首页|基于真实世界监测数据分析吡拉西坦注射剂不良反应

基于真实世界监测数据分析吡拉西坦注射剂不良反应

扫码查看
目的 分析吡拉西坦注射剂药品不良反应的用药特点和影响因素,为临床安全用药提供参考。方法 收集 2017~2022 年河北省内吡拉西坦注射剂不良反应报告,进行回顾性分析。结果 1 012 例吡拉西坦注射剂不良反应报告中,主要集中在中老年患者(>85%);涉及的药品以高浓度(20%)吡拉西坦氯化钠注射液为主;累及系统-器官主要为全身性损害(28。55%)和皮肤及附件损害(24。31%)。结论 药品上市许可持有人应持续加强上市后产品监测,特别是对老年患者使用吡拉西坦的用药监护。临床应严格按照说明书用药,并密切监测过敏性休克等严重不良反应的发生。
Analysis of adverse reactions of piracetam injection based on real-world monitoring data
Objective To analyze the characteristics and influencing factors of adverse drug reactions(ADR)caused by piracetam injection,and the related risk factors of these adverse reactions,so as to provide reference for safe clinical medication.Methods ADR reports of piracetam injection in Hebei province from 2017 to 2022 were collected and analyzed retrospectively.Results Among the 1 012 ADR cases of piracetam injection,most of them were middle-aged and elderly patients(>85%);the adverse drug reactions were mainly caused by high concentration of piracetam and sodium chloride injection(20%);the main system-organs involved were systemic damage(28.55%)and skin and accessory damage(24.31%).Conclusion Marketing authorization holder(MAH)should continue to strengthen post-marketing product monitoring,especially for the use of piracetam in elderly patients.Clinicians should strictly follow the instructions and closely monitor the occurrence of severe adverse reactions such as allergic shock.

Piracetam injectionAdverse drug reactionsRational drug useSafety

黄静、冯亚楠

展开 >

石家庄市药品不良反应监测中心,石家庄 050090

河北省药品审评中心,石家庄 050090

吡拉西坦注射剂 药品不良反应 合理用药 安全性

河北省药品监督管理局科技计划项目

2022ZC1051

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(9)