VETERANS AFFAIRS COOPERATIVE STUDY ON GLYCEMIC CONTROL AND COMPLICATIONS IN TYPE-II DIABETES (VA CSDM) - RESULTS OF THE FEASIBILITY TRIAL
VETERANS AFFAIRS COOPERATIVE STUDY ON GLYCEMIC CONTROL AND COMPLICATIONS IN TYPE-II DIABETES (VA CSDM) - RESULTS OF THE FEASIBILITY TRIAL
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DOI：
10.2337/diacare.18.8.1113
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发表时间：
1995-08-01
期刊：
影响因子：
16.2
通讯作者：
LEE, HS
中科院分区：
文献类型：
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作者：
ABRAIRA, C;COLWELL, JA;LEE, HS
目的 - 对于非胰岛素依赖型糖尿病（NIDDM），强化药物治疗是否能有效维持尚不清楚。 NIDDM 强化胰岛素治疗的相对风险和益处尚不明确。因此，我们设计了一项可行性研究，对一组因持续高血糖而需要胰岛素的 NIDDM 男性进行标准治疗和强化治疗的比较。 研究设计和方法 - 在五个医疗中心对 153 名 60 +/- 6 岁男性进行了一项前瞻性试验，这些男性已知患有糖尿病 7.8 +/- 4 年。他们被随机分配到标准胰岛素治疗组（每天早上注射一次）或强化治疗组，旨在获得接近正常的血糖和与标准组相比具有临床意义的糖化血红蛋白分离。强化治疗组采用四步计划，并每日自我监测血糖：1）晚间注射胰岛素，2）同一注射添加日间格列吡嗪，3）单独注射两次胰岛素，4）每日多次注射。对患者的累积和依从性、糖化血红蛋白 (HbA(1c))、副作用以及前瞻性长期试验的终点测量进行了评估。 结果 - 达到了累积目标，平均随访时间为 27 个月（范围 18-35 个月），并且患者保留了 98.6% 的计划就诊。 6 个月后，强化治疗组的平均 HbA(1c) 等于或低于 7.3%，并且在试验期间仍比标准组低 2%。强化组中平均 HbA(1c) 的大部分下降是通过单次注射晚间中间胰岛素（单独注射或与日间格列吡嗪联合注射）实现的。试验结束时，64% 的患者已提前每天注射两次或两次以上胰岛素，以达到正常的 HbAlc。然而，HbA(1c) 仅小幅额外下降。严重低血糖很少见（每年每 100 名患者发生两次事件），并且各组之间没有显着差异，体重、血压或血脂变化也没有显着差异。 40 名患者中发生了 61 起新的心血管事件，其中 10 人死亡（其中 6 人死于心血管原因）。 结论 - 对于药物治疗血糖控制失败的 NIDDM 患者，强化阶梯式胰岛素治疗可有效维持接近正常的血糖控制超过 2 年，且不会出现过度严重的低血糖、体重增加、高血压或血脂异常。 NIDDM 的这一阶段心血管事件发生率很高。需要进行长期前瞻性试验来评估需要胰岛素的 NIDDM 患者高血糖强化治疗的风险效益比。
OBJECTIVE - It is not clear whether intensive pharmacological therapy can be effectively sustained in non-insulin-dependent diabetes mellitus (NIDDM). The relative risks and benefits of intensive insulin therapy in NIDDM are not well defined. Accordingly, we designed a feasibility study that compared standard therapy and intensive therapy in a group of NIDDM men who required insulin due to sustained hyperglycemia.RESEARCH DESIGN AND METHODS - A prospective trial was conducted in five medical centers in 153 men of 60 +/- 6 years of age age who had a known diagnosis of diabetes for 7.8 +/- 4 years. They were randomly assigned to a standard insulin treatment group (one morning injection per day) or to an intensive therapy group designed to attain near-normal glycemia and a clinically significant separation of glycohemoglobin from the standard arm. A four-step plan was used in the intensive therapy group along with daily self-monitoring of glucose: 1) an evening insulin injection, 2) the same injection adding daytime glipizide, 3) two injections of insulin alone, and 4) multiple daily injections. Patient accrual and adherence, glycohemoglobin (HbA(1c)), side effects, and measurements of endpoints for a prospective long-term trial were assessed.RESULTS - Accrual goals were met, mean follow-up time was 27 months (range 18-35 months), and patients kept 98.6% of scheduled visits. After 6 months, the mean HbA(1c) in the intensive therapy group was at or below 7.3% and remained 2% lower than the standard group for the duration of the trial. Most of the decrease in the mean HbA(1c) in the intensive group was the obtained by a single injection of evening intermediate insulin, alone or with daytime glipizide. By the end of the trial, 64% of the patients had advanced to two or more injections of insulin a day, aiming for normal HbAlc. However, only a small additional fall in HbA(1c) was attained. Severe hypoglycemia was rare (two events per 100 patients per year) and not significantly different between the groups, nor were changes in weight, blood pressure, or plasma lipids. There were 61 new cardiovascular events in 40 patients and 10 deaths (6 due to cardiovascular causes).CONCLUSIONS - Intense stepped insulin therapy in NIDDM patients who have failed glycemic control on pharmacological therapy is effective in maintaining near-normal glycemic control for >2 years without excessive severe hypoglycemia, weight gain, hypertension, or dyslipidemia. Cardiovascular event rates are high at this stage of NIDDM. A long-term prospective trial is needed to assess the risk-benefit ratio oi intensified treatment of hyperglycemia in NIDDM patients requiring insulin.