Estanislao Lydia, Carter Kay, McArthur Justin, Olney Richard, Simpson David
Department of Neurology and Clinical Neurophysiology, Mount Sinai Medical Center, New York, NY 10029, USA.
J Acquir Immune Defic Syndr. 2004 Dec 15;37(5):1584-6. doi: 10.1097/00126334-200412150-00010.
To investigate the analgesic efficacy and safety of 5% lidocaine gel in painful HIV-associated distal sensory polyneuropathy (DSP).
Painful DSP, the most common neurologic complication in HIV infection, is difficult to treat. Lidocaine 5% gel was effective in alleviating neuropathic pain in an open-label study of HIV DSP.
In a double-blind, placebo-controlled, crossover, multi-center study, 64 subjects were randomized to receive 5% lidocaine or vehicle gel for 2 weeks (phase A). A washout period of 2 weeks was followed by a crossover to the alternate agent for another 2 weeks (phase B). The primary outcome was difference in average pain scores (Gracely pain scale) between the 2 groups during the second week of each treatment period. Secondary outcomes included differential effect of the first treatment, difference in global pain relief, and pain response by neurotoxin exposure.
The baseline pain scores of the 2 groups were similar. The average pain scores during the second week of each phase of the lidocaine gel group did not differ from those of the placebo group (phase A: lidocaine 1.09, placebo 1.15; phase B: lidocaine 1.16, placebo 1.10). There also was no difference noted in secondary outcomes. The pain responses of lidocaine gel-treated subjects with current exposure to neurotoxic antiretrovirals (1.18) did not differ compared with those without (1.10) (P = 0.358). There were no significant adverse effects.
Lidocaine 5% gel is a safe but ineffective agent in the treatment of pain in HIV-associated DSP.
探讨5%利多卡因凝胶治疗HIV相关远端感觉性多发性神经病变（DSP）疼痛的疗效及安全性。
疼痛性DSP是HIV感染最常见的神经并发症，难以治疗。在一项关于HIV DSP的开放标签研究中，5%利多卡因凝胶可有效缓解神经性疼痛。
在一项双盲、安慰剂对照、交叉、多中心研究中，64名受试者被随机分为两组，分别接受5%利多卡因凝胶或赋形剂凝胶治疗2周（A期）。经过2周的洗脱期后，交叉使用另一种药物再治疗2周（B期）。主要结局是每个治疗期第二周两组平均疼痛评分（格雷西疼痛量表）的差异。次要结局包括首次治疗的差异效应、总体疼痛缓解的差异以及神经毒素暴露后的疼痛反应。
两组的基线疼痛评分相似。利多卡因凝胶组各阶段第二周的平均疼痛评分与安慰剂组无差异（A期：利多卡因1.09，安慰剂1.15；B期：利多卡因1.16，安慰剂1.10）。次要结局也未观察到差异。目前暴露于神经毒性抗逆转录病毒药物的利多卡因凝胶治疗受试者的疼痛反应（1.18）与未暴露者（1.10）相比无差异（P = 0.358）。未出现明显不良反应。
5%利多卡因凝胶治疗HIV相关DSP疼痛安全但无效。
