2018—2022年湖北地区伊立替康不良反应661例分析

Analysis of 661 Reports of Adverse Reactions Induced by Irinotecan in Hubei Province from 2018 to 2022

目的研究伊立替康不良反应(adverse drug reaction,ADR)的发生特点,为临床安全使用伊立替康提供参考。方法回顾性分析2018年1月至2022年12月国家药品不良反应监测系统湖北省数据库中收集的661例伊立替康ADR报告资料。结果661例伊立替康ADR报告中,45岁以上中老年患者发生ADR居多;ADR主要发生于给药后7 d内;ADR临床表现以胃肠系统(49.31%)为主,血液系统(35.23%)损害次之;绝大部分ADR报告患者转归为痊愈(15.73%)或好转(74.89%),有1例患者因重度骨髓抑制死亡。结论加强对45岁以上中老年患者(特别是肿瘤复发)在给药后7 d内的监护,尽量避免循证医学证据低或不足的超适应证用药,以减少或避免伊立替康所致ADR的发生,保证患者用药安全。

Objective To study the characteristics of irinotecan-induced adverse drug reaction(ADR)and to offer reference for the safe use of irinotecan in clinical practice.Methods 661 cases of irinotecan-induced ADR reports in the database of Hubei Province of National Adverse Drug Reaction Monitoring System from January 2018 to December 2022 were retrospectively analyzed.Results The majority of ADR occurred in middle-aged and elderly patients over 45 years old in 661 cases of irinotecan ADR reports.Moreover,ADR mainly occurred within 7 days after administration.The main clinical manifestations of ADR were gastrointestinal system(49.31%),followed by blood system(35.23%).Most of the ADR patients were cured(15.73%)or improved(74.89%),and one patient died due to severe myelosuppression.Conclusion It is necessary to strengthen the monitoring of middle-aged and elderly patients over 45 years old(especially tumor recurrence)within 7 days after administration,avoid off-label drug use with low or insufficient evidence of evidence-based medicine,reduce or avoid ADR caused by irinotecan as much as possible,and ensure drug safety for patients.