【摘要】 目的 基于美国食品药品管理局不良事件报告系统（FAERS）数据库，对引起血小板减少症的药物进行挖掘，为临床安全用药提供参考。方法 收集美国FAERS数据库2004年第1季度至2024年第3季度与血小板减少症相关的不良事件（ADE）报告，采用报告比值比法（ROR）、比例报告比值法（PRR）、贝叶斯置信区间递进神经网络法（BCPNN）和多项式伽马泊松分布缩减法（MGPS）联合进行信号检测和数据分析，采用中位数、四分位间距和韦伯分布评估ADE发生时间。结果 共收集发生血小板减少症ADE报告199 497份，获得首要怀疑药物1 701种，其中阳性信号药物261种；除性别缺失外，女性患者略多（44.02%），导致危及生命或死亡的结局患者共48 238例（24.61%）；按解剖治疗化学Ⅰ级分类，报告数量最多的药物类别是抗肿瘤和免疫调节药物（48.96%），其次是血液和造血器官用药（7.70%）；报告数量最多的3种药物是来那度胺（12 165例），尼拉帕尼（4 996例）和芦可替尼（4 978例）；ROR值最高的3种药物为罗普司亭[ROR=28.22,95%CI(27.20,29.28)]，艾曲泊帕[ROR=25.24,95%CI(24.50,26.00)]和利奈唑胺[ROR=16.37,95%CI(15.65,17.13)]；死亡例数最高的为来那度胺（1 391例）；根据韦伯分布形状参数分析结果，大多数导致血小板减少症的药物具有早期失效类型。结论 监测到与血小板减少症相关的阳性信号药物共261种，其潜在风险等级不同；临床用药过程中，应密切监测血液学相关指标，尤其关注说明书中尚未记载血小板减少风险的药物，以预防血小板减少症的发生。更多还原

【Abstract】 Objective To identify drugs associated with thrombocytopenia based on the U.S. FDA Adverse Event Reporting System(FAERS) database, and to provide reference for safe clinical drug use. Methods Adverse drug event(ADE) reports related to thrombocytopenia were extracted from the FAERS database(Q1 2004 to Q3 2024). Signal detection and data analysis were performed using the reporting odds ratio(ROR) method, proportional reporting ratio(PRR) method, Bayesian confidence propagation neural network(BCPNN) method, and multi-item gamma Poisson shrinker(MGPS) method. The time-to-onset of ADEs were evaluated using median, interquartile range, and Weibull Distribution. Results A total of 199,497 thrombocytopeniarelated ADE reports were collected, identifying 1,701 primary suspected drugs, with 261 drugs showing positive signals. Excluding cases with missing gender data, female patients accounted for a slightly higher proportion(44.02%). Life-threatening or fatal outcomes were reported in 48,238 cases(24.61%). The most frequently reported first-level Anatomical Therapeutic Chemical(ATC) groups were the drugs for the antineoplastic and immunomodulating agents system(48.96%), followed by drugs for blood and hematopoietic organs(7.70%). The top three drugs by report frequency were lenalidomide(12,165 cases), niraparib(4,996 cases), and ruxolitinib(4,978 cases). The three drugs with the highest ROR values were romiplostim [ROR=28.22, 95%CI(27.20, 29.28)), eltrombopag [ROR=25.24, 95%CI(24.50, 26.00)), and linezolid[ROR=16.37, 95%CI(15.65, 17.13)). Lenalidomide was associated with the highest number of fatal outcomes(1,391 cases). Weibull shape parameter analysis indicated that most thrombocytopenia-inducing drugs exhibited an early failure pattern. Conclusion A total of 261 drugs associated with positive signals of thrombocytopenia were monitored, with varying risk levels. Clinicians should closely monitor hematologic parameters during treatment, particularly for drugs that do not mention the risk of thrombocytopenia in their inserts, in order to prevent thrombocytopenia.更多还原