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Preliminary mining and analysis of ADE signal of ofatumumab
- ZHONGGUO YAOFANG Vol. 35, Issue 17, Pages: 2120-2125(2024)
- 作者机构：
1.皖北煤电集团总医院药物临床试验机构办公室，安徽 宿州;234000
2.安徽医科大学附属宿州医院药学部，安徽 宿州 234000
3.皖南医学院药学院，安徽 芜湖 241002
4.皖北煤电集团总医院药学部，安徽 宿州 234000
5.中国科学技术大学附属第一医院（安徽省立医院）药学部，合肥 230001
- 作者简介：
- 基金信息：
DOI：10.6039/j.issn.1001-0408.2024.17.11
CLC： R969.3Published：15 September 2024，
Received：02 January 2024，
Revised：15 August 2024，
- 稿件说明：
移动端阅览
杨小娟,张清文,杜潇洒等.奥法妥木单抗ADE信号的初步挖掘与分析 Δ[J].中国药房,2024,35(17):2120-2125.
YANG Xiaojuan,ZHANG Qingwen,DU Xiaosa,et al.Preliminary mining and analysis of ADE signal of ofatumumab[J].ZHONGGUO YAOFANG,2024,35(17):2120-2125.
杨小娟,张清文,杜潇洒等.奥法妥木单抗ADE信号的初步挖掘与分析 Δ[J].中国药房,2024,35(17):2120-2125. DOI： 10.6039/j.issn.1001-0408.2024.17.11.
YANG Xiaojuan,ZHANG Qingwen,DU Xiaosa,et al.Preliminary mining and analysis of ADE signal of ofatumumab[J].ZHONGGUO YAOFANG,2024,35(17):2120-2125. DOI： 10.6039/j.issn.1001-0408.2024.17.11.
摘要
目的
2
筛选奥法妥木单抗治疗多发性硬化症（MS）的潜在药物不良事件（ADE）信号，为临床安全用药提供参考依据。
方法
2
以“ofatumumab”及其商品名“Kesimpta”为检索关键词，筛选2009年1月至2023年12月美国FDA不良事件监测系统数据库收录的奥法妥木单抗相关不良事件（AE）报告，且该报告使用原因中包含“multiple sclerosis”字段。综合报告比值比、比例报告比值比两种方法进行ADE信号的挖掘与分析。
结果
2
共筛选出符合条件的AE报告21 759份，包括62 449例AE，涉及一般疾病和给药部位各种反应（15 021例），神经系统疾病（9 668例），感染和侵袭类疾病（5 967例），伤害、中毒和手术并发症（4 952例），肌肉骨骼和结缔组织疾病（4 647例）等27个系统器官分类。21 759份AE报告对应606个ADE信号，其中有234个阳性信号。有107个ADE阳性信号未被奥法妥木单抗说明书收录，包括流感样疾病、鼻咽炎、咳嗽、泌尿道感染、口咽痛、失眠 、流涕、贫血、脱发、房颤与血小板减少等。
结论
2
临床在使用奥法妥木单抗治疗MS的过程中，除应对说明书明确收录的ADE予以足够重视外，还应对本研究筛选出的信号强度较强的ADE（如流感样疾病、血细胞减少、温度不耐受性、视神经炎与烟雾病等）格外注意。奥法妥木单抗增加的感染风险、心血管疾病风险以及其可能对呼吸系统、精神系统等造成的损害也不容忽视。
Abstract
OBJECTIVE
2
To screen potential adverse drug event （ADE） signals for the treatment of multiple sclerosis （MS） with ofatumumab， and to provide reference for the safe use of drugs in clinical practice.
METHODS
2
Using “ofatumumab” and the trade name “Kesimpta” as the search keywords， adverse event （AE） reports related to ofatumumab included in FDA Adverse Event Reporting System database from January 2009 to December 2023 were screened， and their reason contained the “multiple sclerosis”； ADE signal mining and analysis were conducted by reporting odds ratio method and proportional reporting ratio method.
RESULTS
2
A total of 21 759 eligible AE reports were selected， involving 62 449 AE cases； 27 system organ classes included general diseases and various reactions at the site of administration （15 021 cases）， neurological diseases （9 668 cases）， infectious and invasive diseases （5 967 cases）， injury， poisoning and surgical complications （4 952 cases）， musculoskeletal and connective tissue disorders （4 647 cases）. A total of 21 759 AE reports correspond to 606 ADE signals， including 234 ADE positive signals. A total of 107 ADE positive signals were not included in drug instruction of ofatumumab， including flu-like diseases， nasopharyngitis， cough， urinary tract infection， sore throat， insomnia， runny nose， anemia， hair loss， atrial fibrillation， and thrombocytopenia， etc.
CONCLUSIONS
2
In the process of using ofatumumab for MS， sufficient attention should be paid to ADE included in drug instructions. The ADE with strong signal strength screened in this study should also be paid special attention to， such as flu-like diseases， hemocytopenia， temperature intolerance， optic neuritis， and moyamoya disease. The increased risk of infection， cardiovascular disease， and potential damage to the respiratory and spiritual systems caused by ofatumumab can not be ignored.
关键词
奥法妥木单抗多发性硬化症FAERS数据库报告比值比法比例报告比值比法药物不良事件鼻咽炎房颤
Keywords
multiple sclerosisFAERS datareporting odds ratio methodproportional reporting ratio methodadverse drug eventnasopharyngitisatrial fibrillation
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