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目的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。方法以“saxagliptin”和“metformin”为关键词检索PubMed和EMbase数据库,筛选出沙格列汀治疗2型糖尿病的所有随机对照试验(RCTs),根据纳入标准对文献进行筛选和评估,采用RevMan 5.1软件进行meta分析,比较沙格列汀联合二甲双胍(沙格列汀组)与安慰剂(安慰剂对照组)或其他降糖药物联合二甲双胍(阳性药物对照组)治疗对2型糖尿病患者糖化血红蛋白(HbA1c)和空腹血糖(FPG)水平的影响,并比较低血糖发生率,结果以平均差(MD)、相对危险系数(RR)及其95%置信区间(CI)表示。结果共纳入5项RCTs研究。meta分析结果显示,在降低患者HbA1c水平方面,沙格列汀组明显优于安慰剂对照组(MD=-0.59,95%CI为-0.87～-0.32,P=0.00),也优于阳性药物对照组(MD=-0.36,95%CI为-0.73～-0.54,P=0.00)。在降低患者FPG水平方面,沙格列汀组的治疗效果明显优于安慰剂对照组(MD=-16.27,95%CI为-21.64～-10.91,P=0.00),而与阳性药物对照组的治疗效果相比,差异无统计学意义(MD=-2.75,95%CI为-22.52～17.01,P=0.78)。沙格列汀组与安慰剂或阳性药物对照组患者的低血糖发生率差异无统计学意义(RR=0.55,95%CI为0.15～2.09,P=0.38)。结论沙格列汀联合二甲双胍治疗能有效降低2型糖尿病患者的HbA1c和FPG水平,且安全性较好。
Objective To evaluate the efficacy and safety of saxagliptin and metformin in the treatment of type 2 diabetes. Methods PubMed and EMbase databases were searched using the keywords “saxagliptin” and “metformin” to screen out all randomized controlled trials (RCTs) of saxagliptin for type 2 diabetes and to screen and evaluate the literature based on the inclusion criteria , A meta-analysis using RevMan 5.1 software was performed to compare the effects of saxagliptin plus metformin (placebo) and placebo (placebo) or other antidiabetic drugs plus metformin (positive control) on type 2 diabetes (HbA1c) and fasting plasma glucose (FPG) were measured. The incidences of hypoglycemia were compared. The results were expressed as mean difference (MD), relative risk coefficient (RR) and 95% confidence interval (CI) Results A total of five RCTs were included in the study. Meta-analysis showed that saxagliptin was significantly superior to placebo in reducing HbA1c (MD = -0.59, 95% CI -0.87 to -0.32, P = 0.00), but also superior to the positive drug Control group (MD = -0.36, 95% CI -0.73 -0.54, P = 0.00). In reducing the level of FPG in patients, the treatment with saxagliptin was superior to placebo (MD = -16.27, 95% CI -21.64 -10.91, P = 0.00), but not with placebo The difference was not statistically significant (MD = -2.75, 95% CI -22.52-17.01, P = 0.78). There was no significant difference in the incidence of hypoglycaemia between the sitagliptin group and the placebo or positive control group (RR = 0.55, 95% CI 0.15-2.09, P = 0.38). Conclusions Saxagliptin combined with metformin can effectively reduce the levels of HbA1c and FPG in type 2 diabetic patients and is safe.