西咪替丁注射剂不良反应分析

Analysis of Adverse Reactions of Cimetidine Injection

目的:分析西咪替丁注射剂的药品不良反应(ADR),为临床安全用药提供参考。方法:对西咪替丁注射剂在我国上市及管理情况、国家药品不良反应监测系统湖北省数据库ADR报告、国内西咪替丁注射剂ADR文献资料,根据个例文献及临床研究文献进行分类汇总,提取病例信息进行整理与分析。结果:我国上市的西咪替丁注射剂均为国产药品,其所致ADR类型广泛,可致多系统-器官损害,常见ADR为神经毒性、全身性损害、心血管系统损害和呼吸系统损害,严重可致过敏性休克、心脏骤停、肝功能损害等,老年患者和儿童用药发生严重ADR的风险增加,临床超剂量和超适应证用药应予以关注。结论:为保障公众用药安全,上市许可持有人、医疗机构和监管监测部门应共同努力,加强药品ADR监测工作,规范临床合理用药,完善药品说明书不良反应和特殊人群用药等安全性信息。

Objective:To analyze the adverse drug reaction(ADR)of cimetidine injection and provide reference for its rational clinical saft use.Methods:To summarize and analyze the materials about the marketing and management of cimetidine injection in China,and the ADR reports from the database of Hubei Province of the National Adverse Drug Reaction Monitoring System as well as the domestic literatures of cimetidine injection ADR based on case reports and clinical research,and extract case information for sorting and analysis.Results:The cimetidine injection listed in China were all domestically-produced medicines.Cimetidine injection might cause many types of adverse reactions,including common ones of neurotoxicity,systemic damage,cardiovascular system damage and respiratory system damage,and more serious ones of severe anaphylactic shock,cardiac arrest,liver function impairment,etc.In addition,more attention should be paid to the elderly patients and children who have an increased risk of severe ADR,and clinical over-dose and over-indications.Conclusion:In order to ensure the public use of cimetidine injection,the listed license holders,medical institutions and supervision departments should work together to strengthen the monitoring of adverse drug reactions/events,standardize the clinical rational medication,and improve the safety information such as drug instructions of adverse reactions and medication for special people.