摘要
目的:系统评价坎格列净治疗2型糖尿病的疗效与安全性,以为临床治疗提供循证参考。方法:计算机检索Cochrane图书馆、Pub Med、EMBase、中国生物医学文献数据库、万方数据库,收集坎格列净(试验组)对比安慰剂(对照组)治疗2型糖尿病的随机对照试验(RCT),提取资料并评价质量后,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入7项RCT,合计2 188例患者。Meta分析结果显示,试验组患者糖化血红蛋白(Hb A1c)水平[WMD=-0.82,95%CI(-0.99,-0.65),P<0.001]、Hb A1c<7%的患者比例[RR=2.51,95%CI(1.98,3.19),P<0.001]、空腹血糖水平[WMD=-32.91,95%CI(-39.65,-26.17),P<0.001]显著优于对照组。生殖道感染发生率显著高于对照组[RR=3.76,95%CI(2.23,6.35),P<0.001];而低血糖发生率[RR=1.13,95%CI(0.40,3.20),P=0.81]、尿路感染发生率[RR=1.19,95%CI(0.82,1.73),P=0.36]与对照组比较,差异无统计学意义。结论:坎格列净治疗2型糖尿病安全、有效,临床使用时应注意预防患者生殖道感染。受纳入研究方法学限制,该结论尚需大样本、多中心的RCT进一步验证。
OBJECTIVE： To make a systematic review on the efficacy and safety of canagliflozin in the treatment of type 2 diabetes, and to provide evidence-based reference for clinical treatment. METHODS： Retrieved from Cochrane Library, PubMed, EM- Base, CBM and Wanfang database, randomized controlled trials （RCT） of canagliflozin （test group） versus placebo （control group） in the treatment of type 2 diabetes were collected, and Meta-analysis was performed by using Rev Man 5.2 statistical software after extracting data and evaluating quality. RESULTS： A total of 7 RCTs were included, involving 2 188 patients. The results of Meta analysis indicated that glycosylated hemoglobin levels [WMD =- 0.82,95 % CI（- 0.99,- 0.65）, P〈0.001], the proportion of HbA1c〈7%[RR=2.51,95%CI（1.98,3.19）,P〈0.001], fasting plasma glucose levels [WMD=-32.91,95%CI（-39.65,-26.17）, P〈：0.001] in test group were significantly better than those of control group, the incidence of genital tract infections was significantly higher than control group [RR= 3.76,95 % CI（2.23,6.35）, P〈0.001] ; however, compared with control group, there was no significant difference in the incidence of hypoglycemia [RR=I.13, 95% CI（0.40, 3.20）, P=0.81] and urinary tract infections[RR= 1.19,95%CI（0.82,1.73）, P=0.36]. CONCLUSIONS： Canagliflozin is safe and effective in the treatment of type 2 diabetes, and it needs to be noticed with genital tract infections during the clinical use. Due to the limitation of methodology, large-scale and polycentric RCT are required for further validation of the conclusions.
出处
《中国药房》
CAS
北大核心
2015年第24期3382-3385,共4页
China Pharmacy
关键词
坎格列净
2型糖尿病
系统评价
疗效
安全性
Canagliflozin
Type 2 diabetes
Systematic review
Efficacy
Safety
