二甲双胍单药治疗儿童及青少年2型糖尿病的系统评价

Metformin Monotherapy for Type 2 Diabetes in Children and Adolescents: A Systematic Review

目的:系统评价二甲双胍(MET)治疗儿童及青少年2型糖尿病的疗效和安全性。方法:计算机检索PubMed、The Cochrane Library(2013年第9期)、EMbase、VIP、WanFang Data、CBM和CNKI数据库,检索时限均为从建库至2013年9月,收集二甲双胍治疗儿童及青少年2型糖尿病的临床试验。由两位研究者按照纳入与排除标准独立进行文献筛选、资料提取和评价纳入研究的方法学质量,以改善糖化血红蛋白和空腹血糖作为主要疗效判定指标,采用RevMan5.2软件进行Meta分析。结果:共纳入4项研究1 345例患儿。Meta分析结果显示,MET单药组能够降低患儿糖化血红蛋白和空腹血糖水平,改善临床症状,但与其他治疗组比较差异无统计学意义(P>0.05);MET能够降低体重和血脂的部分指标(P<0.05);MET最常见的不良反应是腹痛、腹泻和恶心呕吐。结论:二甲双胍单药治疗能降低儿童及青少年2型糖尿病患者糖化血红蛋白和空腹血糖水平,但和其他治疗相比,并无显著优势。对于病情发展更迅速的青少年2型糖尿病患者,有必要采取联合用药等更积极的治疗措施。

Objective： To assess the efficacy and safety of metformin monotherapy for Type 2 Diabetes （T2DM） in children and adolescents. Methods： Such databases as PubMed, The Coehrane Library （2013, 9 issue） , EMbase, VIP, WanFang Data, CBM and CNKI were electronically searched from inception to September 2013 for clinical trials on metformin monotherapy for T2DM in children and adolescents. Two reviewers independently screened literatures according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality. Then, recta-analysis was performed by using RevMan 5.2. Results： Four trials were included involving a total of 1,345 patients. The results of recta-analysis showed that： glycosylated hemoglobin levels and fasting plasma glucose levels had no significant difference between the metformin monotherapy group and the control group （ P〉0.05 ）. Mefformin had beneficial effects in reducing weight, BMI, LDL and TG （P〈0.05）. The most commonly reported adverse drug reactions were abdominal pain, diarrhea, nausea and vomiting. Conclusions： Metformin can decrease glyeosylated hemoglobin levels and fasting plasma glucose levels. Mefformin monotherapy was no better than other therapy. Combined treatment was more necessary for adolescents with type 2 diabetes.