注射用鼠神经生长因子安全性风险的分析及思考

Risks of Gastrodin Injection

目的分析注射用鼠神经生长因子的安全性风险,为临床合理用药提供参考。方法对2004年1月1日至2019年10月31日我国药品不良反应监测数据库和自建库起至2020年2月29日国内外文献数据库中的不良反应报告及国内风险控制措施等相关资料进行整理与分析。结果和结论应严格按照说明书规定的用法用量使用本品,关注本品的严重过敏等不良反应,严格把握特殊人群用药指证。药品生产企业应加强企业产品不良反应监测与评价的主体责任,健全药品不良反应信息收集渠道,加强药品不良反应的分析评价,及时完善药品说明书安全性信息,必要时应主动开展上市后安全研究。

Objective To analyze the risk of the mouse nerve growth factor for injection in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions reported in China adverse drug reaction(ADR) database between January 1, 2004 and October 31, 2019,domestic and foreign literature published from the inception of the library to February 29, 2020, and risk management measures taken in China were analyzed. Results and Conclusion It was found that this product should be used at the dosage stipulated in the specifications, clinicians should be alert to such adverse reactions as severe allergies, and that indications of special populations should be monitored. Drug manufacturers should assume more responsibility for adverse drug reaction monitoring and evaluation, improve the information collection channels of ADR, upgrade the analysis and evaluation of adverse drug reactions, update the information on safety in drug labels, and take the initiative to carry out post-market safety studies when necessary.