抗肿瘤创新药普拉替尼不良反应信号挖掘与分析

目的 通过对抗肿瘤创新药普拉替尼药物不良反应(adverse drug reactions，ADR)信号的挖掘分析，为临床安全用药提供参考。方法 基于海南省药品ADR监测中心2020年9月—2021年7月数据，运用ROR法和MHRA法挖掘普拉替尼ADR风险信号。结果 根据监管活动医学词典的系统器官分类，普拉替尼ADR损害主要集中在各类检查指标(39.6%)，血液及淋巴系统疾病(20.8%)，肝胆系统疾病(14.6%)。采用ROR法、MHRA法挖掘到普拉替尼ADR 5个风险信号：中性粒细胞计数减少，骨髓抑制，肝功能异常，丙氨酸氨基转移酶升高，天门冬氨酸氨基转移酶升高；还存在一些可疑信号，特别是说明书未提及的潜在ADR信号，如肾功能损害，急性心肌梗死，在临床用药过程中仍需警惕。结论 采用ROR法、MHRA法有效挖掘出普拉替尼的ADR风险信号，临床用药时应关注普拉替尼导致的各种ADR，为临床安全用药提供参考。

Mining and Analysis of the Adverse Drug Reaction Signals for Innovative Antitumor Drug Pralsetinib

OBJECTIVE To mine and analysis the adverse drug reaction(ADR) signals of the new antitumor drug pralsetinib, in order to provide references for safe clinical medication. METHODS Based on data of Center for ADR Monitoring of Hainan Province from September 2020 to July 2021, the ROR and the MHRA were adopted to mine the ADR risk signals of pralsetinib. RESULTS According to System Organ Classification in the Medical Dictionary for Regular Activities, the ADR damage of pralsetinib was mainly concentrated in various examination indicators(39.6%), blood and lymphatic system diseases(20.8%), and hepatobiliary system diseases(14.6%); Five ADR risk signals of pralsetinib had been mined by the ROR and the MHRA methods, which were granulocytopenia, myelosuppression, hepatic function abnormal, alanine aminotransferase increase, aspartate aminotransferase increase. In clinical medication, that still needed to be alert to some suspicious signals such as renal impairment, acute myocardial infarction, especially the potential adverse reactions not mentioned in the instructions. CONCLUSION ADR risk signals of pralsetinib are effectively mined by the ROR and the MHRA methods. In clinical medication, attention should be paid to the ADRs of plastectinib, in order to provide references for safe clinical medication.