高剂量卡格列净对2型糖尿病安全性的Meta分析  

Safety of High-dose Canagliflozin for Type 2 Diabetes Mellitus:A Meta Analysis

作　　者：陈琪莹 黄丹丹[1] 陈添玉 CHEN Qiying;HUANG Dandan;CHEN Tianyu(Department of Pharmacy,the Second Affiliated Hospital of Fujian Medical University,Quanzhou Fujian 362000 China;Department of Nursing,Quanzhou Medical College,Quanzhou Fujian 362011,China)

机构地区：[1]福建医科大学附属第二医院药学部,福建泉州362000 [2]泉州医学高等专科学校护理学院,福建泉州362011

出　　处：《中国药物警戒》2021年第2期150-154,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的系统评价高剂量卡格列净对2型糖尿病患者的安全性。方法检索PubMed、Medline、Cochrane Library、Embase、中国知网、万方数据、维普网、中国生物医学文献数据库,检索时间为建库至2019年9月23日,收集卡格列净低剂量(100 mg/d)及高剂量(300 mg/d)用于治疗2型糖尿病的随机对照试验数据,采用RevMan5.3统计软件进行Meta分析。结果共纳入14项随机对照试验,合计患者6233例。Meta分析结果显示高剂量卡格列净在男性生殖器真菌感染上风险更高,差异具有统计学意义[RR=1.38,95%CI(1.06,1.79),P=0.02];在血容量不足相关不良反应事件上风险也更高,差异具有统计学意义[RR=1.44,95%CI(1.05,1.98),P=0.03];低密度脂蛋白胆固醇水平升高更多,差异具有统计学意义[MD=0.05,95%CI(0.00,0.10),P=0.04]。其他不良反应的发生与低剂量基本相似。结论高剂量卡格列净可增加男性生殖器真菌感染、血容量不足相关不良反应及低密度酯蛋白胆固醇水平升高的风险,其他不良反应的发生无显著差异。该结论尚需长期的随机对照试验进一步验证。Objective To evaluate the safety of high-dose canagliflozin(CANA)in the treatment of type 2 diabetes mellitus(T2DM).Methods PubMed,Medline,Cochrane Library,Embase,CNKI,Wanfang Database,VIP and CBM were searched for randomized controlled trials(RCTs)published from the inception of the database to September 2019.Data on randomized controlled trials related to canagliflozin at a low dose of 100 mg/d and at a high dose of 300 mg/d used for treating type 2 diabetes mellitus was collected and analyzed using the RevMan5.3 software.Results A total of 14 RCTs and 6,233 cases of patients were included.Meta analysis results showed that high doses of calpagliflozin were more likely to cause male genital fungal infections,and the difference was statistically significant[RR=1.38,95%CI(1.06,1.79),P=0.02].The risk was also higher for volume depletionrelated AEs and the difference was statistically significant[RR=1.44,95%CI(1.05,1.98),P=0.03].LDL-C levels increased more significantly,and the difference was statistically significant[MD=0.05,95%CI(0.00,0.10),P=0.04].The occurrence of ther difference was basically similar to that of low dose.Conclusion High-dose canaglif102in can in rease the risk of male genital fungal infections,volume depletion-related AEs.and elevated the LDL-C levels There is no significant difference in the occurrence of other adverse reactions.However,this conclusion needs to be verified by long-term RCTs.

关 键 词：卡格列净 2型糖尿病 META分析 药品不良反应 安全性 

分 类 号：R977.15[医药卫生—药品]