基于美国食品药品监督管理局不良事件报告系统数据库儿童应用乌司奴单抗安全信号挖掘与分析OA
Safety Signal Mining and Analysis for Ustekinumab Used in Children Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database
目的:探讨乌司奴单抗在儿童患者中潜在的药品不良事件(ADE),为临床合理用药提供参考.方法:基于美国食品药品监督管理局不良事件报告系统(FAERS),采用报告比值比(ROR)法和比例报告比值(PRR)法对FAERS中2015-2023年上报的乌司奴单抗为首要怀疑ADE进行数据挖掘和分析,按国际医学用语词典(MedDRA)的首选术语(PT)和系统-器官分类(SOC)进行统计分析.结果:共检索到乌司奴单抗儿童ADE报告1 050例,以女性患儿为主(568例,54.1％),0～5岁81例(7.7％),＞5～11岁129例(12.3％),＞11～17岁840例(80.0％).主要上报国家为美国(774例,73.7％),报告者职业以卫生专业人员为主(295例,28.1％),报告数量在2019年达到峰值.共检索到乌司奴单抗PT 554个,经ROR法和PRR法得到66个ADE信号,涉及15个SOC.对有信号的PT按照报告数和信号强度排序,常见的ADE为速发严重过敏反应(ROR=3.25,95％CI 1.95～5.41)、难辨梭状芽孢杆菌感染(ROR=11.88,95％CI7.00～20.18)、治疗反应减弱(ROR=5.79,95％CI 3.42～9.81).相关性最高的 ADE 为肠脓肿(ROR=46.03,95％CI 16.70～126.88)、闪光幻觉(ROR=31.28,95％CI 9.82～99.61)、血铁降低(ROR=12.36,95％CI 3.94～38.73).新的潜在ADE包括闪光幻觉、脱发、难辨梭状芽孢肝菌感染、盗汗、传染性单核细胞增多症、早产儿等.结论:乌司奴单抗在儿童患者中常见ADE信号与药品说明书具有一致性,但仍有药品说明书中未记载的新的SOC和新的ADE信号出现,提示儿童与成人使用乌司奴单抗的ADE发生情况存在差异,需更多的研究来确定其安全性.
Objective:To probe into the potential adverse drug events(ADE)of ustekinumab in children,and to provide reference for clinical rational drug use.Methods:Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were used to mine and analyze the data on ustekinumab as the primary suspect ADE reported in the system from 2015 to 2023.Statistical analysis was performed according to the preferred terms(PT)and system organ class(SOC)of the International Dictionary of Medical Terms(MedDRA).Results:A total of 1,050 reports of ADE related to ustekinumab in children were retrieved,with ADE reports predominantly from females(568 cases,54.1％),and the majority of reports were children aged from 0 to 5 years(81 cases,7.7％),＞5 to 11 years(129 cases,12.3％),and＞11 to 17 years(840 cases,80.0％).The top reporting countries were the United States(774 cases,73.7％),with healthcare professionals being the main reporters(295 cases,28.1％),and the highest number of reports was reported in 2019.A total of 554 ustekinumab PT were retrieved,and 66 ADE signals were obtained by ROR and PRR methods,including 15 SOC.The PT with signals were sorted by signal intensity and occurrence frequency.The most common ADE were rapid severe allergic reactions(ROR=3.25,95％CI 1.95 to 5.41),Clostridium difficile infection(ROR=11.88,95％CI 7.00 to 20.18),and decreased therapeutic response(ROR=5.79,95％CI 3.42 to 9.81).The ADE with the highest signal intensity was intestinal abscess intestinal(ROR=46.03,95％CI 16.70 to 126.88),photopsia(ROR=31.28,95％CI 9.82 to 99.61),decreased blood iron(ROR=12.36,95％CI 3.94 to 38.73).New potential ADE included photopsia,alopecia,C.difficile infection,night sweats,infectious mononucleosis,and premature infants.Conclusion:The common ADE signals of ustekinumab in children is consistent with the drug instructions,yet there are still new SOC and new ADE signals.The results suggest that there is a difference in the occurrence of ADE between children and adults using ustekinumab,and more studies are needed to determine the medication safety.
张玄羿;孔文强;周义录;钟红
自贡市第一人民医院,四川自贡 643000自贡市第一人民医院,四川自贡 643000自贡市第一人民医院,四川自贡 643000自贡市第一人民医院,四川自贡 643000
药学
乌司奴单抗药品不良事件美国食品药品监督管理局不良事件报告系统信号挖掘儿童银屑病
ustekinumabadverse drug eventsthe U.S.AFood and Drug Administration Adverse Event Reporting Systemsignal miningchildrenpsoriasis
《儿科药学杂志》 2025 (4)
4-8,5
自贡市重点科技计划项目,编号2022ZCYKY04.
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