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背景尽管青春期2型糖尿病患病率有所上升,但用于指导治疗的现有资料很少,我们对比了3种疗法对儿童和青少年新发2型糖尿病患者血糖控制的效果。方法本研究入选患者需符合以下条件:10～17岁、用二甲双胍(1 000 mg,2次/d)治疗、糖化血红蛋白(HbA1c)<8%;将患者随机分配到单用二甲双胍治疗组、二甲双胍+罗格列酮(4 mg,2次/d)组、二甲双胍+生活方式干预(通过饮食和运动减轻体质量)组。主要结果为血糖控制失败,即HbA1c水平不低于8%并持续6个月,或持续代谢失代偿需用胰岛素治疗。结果对入选的699例患者(2型糖尿病的平均病程为7.8个月)平均随访3.86年,发现有319例(45.6%)患者血糖失控。单用二甲双胍治疗组、二甲双胍+罗格列酮组、二甲双胍+生活方式干预组的失控率分别为51.7%(120/232)、38.6%(90/233)和46.6%(109/234)。二甲双胍+罗格列酮组的疗效优于单用二甲双胍(P=0.006);二甲双胍+生活方式干预组的疗效居中,但与单用二甲双胍治疗组和二甲双胍+罗格列酮组比较,疗效无明显差异。按照性别和种族进一步分析显示,三种疗法的长期疗效有差异,非西班牙裔黑人参试者单用二甲双胍治疗的效果最差,女性参试者用二甲双胍+罗格列酮效果最好。有19.2%的参试者发生了严重不良事件。结论近半数的2型糖尿病儿童和青少年,其血糖控制与二甲双胍单药疗法相关。在不强调生活干预的情况下,加用罗格列酮治疗的效果优于单用二甲双胍治疗。
Background Although the prevalence of type 2 diabetes in adolescence has increased, there is little available data to guide treatment. We compared the effects of 3 therapies on glycemic control in newly diagnosed type 2 diabetes in children and adolescents. Methods Patients enrolled in this study were eligible to receive 10 to 17 years of treatment with metformin (1000 mg twice daily) and HbA1c <8%. Patients were randomized to metformin alone and metformin + Rosiglitazone (4 mg, 2 times / d) group, metformin + lifestyle intervention (weight loss by diet and exercise) group. The main result is failure to control blood glucose, ie HbA1c level of at least 8% for 6 months, or continuous metabolic decompensation requiring insulin therapy. Results A total of 699 patients (mean duration of type 2 diabetes, 7.8 months) were followed for an average of 3.86 years and 319 (45.6%) were found to have uncontrolled blood glucose. Metformin alone, metformin plus rosiglitazone, metformin + lifestyle interventions had 51.7% (120/232), 38.6% (90/233) and 46.6% (109/234) out of control rates, respectively. Metformin + rosiglitazone group was superior to metformin alone (P = 0.006); metformin + lifestyle intervention group was the middle effect, but compared with metformin alone group and metformin + rosiglitazone group, no significant effect difference. Further analysis by sex and race showed that the long-term efficacy of the three therapies varied. Non-Hispanic blacks had the worst treatment with metformin alone, and metformin + rosiglitazone had the best results in female participants. 19.2% of the participants had serious adverse events. Conclusions Nearly half of children and adolescents with type 2 diabetes have glycemic control associated with metformin monotherapy. In the absence of emphasis on life intervention, the addition of rosiglitazone was superior to metformin alone.