瑞格列奈的疗效和安全性——1项针对未接受过治疗的中国2型糖尿病患者开展的多中心前瞻性观察性研究

Effectiveness and safety of repaglinide:A multicentre,prospective,observational study in treatment of nave patients with type 2 diabetes in China

目的评价瑞格列奈(Rep)对新诊断或既往未经治疗的中国T2DM患者的临床疗效和安全性。方法进行为期16周的多中心、前瞻性、开放标签的非干预性疗效观察研究。纳入本研究的患者均年龄>18岁、HbA1c>6.5%、既往未接受过治疗。疗效指标为HbA1c、FBG、PBG和体重的变化。安全性指标为药物不良反应和低血糖事件。结果 Rep治疗16周后血糖明显改善,HbA1c下降1.7%(P<0.01)、FBG下降2.5mmol/L(P<0.01)和PBG下降6.2mmol/L(P<0.01)。研究结束时,60.5%的患者达到HbA1c<7%(与基线相比P<0.01)。研究过程中低血糖发生率为1.2起事件/患者.年,未发生严重药物不良反应和重度低血糖。结论 Rep能显著改善既往未接受过治疗的T2DM患者的血糖控制且低血糖风险低。

Objective To evaluate the clinical effectiveness and safety of repaglinide in treatment of naive type 2 diabetes subjects in China. Methods This was a 16-week multicentre, prospective, open label, observational study. Any subject with type 2 diabetes, who was above 18 years old, with HbA1 c〉 6.5%, and has not accepted any anti-diabetic treatment previously, was eligible for the study. The effective endpoints were changes in HbA1 c, fasting blood glucose （FBG）, postprandial blood glucose （PBC-） and body weight. The safety endpoints were incidence of adverse drug reactions and hypoglycaemic events. Results The study was conducted in 99 hospitals across China from March 2010 to February 2011. A total of 2,033 eligible patients （1108 males, mean age.. 56. 4±1.9 years and mean BMh 24. 7±3. 0 kg/m2） were recruited in this study. After 16 weeks of treatment, repaglinide improved glycaemic control with significant reductions in mean HbAlc （1.7%, P〈0. 0001）, FBG （2. 5 mmol/1, P〈0. 0001） and PBG （6.2 mmol/1, P〈0. 0001）. At the end of study, 60. 5% of patients achieved HbAlc 〈 7% （P d0. 0001 vs baseline）. Neither serious adverse drug reactions nor major hypoglycaemic events were reported. The incidence of hypoglycaemic events was 1. 2 events/patient · year. Conclusion The present study showed that repaglinide improves glycaemic control in treatment of naive patients with type 2diabetes, with a low risk of hypoglycaemia.