卡格列净治疗2型糖尿病疗效和安全性的系统评价与Meta分析  

The Efficacy and Safety of Canagliflozin for Treatment of Type 2 Diabetes: a Systematic Review and Meta-analysis

作　　者：褚加成[1] 孙明谨[1] 白弘波 周后智 赵玉兰[1] 

机构地区：[1]湖北医药学院附属随州医院内分泌科,湖北随州441300

出　　处：《湖北医药学院学报》2015年第4期377-384,共8页Journal of Hubei University of Medicine

摘　　要：目的:评价卡格列净治疗2型糖尿病的疗效及安全性。方法:计算机检索MEDLINE、EMBASE、CENTRAL、The National Research Register、中国生物医学文献数据库和中国期刊全文数据库,检索时限均为2012年12月至2014年5月31日。纳入以2型糖尿病为研究对象、比较卡格列净与其他疗法的随机对照试验,对合格研究进行资料提取及质量评价后,并用Rev Man 5.3软件进行Meta分析。结果:纳入8个随机对照试验共计5 868例患者。与对照组比较,卡格列净100 mg能显著降低糖化血红蛋白(SMD=-8.95,95%CI=-11.49^-6.41,P=0.002)、降低空腹血糖(SMD=-11.90,95%CI=-15.20^-8.59,P<0.00001)、减轻体质量(SMD=-10.97,95%CI=-14.46^-7.48,P<0.00001);卡格列净300 mg能显著降低糖化血红蛋白(SMD=-11.57,95%CI=-14.24^-8.91,P<0.0001)、降低空腹血糖(SMD=-14.26,95%CI=-18.23^-10.30,P<0.00001)及减轻体质量(SMD=-13.95,95%CI=-16.76^-11.14,P<0.00001)。低血糖的发生率、泌尿系感染的风险及因不良反应导致退出卡格列净100 mg组和300 mg组与对照组差异均无统计学意义,发生生殖系统感染和因渗透性利尿导致尿频、多尿症状的发生率卡格列净100 mg组及300 mg组均高于对照组。结论:当前结果表明卡格列净治疗2型糖尿病的疗效肯定,能改善血糖的控制及降低体质量,有较好的依从性,使用卡格列净治疗过程中发生低血糖风险低于格列美脲,但发生生殖系统感染及多尿、尿频症状高于对照组药物。Objective To systematically review the efficacy and safety of canagliflozin in patients with type 2 diabetes. Moth- ods The database of MEDLINE, EMBASE, CENTRAL, The National Research Register, CBM, CNKI were searched from De- cember 2012 to May 31,2014. The randomized controlled trials（RCTs） carried out in patients with type 2 diabetes were col- lected,and their quality was evaluated and meta-analysis was conducted by using RevMan 5.3 software. Results Eight RCTs including 5 868 patients were yielded. Compared with control group,canagliflozin with a dose of 100 mg significantly reduced glycated hemoglobin A1 C （ SMD = - 8.95,95 % CI = - 11.49 - - 6.41, P = 0.002 ）, FPG （ SMD = - 11.90,95 % CI = ＇- 15.20 - -8.59, P 〈 0.00001 ） and body weight（ SMD = - 10.97,95% CI = - 14.46 - -7. ;48, P 〈 0.00（301 ）, canagliflozin with a dose of 300 mg significantly reduced glycated hemoglobin A1C（ SMD = - 11.57,95% CI = - 14- 24 - - g. 91,P 〈 0. 0001 ）, FPG （ SMD = - 14.26,95% CI = - 18.23 - - 10.30, P 〈 0.00001 ） and body weight （ SMD = - 13.95,95 % CI = - 16.76 - - 11.14,P 〈 0.00001 ）. The incidence rates of hypoglycaemia and urinary tract infections and the ratio of dropping out of canagliflozing program because of its adverse event had no significant difference in two canagli- flozin graoups compared with control group, but the incidence rates of reproductive system infections, frequent micturition and diuresisy induced by osmotic diuresis,in two canagliflozin groups were significantly higher than that of control group. Conclusion Canagliflozin improved glycaemic control, reduced body weight, and showed better compliance in type 2 diabe-tes （T2DM） patients, the incidence rates of hypoglycaemia was lower in canaglittozin group than in glimepiride group, mean- . while, the incidence rates of reproductive system infection, requent micturition and diuresis were higher.

关 键 词：卡格列净 2型糖尿病 系统评价 META分析 

分 类 号：R587.1[医药卫生—内分泌]