205例信迪利单抗注射液药品不良反应报告分析  

205 Cases of Adverse Drug Reactions Induced by Sintilimab Injection

作　　者：李敏 戚迎梅 谢彦军[2] 于文雯 王丽 李霞 LI Min;QI Yingmei;XIE Yanjun;YU Wenwen;WANG Li;LI Xia(Jinan Adverse Drug Reaction and Medical Device Adverse Event Monitoring Center,Jinan,Shangdong 250102,China;Shandong Provincial Adverse Drug Reaction Monitoring Center,Jinan,Shangdong 250014,China)

机构地区：[1]济南市药品不良反应和医疗器械不良事件监测中心,山东济南250102 [2]山东省药品不良反应监测中心,山东济南250014

出　　处：《中国医药指南》2025年第8期1-4,共4页Guide of China Medicine

基　　金：山东省药品不良反应专业评价(济南平台)项目(药品-2023-SDADR007)。

摘　　要：目的 分析信迪利单抗注射液药品不良反应(ADR)发生特点,为安全合理用药提供参考。方法 对监测系统2018年12月至2022年10月收到的205例信迪利单抗注射ADR报告进行汇总分析。结果 患者主要集中在51~80岁(183例次,占比89.27%),累及系统主要是皮肤及其附件损害(87例次,占比25.14%)、全身性损害(56例次,占比16.18%),且多于用药初期出现。严重ADR占比较高(71.97%),主要表现为骨髓抑制、皮疹等。存在超说明书用药情况。结论 临床应警惕信迪利单抗注射液严重ADR,加强使用管理和培训,严格按照说明书用药,加强对特殊人群的监护,定期检测相应指标,预防和减少ADR的发生。Objective To analyze the characteristics of adverse drug reactions(ADR)induced by Sintilimab Injection so as to provide reference for safe clinical drug use.Methods A total of 205 cases of ADR induced by Sintilimab Injection submitted to the National ADR Monitoring Center from December 2018 to October 2022 were analyzed retrospectively.Results The majority of the ADR induced by Sintilimab Injection were aged 51-80(183,89.27%).Impairments in the skin and its accessories(87,25.14%)and in the systemic reaction(56,16.18%),appearing in the early stage of medication.167 of these cases(71.97%)were severe ADR,accounting highly,mainly myelosuppression,rashes etc.and no deaths.There were cases of off-specification drug usage.Outcome of these adverse reactions were usually remission or cure.Conclusions Clinical managment of Sintilimab Injection should be strengthened especially drug usage on the special groups,and the process of drug administration should be closely according to the specification,and to reduce the occurrence of ADR,particularly severe ADR.

关 键 词：信迪利单抗 药品不良反应 监测 安全用药建议 

分 类 号：R969.3[医药卫生—药理学]