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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 systematically evaluate the efficacy and safety of metformin (MET) in the treatment of type 2 diabetes in children and adolescents. METHODS: The databases of PubMed, The Cochrane Library (No. 9, 2013), EMbase, VIP, WanFang Data, CBM and CNKI were searched by computer. The retrieval time ranged from database construction to September 2013. Metformin was collected in children and adolescent type 2 Diabetes clinical trials. According to the inclusion and exclusion criteria, two investigators independently conducted literature screening, data extraction and evaluation of the methodology involved in the study to improve glycosylated hemoglobin and fasting blood glucose as the main indicators of efficacy, using RevMan5.2 software for meta-analysis. Results: A total of 4 studies enrolled 1 345 children. Meta-analysis showed that MET monotherapy group could reduce the level of HbA1c and fasting blood glucose in children and improve clinical symptoms, but there was no significant difference compared with other treatment groups (P> 0.05); MET could reduce some indicators of body weight and blood lipid (P <0.05). The most common adverse reactions of MET were abdominal pain, diarrhea and nausea and vomiting. CONCLUSIONS: Metformin monotherapy reduces glycosylated hemoglobin and fasting plasma glucose in children and adolescents with type 2 diabetes, but has no significant advantage over other treatments. For more rapid onset of adolescent type 2 diabetes, it is necessary to take more active treatment such as combination therapy.