目的 挖掘FAERS数据库中替尔泊肽相关不良事件的风险信号，全面评估该药临床应用的安全性。方法 收集FAERS数据库中2022年第2季度—2024年第3季度上报的替尔泊肽的不良事件报告。采用报告比值比（ROR）法、贝叶斯置信区间递进神经网络（BCPNN）法进行数据分析，使用国际医学用语词典（MedDRA）药物不良反应术语集中的系统器官分类（SOC）和首选术语（PT）进行规范汉化及分类统计。结果 提取到替尔泊肽为首要怀疑药物的不良事件报告47 306例，经过ROR法和BCPNN法进行检测，排除产品问题、各类损伤中毒及操作并发症等与药物无关的信号后最终获得178个PT，涉及20个SOC。PT中包括常见不良事件如注射部位不适、其次为恶心、便秘、胰腺炎等，严重不良事件如甲状腺癌。还检测到血降钙素升高、皮质醇增加、月经期出血过多等说明书未提及的不良事件。此外，使用韦伯分布检验分析了替尔泊肽不良事件的发生时间（TTO），发现不良事件的中位TTO为28 d，四分位距为7～92 d，大多数病例发生在替尔泊肽给药后30 d内（52.44%）。结论 除了发现替尔泊肽说明书提及的常见不良反应外，还发现了该药新的、严重的不良反应，有助于替尔泊肽给药后不良事件的临床监测和风险识别，保障临床安全用药。

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.

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