氢溴酸高乌甲素注射剂药品不良反应及风险因素分析

Analysis of Adverse Drug Reaction and Risk Factors Induced by Lappaconitine Hydrobromide Injection

目的探讨氢溴酸高乌甲素注射剂药品不良反应发生的规律、特点及影响因素,为临床安全用药提供参考。方法对山东省药品不良反应监测数据库中2017年1月至2021年12月1196例涉及氢溴酸高乌甲素注射剂药品不良反应报告的年龄、不良反应发生时间、不良反应累及系统和不良反应表现等进行分析。结果氢溴酸高乌甲素注射剂不良反应为多发生在用药1天内,主要累及皮肤及其附件、胃肠系统、中枢及外周神经系统损害;严重不良反应主要累及皮肤及其附件、呼吸系统、全身性损害。不良反应主要表现为瘙痒、皮疹、胸闷、寒战、发热、心悸、肝功能异常等,氢溴酸高乌甲素注射液严重不良反应报告占比显著高于注射用氢溴酸高乌甲素。结论应关注氢溴酸高乌甲素注射剂的药品不良反应,药品生产企业需加强安全用药的研究,进一步完善说明书,进一步保障用药安全。

Objective To probe into the status,characteristics and influencing factors of ADR(adverse drug reaction)cases induced by Lappaconitine Hydrobromide Injection,so as to provide reference for clinic safe use of drugs.Methods We analyzed 1196 ADR cases induced by Lappaconitine Hydrobromide Injection which were collected by Shandong adverse drug reaction monitoring database from January 2017 to December 2021.We analyzed the patient’s age,ADR occurrence time,adverse drug reactions involved system and the manifestation,etc.Results The ADRs induced by Lappaconitine Hydrobromide Injection occurred most frequently within 1 day of medication,mainly involved in skin and its accessories,gastrointestinal system,central and peripheral nervous system damage.Severe ADRs mainly involved in skin and its accessories,respiratory system,systemic damage.The ADRs mainly presented pruritus,rash,chest tightness,chills,fever,palpitations,abnormal liver function,etc.The incidence of serious adverse reactions of Lappaconitine Hydrobromide Injection was significantly higher than that of Lappaconitine Hydrobromide for Injection.Conclusion Attention should be paid to the ADRs induced by Lappaconitine Hydrobromide Injection.Pharmaceutical manufacturers need to strengthen the research on safe drug use and improve the drug package inserts so as to ensure the drug use safety.