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撤回:用于预防和治疗糖尿病性周围神经病变的醛糖还原酶抑制剂。

WITHDRAWN: Aldose reductase inhibitors for the prevention and treatment of diabetic peripheral neuropathy.

作者信息

Airey M, Bennett C, Nicolucci A, Williams R

出版信息

Cochrane Database Syst Rev. 1996 Apr 22(1):CD002182. doi: 10.1002/14651858.CD002182.

DOI:10.1002/14651858.CD002182
PMID:17636697
Abstract

BACKGROUND

Diabetic peripheral neuropathy is a common complication of diabetes mellitus.

OBJECTIVES

To assess the efficacy of aldose reductase inhibitors in the prevention, reversal or delay in the progression of diabetic peripheral neuropathy.

SEARCH STRATEGY

The Cochrane Diabetes Group's database was searched and the citation lists of identified trials and previous reviews checked. Investigators identified as active in the field were approached for overlooked studies.

SELECTION CRITERIA

Randomised controlled trials of aldose reductase inhibitors versus placebo, no treatment or other treatment in diabetic patients with or without clinical neuropathy.

DATA COLLECTION AND ANALYSIS

Nerve conduction velocity was the only end point measured in all trials. Treatment effect was evaluated in terms of nerve conduction velocity mean difference in median and peroneal motor and median and sural sensory nerves.

MAIN RESULTS

19 trials, testing 4 different aldose reductase inhibitors for between 4 to 208 weeks duration (median 24 weeks), met the inclusion criteria for the meta-analysis. A small but statistically significant reduction in decline of median and peroneal motor nerve conduction velocities was present in the treated group when compared to the control group (weighted mean 0.66 m/s 95% CI 0.18-1.14 m/s and 0.53 m/s 95% CI 0.02-1.04m/s respectively). No clear benefit of aldose reductase inhibitor treatment was observed in either of the sensory nerves.

AUTHORS' CONCLUSIONS: Although aldose reductase inhibitor treatment has been demonstrated to diminish the reduction in motor nerve conduction velocity, the clinical relevance of such a change in this outcome measure is uncertain. There was no effect in terms of this outcome measure in the smaller sensory fibres, degeneration of which is primarily responsible for the most common neuropathic syndrome associated with diabetes, that of severe pain and loss of sensation in the extremity leading in some cases to ulceration and eventual amputation.

摘要

背景

糖尿病周围神经病变是糖尿病常见的并发症。

目的

评估醛糖还原酶抑制剂在预防、逆转或延缓糖尿病周围神经病变进展方面的疗效。

检索策略

检索了Cochrane糖尿病组数据库,并检查了已识别试验和既往综述的参考文献列表。还联系了该领域活跃的研究人员,以获取被忽视的研究。

入选标准

醛糖还原酶抑制剂与安慰剂、不治疗或其他治疗对比,用于有或无临床神经病变的糖尿病患者的随机对照试验。

数据收集与分析

所有试验中唯一测量的终点是神经传导速度。根据正中神经和腓总运动神经以及正中神经和腓肠感觉神经的神经传导速度平均差异评估治疗效果。

主要结果

19项试验符合荟萃分析的纳入标准,这些试验测试了4种不同的醛糖还原酶抑制剂,持续时间为4至208周(中位数为24周)。与对照组相比,治疗组正中神经和腓总运动神经传导速度下降幅度有小幅但具有统计学意义的降低(加权平均值分别为0.66 m/s,95%可信区间为0.18 - 1.14 m/s和0.53 m/s,95%可信区间为0.02 - 1.04 m/s)。在任何一条感觉神经中均未观察到醛糖还原酶抑制剂治疗有明显益处。

作者结论

尽管已证明醛糖还原酶抑制剂治疗可减少运动神经传导速度的降低,但这种结局指标变化的临床相关性尚不确定。对于较小的感觉纤维,该结局指标未显示有效果,而感觉纤维变性是与糖尿病相关的最常见神经病变综合征的主要原因,即严重疼痛和肢体感觉丧失,在某些情况下会导致溃疡和最终截肢。

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