目的 挖掘FAERS數(shù)據(jù)庫中替爾泊肽相關不良事件的風險信號，全面評估該藥臨床應用的安全性。方法 收集FAERS數(shù)據(jù)庫中2022年第2季度—2024年第3季度上報的替爾泊肽的不良事件報告。采用報告比值比（ROR）法、貝葉斯置信區(qū)間遞進神經(jīng)網(wǎng)絡（BCPNN）法進行數(shù)據(jù)分析，使用國際醫(yī)學用語詞典（MedDRA）藥物不良反應術語集中的系統(tǒng)器官分類（SOC）和首選術語（PT）進行規(guī)范漢化及分類統(tǒng)計。結果 提取到替爾泊肽為首要懷疑藥物的不良事件報告47 306例，經(jīng)過ROR法和BCPNN法進行檢測，排除產(chǎn)品問題、各類損傷中毒及操作并發(fā)癥等與藥物無關的信號后最終獲得178個PT，涉及20個SOC。PT中包括常見不良事件如注射部位不適、其次為惡心、便秘、胰腺炎等，嚴重不良事件如甲狀腺癌。還檢測到血降鈣素升高、皮質醇增加、月經(jīng)期出血過多等說明書未提及的不良事件。此外，使用韋伯分布檢驗分析了替爾泊肽不良事件的發(fā)生時間（TTO），發(fā)現(xiàn)不良事件的中位TTO為28 d，四分位距為7～92 d，大多數(shù)病例發(fā)生在替爾泊肽給藥后30 d內（52.44%）。結論 除了發(fā)現(xiàn)替爾泊肽說明書提及的常見不良反應外，還發(fā)現(xiàn)了該藥新的、嚴重的不良反應，有助于替爾泊肽給藥后不良事件的臨床監(jiān)測和風險識別，保障臨床安全用藥。

Objective To explore the risk signals of tilposide related adverse events in FEARS database, and comprehensively evaluate the safety of the drug in clinical application. Methods The adverse events reports of tilposide from the second quarter of 2022 to the third quarter of 2024 in FAERS database were collected. The reported odds ratio (ROR) method and Bayesian confidence interval progressive neural network (BCPNN) method were used for data analysis, and the system organ classification (SOC) and preferred term (PT) in the International Dictionary of medical terms (MedDRA) adverse drug reaction terminology set were used for standardized sinicization and classification statistics. Results A total of 47 306 adverse events reports with tilposide as the primary suspected drug were extracted. After ROR method and BCPNN method were used to detect, 178 PTs involving 20 SOC were finally obtained after excluding signals unrelated to the drug, such as product problems, various injuries, poisoning, and operation complications. PT includes common adverse events such as discomfort at the injection site, followed by nausea, constipation, pancreatitis, etc, and serious adverse events: thyroid cancer. Adverse events not mentioned in the instructions were also detected, such as elevated levels of calcitonin, cortisol, and heavy menstrual bleed. In addition, we used Weber distribution test to analyze the occurrence time (TTO) of tilposide ade, and found that the median tto of adverse events was 28 days, and the interquartile range was 7 to 92 days. Most cases occurred within 30 days after tilpotide administration (52.44%). Conclusion In addition to the common adverse reactions mentioned in the instruction manual of tilposide, this study also found new and serious adverse reactions of tilposide, which is helpful for the clinical monitoring and risk identification of ADE after tilposide administration, and ensures the clinical safety of drug use.

R977