摘要
目的为临床合理使用二肽基肽酶-Ⅳ(DPP-4)抑制剂提供参考。方法通过美国食品和药物管理局药品不良事件报告系统(FAERS)收集2010年至2021年各季度以全球已上市DPP-4抑制剂为首要怀疑药物的药品不良事件(ADE)报告,采用报告比值比(ROR)法挖掘DPP-4抑制剂的ADE信号,并利用《监管活动医学词典》(MedDRA)中的系统器官分类(SOC)提取并整理其中的皮肤ADE信号。结果以吉格列汀、奥格列汀、曲格列汀、安奈格列汀、依格列汀为首要怀疑药物的ADE报告数均为0份;以西格列汀、维格列汀、沙格列汀、阿格列汀、利格列汀、替格列汀为首要怀疑药物的ADE报告数分别为192131,2034,6787,3635,4532,2份,对应的皮肤ADE信号数依次为20,4,15,10,14,0个,且其中分别有18,2,7,9,8,0个ADE信号未在相应药品说明书中提及。在发生皮肤ADE的患者中,阿格列汀用药患者女性多于男性,其余4种药物反之;年龄多在65岁以上;维格列汀用药时长集中在0.5~1年,其余4种药物的用药时长集中在半年内或1年以上;西格列汀、维格列汀、沙格列汀、阿格列汀、利格列汀用药剂量依次集中在100,50,5,25,5 mg/d。使用西格列汀、阿格列汀的患者临床结局大多为住院,其余3种药物多为其他临床结局。结论DPP-4抑制剂可致多种皮肤ADE,临床用药时应密切监测。
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 192131,2034,6787,3635,4532 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.
作者
幸婷婷
陈光华
李文东
XING Tingting;CHEN Guanghua;LI Wendong(The Affiliated Hospital of North Sichuan Medical College,Nanchong,Sichuan,China 637000)
出处
《中国药业》
CAS
2024年第2期105-109,共5页
China Pharmaceuticals
基金
四川省南充市2019年市校合作科研专项[19SXHZ0163]。
