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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 PubMed、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 HbA1c[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 HbA1c,fasting blood glucose and body mass of patients with type 2 diabetes,and the genital mycotic infection should be attentioned.
坎格列净2 型糖尿病剂量Meta分析疗效安全性
CanagliflozinType 2 diabetesDoseMeta-analysisEfficacySafety
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