不同剂量坎格列净治疗2型糖尿病疗效与安全性的Meta分析

Efficacy and Safety of Different Doses of Canagliflozin in the Treatment of Type 2 Diabetes:A Meta-analysis

目的:系统评价不同剂量坎格列净治疗2型糖尿病的疗效与安全性,以为临床提供循证参考。方法:计算机检索Pub Med、Cochrane图书馆、Clinical Trails.gov、中国期刊全文数据库、万方数据库、中文科技期刊数据库,收集不同剂量坎格列净治疗2型糖尿病的随机对照试验(RCT),对符合纳入标准的研究进行资料提取,并采用Cochrane系统评价员手册5.1.0进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入11项RCT,合计5 399例患者。Meta分析结果显示,给予坎格列净300 mg/d在糖化血红蛋白水平[MD=0.14,95%CI(0.09,0.19),P<0.001]、空腹血糖水平[MD=0.40,95%CI(0.20,0.61),P<0.001]和体质量降低率[MD=0.69,95%CI(0.42,0.96),P<0.001]方面均显著优于100 mg/d剂量,差异均有统计学意义;两组患者总体不良反应发生率[RR=0.97,95%CI(0.94,1.01),P=0.10]、低血糖发生率[RR=1.02,95%CI(0.94,1.10),P=0.67]、尿路感染发生率[RR=0.96,95%CI(0.78,1.18),P=0.69]比较,差异均无统计学意义;试验患者的生殖道霉菌感染发生率显著高于对照组,差异有统计学意义[RR=0.84,95%CI(0.70,1.00),P=0.04]。结论:给予坎格列净300 mg/d相比于100 mg/d能更好地控制2型糖尿病患者的糖化血红蛋白、空腹血糖水平和体质量,但临床使用时应特别注意生殖道霉菌感染的发生。

OBJECTIVE： To systematically review the efficacy and safety of different doses of canagliflozin in the treatment of type 2 diabetes, and provide evidence-based reference for the clinical treatment. METHODS： Retrieved from PubMed, Cochrane Library, Clinical Trails.gov, CJFD, Wangfang Database and VIP, randomized controlled trials （RCT） about different doses of canagliflozin in the treatment of type 2 diabetes were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extract and quality evaluation by Cachrane 5.10. RESULTS： Totally 11 RCTs were enrolled, involving 5 399 patients. Results of Meta-analysis showed, canagliflozin 300 mg/d were superior to 100 mg/d in reducing HbAlc[MD=0.14,95%CI（0.09,0.19）, P〈0.001], FPG[MD=0.40,95%CI（0.20,0.61） ,P〈0.001] and reduction rate of body mass[MD=0.69,95%CI（0.42,0.96）, P〈 0.001], the differences were statistically significant; and there were no significant differences in the incidence of total adverse reactions [RR=0.97,95%CI（0.94,1.01） ,P=0.10] ,hypoglycemia [RR= 1.02,95%CI（0.94,1.10） ,P=0.67] ,urinary tract infection[RR= 0.96,95%CI （0.78, 1.18）,P=0.69] in 2 groups; There was significantly different of genital mycotic infection in 2 groups[RR= 0.84,95%CI（0.70,1.00） ,P=0.04]. CONCLUSIONS： Canagliflozin 300 mg/d is better than 100 mg/d in controlling HbAlc, fasting blood glucose and body mass of patients with type 2 diabetes, and the genital mycotic infection should be attentioned.