121例纤溶酶注射剂不良反应报告分析

Analysis of 121 Cases of Adverse Drug Reactions Caused by Fibrinogenase Injection

目的:探讨纤溶酶注射剂不良反应(ADR)的特点及其可能的原因,为临床安全用药提供参考。方法:收集浙江省药品不良反应监测中心数据库中2010年1月～2018年4月上报的121例纤溶酶注射剂ADR报告,分别按ADR类型、患者性别、年龄、用药原因、用药情况、累及系统/器官及临床表现、发生时间等进行统计分析。结果:纤溶酶注射剂新的ADR占95.04%,以45岁以上的患者居多(94.20%);ADR累及系统/器官主要为全身性反应,严重的ADR主要表现为胸闷、寒战、过敏样反应、发热、呼吸困难等;ADR主要发生在用药过程中。结论:临床应重视纤溶酶注射剂引起的ADR,尤其是严重过敏反应;生产企业应完善药品说明书安全性信息,以指导临床安全用药。

Objective:To investigate the occurrence and characteristics of adverse drug reactions(ADRs)caused by fibrinogenase injection,so as to provide reference for safety medication in the clinic.Methods:The retrospective study method was used to analyze 121 cases of ADRs caused by fibrinogenase injection.These ADRs were collected by Zhejiang ADRs monitoring system from January 2010 to April 2018.The analysis includes the type of reports,the case of gender,age,medication situation,adverse drug reactions and occurrence time.Results:95.04%cases were new ADR reports.ADRs caused by fibrinogenase injection mostly occurred in the patients aged above 45 years old(94.2%).The SOCs mostly involved in ADRs were systemic reaction.The main clinical manifestations of serious ADRs are chest distress,rigors,anaphylactoid reaction,fever,dyspnea,etc.Adverse reactions mainly occur in the course of medication.Conclusion:More attention should be paid to ADRs caused by Fibrinogenase injection in clinic,especially the serious allergic reaction.Drug manufacturers should promptly improve the safety information of drug instructions.,so as to guide the clinical safety medication.