目的 探討藥物警戒視角下黃體酮注射液致用藥部位出現(xiàn)藥品不良反應/事件（ADR/ADE）的原因，提出安全用藥和風險管理建議。方法 對國家藥品不良反應監(jiān)測系統(tǒng)（https://www.adrs.org.cn）中涉及河南省行政區(qū)域的不良反應報告進行檢索，檢索時間2010年1月—2022年12月（按藥品不良反應發(fā)生時間計），懷疑藥品為黃體酮注射液，報告單位類別為醫(yī)療機構(gòu)，篩選黃體酮注射液相關(guān)的ADR/ADE。在中國學術(shù)期刊全文數(shù)據(jù)庫（CNKI）、維普生物醫(yī)學數(shù)據(jù)庫（VIP）和萬方數(shù)據(jù)庫（Wanfang Data）中，以“黃體酮注射液”“致”“不良反應”“不良事件”“風險”等為關(guān)鍵詞進行組合檢索，檢索周期2000年1月—2022年12月，剔除非安全性文獻和重復文獻，檢索黃體酮注射液ADR/ADE?；邳S體酮注射液ADR/ADE發(fā)生特點，分析黃體酮注射液致ADR/ADE的風險來源，進而探討控制措施并提出建議。結(jié)果 通過國家藥品不良反應監(jiān)測系統(tǒng)檢索河南省報告藥品不良反應結(jié)果發(fā)現(xiàn)黃體酮注射液 ADR/ADE 個例報告 263例，涉及 ADR/ADE 表現(xiàn) 454例次，ADR/ADE例次數(shù)較多的損害表現(xiàn)為注射部位紅腫、硬結(jié)、疼痛、脂膜炎、紅斑、皮疹等。文獻檢索得到黃體酮注射液相關(guān)安全性文獻 23篇，共提取出個例 ADR/ADE報告 125例，涉及 ADR/ADE表現(xiàn) 147例次，ADR/ADE例次數(shù)較多的依次為注射部位脂膜炎、硬結(jié)、疼痛、皮疹等。黃體酮注射液致用藥部位損害的原因可能與不合理用藥因素、輔料因素、說明書缺陷因素等有關(guān)。結(jié)論 建議提升黃體酮注射液質(zhì)量標準、提高合理用藥水平、修訂完善藥品說明書，最終保護患者用藥安全。

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

河南省科技攻關(guān)計劃（212102311047）：河南省藥品上市許可持有人藥品不良反應風險分級與應用研究