目的 利用美国FDA不良事件报告系统（FAERS）数据，采用报告比值比法（ROR）和联合综合标准法（MHRA）挖掘度维利塞相关不良反应信号，为临床安全用药提供参考。方法 从OenFDA API采集自2020年1月—2025年12月的FAERS数据，采用ROR联合MHRA法进行信号检测，采用SPSS 26.0和Excel 16.65软件对相关数据进行分析。结果 共获取度维利塞相关不良反应报告2 241例，ROR法和联合MHRA法获得的度维利塞不良反应风险信号基本一致，共获得不良反应信号41个，其中胃肠道系统疾病不良反应信号最强，其中憩室炎和周围神经病变2个症状为说明书中未收录或强调不充分的潜在新信号，同时有心肺基础疾病和肠道炎病症的患者应需重点监测。结论 利用FAERS数据库可对度维利塞的不良反应信号进行挖掘与分析，全面了解其安全性特征，发现潜在的、特别是说明书中未明确记载的不良事件风险信号，为临床安全用药提供参考。

Objective To utilise data from the FAERS to investigate adverse drug reaction signals associated with dvelisib using ROR ombined with MHRA, providing references for safe clinical use. Methods FAERS data from January 2020 to December 2025 were collected via the openFDA API, and signal detection was conducted using the ROR combined with the MHRA method. Related data were analysed using SPSS 26.0 and Excel 16.65 software. Results A total of 2 241 adverse drug reaction reports related to duvelisib were obtained, ROR and MHRA algorithms produced largely concordant results, identifying 41 duvelisib-associated adverse drug reaction signals after false-positive filtering, among which gastrointestinal system disorders showed the strongest adverse drug reaction signals. Diverticulitis and peripheral neuropathy were identified as two potential new signals either not included or insufficiently emphasised in the drug label, and patients with underlying cardiopulmonary disease and intestinal inflammation should be closely monitored. Conclusion The FAERS database can be used to explore and analyse adverse drug reaction signals of duvelisib, providing a comprehensive understanding of its safety profile and identifying potential risk signals, particularly those not clearly documented in the drug label, thus providing references for safe clinical use.

R973

国家自然科学基金项目（82104279）