辣椒素179毫克（8%重量/重量）皮肤贴片对老年外周神经病理性疼痛患者来说是一种合适的治疗选择吗？

Is the Capsaicin 179 mg (8% w/w) Cutaneous Patch an Appropriate Treatment Option for Older Patients with Peripheral Neuropathic Pain?

作者信息

Pickering Gisèle, Engelen Sylvia, Stupar Maria, Ganry Hervé, Eerdekens Mariëlle

机构信息

Faculty of Medicine Inserm 1107, Clinical Pharmacology Centre, CPC/CIC Inserm 1405 University Hospital, Clermont-Ferrand, France.

Grünenthal GmbH, Aachen, Germany.

出版信息

J Pain Res. 2024 Mar 27;17:1327-1344. doi: 10.2147/JPR.S435809. eCollection 2024.

DOI:10.2147/JPR.S435809

PMID:38560405

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10981873/

Abstract

INTRODUCTION

Capsaicin 179 mg (8% weight per weight) cutaneous patch ("capsaicin patch") is a recommended topical treatment for peripheral neuropathic pain (PNP). In older patients, topical treatments may be preferred over systemic treatments, but data specific to the older population are scarce.

METHODS

We conducted pooled analyses of multiple clinical trials to evaluate efficacy and safety of capsaicin patch in older patients. The analysis of efficacy included four randomized, double-blind, 12-week studies with similar trial design comparing a single treatment of capsaicin 179 mg cutaneous patch vs low-dose control patch in post-herpetic neuralgia. For the safety evaluation, data were pooled from 18 interventional studies in which capsaicin patch was used in PNP with varying etiologies.

RESULTS

Capsaicin patch had similar analgesic efficacy in elderly (n=582) and non-elderly patients (n=545) in terms of change from baseline to 2-12 weeks in the 11-point numeric pain rating scale (NPRS) score for average pain over the previous 24 hours. In both age groups, decrease in NPRS score was significantly greater with capsaicin patch vs control. Older patients treated with capsaicin patch were significantly more likely than those in the control group to achieve responder status (ie mean decrease in NPRS score from baseline to week 2-12 of at least 30% or ≥2 points): 36.1% vs 27.1% (odds ratio [OR] [95% CI] 1.52 [1.06, 2.18]; =0.0231) and 33.1% vs 20.9% (OR [95% CI] 1.90 [1.30, 2.78]; =0.0009) for active treatment vs control group, respectively. Similar proportions of non-elderly patients (n=2,311) and elderly patients (n=537) treated with capsaicin patch experienced treatment-emergent adverse events (TEAEs) (81.6% and 78.1%, respectively) and serious TEAEs (8.2% and 7.2%), with application-site reactions the most common TEAEs in both groups.

CONCLUSION

The capsaicin patch was equally efficacious and well tolerated in older patients as in younger patients.

摘要

引言

辣椒素179毫克（重量百分比为8%）皮肤贴片（“辣椒素贴片”）是外周神经性疼痛（PNP）的推荐局部治疗方法。在老年患者中，局部治疗可能比全身治疗更受青睐，但针对老年人群的具体数据较少。

方法

我们对多项临床试验进行了汇总分析，以评估辣椒素贴片在老年患者中的疗效和安全性。疗效分析包括四项随机、双盲、为期12周的研究，这些研究具有相似的试验设计，比较了辣椒素179毫克皮肤贴片与低剂量对照贴片在带状疱疹后神经痛中的单一治疗效果。对于安全性评估，数据来自18项干预性研究，其中辣椒素贴片用于不同病因的PNP患者。

结果

在24小时内平均疼痛的11点数字疼痛评分量表（NPRS）得分从基线到2 - 12周的变化方面，辣椒素贴片在老年患者（n = 582）和非老年患者（n = 545）中具有相似的镇痛效果。在两个年龄组中，与对照组相比，辣椒素贴片导致的NPRS得分下降均显著更大。接受辣椒素贴片治疗的老年患者比对照组患者更有可能达到缓解状态（即NPRS得分从基线到第2 - 12周平均下降至少30%或≥2分）：活性治疗组与对照组分别为36.1%对27.1%（优势比[OR][置信区间95%]1.52[1.06, 2.18]；P = 0.0231）和33.1%对20.9%（OR[置信区间95%]1.90[1.30, 2.78]；P = 0.0009）。接受辣椒素贴片治疗的非老年患者（n = 2311）和老年患者（n = 537）出现治疗中出现的不良事件（TEAE）的比例相似（分别为81.6%和78.1%）以及严重TEAE的比例相似（分别为8.2%和7.2%），两组中最常见的TEAE均为应用部位反应。