目的 基于FAERS數(shù)據(jù)庫挖掘卡匹色替上市后的藥品不良事件信號(hào)，旨在全面評(píng)估該藥臨床應(yīng)用的安全性，并為臨床合理用藥提供參考，以保障患者用藥安全。方法 提取FAERS數(shù)據(jù)庫中2023年第4季度—2025年第1季度與卡匹色替相關(guān)的不良事件報(bào)告數(shù)據(jù)，經(jīng)過數(shù)據(jù)清洗和標(biāo)準(zhǔn)化處理，聯(lián)用報(bào)告比值比法（ROR）、綜合標(biāo)準(zhǔn)法（MHRA）和貝葉斯置信傳播神經(jīng)網(wǎng)絡(luò)法（BCPNN）篩選其不良事件風(fēng)險(xiǎn)信號(hào)，挖掘出以卡匹色替為首要懷疑藥物的不良事件報(bào)告。結(jié)果 提取到以卡匹色替為首要懷疑藥物的不良事件報(bào)告共2 400份，涉及患者975例，已知性別的患者中女性占絕大多數(shù)，主要上報(bào)國家是美國。在剔除涉及藥物適應(yīng)證及藥物不耐受等與藥物無明確相關(guān)性的不良事件信號(hào)后共挖掘出相關(guān)不良事件風(fēng)險(xiǎn)信號(hào)65個(gè)，累及17個(gè)器官系統(tǒng)，不良事件信號(hào)中以腹瀉、皮疹、死亡、高血糖癥、血葡萄糖升高、嘔吐等報(bào)告頻次較高，還檢測(cè)到低血壓、周圍神經(jīng)病、房顫等說明書中未提及的不良事件，在臨床使用中需要警惕。結(jié)論 基于FAERS數(shù)據(jù)庫挖掘出的卡匹色替不良事件與最新的藥品說明書基本相符，腹瀉、皮疹、高血糖癥等高頻報(bào)告的不良事件需要臨床高度重視并及時(shí)防范、干預(yù)。針對(duì)潛在的新的不良事件信號(hào)，臨床醫(yī)生和藥師應(yīng)充分了解并進(jìn)一步關(guān)注，以保障卡匹色替臨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

郴州市科技發(fā)展計(jì)劃項(xiàng)目（ZDYF2020228）