中国药业2024，Vol.33Issue(2)：105-109,5.DOI:10.3969/j.issn.1006-4931.2024.02.026
基于FAERS的二肽基肽酶-Ⅳ抑制剂皮肤不良事件信号挖掘与评价
Mining and Evaluation of Skin Adverse Event Signals Induced by Dipeptidyl Peptidase-4 Inhibitors Based on FAERS
摘要
Abstract
Objective To provide a reference for the rational use of dipeptidyl peptidase-4(DPP-4)inhibitors in clinical practice.Methods The adverse drug event(ADE)reports with DPP-4 inhibitors marketed in the world as the primary suspected drugs for each quarter from 2010 to 2021 in the Food and Drug Administration Adverse Event Reporting System(FAERS)were collected.The ADE signals of DPP-4 inhibitors were mined by the reporting odds ratio(ROR)method,and the skin ADE signals were extracted and analyzed by the system and organ classification(SOC)in the Medical Dictionary for Regulatory Activities(MedDRA).Results There was zero ADE report with gemigliptin,omarigliptin,trelagliptin,anagliptin and evogliptin as the primary suspected drugs.There were 192 131,2 034,6 787,3 635,4 532 and two ADE reports with sitagliptin,vildagliptin,saxagliptin,alogliptin,linagliptin and teneligliptin as the primary suspected drugs respectively,corresponding to twenty,four,fifteen,ten,fourteen and zero skin ADE signals respectively,among which,there were eighteen,two,seven,nine,eight and zero ADE signals not mentioned in the drug instructions respectively.Among the patients with skin ADEs,there were more females than males taking alogliptin,while more males than females taking sitagliptin,vildagliptin,saxagliptin and linagliptin;most people were over 65 years;the duration of medication was mainly half a year to one year for vildagliptin,while that was mainly within six months or more than one year for sitagliptin,saxagliptin,alogliptin and linagliptin;the main dosages of sitagliptin,vildagliptin,saxagliptin,alogliptin and linagliptin were 100,50,5,25,and 5 mg/d respectively;the clinical outcome of patients taking sitagliptin and alogliptin was mostly hospitalization,while that of patients taking the vildagliptin,saxagliptin and linagliptin was mostly others.Conclusion DPP-4 inhibitors can induce various skin ADEs,and close monitoring should be carried out during its clinical use.关键词
二肽基肽酶-Ⅳ抑制剂/皮肤不良事件/FAERS/报告比值比法/信号挖掘Key words
dipeptidyl peptidase-4 inhibitor/skin adverse event/FAERS/reporting odds ratio/signal mining分类
医药卫生引用本文复制引用
幸婷婷,陈光华,李文东..基于FAERS的二肽基肽酶-Ⅳ抑制剂皮肤不良事件信号挖掘与评价[J].中国药业,2024,33(2):105-109,5.基金项目
四川省南充市2019年市校合作科研专项[19SXHZ0163]. （）
