Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA.
BMC Neurol. 2010 Oct 11;10:92. doi: 10.1186/1471-2377-10-92.
Postherpetic neuralgia (PHN) is a painful and difficult to treat complication of acute herpes zoster. Current treatment options provide only partial relief and are often limited by poor tolerability. We evaluated the safety and efficacy of a single 60-minute application of NGX-4010, an 8% capsaicin patch, in patients with PHN.
This multicenter, double-blind, controlled study randomized 155 patients 2:1 to receive either NGX-4010 or a 0.04% capsaicin control patch. Patients were at least 18 years old with PHN for at least 3 months, and an average Numeric Pain Rating Scale (NPRS) score of 3 to 9. The primary efficacy endpoint was the percentage change in NPRS score from baseline to weeks 2-8.
The mean percent reduction in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 was greater in the NGX-4010 group (36.5%) compared with control (29.9%) although the difference was not significant (p = 0.296). PGIC analysis demonstrated that more NGX-4010 recipients considered themselves improved (much, or very much) compared with control at weeks 8 and 12, but the differences did not reach statistical significance. Post hoc analyses of patients with PHN for at least 6 months showed significantly greater reductions in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 in NGX-4010 patients compared to controls (37.6% versus 23.4%; p = 0.0291). PGIC analysis in this subgroup demonstrated that significantly more NGX-4010 recipients considered themselves much or very much improved compared with control at week 12 (40% versus 20%; p = 0.0403;).
Although treatment appeared to be safe and well tolerated, a single 60-minute application of NGX-4010 failed to show efficacy in this study which included patients with PHN for less than 6 months. Large reductions in pain observed among control patients with pain for less than 6 months may have been due to spontaneous resolution of PHN, may have confounded the results of the prespecified analyses, and should be taken into account when designing PHN studies.
NCT00068081.
带状疱疹后神经痛 (PHN) 是一种疼痛且难以治疗的急性带状疱疹并发症。目前的治疗选择仅提供部分缓解，并且常常因耐受性差而受到限制。我们评估了 NGX-4010（一种 8%辣椒素贴片）单次 60 分钟应用于 PHN 患者的安全性和疗效。
这项多中心、双盲、对照研究将 155 名患者随机分为 2:1 组，分别接受 NGX-4010 或 0.04%辣椒素对照贴片治疗。患者年龄至少 18 岁，患有 PHN 至少 3 个月，平均数字疼痛评分量表 (NPRS) 评分为 3 至 9。主要疗效终点为从基线到第 2-8 周 NPRS 评分的变化百分比。
NGX-4010 组（36.5%）与对照组（29.9%）相比，从基线到第 2-8 周时“过去 24 小时平均疼痛”NPRS 评分的平均降低百分比更大，但差异无统计学意义（p=0.296）。PGIC 分析表明，与对照组相比，NGX-4010 组在第 8 周和第 12 周时更多的患者认为自己有明显改善（明显、非常明显），但差异无统计学意义。对 PHN 至少 6 个月的患者进行事后分析显示，与对照组相比，NGX-4010 患者从基线到第 2-8 周时“过去 24 小时平均疼痛”NPRS 评分的降低幅度显著更大（37.6%对 23.4%；p=0.0291）。在该亚组中，PGIC 分析表明，与对照组相比，NGX-4010 组更多的患者在第 12 周时认为自己有明显改善（40%对 20%；p=0.0403）。
尽管治疗似乎是安全且耐受良好的，但单次 60 分钟应用 NGX-4010 未能在这项包括 PHN 患者少于 6 个月的研究中显示疗效。在疼痛持续时间少于 6 个月的对照组患者中观察到的疼痛大幅降低可能是由于 PHN 的自发缓解，可能使预先指定的分析结果复杂化，在设计 PHN 研究时应予以考虑。
NCT00068081。
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