目的 基于FAERS数据库挖掘卡匹色替上市后的药品不良事件信号，旨在全面评估该药临床应用的安全性，并为临床合理用药提供参考，以保障患者用药安全。方法 提取FAERS数据库中2023年第4季度—2025年第1季度与卡匹色替相关的不良事件报告数据，经过数据清洗和标准化处理，联用报告比值比法（ROR）、综合标准法（MHRA）和贝叶斯置信传播神经网络法（BCPNN）筛选其不良事件风险信号，挖掘出以卡匹色替为首要怀疑药物的不良事件报告。结果 提取到以卡匹色替为首要怀疑药物的不良事件报告共2 400份，涉及患者975例，已知性别的患者中女性占绝大多数，主要上报国家是美国。在剔除涉及药物适应证及药物不耐受等与药物无明确相关性的不良事件信号后共挖掘出相关不良事件风险信号65个，累及17个器官系统，不良事件信号中以腹泻、皮疹、死亡、高血糖症、血葡萄糖升高、呕吐等报告频次较高，还检测到低血压、周围神经病、房颤等说明书中未提及的不良事件，在临床使用中需要警惕。结论 基于FAERS数据库挖掘出的卡匹色替不良事件与最新的药品说明书基本相符，腹泻、皮疹、高血糖症等高频报告的不良事件需要临床高度重视并及时防范、干预。针对潜在的新的不良事件信号，临床医生和药师应充分了解并进一步关注，以保障卡匹色替临床使用的有效性和安全性。

Objective To mine the adverse drug event signals of capivasertib based on the FAERS database, to comprehensively evaluate the safety of the drug in clinical application, and provide a reference for rational clinical drug use to ensure the safety of patient medication. Methods The adverse event report data related to capivasertib from the FAERS database from the 4th quarter of 2023 to the 1st quarter of 2025 were extracted. After data cleaning and standardization, the ROR, MHRA, and BCPNN were used to screen their adverse event risk signals, and adverse event reports with capivasertib as the primary suspect drug were mined. ResultsA total of 2 400 adverse events were reported with capivasertib as the primary suspect drug, involving 975 patients. Women accounted for the vast majority of patients with known gender, and the main reporting country was the United States. After eliminating adverse event signals involving drug indications and drug intolerance, which have no clear correlation with drugs, such as drug indications and drug intolerance, a total of 65 related adverse event risk signals were excavated, involving 17 organ systems. Among the adverse event signals, diarrhea, rash, death, hyperglycemia, elevated blood glucose, vomiting, etc., they were also detected. Adverse events not mentioned in the instructions for hypotension, peripheral neuropathy, atrial fibrillation, etc., which need to be vigilant during clinical use. Conclusion Capivasertib adverse events mined based on the FAERS database are basically consistent with the latest drug instructions. Adverse events reported by high-frequency diarrhea, rash, hyperglycemia, etc. need to be taken seriously in clinical practice and timely prevention and intervention. Clinicians and pharmacists should fully understand and pay further attention to the potential new adverse event signals to ensure the effectiveness and safety of capivasertib.

R979.1

郴州市科技发展计划项目（ZDYF2020228）