688例米索前列醇药品不良反应报告分析

目的分析米索前列醇的药品不良反应(ADR)报告数据,了解该药ADR发生的特点和临床使用情况,为临床安全合理用药提供参考。方法由北京市药品不良反应监测中心提供2003年至2018年米索前列醇的ADR报告数据,对发生ADR的患者基本情况、ADR类型、累及系统-器官及临床表现、转归数据等信息进行统计分析。结果共有688例ADR报告纳入分析,ADR累及系统-器官以胃肠疾病、全身整体疾病、皮肤及皮肤附件疾病、神经系统疾病等为主。共有5例严重ADR,主要表现为过敏性休克,其中死亡1例。结论上报米索前列醇ADR的患者均为女性,用药目的多为药物流产,需要有针对性地做好ADR的预防和处置。对高风险人群要进行药学监护和干预,使临床用药做到安全、合理、有效。

Analysis of 688 Cases of Adverse Drug Reaction Induced by Misoprostol

Objective To analyze the adverse drug reactions(ADR)induced by misoprostol,find out about the characteristics of such ADR and to provide technical support for safe clinical application of misoprostol.Methods Data on ADR of misoprostol between 2003 and 2018 was provided by Beijing Adverse Drug Reaction Monitoring Center.Statistical analysis was performed on the basic information of patients with ADR,types of ADR,involved system-organ and clinical manifestations,and outcomes.Results A total of 668 reports of ADR were included in the analysis.ADR mainly manifested themselves in gastrointestinal diseases,systemic diseases,skin and its appendage diseases,and nervous system diseases.There were a total of 5 cases of severe ADR,including one case of death,in which anaphylactic shock was observed.Conclusion Most of the patients who reported ADR were females who used misoprostil for abortion purposes.This indicates the need to strengthen the safe and rational use of misoprostol in clinic.Pharmaceutical care and intervention should be carried out for high-risk groups to make clinical medication safe,proper and effective.