The effects of intensive glycemic control on neuropathy in the VA cooperative study on type II diabetes mellitus (VA CSDM)
The effects of intensive glycemic control on neuropathy in the VA cooperative study on type II diabetes mellitus (VA CSDM)
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DOI：
10.1016/s1056-8727(99)00062-8
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发表时间：
1999-09-01
影响因子：
3
通讯作者：
Rubino, FA
中科院分区：
文献类型：
--
作者：
Azad, N;Emanuele, NV;Rubino, FA
确定标准治疗 (STD) 组和强化治疗 (INT) 组之间是否可以安全地维持 HbA(1c) 差异，同时将双组的 HbA(1c) 水平维持在社区实践可接受的范围内。本次可行性试验研究了强化治疗对各种参数的影响。我们在此报告 24 个月的 INT 对周围神经和自主神经病变的结果。 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 7.8 +/- 糖尿病。 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。周围神经病变是通过病史和体格检查以及异常自主神经病变 Valsalva 比值 (VR < 1.2) 和 RR 变异 (RRV < 10) 进行临床诊断。INT 实现的平均 HbA(1c) 分离率为 2.07%，HbA(1c) 等于或低于 7.3%（与 STD 相比，p = 0.001）。 STD 中周围神经病变的基线患病率为 53%，INT 中的周围神经病变基线患病率为 48%。到 24 个月时，STD 患病率增至 69%（与基线相比，p = 0.005），INT 患病率增至 64%（与基线相比，p = 0.008，但与 STD 没有什么不同）。虽然 INT 并没有逆转周围神经病变的所有因素，但 INT 中颅神经病变的患病率降低（与 STD 相比，p = 0.053），并且上肢触觉保留更频繁（与 STD 相比，p = 0.03）。基线时，38% 的 STD 患者和 31% 的 INT 患者存在异常 Valsalva 比率和/或 RR 变异。到 24 个月时，STD 患者的患病率上升至 55%（与基线相比，p = 0.0067），而 INT 患者的患病率升至 48%（与基线相比，p = 0.012，与 STD 没有差异）。 STD 中勃起功能障碍的患病率从基线时的 53% 增加到 2 年时的 73%，p = 0.002，2 年时从 51% 增加到 73%（与基线相比，p = 0.003），与 STD 没有差异。异常胃肠道或出汗症状的频率没有变化。我们的结论是，2 年严格的血糖控制并没有降低周围或自主神经病变的总体患病率。事实上，两个治疗组的患病率均显着上升。然而，在降低颅神经病变频率和更好地保留 INT 触觉方面也有一些好处。 (C) 2000 爱思唯尔科学公司。
To determine whether a difference in HbA(1c) could be safely sustained between a standard therapy (STD) arm and an intensive therapy (INT) arm, while maintaining HbA(1c) levels in both arms within a range acceptable in community practice. The effects of intensive treatment on various parameters were studied in this feasibility trial. We report here the results of 24 months of INT on peripheral and autonomic neuropathy.A prospective trial was conducted in five medical centers in 153 men of 60 +/- 6 years of 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. Peripheral neuropathy was diagnosed clinically by a history and physical examination, and by abnormal autonomic neuropathy Valsalva ratio (VR < 1.2) and RR variation (RRV < 10).An average HbA(1c) separation of 2.07% was achieved with INT, having HbA(1c) at or below 7.3% (p = 0.001 versus STD). Baseline prevalence of peripheral neuropathy was 53% in STD, and 48% in INT. By 24 months, the prevalence increased to 69% in STD (p = 0.005 versus baseline), and to 64% in INT (p = 0.008 versus baseline, but no different than STD). Though INT did not reverse all elements of peripheral neuropathy, there was a decreased prevalence of cranial neuropathy (p = 0.053 versus STD) and more frequent preservation of touch sensation in the upper extremities (p = 0.03 versus STD) in INT. At baseline, an abnormal Valsalva ratio and/or RR variation was seen in 38% of STD and 31% of INT, By 24 months in STD, the prevalence rose to 55% (p = 0.0067 versus baseline), and in INT, to 48% (p = 0.012 versus baseline and no different from STD). The prevalence of erectile dysfunction increased from 53% at baseline to 73% at 2 years, p = 0.002 in STD, and from 51% to 73% at 2 years (p = 0.003 versus baseline) and no different from STD. There was no change in the frequency of abnormal gastrointestinal or sweating symptoms.Our conclusion was that 2 years of meticulous glycemic control did not decrease overall prevalence of peripheral or autonomic neuropathy. In fact, the prevalence rose equivalently and significantly in both treatment arms. There was some benefit, however, in decreased frequency of cranial neuropathy and better preservation of touch sensation in INT. (C) 2000 Elsevier Science Inc.