Department of Internal Medicine, Istanbul Medeniyet University, Göztepe Education and Research Hospital, Istanbul, Turkey.
Curr Med Res Opin. 2013 Aug;29(8):911-20. doi: 10.1185/03007995.2013.803053. Epub 2013 Jun 17.
To assess factors associated with insulin regimens at initiation, changes in treatment and metabolic control over 2 years of insulin therapy in patients with type 2 diabetes in five countries.
TREAT was a prospective, 24 month, observational study in patients with type 2 diabetes initiating insulin in clinical practice. Patient characteristics were collected at baseline and metabolic outcomes at 3, 6, 12, 18 and 24 months after initiation.
A total of 985 patients were enrolled, 886 assessed at baseline and 734 (82.8%) at 24 months. Baseline characteristics varied between countries: 52.8% of patients were men; mean age was 60.4 years; body mass index, 29.7 kg/m²; time since diagnosis, 10.1 years; HbA1c, 9.6%. Less than 25% of patients met ADA/IDF targets for blood pressure/LDL cholesterol. Overall, 50.1% of patients were initiated on long/intermediate insulin, 39.3% on mixture and 7.8% on basal-bolus; distribution varied between countries. Patients on long/intermediate were more likely to have lower baseline HbA1c and be intensified to other regimens (19.4%). No oral antidiabetic medication was used for 16.4% initiating on long/intermediate, 47.4% on mixture and 62.3% with basal-bolus. Overall, mean HbA1c decreased from 9.6% to 7.6%, with little difference between regimens at endpoint. The percentage of patients with hypoglycaemia was highest at 6 months and with basal-bolus.
Sites were not selected at random. Drop-out of patients prior to 24 months may have introduced a bias that favoured responders.
Mean baseline HbA1c was high, indicating delayed initiation of insulin treatment. Blood pressure and lipids were suboptimally controlled. Insulin regimens varied between countries, changed little and resulted in similar HbA1c levels after 24 months.
评估五种国家中 2 型糖尿病患者起始胰岛素治疗时胰岛素方案的相关因素、治疗变化以及 2 年的代谢控制情况。
TREAT 是一项前瞻性、24 个月的观察性研究，研究对象为在临床实践中起始胰岛素治疗的 2 型糖尿病患者。患者特征在基线时收集，起始后 3、6、12、18 和 24 个月时评估代谢结果。
共纳入 985 例患者，886 例在基线时评估，734 例（82.8%）在 24 个月时评估。各国之间的基线特征存在差异：52.8%的患者为男性；平均年龄为 60.4 岁；体重指数为 29.7kg/m²；诊断时间为 10.1 年；HbA1c 为 9.6%。不到 25%的患者达到 ADA/IDF 血压/LDL 胆固醇目标。总体而言，50.1%的患者起始使用长效/中效胰岛素，39.3%起始使用预混胰岛素，7.8%起始使用基础-餐时胰岛素；各国之间的分布情况存在差异。起始使用长效/中效胰岛素的患者基线 HbA1c 较低，更有可能被强化为其他方案（19.4%）。起始使用长效/中效胰岛素、预混胰岛素和基础-餐时胰岛素的患者中，分别有 16.4%、47.4%和 62.3%未使用口服降糖药物。总体而言，HbA1c 从 9.6%降至 7.6%，不同方案在终点时差异不大。低血糖发生率在 6 个月时最高，且基础-餐时胰岛素发生率最高。
研究地点并非随机选择。在 24 个月前脱落的患者可能存在偏向应答者的偏倚。
平均基线 HbA1c 较高，表明胰岛素治疗起始延迟。血压和血脂控制不理想。各国之间的胰岛素方案存在差异，治疗变化不大，24 个月后 HbA1c 水平相似。
