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L-乙酰肉碱治疗周围神经病患者:426例患者的短期双盲临床研究

L-Acetylcarnitine in the Treatment of Patients with Peripheral Neuropathies : A Short Term, Double-Blind Clinical Study of 426 Patients.

作者信息

De Grandis D, Santoro L, Di Benedetto P

机构信息

Department of Neurology, Arcispedale S. Anna, Corso Giovecca 203, 44100, Ferrara, Italy.

Department of Clinical Neurophysiology, II Policlinico University of Naples, Naples, Italy.

出版信息

Clin Drug Investig. 1995 Dec;10(6):317-22. doi: 10.2165/00044011-199510060-00001.

Abstract

426 patients with peripheral motor or sensory neuropathies were recruited and randomly assigned to 2 treatment groups in a double-blind, 30-day, prospective trial comparing L-acetylcarnitine (LAC) [1000 mg/day intramuscularly for the first 10 days then 2000 mg/day orally for the remaining 20 days] with placebo. Treatment efficacy was assessed by commonly employed electrophysiological tests performed at baseline and at the end of treatment. Safety and tolerability evaluations were performed on the entire patient population, although the statistical analysis for efficacy was restricted to the 298 patients with lower-than-normal nerve conduction velocities (CVs) at baseline. Among patients with impaired motor nerve function, a statistically significant improvement in mean CV (p < 0.01 vs placebo) was detected in LAC-treated individuals with mononeuropathies, whereas no statistical difference emerged between the LAC- and placebo-treated groups in patients with motor nerve poly neuropathies. In contrast, there were statistically significant differences between the LAC and placebo groups in terms of improvement in mean CV in patients with sensory nerve mononeuropathies (p < 0.05) and in those with sensory nerve polyneuropathies (p < 0.05). Only 17 patients reported poor tolerability to treatment, and only 7 of the 32 patients who were withdrawn from the study did so because of adverse events. Our trial demonstrated the efficacy of LAC in improving electrophysiological nerve conduction properties in patients with sensory or motor neuropathies.

摘要

招募了426例患有周围运动或感觉神经病变的患者,并将其随机分配到两个治疗组,进行一项为期30天的双盲前瞻性试验,比较L-乙酰肉碱(LAC)[前10天每天肌肉注射1000毫克,然后在剩余20天每天口服2000毫克]与安慰剂。通过在基线和治疗结束时进行的常用电生理测试评估治疗效果。对全体患者进行了安全性和耐受性评估,尽管疗效的统计分析仅限于基线时神经传导速度(CV)低于正常的298例患者。在运动神经功能受损的患者中,LAC治疗的单神经病变个体的平均CV有统计学显著改善(与安慰剂相比,p<0.01),而在运动神经多神经病变患者中,LAC治疗组和安慰剂治疗组之间没有统计学差异。相比之下,在感觉神经单神经病变患者(p<0.05)和感觉神经多神经病变患者(p<0.05)中,LAC组和安慰剂组在平均CV改善方面存在统计学显著差异。只有17例患者报告对治疗耐受性差,在退出研究的32例患者中,只有7例是因为不良事件而退出。我们的试验证明了LAC在改善感觉或运动神经病变患者的电生理神经传导特性方面的疗效。

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