Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy
Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy
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DOI：
10.1212/01.wnl.0000314647.35825.9c
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发表时间：
2008-06-10
期刊：
影响因子：
9.9
通讯作者：
Tobias, Jeffrey
中科院分区：
文献类型：
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作者：
Simpson, David M.;Brown, Stephen;Tobias, Jeffrey
背景：HIV相关的远端感觉性多发性神经病（HIV-DSP）是一种有效治疗有限的疼痛性疾病。辣椒素使皮肤伤害感受器脱敏，从而减少疼痛。我们报告了一个安慰剂对照研究的高浓度辣椒素皮肤补丁（NGX-4010）的治疗疼痛的HIV-DSP.Methods：这双盲多中心研究随机307例疼痛的HIV-DSP接受NGX-4010或控制，低浓度辣椒素补丁。在应用局部麻醉剂后，将NGX-4010或对照品应用于足部疼痛区域一次，持续30、60或90分钟。主要疗效终点是从第2周至第12周，数字疼痛评定量表（NPRS）的平均“过去24小时的平均疼痛”评分较基线的百分比变化。结果：单次NGX-4010应用导致第2周至第12周期间平均疼痛减轻22.8%，而对照组减轻10.7%（p = 0.0026）。在短暂的治疗相关疼痛增加后，疼痛减轻;到第2周时明显改善，并在整个对照的12周观察期内持续改善。NGX-4010 30分钟、60分钟和90分钟组的平均疼痛减轻分别为27.7%、15.9%和24.7%（与对照组相比，p = 0.0007、0.287和0.0046）。与对照组的18%相比，NGX-4010治疗的三分之一的患者报告疼痛从基线减少>= 30%（p = 0.0092）。自限性，轻度至中度的局部皮肤反应是常见observed.Conclusions：一个单一的NGX-4010应用程序是安全的，并提供至少12周的疼痛减轻艾滋病毒相关的远端感觉多发性神经病患者。这些结果表明，NGX-4010可以为疼痛的HIV神经病变提供一种有希望的新治疗方法。
Background: HIV-associated distal sensory polyneuropathy (HIV-DSP) is a painful condition with limited effective treatment. Capsaicin desensitizes cutaneous nociceptors resulting in reduced pain. We report a placebo-controlled study of a high-concentration capsaicin dermal patch (NGX-4010) for the treatment of painful HIV-DSP.Methods: This double-blind multicenter study randomized 307 patients with painful HIV-DSP to receive NGX-4010 or control, a low-concentration capsaicin patch. After application of a topical anesthetic, NGX-4010 or control was applied once for 30, 60, or 90 minutes to painful areas on the feet. The primary efficacy endpoint was percent change in Numeric Pain Rating Scale (NPRS) from baseline in mean "average pain for past 24 hours" scores from weeks 2 to 12.Results: A single NGX-4010 application resulted in a mean pain reduction of 22.8% during weeks 2 to 12 as compared to a 10.7% reduction for controls (p = 0.0026). Following a transient treatment-related pain increase, pain was reduced; significant improvement was apparent by week 2 and continued throughout the controlled 12-week observation period. Mean pain reductions in the NGX-4010 30-, 60-and 90-minute groups were 27.7%, 15.9%, and 24.7% (p = 0.0007, 0.287, and 0.0046 vs control). One third of NGX-4010-treated patients reported >= 30% pain decrease from baseline as compared to 18% of controls (p = 0.0092). Self-limited, mild-to-moderate local skin reactions were commonly observed.Conclusions: A single NGX-4010 application was safe and provided at least 12 weeks of pain reduction in patients with HIV-associated distal sensory polyneuropathy. These results suggest that NGX-4010 could provide a promising new treatment for painful HIV neuropathy.