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 (VIP), and Wanfang Data, a combination search was conducted using keywords such as "progesterone injection", "cause", "adverse reactions", "adverse events", and "risks". The search cycle was from January 2000 to December 2022, excluding non-safety and duplicate literature, and searching for Progesterone Injection ADR/ADE. Based on the characteristics of ADR/ADE caused by Progesterone Injection, the risk sources of ADR/ADE caused by Progesterone Injection were analyzed, and control measures was explored and suggestions was proposed.Results The results showed that 263 cases of ADR/ADE related to Progesterone Injection were reported through the Henan Province Drug Adverse Reaction Spontaneous Reporting System, involving 454 ADR/ADE manifestations. The more ADR/ADE cases, the more damage manifestations were redness and swelling at the injection site, 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.

R969.3

河南省科技攻关计划（212102311047）：河南省药品上市许可持有人药品不良反应风险分级与应用研究