535例氢溴酸高乌甲素制剂新的和严重的药品不良反应报告分析

535 reports of new and serious adverse drug reactions caused by preparations of lappaconitine hydrobromide

目的分析氢溴酸高乌甲素制剂新的和严重的药品不良反应(ADR)临床表现,为临床合理用药提供参考。方法对2011年1月1日至2021年12月31日山东省药品不良反应数据库中535例涉及氢溴酸高乌甲素制剂新的和严重的ADR报告进行回顾性分析。结果氢溴酸高乌甲素制剂新的和严重的不良反应发生人群以45~64岁为主,不良反应多发生在用药1 d内,主要累及胃肠、全身性、皮肤及其附件、神经等多系统-器官损害,肝功能异常、过敏反应、过敏性休克等风险在说明书中均未提及。结论氢溴酸高乌甲素制剂药品说明书警示力度不足,药品上市许可持有人需加强对上市后数据的研究,进一步完善说明书,保障患者用药安全。

Objective To study the clinical manifestations of adverse drug reactions(ADR)caused by lappaconitine hydrobromide as reference for clinical rational drug use.Methods A total of 535 reports of new and serious ADR involving lappaconitine hydrobromide in Shandong Provincial ADR Database from January 1,2011 to December 31,2021 were retrospectively analyzed.Results The new and serious adverse reactions of lappaconitine hydrobromide were more prevalent in people ages 45~65,and most of the ADR occurred within one day of administration.The ADR of lappaconitine hydrobromide mainly presented as multiple systemic and organ damage such as gastrointestinal damage,systemic damage,and damage to the skin and its attachments.The risks of abnormal liver function,allergic reactions or anaphylactic shock were not mentioned in the instructions.Conclusion The warning in the instructions for preparations of lappaconitine hydrobromide is inadequate.Marketing authorization holders need to study post-marketing data and improve the instructions to ensure the safety of patients.