【摘要】 目的探讨65岁以上中国老年T2DM患者起始加用每日1次地特胰岛素的安全性和有效性。方法本研究是一项为期24周的多中心开放观察性研究。本研究将入选的中国患者分为高龄组(≥65岁)和低龄组(<65岁)进行比较分析。结果进入试验的患者中高龄组702例(21.5%),低龄组2565例(78.4%)。整个研究过程中两组均未报告严重药物不良反应和严重低血糖事件。和胰岛素治疗前比较,试验结束时平均体重的变化值高龄组-0.17kg(95%CI:-0.39~0.04),低龄组-0.15kg(95%CI:-0.29~-0.01);HbA1c变化值高龄组-0.99%(95%CI:-1.12~-0.86),低龄组-1.22%(95%CI:-1.29~-1.14);FPG变化值高龄组-2.48 mmol/L(95%CI:-2.69~-2.27),低龄组-2.74mmol/L(95%CI:-2.86~-2.62)。试验结束时,高龄组试验前接受过胰岛素治疗的患者平均胰岛素日剂量为12.33IU,未接受过胰岛素治疗的患者为15.38IU;低龄组试验前接受过胰岛素治疗的患者平均胰岛素日剂量为15.03IU,未接受过胰岛素治疗的患者16.98IU。结论对65岁以上老年T2DM口服降糖药效果不佳的患者起始加用每日1次地特胰岛素治疗安全有效,其安全性及降糖效果均与65岁以下患者相似。更多还原

【Abstract】 Objective To explore the safety and efficacy of initiating once-daily insulin detemir in Chinese patients with type 2diabetes aged 65years or older.Methods The SOLVETMstudy was a 24-week,multi-centre,open-label observational study.A sub-analysis was conducted and compared by dividing all Chinese subjects into two groups(aged≥65years and<65years).Results The Chinese cohort was comprised of 702(21.5%)patients aged≥65years and 2565(78.4%)patients aged <65years.No serious drug adverse reactions or major hypoglycaemic events were reported in either group during the study.Compared to pretherapy with insulin,the results at the end of trial showed that(1)The changes of mean body weight were-0.17kg(95%CI:-0.39~0.04)in patients aged ≥ 65years and-0.15kg(95%CI:-0.29~-0.01)in patients aged<65years;(2)The changes of glycosylated haemoglobin A1 c level were-0.99%(95%CI:-1.12~-0.86)in patients aged ≥ 65years and-1.22%(95%CI:-1.29~-1.14)in patients aged<65years;(3)The changes of fasting glucose level were-2.48mmol/L(95%CI:-2.69~-2.27)in patients aged≥65years and-2.74mmol/L(95%CI:-2.86~-2.62)in patients aged<65years;(4)The mean daily dose of insulin was 12.33IU and 15.38IU in patients aged≥65 years with and without insulin therapy prior to the sudy respectively,and was 15.03IU and 16.98IU in patients aged<65years with and without insulin therapy prior to the sudy respectively.ConclusionT he once-daily insulin detemir as add-on therapy to previously existing OAD regimens is safe and effective in the elderly patients(≥65years),and it has similar safety and effectiveness as compared to those in younger patients(<65years).更多还原