Turner R, Cull C, Holman R
United Kingdom Prospective Diabetes Study Group, Radcliffe Infirmary, Oxford.
Ann Intern Med. 1996 Jan 1;124(1 Pt 2):136-45. doi: 10.7326/0003-4819-124-1_part_2-199601011-00011.
To report the progress (after 9-year follow-up) of a study designed to determine whether improved glucose control in patients with newly diagnosed non-insulin-dependent diabetes mellitus (NIDDM) is effective in reducing the incidence of clinical complications.
A multicenter, randomized, controlled trial of different therapies for NIDDM. After initial diet therapy, 4209 asymptomatic patients who remained hyperglycemic (fasting plasma glucose levels, 6.0 to 15.0 mmol/L) were assigned to either a conventional therapy policy, primarily with diet alone, or to an intensive therapy policy, aiming for fasting plasma glucose levels of less than 6.0 mmol/L, with assignment to primary therapy with sulfonylurea or insulin (which increased insulin supply) or metformin (which enhanced insulin sensitivity).
All three modes of pharmacologic therapy in the intensively treated group-sulfonylurea, insulin, and metformin-had similar efficacy in reducing the fasting plasma glucose and glycated hemoglobin levels. Over 9 years, patients assigned to intensive therapy with sulfonylurea or insulin had lower fasting plasma glucose levels (median, 7.3 and 9.0 mmol/L, respectively) than patients assigned to conventional therapy. Regardless of the assigned therapy, however, the fasting plasma glucose and hemoglobin A1c levels increased, and maintaining near-normal glycemia was, in general, not feasible. Even insulin therapy did not achieve the therapeutic goal of near-normal glycemia because of the difficulty in treating marked hyperglycemia and the risk for hypoglycemic episodes. Nine years after the diagnosis of diabetes, 29% of the patients had had a diabetes-related clinical end point, 20% had had a macrovascular complication, and 9% had had a microvascular complication.
A report will be published in 1998 after a median duration from randomization of 11 years (range, 6 to 20 years) with an 81% power at a 1% level of significance of detecting whether the obtained improvement in glucose control causes a 15% decrease or increase in the incidence of major complications and whether any specific therapy is advantageous or disadvantageous.
报告一项旨在确定新诊断的非胰岛素依赖型糖尿病（NIDDM）患者改善血糖控制是否能有效降低临床并发症发生率的研究进展（9年随访后）。
一项针对NIDDM不同治疗方法的多中心、随机、对照试验。初始饮食治疗后，4209例仍处于高血糖状态（空腹血糖水平为6.0至15.0 mmol/L）的无症状患者被分配至传统治疗策略组（主要仅采用饮食治疗）或强化治疗策略组，强化治疗策略旨在使空腹血糖水平低于6.0 mmol/L，并分配至采用磺脲类药物或胰岛素（增加胰岛素供应）或二甲双胍（增强胰岛素敏感性）进行初始治疗。
强化治疗组的所有三种药物治疗模式——磺脲类药物、胰岛素和二甲双胍——在降低空腹血糖和糖化血红蛋白水平方面具有相似的疗效。在9年时间里，分配至采用磺脲类药物或胰岛素进行强化治疗的患者空腹血糖水平（中位数分别为7.3和9.0 mmol/L）低于分配至传统治疗的患者。然而，无论分配何种治疗，空腹血糖和糖化血红蛋白A1c水平均升高，总体而言，维持血糖接近正常并不可行。即使胰岛素治疗也未实现血糖接近正常的治疗目标，原因在于治疗显著高血糖存在困难以及发生低血糖事件的风险。糖尿病诊断9年后，29%的患者出现了与糖尿病相关的临床终点事件，20%出现了大血管并发症，9%出现了微血管并发症。
在随机分组后的中位时间为11年（范围为6至20年），检测所获得的血糖控制改善是否会使主要并发症发生率降低或升高15%以及任何特定治疗是否有利或不利的检验效能为81%、显著性水平为1%的情况下，将于1998年发表一份报告。
