A Randomized, Controlled, Open-Label Study of the Long-Term Effects of NGX-4010, a High-Concentration Capsaicin Patch, on Epidermal Nerve Fiber Density and Sensory Function in Healthy Volunteers
A Randomized, Controlled, Open-Label Study of the Long-Term Effects of NGX-4010, a High-Concentration Capsaicin Patch, on Epidermal Nerve Fiber Density and Sensory Function in Healthy Volunteers
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DOI：
10.1016/j.jpain.2009.09.019
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发表时间：
2010-06-01
期刊：
影响因子：
4
通讯作者：
Selim, Mona M.
中科院分区：
文献类型：
--
作者：
Kennedy, William R.;Vanhove, Geertrui F.;Selim, Mona M.
伤害性感觉神经末梢的脱敏是辣椒素在神经病理性疼痛综合征中的治疗用途的基础。本研究评估了NGX-4010（一种高浓度（8% w/w）辣椒素贴剂）单次60分钟应用于健康志愿者大腿的药效学作用。表皮神经纤维（ENF）密度和定量感觉测试（QST）使用热，触觉，和尖锐的机械疼痛（针刺）刺激后1，12和24周辣椒素曝光进行了评价。1周后，与未暴露部位相比，ENF密度降低约80%。此外，与基线相比，触觉阈值增加了约8%，报告为尖锐机械疼痛的刺激比例下降了约15个百分点。暴露于辣椒素12周后，ENF再生明显，但不完全，尖锐的机械疼痛感觉和触觉阈值与未暴露部位没有差异。在24周时观察到ENF几乎完全（93%）恢复。在任何时间点均未观察到热或冷检测阈值的统计学显著变化。NGX-4010通常耐受良好。短暂的，温和的温暖或燃烧的感觉，在现场的应用程序是常见的不良反应.Perspective：本文评估了一个单一的60分钟的NGX-4010应用对ENF密度和QST在健康志愿者24周后的效果。这些结果有助于预测NGX-4010应用于患者的长期安全性。(C)2010年美国疼痛协会
Desensitization of nociceptive sensory nerve endings is the basis for the therapeutic use of capsaicin in neuropathic pain syndromes. This study evaluated the pharmacodynamic effects of a single 60-minute application of NGX-4010, a high-concentration (8% w/w) capsaicin patch, on both thighs of healthy volunteers. Epidermal nerve fiber (ENF) density and quantitative sensory testing (QST) using thermal, tactile, and sharp mechanical-pain (pinprick) stimuli were evaluated 1, 12 and 24 weeks after capsaicin exposure. After 1 week, there was about an 80% reduction of ENF density compared to unexposed sites. In addition, there was about an 8% increase in tactile thresholds compared to baseline and the proportion of stimuli reported as sharp mechanical pain decreased by about 15 percentage points. Twelve weeks after exposure to capsaicin, ENF regeneration was evident, but not complete, and sharp mechanical-pain sensation and tactile thresholds did not differ from unexposed sites. Nearly full (93%) ENF recovery was observed at 24 weeks. No statistically significant changes in heat- or cold-detection thresholds were observed at any time point. NGX-4010 was generally well tolerated. Transient, mild warming or burning sensations at the site of application were common adverse effects.Perspective: This article evaluates the effect of a single 60-minute NGX-4010 application on ENF density and QST in healthy volunteers followed for 24 weeks. The results help predict the long-term safety of NGX-4010 applications in patients. (C) 2010 by the American Pain Society