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SGLT2抑制剂不良反应信号的挖掘与评价
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篇名: SGLT2抑制剂不良反应信号的挖掘与评价
TITLE: Excavation and Evaluation of ADR Signals of SGLT 2 Inhibitors
摘要: 目的:挖掘和评价钠-葡萄糖共转运蛋白2(SGLT2)抑制剂卡格列净、达格列净、恩格列净上市后的不良反应(ADR)信号,为临床合理用药提供参考。方法:采用比例报告比法(PRR)和报告比值比法(ROR)对2013年第2季度至2020年第3季度美国FDA不良事件报告系统自发呈报系统中接收的卡格列净、达格列净、恩格列净等3种SGLT2抑制剂的ADR进行信号挖掘,分析ADR报告中对应患者的基本信息(包括性别、年龄、上报年份、上报国家、严重ADR)和安全警告信号。结果:收集到的6029375份ADR报告中,SGLT2抑制剂为伴随和怀疑药物的ADR报告有43807份,其中卡格列净ADR报告19301份、达格列净ADR报告10960份、恩格列净ADR报告13546份。除性别未知和年龄缺失的ADR报告外,纳入报告患者的性别分布均衡,主要集中在50~75岁范围内,上报年份主要在2018年,主要上报国家为美国,以“住院或住院时间延长”为主要的严重ADR。共挖掘得到ADR信号573个,累及系统26个,主要集中在代谢与营养类疾病、内分泌失调、肾脏及泌尿系统疾病、感染及侵扰类疾病等方面。卡格列净、达格列净、恩格列净ADR频数排序前10位的主要ADR信号共14个,达格列净、恩格列净的ADR信号中强度最强的信号都依次为酮症酸中毒(PRR值分别为119.64、140.11,ROR值的95%CI下限分别为148.28、178.78)和真菌感染(PRR值分别为47.76、34.77,ROR值的95%CI下限分别为50.69、36.28);而卡格列净除上述2个信号较强外,截趾(PRR值为489.79,ROR值的95%CI下限为520.15)和骨髓炎(PRR值为61.42,ROR值的95%CI下限为65.38)的信号也较强。结论:SGLT2抑制剂在代谢与营养类疾病、内分泌失调、肾脏及泌尿系统疾病、感染及侵扰类疾病方面的安全风险较高。达格列净、卡格列净、恩格列净易引起酮症酸中毒、真菌感染等ADR,卡格列净还易引起截趾、骨髓炎等ADR。
ABSTRACT: OBJECTIVE:To excavate and evaluate ADR signals of SGLT 2 inhibitors as canagliflozin ,dapagliflozin and empagliflozin,and to provide reference for rational drug use in the clinic. METHODS :The proportional reporting ratio (PRR)and reporting odds ratio (ROR)were used to find the adverse drug reactions (ADR)signal of SGLT 2 inhibitors as canagliflozin , dapagliflozin and empagliflozin from the second quarter of 2013 to the third quarter of 2020 in the US FDA Adverse Event Reporting System (FAERS). The basic information (including gender ,age,reporting year ,reporting country ,severe ADR )and safety warning signals of corresponding patients in ADR report were analyzed. RESULTS :Among 6 029 375 ADR reports ,SGLT2 inhibitors of 43 807 ADR reports were concomitant and suspected drugs ;there were 19 301 ADR reports of canagliflozin ,10 960 ADR reports of dapagliflozin ,13 546 ADR reports of empagliflozin. Except for the ADR patients with unknown gender and missing age ,the gender distribution of the included reports was balanced ,mainly in the range of 50-75 years old. The reporting year was mainly in 2018,and the main reporting country was the United States ,with“hospitalization or prolonged hospitalization ” as the main serious ADR. A total of 573 ADR signals were obtained ,involving 26 systems,mainly focusing on metabolic and nutritional diseases ,endocrine disorders ,kidney and urinary system disease ,infection and invasion diseases ,etc. The results showed that there were 14 main ADR signals in the top 10 ADR of canagliflozin ,dapagliflozin and empagliflozin. The strongest ADR signals of dapagliflozin and empagliflozin were ketoacidosis (PRR=119.64/140.11,95%CI lower limit of ROR =148.28/ 178.78)and fungal infection (PRR=47.76/34.77,95% CI lower limit of ROR =50.69/36.28);except above signals in addition , toe amputation (PRR=489.79,95%CI lower limit of ROR =520.15)and osteomyelitis (PRR=61.42,95%CI lower limit of ROR=65.38)were strong in the ADR signals of canagliflozin. CONCLUSIONS :SGLT2 inhibitors have a higher security risk in metabolic and nutritional diseases ,endocrine disorders ,kidney and urinary system ,and infection and intrusion diseases. Dapagliflozin,canagliflozin and empag liflozin are prone to cause ADR such as ketoacidosis and fungal infection ,while canagliflozin is easy to cause ADRs such as toe amputation and osteomyelitis.
期刊: 2021年第32卷第08期
编辑: 郑淑芬,钟诗龙
AUTHORS: ZHENG Shufen ,ZHONG Shilong
关键字: 钠-葡萄糖共转运蛋白2抑制剂;卡格列净;达格列净;恩格列净;数据挖掘;不良事件报告系统;不良反应信号
KEYWORDS: SGLT2 inhibitors;Canagliflozin;Dapagliflozin;
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