二甲双胍联合胰岛素治疗治疗 1 型糖尿病青少年的疗效和安全性：10 项随机对照试验的更新荟萃分析。
Effect and Safety of Adding Metformin to Insulin Therapy in Treating Adolescents With Type 1 Diabetes Mellitus: An Updated Meta-Analysis of 10 Randomized Controlled Trials.
机构信息
Department of Pediatrics, West China Second Hospital, Sichuan University, Chengdu, China.
Center of Translational Medicine, Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.
出版信息
Front Endocrinol (Lausanne). 2022 May 30;13:878585. doi: 10.3389/fendo.2022.878585. eCollection 2022.
BACKGROUND
The role of metformin in the treatment of adolescents with type 1 diabetes mellitus (T1DM) remains controversial. We conducted this updated meta-analysis to generate a comprehensive assessment regarding the effect and safety of metformin in treating adolescents with T1DM.
METHODS
We systematically searched PubMed, Embase, and the Cochrane Central Registry of Controlled Trials (CENTRAL) from their inception to November 2021 to identify randomized controlled trials evaluating the efficacy of metformin in the treatment of adolescents with T1DM. The primary outcome was the HbA1c level, and secondary outcomes included the body mass index (BMI), total insulin daily dose (TIDD) (unit/kg/d), hypoglycemia events, diabetes ketoacidosis (DKA) events, and gastrointestinal adverse events (GIAEs). Statistical analysis was conducted using RevMan 5.4 and STATA 14.0.
RESULTS
Ten studies enrolling 539 T1DM adolescents were included. Results suggested that metformin significantly decreased the HbA1c level at 12 months (mean difference [MD])=-0.50, 95% confidence interval [CI]=-0.61 to -0.39, P < 0.01); BMI (kg/m) at 3 months (MD=-1.05, 95%CI=-2.05 to -0.05, P=0.04); BMI z-score at 6 months (MD=-0.10, 95%CI=-0.14 to -0.06, P<0.01); and TIDD at 3 (MD=-0.13, 95%CI=-0.20 to -0.06, P<0.01), 6 (MD=-0.18, 95%CI=-0.25 to -0.11, P<0.01), and 12 (MD=-0.42, 95%CI=-0.49 to -0.35, P<0.01) months but significantly increased the risk of hypoglycemia events (risk ratio [RR]=3.13, 95%CI=1.05 to 9.32, P=0.04) and GIAEs (RR=1.64, 95%CI=1.28 to 2.10, P<0.01). For remaining outcomes at other time points, no statistical difference was identified. Sensitivity analysis confirmed the robustness of all pooled results.
CONCLUSIONS
The use of metformin might result in decreased BMI (kg/m), BMI z-score, and TIDD and increased risk of hypoglycemia events and GIAEs in adolescents with T1DM. However, future studies are required to further confirm the optimal dose and duration of metformin therapy.
背景
二甲双胍在 1 型糖尿病（T1DM）青少年患者中的治疗作用仍存在争议。我们进行了这项更新的荟萃分析，以全面评估二甲双胍治疗 T1DM 青少年的疗效和安全性。
方法
我们系统地检索了 PubMed、Embase 和 Cochrane 对照试验中心注册库（CENTRAL）从成立到 2021 年 11 月的数据，以确定评估二甲双胍治疗 T1DM 青少年疗效的随机对照试验。主要结局为糖化血红蛋白（HbA1c）水平，次要结局包括体重指数（BMI）、总胰岛素日剂量（TIDD）（单位/kg/d）、低血糖事件、糖尿病酮症酸中毒（DKA）事件和胃肠道不良事件（GIAEs）。使用 RevMan 5.4 和 STATA 14.0 进行统计分析。
结果
共纳入 10 项研究，涉及 539 名 T1DM 青少年。结果表明，二甲双胍治疗可显著降低青少年患者在 12 个月时的 HbA1c 水平（MD=-0.50，95%CI=-0.61 至-0.39，P<0.01）；3 个月时的 BMI（kg/m）（MD=-1.05，95%CI=-2.05 至-0.05，P=0.04）；6 个月时的 BMI z 评分（MD=-0.10，95%CI=-0.14 至-0.06，P<0.01）；以及 3 个月（MD=-0.13，95%CI=-0.20 至-0.06，P<0.01）、6 个月（MD=-0.18，95%CI=-0.25 至-0.11，P<0.01）和 12 个月（MD=-0.42，95%CI=-0.49 至-0.35，P<0.01）时的 TIDD，但显著增加低血糖事件（RR=3.13，95%CI=1.05 至 9.32，P=0.04）和 GIAEs（RR=1.64，95%CI=1.28 至 2.10，P<0.01）的风险。对于其他时间点的其余结局，未发现统计学差异。敏感性分析证实了所有汇总结果的稳健性。
结论
二甲双胍可能会导致 T1DM 青少年的 BMI（kg/m）、BMI z 评分和 TIDD 降低，以及低血糖事件和 GIAEs 的风险增加。然而，需要进一步的研究来证实二甲双胍治疗的最佳剂量和持续时间。
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