偶見，且不屬于嚴重不良反應，臨床應用相對安全，建議生產(chǎn)廠家應進行滴速方面的相關研究，進一步完善說明書信息、規(guī)范臨床使用。

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.