摘要
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 combination therapy with saxagliptin and metformin in patients with type 2 diabetes. Methods ＂saxagliptin＂ and ＂metformin＂ were selected as keywords and PubMed and EMbase were searched. All randomized controlled trials （RCTs） of saxagliptin therapy in patients with type 2 diabetes were selected. According to the inclusion criteria, the articles were selected, evaluated, and meta-analyzed with RevMan 5.1 software. The levels of glycosylated haemoglobin （HbA1 c） and fasting plasma glucose （FPG） , the incidence of hypoglycemia after the treatment with saxagliptin ＋ metformin （the saxagliptin group）, placebo ＋ metformin （the placebo control group） and other hypoglycemic drugs ＋ metformin （the positive drug control group） were compared in patients with type 2 diabetes and their results were presented in mean difference （MD） or relative risk （RR） with 95% confidence interval （CI）. Results A total of 5 RCTs were entered. The results of recta-analysis were as follows： the treatment effect of decrease in HbA1 c levels in the saxagliptin group was better than that in the placebo control group （ MD = -0.59,95% CI： - O. 87 to - O. 32, P = 0.00） and the positive drug control group （MD = - O. 36, 95% CI： - O. 73 to - 0. 54, P = 0.00 ） ; the treatment effect of decrease in FPG levels in the saxagliptin group was better than that in the placebo control group （MD = - 16. 27,95 % C1 ： - 21.64 to - 10.91, P = O. 00） ; however, the difference in treatment effect of decrease in FPG levels between the saxagliptin group and the positive drug control group was not statistically significant （MD = -2.75, 95% CI： -22.52 to 17. Ol , P = 0.78 ） ; there was no significant difference in the incidence of hypoglycemia between the saxagliptin group and the placebo control group or the positive drug control group （ RR = O. 55,95% CI： O. 15 to 2.09, P = 0.38 ）. Conclusion The combination therapy with saxagliptin and met
出处
《药物不良反应杂志》
2012年第5期277-281,共5页
Adverse Drug Reactions Journal
