NGX-4010, a Capsaicin 8% Dermal Patch, Administered Alone or in Combination With Systemic Neuropathic Pain Medications, Reduces Pain in Patients With Postherpetic Neuralgia
NGX-4010, a Capsaicin 8% Dermal Patch, Administered Alone or in Combination With Systemic Neuropathic Pain Medications, Reduces Pain in Patients With Postherpetic Neuralgia
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DOI：
10.1097/ajp.0b013e318227403d
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发表时间：
2012-02-01
影响因子：
2.9
通讯作者：
Vanhove, Geertrui F.
中科院分区：
文献类型：
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作者：
Irving, Gordon A.;Backonja, Miroslav;Vanhove, Geertrui F.
目的：对 4 项受控带状疱疹后神经痛研究的综合数据进行分析，评估 NGX-4010（一种 8% 辣椒素贴剂）单独使用或与全身性神经病理性疼痛药物一起使用的效果。方法：患者使用 11 点数字疼痛评定量表 (NPRS) 每天记录“过去 24 小时的平均疼痛”，持续 12 周。疗效评估包括第 2 至 8 周和第 2 至 12 周期间 NPRS 评分较基线下降的百分比、第 2 至 8 周和第 2 至 12 周期间有反应的患者比例以及第 8 周和第 12 周时的患者总体变化印象 (PGIC)。 结果：在研究期间，302 名 NGX-4010 和 250 名对照（辣椒素，0.04% wt/wt）患者至少使用了1.全身性神经病理性止痛药； 295 名 NGX-4010 患者和 280 名对照患者则没有。在第2周至第8周期间，NGX-4010患者报告与对照组相比，使用全身性神经病理性疼痛药物的患者（-26.1% vs. -18.1%，P=0.0011）和未使用这些药物的患者（-36.5% vs. -26.2%，P=0.0002）的NPRS评分都有更大的降低。在 NGX-4010 和对照组中，与使用这些药物的患者相比，未使用全身性神经病理性疼痛药物的患者报告疼痛有更大程度的减轻，导致 NGX-4010 和对照组之间的治疗差异相当，无论是否使用全身神经病理性疼痛药物。在第 2 周至第 12 周期间，应答者和 PGIC 分析也出现了类似的结果。短暂的、与辣椒素相关的应用部位反应是最常见的不良事件，并且不受全身神经病理性疼痛药物使用的影响。结论：无论是否同时使用全身神经病理性疼痛药物，单次 60 分钟的 NGX-4010 治疗均可减少 PHN 长达 12 周。
Objectives: Analyses of integrated data from 4 controlled postherpetic neuralgia studies evaluated the effect of NGX-4010, a capsaicin 8% patch, administered alone or together with systemic neuropathic pain medications.Methods: Patients recorded their "average pain for the past 24 hours" daily for 12 weeks using an 11-point Numeric Pain Rating Scale (NPRS). Efficacy assessment included the percentage NPRS score reduction from baseline during weeks 2 to 8 and 2 to 12, the proportion of patients responding during weeks 2 to 8 and 2 to 12 and the Patient Global Impression of Change (PGIC) at weeks 8 and 12.Results: During the studies, 302 NGX-4010 and 250 control (capsaicin, 0.04% wt/wt) patients were using at least 1 systemic neuropathic pain medication; 295 NGX-4010 and 280 control patients were not. During weeks 2 to 8, NGX-4010 patients reported greater reductions in NPRS scores compared with control both in patients using systemic neuropathic pain medications (-26.1% vs. -18.1%, P=0.0011) and in patients not using these medications (-36.5% vs. -26.2%, P=0.0002). Patients not using systemic neuropathic pain medications reported a greater reduction in pain compared with patients using these medications in both, NGX-4010 and control groups, resulting in comparable treatment differences between NGX-4010 and control regardless of systemic neuropathic pain medication use. Similar results were seen during weeks 2 to 12, for the responder and PGIC analyses. Transient, capsaicin-related application site reactions were the most common adverse events and not affected by systemic neuropathic pain medication use.Conclusion: A single 60-minute NGX-4010 treatment reduces PHN for up to 12 weeks regardless of concomitant systemic neuropathic pain medication use.