摘要
目的:系统评价沙格列汀联合二甲双胍治疗2型糖尿病的疗效和安全性。方法:计算机检索Pub Med、Cochrane图书馆、EMBASE中的文献,同时筛查纳入文献的参考文献,按纳入与排除标准纳入沙格列汀联合二甲双胍治疗2型糖尿病的随机对照试验。由2名评价员独立评价文献质量、提取资料并交叉核对,采用Rev Man 5.2软件进行统计分析。结果:共纳入5项临床研究,包括2 156例2型糖尿病患者。文献荟萃(Meta)分析结果显示:(1)在降低患者糖化血红蛋白水平方面,沙格列汀联合二甲双胍组优于二甲双胍组,差异有统计学意义(WMD=-0.47,95%CI=-0.68^-0.14,P<0.05);(2)在降低空腹血糖水平方面,沙格列汀联合二甲双胍组优于二甲双胍组,差异有统计学意义(WMD=-15.52,95%CI=-19.85^-11.19,P<0.05);(3)在低血糖发生率方面,沙格列汀联合二甲双胍组与二甲双胍组相当,差异无统计学意义(RR=1.15,95%CI=0.75~1.76,P=0.52)。结论:沙格列汀联合二甲双胍治疗2型糖尿病安全、有效,在降低糖化血红蛋白和空腹血糖水平方面均优于二甲双胍组,但在低血糖发生率方面,沙格列汀联合二甲双胍组与二甲双胍组的差异无统计学意义。
OBJECTIVE： To evaluate the efficacy and safety of saxagliptin plus metformin for type 2 diabetes mellitus. METHODS： The databases including Cochrane Library,Pub Med and EMbase were searched to collect the randomized controlled trials（ RCTs） on saxagliptin plus metformin in the treatment of type 2 diabetes mellitus in accordance with the exclusion and inclusion criteria. Meanwhile,the references of the included studies were also retrieved. Two reviewers independently assessed the quality of the RCTs,collected and cross-checked the data. All data were analysed statistically using Review Manager 5. 2 software. RESULTS： Five studies involving 2 156 participants were included. Te results of meta-analysis showed that saxagliptin plus metformin group was better than in metformin group in terms of improvement of Hb A1 c levels（ WMD =- 0. 47,95% CI =- 0. 68-- 0. 14,P〈0. 05） and in FPG levels（ WMD =- 15. 52,95% CI =- 19. 85-- 11. 19,P〈0. 05）. However,there was no statistically significant diference between the two groups in hypoglycemia events（ RR = 1. 15,95% CI = 0. 75-1. 76,P = 0. 52）.CONCLUSIONS： Saxagliptin plus metformin is safe and effective in treatment of type 2 diabetes mellitus,which is better than metformin alone in reducing Hb A1 c level and FBG（ fasting blood glucose） level; however,there is no statistically significant diference between the two groups in hypoglycemia events.
出处
《中国医院用药评价与分析》
2015年第7期941-944,共4页
Evaluation and Analysis of Drug-use in Hospitals of China
