二甲双胍治疗中国新诊断2型糖尿病患者临床疗效的预测因素分析

Factors predicting therapeutic efficacy of initial metformin monotherapy in Chinese newly diagnosed patients with type 2 diabetes mellitus

目的探索二甲双胍单药治疗中国新诊断2型糖尿病（T2DM）患者临床疗效的预测因素。方法选取2008年11月至2011年6月参加“阿卡波糖对中国新诊断T2DM患者的作用机制研究”（MARCH研究）的二甲双胍单药治疗48周的患者为研究对象，以糖化血红蛋白降低值（ΔHbA1c）为因变量，以基线各参数为自变量进行多元线性回归分析。结果（1）本研究共纳入354例新诊断T2DM患者，男性208例，女性146例，平均年龄（50±9）岁，平均病程（3.3±5.0）个月；（2）多元线性回归结果显示，12周时对ΔHbA1c的独立影响因素：HbA1c、空腹血糖（FPG）（β=-0.924、0.216，t=-27.71、6.24，均P〈0.01）、舒张压（DBP）、稳态模型胰岛素抵抗指数（HOMA-IR）、胰高血糖素曲线下面积（AUCglucagon）、胰高血糖素样肽1（GLP-1）曲线下面积（AUCGLP-1）（β=-0.075-0.076，t=-2.33-2.49，均P〈0.05）；（3）48周ΔHbA1c的独立影响因素：HbA1c（β=-0.860，t=-23.40，P〈0.01）及FPG（β=0.106，t=2.89， P=0.004）。结论二甲双胍对具有较高基线HbA1c、HOMA-IR、AUCGLP-1及较低FPG、AUCglucagon的新诊断T2DM患者疗效更好。

Objective To analyze the predictive parameters for therapeutic efficacy of metformin monotherapy in Chinese newly diagnosed patients with type 2 diabetes. Methods Subjects who were treated with metformin monotherapy for 48 weeks from“Study on the Mechanism of acarbose in Chinese Newly diagnosed Type 2 Diabetic Patient”（MARCH study） from November 2008 to June 2011 were enrolled. To assess the predictive parameters for therapeutic efficacy, a multiple linear regression analysis was performed, taking glycosylated hemoglobin （HbA1c） reduction as a dependent variable, and baseline parameters as independent variables. Results （1） A total of 354 patients （208 men and 146 women） with type 2 diabetes were enrolled. The mean age was（50±9）yrs, and the mean duration of diabetes was （3.3±5.0） months. （2） Multiple linear regression analysis indicated that baseline HbA1c, fasting plasma glucose （FPG） （β=-0.924, 0.216, t=-27.71, 6.24, all P〈0.01）, diastolic blood pressure （DBP）, homeostasis model assessment of insulin resistance （HOMA-IR）, area under the curve of glucagon （AUCglucagon） and area under the curve of plasma glucagon-like peptide-1 （AUCGLP-1） （β=-0.075-0.076, t=-2.33-2.49, all P〈0.05） were independent influencing factors forΔHbA1c at week 12;（3） HbA1c （β=-0.860, t=-23.40, P〈0.01） and FPG （β=0.106, t=2.89, P=0.004）were independent influencing factors for ΔHbA1c at week 48. Conclusion Metformin may be more effective in patients with newly diagnosed type 2 diabetes with higher baseline HbA1c, HOMA-IR, AUCGLP-1 and lower FPG and AUCglucagon.