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2种喜树碱类拓扑异构酶1抑制剂ADE信号的挖掘与分析
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| 篇名： | 2种喜树碱类拓扑异构酶1抑制剂ADE信号的挖掘与分析 |
| TITLE： | Mining and analysis of ADE signals of two camptothecin topoisomerase 1 inhibitors |
| 摘要： | 目的 对2种喜树碱类拓扑异构酶1抑制剂伊立替康和托泊替康的药物不良事件（ADE）信号进行挖掘与分析，为临床安全用药提供参考。方法基于美国FDA不良事件报告系统（FAERS）数据库，提取2004年1月1日至2023年3月31日上述2种药物的ADE报告数据。对数据进行处理后，采用报告比值比法联合贝叶斯置信传播神经网络法进行信号挖掘，并进行分析。结果共筛选出相关ADE报告14738份，其中伊立替康11483份，托泊替康3255份。伊立替康的ADE报告性别以男性为主，托泊替康以女性为主；两药的使用患者年龄均主要集中于45～＜75岁。共检测出847个信号，累及24个系统器官分类（SOC）。其中，伊立替康检测出565个信号，累及24个SOC，主要集中于胃肠系统疾病、全身性疾病及给药部位各种反应、血液及淋巴系统疾病等；报告频数最多的ADE为腹泻，信号强度最大的ADE为胆碱能综合征。托泊替康检测出282个信号，累及22个SOC，主要集中于全身性疾病及给药部位各种反应、各类检查、血液及淋巴系统疾病、胃肠系统疾病等；报告频数较多的ADE为死亡和贫血，信号强度最大的ADE为发热性骨髓再生障碍。伊立替康的转移性结肠直肠癌、外周感觉神经病、脂肪性肝炎等ADE和托泊替康的虹膜萎缩、视网膜变性、玻璃体积血等ADE均未在各自说明书中提及。结论伊立替康和托泊替康的ADE主要累及消化系统和血液系统，临床上应重点监测；伊立替康所引起的胆碱能综合征应引起关注。除此之外，使用伊立替康的患者还应关注转移性结肠直肠癌、外周感觉神经病、脂肪性肝炎、蛋白尿等ADE，使用托泊替康的患者应加强眼器官疾病的监测，以确保用药安全。 |
| ABSTRACT： | OBJECTIVE To mine and analyze the adverse drug events （ADE） signals of two camptothecin topoisomerase 1 inhibitors， i.e. irinotecan and topotecan， and to provide reference for clinical medication safety. METHODS Based on the U.S. Food and Drug Administration Adverse Event Reporting System （FAERS） database， ADE report data for the aforementioned two drugs were extracted from January 1， 2004 to March 31， 2023. After processing the data， signal mining was conducted by using the reporting odds ratio in conjunction with the Bayesian confidence propagation neural network， followed by analysis. RESULTS A total of 14 738 relevant ADE reports were screened， among which 11 483 were associated with irinotecan and 3 255 with topotecan. The ADE reports for irinotecan were predominantly male， whereas for topotecan， they were predominantly female； the age of patients using the two drugs mainly concentrated in 45-＜75 years old. A total of 847 signals were detected， involving 24 system organ classes （SOCs）. Among them， 565 signals of irinotecan were detected， involving 24 SOCs， primarily concentrating on gastrointestinal disorders， general disorders and administration site conditions， blood and lymphatic system disorders； the most frequently reported ADE was diarrhea， and the ADE with the strongest signal intensity was cholinergic syndrome. A total of 282 signals of topotecan were detected， involving 22 SOCs， primarily concentrating on general disorders and administration site conditions， investigations， blood and lymphatic system disorders， and gastrointestinal disorders； the most frequently reported ADEs were death and anemia， and the ADE with the strongest signal intensity was febrile bone marrow aplasia. ADE signals for irinotecan such as metastatic colorectal cancer， peripheral sensory neuropathy， steatohepatitis， and those for topotecan such as iris atrophy， retinal degeneration， vitreous hemorrhage， were not documented in their respective drug instruction. CONCLUSIONS ADEs of irinotecan and topotecan primarily involve the digestive and hematologic systems， warranting close clinical monitoring. Cholinergic syndrome caused by irinotecan should be concerned. In addition， patients receiving irinotecan should also be monitored for ADE such as metastatic colorectal cancer， peripheral sensory neuropathy， steatohepatitis， and proteinuria； for patients using topotecan， enhanced surveillance of ocular diseases is recommended to ensure medication safety. |
| 期刊： | 2024年第35卷第09期 |
| 作者： | 吴镇江；刘建军；白翔宇；杨茂凡；樊文海；王攀；杨钧淞 |
| AUTHORS： | WU Zhenjiang，LIU Jianjun，BAI Xiangyu，YANG Maofan，FAN Wenhai，WANG Pan，YANG Junsong |
| 关键字： | 喜树碱类拓扑异构酶1抑制剂；伊立替康；托泊替康；胆碱能综合征；虹膜萎缩；视网膜变性；玻璃体积血 |
| KEYWORDS： | camptothecin topoisomerase 1 inhibitor； irinotecan； topotecan； cholinergic syndrome； iris atrophy； retinal |
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