药物警戒视角下黄体酮注射液致注射部位不良反应/事件原因分析及对策建议

Causes and countermeasures of adverse reactions/events caused by Progesterone Injection from perspective of pharmacovigilance

目的探讨药物警戒视角下黄体酮注射液致用药部位出现药品不良反应/事件(ADR/ADE)的原因,提出安全用药和风险管理建议。方法对国家药品不良反应监测系统(https://www.adrs.org.cn)中涉及河南省行政区域的不良反应报告进行检索,检索时间2010年1月—2022年12月(按药品不良反应发生时间计),怀疑药品为黄体酮注射液,报告单位类别为医疗机构,筛选黄体酮注射液相关的ADR/ADE。在中国学术期刊全文数据库(CNKI)、维普生物医学数据库(VIP)和万方数据库(Wanfang Data)中,以“黄体酮注射液”“致”“不良反应”“不良事件”“风险”等为关键词进行组合检索,检索周期2000年1月—2022年12月,剔除非安全性文献和重复文献,检索黄体酮注射液ADR/ADE。基于黄体酮注射液ADR/ADE发生特点,分析黄体酮注射液致ADR/ADE的风险来源,进而探讨控制措施并提出建议。结果通过国家药品不良反应监测系统检索河南省报告药品不良反应结果发现黄体酮注射液ADR/ADE个例报告263例,涉及ADR/ADE表现454例次,ADR/ADE例次数较多的损害表现为注射部位红肿、硬结、疼痛、脂膜炎、红斑、皮疹等。文献检索得到黄体酮注射液相关安全性文献23篇,共提取出个例ADR/ADE报告125例,涉及ADR/ADE表现147例次,ADR/ADE例次数较多的依次为注射部位脂膜炎、硬结、疼痛、皮疹等。黄体酮注射液致用药部位损害的原因可能与不合理用药因素、辅料因素、说明书缺陷因素等有关。结论建议提升黄体酮注射液质量标准、提高合理用药水平、修订完善药品说明书,最终保护患者用药安全.

Objective To investigate the causes of adverse drug reactions/adverse drug events(ADR/ADE)caused by Progesterone Injection from the perspective of pharmacovigilance,and to put forward suggestions on safe drug use and risk management.Methods National Adverse Drug Reaction Monitoring System(https://www.adrs.org.cn)were used to search for adverse reaction reports related to the administrative region of Henan Province from January 2010 to December 2022(based on the time of adverse drug reactions).The drug Progesterone Injection was suspected,and the reporting unit was a medical institution.ADR/ADE related to Progesterone Injection were screened.In the Chinese Academic Journal Full Text Database(CNKI),VIP Biomedical Database induration,pain,panniculitis,erythema,rash,etc.A literature search yielded 23 safety literature related to Progesterone Injection,and a total of 125 ADR/ADE reports were extracted,involving 147 ADR/ADE manifestations.The most frequent ADR/ADE cases were injection site panniculitis,induration,pain,rash,etc.The causes of damage to the medication site caused by Progesterone Injection may be related to factors such as unreasonable drug use,excipients,and defects in the instructions.Conclusion It is suggested to improve the quality standard of Progesterone Injection,improve the level of rational drug use,revise and perfect the drug instructions,and finally protect the drug safety of patients.