Kemper C A, Kent G, Burton S, Deresinski S C
Department of Medicine, Santa Clara Valley Medical Center, San Jose, California 95128, USA.
J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Dec 1;19(4):367-72. doi: 10.1097/00042560-199812010-00007.
Although mexiletine, an antiarrhythmic with local anesthetic properties, has been reported to relieve discomfort in diabetic neuropathy, its usefulness in the treatment of HIV-related painful peripheral neuropathy (PPN) has not been determined. The tolerance and effectiveness of mexiletine in HIV-related PPN were assessed in 22 patients who were randomized to receive mexiletine (maximum dose, 600 mg/day) or placebo for 6 weeks, followed by the alternative intervention for 6 weeks after a 1-week washout period. The daily pain response was assessed using a visual analogue scale card in 19 patients who received at least 2 weeks of the drug, 16 of whom were crossed-over to receive the alternate agent. No statistically significant difference was found between the mean daily pain scores for patients receiving mexiletine versus placebo, irrespective of the order in which the agents were received. Comparing the mean individual daily pain scores for each phase of study, 5 patients (31%) had significantly less pain while receiving mexiletine compared with their response to placebo, 5 patients (31%) had significantly less pain while receiving placebo, and no difference was noted in 6 patients (38%). Crossover and multivariate analyses for repeated measures showed no apparent difference in the response to mexiletine versus placebo. Dose-limiting adverse events occurred in 39% of those receiving mexiletine, but only 1 patient (5%) discontinued placebo. Mexiletine was only modestly well tolerated despite its relatively brief period of administration, and no evidence was found to support its benefit in HIV-related PPN. Although a first-drug effect was not demonstrated, a powerful placebo effect was seen in some patients.
尽管已报道具有局部麻醉特性的抗心律失常药美西律可缓解糖尿病性神经病变的不适，但它在治疗HIV相关的疼痛性周围神经病变（PPN）中的效用尚未确定。对22例患者评估了美西律在HIV相关PPN中的耐受性和有效性，这些患者被随机分配接受美西律（最大剂量600mg/天）或安慰剂治疗6周，在1周的洗脱期后接着接受替代干预6周。使用视觉模拟量表卡对19例接受至少2周药物治疗的患者评估每日疼痛反应，其中16例交叉接受替代药物。接受美西律与接受安慰剂的患者的平均每日疼痛评分之间未发现统计学上的显著差异，无论药物的接受顺序如何。比较研究各阶段的平均个体每日疼痛评分，5例患者（31%）接受美西律时的疼痛明显低于接受安慰剂时，5例患者（31%）接受安慰剂时疼痛明显减轻，6例患者（38%）未观察到差异。重复测量的交叉分析和多变量分析显示，美西律与安慰剂的反应无明显差异。接受美西律的患者中有39%发生了剂量限制性不良事件，但仅1例患者（5%）停用安慰剂。尽管美西律的给药期相对较短，但其耐受性仅属中等，未发现证据支持其对HIV相关PPN有益。虽然未显示出首剂效应，但在一些患者中观察到了强大的安慰剂效应。
