摘要
目的:系统评价钠-葡萄糖共转运蛋白2(SGLT-2)抑制剂发生糖尿病酮症酸中毒(DKA)和非高血糖性糖尿病酮症酸中毒(euDKA)的风险。方法:计算机检索PubMed、Embase、the Cochrane Library、ClinicalTrials.gov、中国知网、万方数据库和维普数据库等,收集建库至2024年3月31日发表的SGLT-2抑制剂治疗后出现DKA/euDKA的相关文献。筛选文献、提取数据,根据Cochrane系统评价员手册6.4版的偏倚风险评估工具对文献质量进行评价,并应用RevMan 5.3软件记录和制图。采用ADDIS 1.16.5软件进行网状Meta分析和概率排序;采用Stata 16.0软件进行证据网络关系图绘制和发表偏倚分析。结果:共纳入32篇文献,包括83132例患者,涉及12种干预措施。网状Meta分析及概率排序结果显示,DKA的风险从高至低依次为卡格列净300 mg/d>艾格列净15 mg/d>艾格列净5 mg/d>卡格列净100 mg/d>索格列净400 mg/d>达格列净5 mg/d>索格列净200 mg/d>恩格列净10 mg/d>达格列净10 mg/d=恩格列净2.5 mg/d=恩格列净25 mg/d=安慰剂;euDKA的风险从高至低依次为达格列净>卡格列净>恩格列净>安慰剂。结论:卡格列净300 mg/d和达格列净可能分别是发生DKA和euDKA风险最高的SGLT-2抑制剂。对于合并DKA或euDKA其他诱因的患者,建议避免选择上述药物。由于当前纳入研究数据的数量和质量存在局限,需要未来开展更多高质量的随机对照研究进一步验证上述结论。
OBJECTIVE:To systematically evaluate risk of diabetic ketoacidosis(DKA)and euglycemic diabetic ketoacidosis(euDKA)induced by sodium-glucose linked transporter 2(SGLT-2)inhibitor.METHODS:PubMed,Embase,the Cochrane Library,ClinicalTrials.gov,CNKI,Wanfang Data and VIP were retrieved to collect related literature of DKA/euDKA after treatment of SGLT-2 inhibitors.The retrieval time was from the database establishment to Mar.31st,2024.After literature screening and data extraction,the quality evaluation of included literature was performed with bias risk assessment tool recommended by the Cochrane system evaluator handbook 6.4,and RevMan 5.3 software was used for recording and mapping.ADDIS 1.16.5 was used for network Meta-analysis and probability ranking.Stata 16.0 was used to draw evidence network diagram and analyze publication bias.RESULTS:A total of 32 articles were included,with a total of 83132 patients and 12 kinds of interventions.Meta-analysis and probability ranking showed that the risk of DKA from high to low was canagliflozin 300 mg/d>ertugliflozin 15 mg/d>ertugliflozin 5 mg/d>canagliflozin 100 mg/d>sotagliflozin 400 mg/d>dapagliflozin 5 mg/d>sotagliflozin 200 mg/d>empagliflozin 10 mg/d>dapagliflozin 10 mg/d=empagliflozin 2.5 mg/d=empagliflozin 25 mg/d=placebo,and the risk of euDKA from high to low was dapagliflozin>canagliflozin>empagliflozin>placebo.CONCLUSIONS:The SGLT-2 inhibitors with highest risk of DKA and euDKA may be canagliflozin 300 mg/d and dapagliflozin,respectively.For patients with other incentives of DKA or euDKA,avoiding these agents is recommended.As the quantity and quality of data currently included in the study are limited,more high-quality RCT are needed to further verify the above conclusions.
作者
黄文辉
华春红
陈秋红
薛鸿林
张云琛
陈秀芬
陈锦珊
HUANG Wenhui;HUA Chunhong;CHEN Qiuhong;XUE Honglin;ZHANG Yunchen;CHEN Xiufen;CHEN Jinshan(Dept.of Pharmacy,the 909th Hospital/Dongnan Hospital of Xiamen University,Fujian Zhangzhou 363000,China;Zhangzhou Quality and Technology Evaluation and Monitoring Center,Fujian Zhangzhou 363000,China)
出处
《中国医院用药评价与分析》
2025年第8期989-994,998,共7页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
福建省药品监督管理局科技项目(No.2024010)
中国研究型医院学会药物评价专委会《临床重点药品的使用监测和评价研究专项(2023)》(No.Y2023FH-YWPJ03-204)。
关键词
钠-葡萄糖共转运蛋白2抑制剂
糖尿病酮症酸中毒
网状Meta分析
Sodium-glucose linked transporter 2 inhibitor
Canagliflozin
Dapagliflozin
Diabetic ketoacidosis
Network Meta-analysis
