Abraira C, Colwell J, Nuttall F, Sawin C T, Henderson W, Comstock J P, Emanuele N V, Levin S R, Pacold I, Lee H S
Endocrinology/Diabetes Section, Edward Hines, Jr, Veterans Affairs Hospital, Ill, USA.
Arch Intern Med. 1997 Jan 27;157(2):181-8.
The risks and benefits of intensive therapy in non-insulin-dependent diabetes mellitus (NIDDM) need to be defined. In preparation for a long-term trial, a feasibility study of 153 men in 5 medical centers compared standard vs intensive insulin therapy.
To assess the rate of development of new cardiovascular events and their correlates.
Patients with a mean +/- SD age of 60 +/- 6 years and diagnosis of NIDDM for 7.8 +/- 4.0 years were randomly assigned to a standard (1 insulin injection every morning) or to an intensive treatment arm (stepped plan from 1 evening injection of insulin, alone or with glipizide, to multiple daily injections) designed to attain near-normal glycemia levels. A 2.07% separation of glycosylated hemoglobin (HbA1c) was sustained for a mean follow-up of 27 months (P < .001). Predefined cardiovascular events were assessed by a committee unaware of treatment assignment.
Mild and moderate hypoglycemic events were more frequent in the intensive than in the standard treatment arm (16.5 vs 1.5 per patient per year, respectively). Mean insulin dose was 23% lower in the standard treatment arm (P < .001). There were 61 new cardiovascular events in 24 patients (32%) in the intensive treatment arm and in 16 patients (20%) in the standard treatment arm (P = .10). There was no difference in total and cardiovascular mortality (n = 5 and n = 3 in the intensive and standard treatment arms, respectively) or in new events in patients with cardiovascular history (n = 10 in each arm). In Cox regression analysis, the only significant correlate for new cardiovascular events was previous cardiovascular disease (P = .04). Entering in the analysis any baseline cardiovascular abnormality, the regression model indicated a lower HbA1c level prior to the event as the only correlate for new cardiovascular events (P = .05).
A long-term prospective trial is needed to assess the risk-benefit ratio of intensive insulin therapy for NIDDM in patients who require it.
需要明确非胰岛素依赖型糖尿病（NIDDM）强化治疗的风险与益处。在筹备一项长期试验时，5个医疗中心对153名男性进行了一项可行性研究，比较了标准胰岛素治疗与强化胰岛素治疗。
评估新发生心血管事件的发生率及其相关因素。
将平均年龄为60±6岁、诊断为NIDDM 7.8±4.0年的患者随机分为标准治疗组（每天早晨注射1次胰岛素）或强化治疗组（从每晚1次胰岛素注射，单独使用或与格列吡嗪联合使用，逐步过渡到每日多次注射的方案），旨在使血糖水平接近正常。糖化血红蛋白（HbA1c）平均分离2.07%，平均随访27个月（P<.001）。由不了解治疗分配情况的委员会评估预先定义的心血管事件。
强化治疗组轻度和中度低血糖事件比标准治疗组更频繁（分别为每年每位患者16.5次和1.5次）。标准治疗组的平均胰岛素剂量低23%（P<.001）。强化治疗组24例患者（32%）发生了新的心血管事件，标准治疗组16例患者（20%）发生了新的心血管事件（P = 0.10）。总死亡率和心血管死亡率（强化治疗组和标准治疗组分别为5例和3例）或有心血管病史患者的新事件发生率（每组10例）无差异。在Cox回归分析中，新发生心血管事件的唯一显著相关因素是既往心血管疾病（P = 0.04）。将任何基线心血管异常纳入分析后，回归模型表明事件发生前较低的HbA1c水平是新发生心血管事件的唯一相关因素（P = 0.05）。
对于需要强化胰岛素治疗的NIDDM患者，需要进行一项长期前瞻性试验来评估其风险效益比。
