989例注射用多种维生素(12)不良反应报告分析

989 cases of adverse drug reactions caused by multivitamins for injection(12)

目的 分析注射用多种维生素(12)药品不良反应(ADR)的发生情况,为临床安全合理用药提供参考。方法 检索2015年1月1日至2020年5月31日江苏省药品不良反应监测系统,采用回顾性统计法对注射用多种维生素(12)的ADR报告进行综合分析。结果 注射用多种维生素(12)ADR以女性居多,年龄集中在41~70岁(56.32%);ADR累及系统-器官为全身性损害(26.95%)、皮肤及其附件(20.41%)、胃肠系统(10.87%);严重ADR累及系统-器官主要为免疫系统(27.55%)、全身性损害(21.43%)、皮肤及其附件(15.31%)。结论 药品上市许可持有人应持续加强上市后产品的ADR监测。临床应重视注射用多种维生素(12)的安全使用,重点关注过敏性休克等严重ADR。

Objective To investigate the incidence of adverse drug reactions(ADR) caused by multivitamins for injection(12) so as to provide reference for clinical rational drug use.Methods 989 cases of ADR related to multivitamins for injection(12) were collected from the national adverse drug reaction monitoring system in Jiangsu between January 1,2015 and May 31,2020 before being analyzed retrospectively.Results 52.88% of these cases involved new ADR.Most of the adverse reactions involved females,and most of the patients ranged from 41 to 70 years old(56.32%).As for SOCs,systemic reactions accounted for 26.95%,skin and its accessories 20.41%,and the gastrointestinal system 10.87%.Serious ADR mainly involved the immune system(27.55%),systemic reactions(21.43%),and skin and its accessories(15.31%).Conclusion Marketing authorization holders should strengthen the post-marketing surveillance of drugs.More attention should be paid to the safe use of drugs and serious adverse reactions such as anaphylactic shock.