基于FAERS的二肽基肽酶4抑制剂相关不良事件信号挖掘-中国药房

基于FAERS的二肽基肽酶4抑制剂相关不良事件信号挖掘

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篇名：	基于FAERS的二肽基肽酶4抑制剂相关不良事件信号挖掘
TITLE：	Excavation of adverse event signals of dipeptidyl deptidase-4 inhibitors based on FAERS
摘要：	目的挖掘二肽基肽酶4（DPP-4）抑制剂相关不良事件（AE）的风险信号，为该类药物的临床安全使用提供参考。方法收集FAERS数据库中2006年10月17日至2021年12月31日上报的5种DPP-4抑制剂（西格列汀、沙格列汀、维格列汀、利格列汀、阿格列汀）的AE报告。采用报告比值比（ROR）法进行数据挖掘，利用《国际医学用语词典》（24.0版）药物不良反应术语集中的系统器官分类（SOC）和首选术语（PT）进行分类统计。结果共检索到DPP-4抑制剂相关AE报告120510份，风险信号1707个，其中西格列汀（80570份，717个）、沙格列汀（10009份，173个）、利格列汀（18214份，317个）、维格列汀（7893份，375个）、阿格列汀（3824份，125个）。这些报告中，女性（47.27%）多于男性（44.61%），患者年龄以61～75岁（28.37%）为主，以美国数量最多（56.17%）；严重AE报告有65458份（54.32%），以住院或住院时间延长为主（36.28%）。西格列汀、沙格列汀和阿格列汀均以胃肠系统疾病为主，利格列汀主要为内分泌系统疾病、肾脏及泌尿系统疾病、各类检查等，维格列汀主要为内分泌系统疾病、全身性疾病及给药部位各种反应、神经系统疾病等；其中西格列汀和利格列汀的风险信号均以血糖升高为主，沙格列汀以充血性心力衰竭和心力衰竭为主，维格列汀和阿格列汀分别以类天疱疮和呕吐为主。以2个及以上药物共同PT进行分析的结果显示，血糖升高、胰腺炎与西格列汀的关联性最大；体质量减轻与沙格列汀的关联性最大；肾衰竭与利格列汀的关联性最大；糖尿病酮症酸中毒与阿格列汀的关联性最大；低血糖症、急性肾损伤、糖化血红蛋白增加、类天疱疮以及乳酸性酸中毒与维格列汀的关联性最大。结论临床在使用DPP-4抑制剂时，应监测患者的血糖水平和其他血液生化指标，关注皮肤、胰腺和肾功能；若发生相关AE，应及时采取干预措施，以保障患者的用药安全。
ABSTRACT：	OBJECTIVE To excavate the risk signals of adverse events （AE） related to dipeptidyl peptidase-4 （DPP-4） inhibitors， and to provide reference for clinical safe use of these drugs. METHODS AE reports of five DPP-4 inhibitors （sitagliptin， saxagliptin， linagliptin， vildagliptin， anagliptin） reported in FAERS database from October 17th， 2006 to December 31st， 2021 were collected. The reporting odds ratio （ROR） method was used for data mining， and the systematic organ classification （SOC） and preferred terms （PT） in the drug ADR terminology set of the Medical Dictionary for Regulatory Activitios （24.0 edition） were used for classification statistics. RESULTS A total of 120 510 AE reports related to DPP-4 inhibitors were retrieved， with 1 707 risk signals， including sitagliptin （80 570 reports， 717 signals）， saxagliptin （10 009 reports， 173 signals）， linagliptin （18 214 reports， 317 signals）， vildagliptin （7 893 reports，375 signals） and anagliptin （3 824 reports，125 signals）. In these reports， women （47.27%） were more than men （44.61%）； the age of the patients mainly ranged from 61 to 75 years old （28.37%）. The United States had the largest number （56.17%）； there were 65 458 serious AE reports （54.32%）， mainly hospitalization or prolonged hospitalization time （36.28%）. Sitagliptin， saxagliptin and anagliptin mainly induced gastrointestinal diseases； sitagliptin mainly caused endocrine system diseases， kidney and urinary system diseases， various examinations； vildagliptin mainly resulted in endocrine system diseases， systemic diseases and various reactions at the administration site， nervous system diseases， etc. Among them， risk signals of sitagliptin and liggliptin mainly manifested as the increase of blood glucose， those of saxagliptin as the congestive heart failure and heart failure， and those of vildagliptin and anagliptin as pemphigoid and vomiting respectively. The results of PT analysis of two or more drugs showed that the increase of blood glucose and pancreatitis had the greatest correlation with sitagliptin； the weight loss had the greatest correlation with saxagliptin； renal failure had the greatest correlation with linagliptin； diabetic ketoacidosis had the greatest correlation with anagliptin. Hypoglycemia， acute kidney injury， increased glycated hemoglobin， pemphigoid and lactic acidosis were the most associated with vildagliptin. CONCLUSIONS When DPP-4 inhibitors were used clinically， the blood glucose level and other blood biochemical indexes of patients should be monitored， and skin condition， the pancreas and kidney function should be paid attention to. If related AE occurred， timely intervention measures should be taken to ensure the medication safety of patients.
期刊：	2022年第33卷第24期
作者：	张科，邵佳，孙璇，李波，宋崟，李正翔
AUTHORS：	ZHANG Ke，SHAO Jia，SUN Xuan，LI Bo，SONG Yin，LI ZhengXiang
关键字：	二肽基肽酶4抑制剂；不良事件；信号挖掘；2型糖尿病
KEYWORDS：	DPP-4 inhibitors； adverse event； signal excavation； type 2 diabetes
阅读数：	150 次
本月下载数：	6 次

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