Effect of angiotensin-converting-enzyme (ACE) inhibitor trandolapril on human diabetic neuropathy: Randomised doubleblind controlled trial
Effect of angiotensin-converting-enzyme (ACE) inhibitor trandolapril on human diabetic neuropathy: Randomised doubleblind controlled trial
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DOI：
10.1016/s0140-6736(98)02478-7
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发表时间：
1998-12-26
期刊：
影响因子：
168.9
通讯作者：
Boulton, AJM
中科院分区：
文献类型：
--
作者：
Malik, RA;Williamson, S;Boulton, AJM
背景糖尿病是多发性神经病的常见病因。肾病、视网膜病变和神经病变的发生和进展密切相关。血管紧张素转换酶（ACE）抑制剂可延缓肾病和视网膜病变的进展。我们研究了ACE抑制剂对糖尿病neuropathy.Methods的影响，我们招募了41名血压正常的I型或II型糖尿病患者和轻度神经病变的随机双盲安慰剂对照试验。在6个月和12个月时评估神经病变症状和缺陷评分、振动感知阈值、外周神经电生理学和心血管自主神经功能的变化。主要终点是腓神经运动传导velocity.Findings的变化，我们发现在基线年龄，HbA（1C），血压，或两组之间的神经病变的严重程度没有显着差异。治疗期间HbA（1c）无变化。与安慰剂相比，群多普利治疗12个月后，腓神经运动传导速度（p = 0.03）和M波振幅（p = 0.03）增加，F波潜伏期（p=0.03）减少，腓肠神经动作电位振幅增加（p=0.04）。振动感知阈值，自主神经功能，神经病变的症状和赤字评分没有改善，在任何group.Interpretation的ACE抑制剂群多普利可能会改善周围神经病变血压正常的糖尿病患者。在提倡改变临床实践之前，需要更大规模的临床试验来证实这些数据。
Background Diabetes is a common cause of polyneuropathy. The development and progression of nephropathy, retinopathy, and neuropathy are closely related. Angiotensin-converting enzyme (ACE) inhibitors delay progression of both nephropathy and retinopathy. We investigated the effect of ACE inhibition on diabetic neuropathy.Methods We recruited 41 normotensive patients with type I or type II diabetes and mild neuropathy into a randomised double-blind placebo-controlled trial. Changes in the neuropathy symptom and deficit scores, vibration-perception threshold, peripheral-nerve electrophysiology, and cardiovascular autonomic function, were assessed at 6 and 12 months. The primary endpoint was the change in peroneal nerve motor conduction velocity.Findings We found no significant difference at baseline for age, HbA(1c), blood pressure, or severity of neuropathy between two groups. There was no change in HbA(1c) over the treatment period. Peroneal motor nerve conduction velocity (p=0.03) and M-wave amplitude (p=0.03) increased, and the F-wave latency (p=0.03) decreased and sural nerve action potential amplitude increased (p=0.04) significantly after 12 months of treatment with trandolapril compared with placebo. Vibration-perception threshold, autonomic function, and the neuropathy symptom and deficit score showed no improvement in either group.Interpretation The ACE inhibitor trandolapril may improve peripheral neuropathy in normotensive patients with diabetes. Larger clinical trials are needed to confirm these data before changes to clinical practice can be advocated.