Swedish Pain Center, Seattle, WA, USA.
Clin J Pain. 2012 Feb;28(2):101-7. doi: 10.1097/AJP.0b013e318227403d.
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.
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.
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.
A single 60-minute NGX-4010 treatment reduces PHN for up to 12 weeks regardless of concomitant systemic neuropathic pain medication use.
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。
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）。
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。
单次 60 分钟 NGX-4010 治疗可减轻 PHN 长达 12 周，无论是否同时使用系统神经性疼痛药物。
