达格列净联合二甲双胍与单用二甲双胍治疗2型糖尿病疗效比较的meta分析

Dapagliflozin plus metformin versus metformin alone for type 2 diabetes:a meta analysis

目的评价比较达格列净联合二甲双胍与二甲双胍单药治疗2型糖尿病的疗效和安全性。方法以"Dapagliflozin"、"metformin"为关键词检索pubMed、Web、google、EMbase数据库,筛选出达格列净联合二甲双胍治疗2型糖尿病文献行Meta分析,比较达格列净联合二甲双胍(达格列净组)与安慰剂联合二甲双胍(安慰剂对照组)治疗对糖化血红蛋白(HbA1c)和体质量水平的影响,并比较低血糖、尿路感染和生殖器感染的发生率,结果以平均差(MD)、比值比(OR)及95%可信区间(CI)表示。结果共纳入5项随机对照实验(RCTs)研究。Meta分析结果显示,在降低患者HbA1c方面,达格列净联组降低HbA1c水平的效果优于安慰剂联合二甲双胍组,其差异具有统计学意义(MD=-0.42,95%CI=-0.50^-0.35,P<0.01)。在降低体质量方面,达格列净联合二甲双胍组降低体质量的效果优于安慰剂联合二甲双胍组,其差异具有统计学意义(MD=-2.17,95%CI=-2.50^-1.85,P<0.01)。达格列净联合二甲双胍组患者低血糖发生率与安慰剂联合二甲双胍组相似,差异无统计学意义(OR=1.05,95%CI=0.59~1.86,P>0.05)。在尿路感染发生率方面,达格列净联合二甲双胍组尿路感染发生率高于安慰剂联合二甲双胍组,差异有统计学意义(OR=1.61,95%CI=1.02~2.54,P<0.05)。在生殖器感染发生率方面,达格列净联合二甲双胍组生殖器感染发生率高于安慰剂联合二甲双胍组,差异具有统计学意义(OR=2.42,95%CI=1.28~4.60,P<0.05)。结论达格列净联合二甲双胍治疗能有效降低2型糖尿病患者的HbA1c和体质量,且不增加低血糖的发生率,但增加了尿路感染和生殖器感染的发生率。

Objective To evaluate the efficacy and safety of the combination of dapagliflozin and metformin vs metformin alone. Methods Dapaliflozin and metformin were selected as keywords, PubMed,Web, Google and EMbase were searched. All randamized control trails（RCTs） of dapagliflozin plus metformin therapy in patients with type 2 diabetes were selected. Accordiing to the inclution criteria, the articles were .selected, evaluated, and meta-analyzed with Revmen 5.1 software. The levels of glycosylated haemoglol？in（HbA1 c） and body mass,the incidence of hypoglycemia, urinary tract infection and genital infection after the treatment with dapagliflozin＋metform and placebo＋ metformin were compared in patients with type 2 diabetes and their results were presented in mean difference（MD） or odds ratio （OR） with 950/00 confidence interval（ CI ）. Results A total of 5 RCTs were enrolled. The results of meta-analyses were as follows ： the treatmeat effect of decrease in HbA1 c levels in the dapagliflozin＋ metform group was better than that in placebo＋metform group（MD=--0.42,95% CI =-0.50- 0.35, P〈0.01）;the treatment effect of decreace in weight levels in the dapagliflozin＋ metform group was better than that in placebo＋metform group（MD=- 2.17,95 CI =-2.50-1.85, P d0.01）; there was no significant difference in the incidence of hypoglycemia between the dapagliflozin group and the placebo ＋ metform group;the dapagliflozin-α metform group increased the risk of urinary （ OR = 1.61,95 % CI = 1.02-2.54, P 〈 0.05） and genital tract infection （ OR = 2.42,95 % CI = 1.28-4.60, P 0.05）. Conclusion The combination therapy of dapagliftozin and metform is effective to decrease the HbA1 c and body mass levels in patients with type 2 diabetes. It does not increase the incidence of hypoglycemia, but can increase the risk of urinary and genital tract infection.