NGX-4010，一种 8%辣椒素透皮贴剂，单独使用或与全身性神经病理性疼痛药物联合使用，均可减轻带状疱疹后神经痛患者的疼痛。

NGX-4010, a capsaicin 8% dermal patch, administered alone or in combination with systemic neuropathic pain medications, reduces pain in patients with postherpetic neuralgia.

机构信息

Swedish Pain Center, Seattle, WA, USA.

出版信息

Clin J Pain. 2012 Feb;28(2):101-7. doi: 10.1097/AJP.0b013e318227403d.

DOI:10.1097/AJP.0b013e318227403d

PMID:21753727

Abstract

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.

摘要

目的

对 4 项带状疱疹后神经痛对照研究的整合数据进行分析，评估辣椒素 8%贴片 NGX-4010 单独或联合系统神经性疼痛药物治疗的效果。

方法

患者使用 11 点数字疼痛评分量表（NPRS），在 12 周内每天记录“过去 24 小时的平均疼痛”。疗效评估包括第 2 周到第 8 周和第 2 周到第 12 周期间从基线的 NPRS 评分降低百分比、第 2 周到第 8 周和第 2 周到第 12 周期间应答的患者比例以及第 8 周和第 12 周的患者整体变化印象（PGIC）。

结果

在研究期间，302 名 NGX-4010 患者和 250 名对照（辣椒素，0.04%wt/wt）患者至少使用了 1 种系统神经性疼痛药物；295 名 NGX-4010 患者和 280 名对照患者未使用。在第 2 周到第 8 周期间，与对照相比，使用系统神经性疼痛药物的 NGX-4010 患者的 NPRS 评分降低更显著（26.1%对 18.1%，P=0.0011），未使用这些药物的患者也如此（36.5%对 26.2%，P=0.0002）。未使用系统神经性疼痛药物的患者与使用这些药物的患者相比，在 NGX-4010 和对照组中均报告疼痛有更大的缓解，因此，无论是否使用系统神经性疼痛药物，NGX-4010 与对照之间的治疗差异相当。在第 2 周到第 12 周期间，应答者和 PGIC 分析也得到了类似的结果。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，且不受系统神经性疼痛药物使用的影响。