【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。本文将入选的中国患者分为高龄组(≥65岁)或低龄组(<65岁)进行比较分析。 结果 进入试验的患者中702例(21.5%)进入高龄组，2565例(78.4%)进入低龄组。整个研究过程中两组均未报告药物严重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-0.17 kg(95%CI:-0.39～0.04)，低龄组-0.15 kg(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-2.74 mmol/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12.33 IU，未接受过胰岛素治疗的患者为15.38 IU;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15.03 IU，未接受过胰岛素治疗的患者16.98 IU。 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。

　　【关键词】 糖尿病，2型;地特胰岛素;老年患者;安全性

Safety and Efficacy of Once-Daily Insulin Detemir in Chinese Patients with Type 2 Diabetes Aged 65 Years or Older: Results from the Chinese Cohort of the SOLVETM Study PAN Chang-yu, JI Li-nong, LU Ju-ming, et al, on behalf of Chinese SOLVETM study group. Department of Endocrinology, Chinese PLA General Hospital, Beijing 100853, China

Corresponding author: PAN Chang-yu, E-mail:panchy301@126.com

　　【Abstract】 Objective To explore the safety and efficacy of initiating once-daily insulin detemir in Chinese patients with type 2 diabetes aged 65 years or older. Methods The SOLVE™ study 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 ≥ 65 years and < 65 years). Results The Chinese cohort was comprised of 702 (21.5%) patients aged ≥65 years and 2565 (78.4%) patients aged < 65 years. 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 ⑴ the changes of mean body weight were −0.17 kg(95%CI：-0.39～0.04) in patients aged ≥ 65 years and −0.15 kg(95%CI:-0.29～-0.01) in patients aged < 65 years; ⑵ the changes of glycosylated haemoglobin A1c level were −0.99%(95%CI：-1.12～-0.86) in patients aged ≥ 65 years and −1.22%(95%CI：-1.29～-1.14) in patients aged < 65 years; ⑶ the changes of fasting glucose level were −2.48 mmol/L(95%CI：-2.69～-2.27) in patients aged ≥ 65 years and −2.74 mmol/L(95%CI：-2.86～-2.62) in patients aged < 65 years. ⑷ the mean daily dose of insulin was 12.33 IU and 15.38 IU in patients aged ≥ 65 years with and without insulin therapy prior to the sudy respectively, and was 15.03 IU and 16.98 IU in patients aged < 65 years with and without insulin therapy prior to the sudy respectively. Conclusion The once-daily insulin detemir as add-on therapy to previously existing OAD regimens is safe and effective in the elderly patients (≥ 65 years) , and it has similar safety and effectiveness as compared to those in younger patients (< 65 years).

　　【Key words】 Diabetes, type 2;Insulin detemir; Elderly patients; Safety