Kieburtz K, Simpson D, Yiannoutsos C, Max M B, Hall C D, Ellis R J, Marra C M, McKendall R, Singer E, Dal Pan G J, Clifford D B, Tucker T, Cohen B
University of Rochester Medical Center, NY 14620, USA.
Neurology. 1998 Dec;51(6):1682-8. doi: 10.1212/wnl.51.6.1682.
Painful sensory neuropathy is a common complication of HIV infection. Based on prior uncontrolled observations, we hypothesized that amitriptyline or mexiletine would improve the pain symptoms.
A randomized, double-blind, 10-week trial of 145 patients assigned equally to amitriptyline, mexiletine, or matching placebo. The primary outcome measure was the change in pain intensity between baseline and the final visit.
The improvement in amitriptyline group (0.31+/-0.31 units [mean+/-SD]) and mexiletine group (0.23+/-0.41) was not significantly different from placebo (0.20+/-0.30). Both interventions were generally well tolerated.
Neither amitriptyline nor mexiletine provide significant pain relief in patients with HIV-associated painful sensory neuropathy.
疼痛性感觉神经病变是HIV感染的常见并发症。基于先前的非对照观察，我们推测阿米替林或美西律可改善疼痛症状。
对145例患者进行了一项随机、双盲、为期10周的试验，这些患者被平均分为三组，分别接受阿米替林、美西律或匹配的安慰剂治疗。主要结局指标是基线至末次访视期间疼痛强度的变化。
阿米替林组（0.31±0.31单位[均值±标准差]）和美西律组（0.23±0.41）的改善与安慰剂组（0.20±0.30）无显著差异。两种干预措施总体耐受性良好。
阿米替林和美西律均不能为HIV相关疼痛性感觉神经病变患者提供显著的疼痛缓解。
