Lifetree Clinical Research and Pain Clinic, Lifetree Medical Inc, Salt Lake City, UT, USA.
J Pain Res. 2012;5:7-13. doi: 10.2147/JPR.S25272. Epub 2012 Jan 20.
The objective of this study was to assess the safety, tolerability, and preliminary efficacy of NGX-4010, a capsaicin 8% patch, following pretreatment with three different topical anesthetics in patients with peripheral neuropathic pain.
This open-label, multicenter study enrolled 117 patients with post-herpetic neuralgia, HIV-associated distal sensory polyneuropathy, or painful diabetic neuropathy. Patients received pretreatment with one of three lidocaine 4%-based topical anesthetics (L.M.X.4(®) [Ferndale Laboratories Inc, Ferndale, MI], Topicaine(®) Gel [Estela Basso, Jupiter, FL], or Betacaine Enhanced Gel 4 [Tiberius Inc, Tampa, FL]) for 60 minutes followed by a single 60- or 90-minute NGX-4010 application, and were followed for 12 weeks. Tolerability and safety measures included "pain now" Numeric Pain Rating Scale (NPRS) scores, dermal assessments, medication use for treatment-related pain, adverse events (AEs), clinical laboratory parameters, physical examinations, and vital signs. The primary efficacy variable was the percentage change in mean NPRS scores for "average pain for the past 24 hours" from baseline to weeks 2 through 12.
Treatment with NGX-4010 following pretreatment with any of the three topical anesthetics was generally safe and well tolerated. Nearly all patients completed ≥90% of the planned NGX-4010 application duration. The most common treatment-related AEs, application-site burning and application-site pain, were transient, mostly mild or moderate, and could be adequately managed by local cooling or short-acting oral opioid analgesics. Although slightly more patients used medication for treatment-related discomfort following pretreatment with Topicaine compared with L.M.X.4 or Betacaine, there were no statistical differences between the topical anesthetics. Neuropathic pain reduction from baseline to weeks 2 through 12 was approximately 30% and was similar among the topical anesthetics; the proportion of responders ranged from 45% to 50%.
Treatment with NGX-4010 following pretreatment with any of the three topical anesthetics was generally safe and well tolerated; no significant differences in the parameters measured were noted between the pretreatment groups.
本研究旨在评估 NGX-4010（一种 8%辣椒素贴片）在三种不同局部麻醉剂预处理后应用于周围神经性疼痛患者的安全性、耐受性和初步疗效。
这是一项开放性、多中心研究，共纳入 117 例带状疱疹后神经痛、HIV 相关远端感觉性多神经病或痛性糖尿病性神经病患者。患者接受三种 4%利多卡因局部麻醉剂（L.M.X.4®[费尔代尔实验室公司，费尔代尔，密歇根州]、Topicaine®凝胶[埃斯特拉·巴索，朱庇特，佛罗里达州]或 Betacaine 增强凝胶 4 [泰伯瑞斯公司，坦帕，佛罗里达州]）预处理 60 分钟，随后单次应用 60 或 90 分钟 NGX-4010，并随访 12 周。耐受性和安全性评估包括“疼痛现在”数字疼痛评分量表（NPRS）评分、皮肤评估、与治疗相关疼痛相关的药物使用、不良事件（AE）、临床实验室参数、体格检查和生命体征。主要疗效变量为从基线到第 2 周到第 12 周，“过去 24 小时平均疼痛”的平均 NPRS 评分变化百分比。
在三种局部麻醉剂预处理后应用 NGX-4010 通常是安全且耐受良好的。几乎所有患者都完成了计划的 NGX-4010 应用时间的≥90%。最常见的与治疗相关的 AE，包括应用部位烧灼感和疼痛，为一过性，大多为轻度或中度，可通过局部冷却或短期阿片类镇痛药充分缓解。与 L.M.X.4 或 Betacaine 相比，虽然预处理后使用治疗相关不适药物的患者略多，但三种局部麻醉剂之间无统计学差异。从基线到第 2 周到第 12 周，神经病理性疼痛减轻约 30%，且在三种局部麻醉剂中相似；应答者比例为 45%至 50%。
在三种局部麻醉剂预处理后应用 NGX-4010 通常是安全且耐受良好的；预处理组之间未见测量参数有显著差异。
