糖尿病控制与并发症试验（DCCT）期间强化胰岛素治疗对糖尿病并发症流行病学（EDIC）研究中 1 型糖尿病周围神经病变的影响。
Effect of prior intensive insulin treatment during the Diabetes Control and Complications Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Diabetes Interventions and Complications (EDIC) Study.
机构信息
Department of Neurology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
出版信息
Diabetes Care. 2010 May;33(5):1090-6. doi: 10.2337/dc09-1941. Epub 2010 Feb 11.
OBJECTIVE
To evaluate the impact of former intensive versus conventional insulin treatment on neuropathy in Diabetes Control and Complications Trial (DCCT) intensive and conventional treatment subjects with type 1 diabetes 13-14 years after DCCT closeout, during which time the two groups had achieved similar A1C levels.
RESEARCH DESIGN AND METHODS
Clinical and nerve conduction studies (NCSs) performed during the DCCT were repeated during the Epidemiology of Diabetes Interventions and Complications (EDIC) study by examiners masked to treatment status on 603 former intensive and 583 former conventional treatment subjects. Clinical neuropathy was defined by symptoms, sensory signs, or reflex changes consistent with distal polyneuropathy and confirmed with NCS abnormalities involving two or more nerves among the median, peroneal, and sural nerves.
RESULTS
The prevalence of neuropathy increased 13-14 years after DCCT closeout from 9 to 25% in former intensive and from 17 to 35% in former conventional treatment groups, but the difference between groups remained significant (P < 0.001), and the incidence of neuropathy remained lower among former intensive (22%) than former conventional (28%) treatment subjects (P = 0.0125). Analytic models of incident neuropathy that adjusted for differences in NCS results at DCCT closeout showed no significant risk reduction associated with former intensive treatment during follow-up (odds ratio 1.17 [95% CI 0.84-1.63]). However, a significant persistent treatment group effect was observed for several NCS measures. Longitudinal analyses of overall glycemic control showed a significant association between mean A1C and measures of incident and prevalent neuropathy.
CONCLUSIONS
The benefits of former intensive insulin treatment persisted for 13-14 years after DCCT closeout and provide evidence of a durable effect of prior intensive treatment on neuropathy.
目的
评估前强化与常规胰岛素治疗对糖尿病控制和并发症试验（DCCT）强化和常规治疗组 1 型糖尿病患者的神经病变的影响，这些患者在 DCCT 结束后 13-14 年期间接受治疗，在此期间两组的 A1C 水平相似。
研究设计和方法
在 DCCT 期间进行的临床和神经传导研究（NCSs），在 EDIC 研究期间，由对治疗状态进行盲法评估的检查人员在 603 名前强化治疗和 583 名前常规治疗患者中重复进行。临床神经病变的定义是症状、感觉体征或反射变化与远端多发性神经病一致，并通过涉及正中神经、腓总神经和腓肠神经的两种或多种神经的 NCS 异常得到证实。
结果
在 DCCT 结束后 13-14 年，前强化治疗组的神经病变患病率从 9%增加到 25%，前常规治疗组从 17%增加到 35%，但两组之间的差异仍然显著（P<0.001），前强化治疗组（22%）的神经病变发生率仍然低于前常规治疗组（28%）（P=0.0125）。调整 DCCT 结束时 NCS 结果差异的神经病变发生率分析模型显示，随访期间前强化治疗与风险降低无关（比值比 1.17[95%CI 0.84-1.63]）。然而，在几项 NCS 测量中观察到了显著的持续治疗组效应。整体血糖控制的纵向分析显示，平均 A1C 与新发和现患神经病变的测量值之间存在显著关联。
结论
前强化胰岛素治疗的益处在 DCCT 结束后持续了 13-14 年，并提供了先前强化治疗对神经病变具有持久影响的证据。
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