摘要
目的为临床安全使用二肽基肽酶-4(DPP-4)抑制剂抗2型糖尿病药物提供参考。方法从美国食品和药物管理局不良事件报告系统(FAERS)数据库中提取2004年第1季度至2018年第4季度(共60个季度)的数据,通过MedEx药品名称标准化、MedDRA不良事件系统分类等对数据进行分析筛选,得到DPP-4抑制剂相关自身免疫性大疱性皮肤病(AIBDs)事件,采用报告比值比(ROR)法和比例报告比值(PRR)法进行信号检测。结果共提取到DPP-4抑制剂相关AIBDs事件383条,其中西格列汀178条(0.20%),维格列汀128条(14.81%),阿格列汀51条(2.81%),沙格列汀13条(0.18%)和利格列汀13条(0.54%);2个首选语(天疱疮和类天疱疮)检索到药品不良事件(ADE)报告,5种DPP-4抑制剂类药品均在"类天疱疮"提示信号,西格列汀在"天疱疮"提示信号。结论应重视DPP-4抑制剂相关AIBDs事件风险,加强临床用药监测,以便及时发现和处理ADE。
Objective To provide a reference for the safe use of dipeptidyl peptidase-4(DPP-4)inhibitors in the treatment of type 2 diabetes mellitus(T2 DM).Methods A total of 60 quarters of FAERS data from the first quarter of 2004 to the fourth quarter of 2018 were downloaded.After drug names standardized by MedEx and adverse events classified by MedDRA,the autoimmune bullous dermatoses(AIBDs)related to DPP-4 inhibitors were searched and the safety signals were detected by ROR and PRR methods.Results A total of 383 AIBDs events related to DPP-4 inhibitors were obtained,including 178(0.20%)reports for sitagliptin,128(14.81%)reports for vildagliptin,51(2.81%)reports for alogliptin,13(0.18%)reports for saxagliptin and 13(0.54%)reports for linagliptin.Adverse drug events(ADE)were detected in 2 phosphotransferase system(PTs)domains(pemphigus and pemphigoid),all the five DPP-4 inhibitors had signal detected in pemphigoid,and sitagliptin had signal detected in pemphigus.Conclusion It is suggested that more attention should be paid to the AIBDs events related to DPP-4 inhibitors,and the monitoring of clinical drug use should be strengthened to detect and deal with ADE in time.
作者
周灵妍
吴斌
何治尧
徐珽
ZHOU Lingyan;WU Bin;HE Zhiyao;XU Ting(Wiest China Sshowl of Medicine,Sichuan Uiniterit,Chengiu,Siciuan,China 61041;Department of Conical Pharmacy,West China Hospial,Sichuan University,Chengdu,Sichuan,China 610041)
出处
《中国药业》
CAS
2020年第23期77-81,共5页
China Pharmaceuticals
基金
2018年四川省干部保健科研课题[川干研2018-104]。
