细辛脑注射液不良反应监测情况浅析

目的通过分析细辛脑注射液不良反应监测病例,为本品进行上市后安全性再评价研究提供参考。方法用同一方法统计本品2000年至2009年发生在同一地区的1429例不良反应报告数据,进行分析讨论,并与从CNKI和维普资讯数据库收集到的2000年至2009年本品不良反应文献报道情况进行比较。结果本品新的、严重的不良反应发生率较高,新的不良反应主要为皮肤及其附件受损,严重的不良反应主要为过敏样反应、过敏性休克;不良反应发生人群以小孩为主。结论本品的临床应用较广,不良反应报告逐年增多,新的、严重的不良反应发生率较高,本品需要加强使用风险管理。

A Breif Analysis on ADR Monitoring Situation of Asarone lnjection

Objective To provide reference for the study of Post-Marketing safety Re-evaluation on as-arone injection,by analyzing it’s adverse reactions cases. Methods By analyzing the reporting data of 1,429 ADR cases which happened in the same area from 2000 to 2009,and compared it with the ADR cases reported in the literature from 2000 to 2009 that collected by searching for CNKI and VIP journals database. Results The new and serious adverse reactions of asarone injection have higher incidence,and the new ADR mainly is the damage of skin and its appendages,the serious ADR were allergic-like reaction and anaphylactic shock; and it mainly occurred on children. Conclusion It has a wide clinical application whose ADR reported has in-creased year by year and the incidence of new,serious ADR was higher. It’s necessary to strengthen the risk management of asarone injection.