辣椒素 179 毫克（8%w/w）贴剂重复应用于周围神经性疼痛的渐进性反应：综合新分析及临床意义。

Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications.

机构信息

Department of Anaesthesiology, Critical Care Medicine, Pain Therapy and Palliative Care, Benedictus Hospital Feldafing, Feldafing, Germany.

Department of Anaesthesiology, Klinikum Rechts der Isar, Technische Universitat Munchen, Munich, Germany.

出版信息

Pain Med. 2021 Oct 8;22(10):2324-2336. doi: 10.1093/pm/pnab113.

OBJECTIVE

To investigate the efficacy of repeated application of capsaicin 179 mg cutaneous patch in nonresponders to the first application.

DESIGN

Post hoc, as-treated analysis of two prospective trials (STRIDE and PACE) with 52-week follow-up.

BLINDING

Open-label.

SETTING

Multicenter clinical trial.

SUBJECTS

STRIDE: nondiabetic neuropathic pain; PACE: painful diabetic peripheral neuropathy.

METHODS

Patients were divided according to number of applications needed before attainment of a ≥30% reduction in average pain intensity (question 5 of the Brief Pain Inventory [BPI-Q5]). We assessed the change from baseline in average pain intensity (BPI-Q5), mean "interference with sleep" score, Patient Global Impression of Change, quality of life (QOL) via the EuroQol 5-dimension, and Self-Assessment of Treatment.

RESULTS

In STRIDE and PACE, respectively, n = 306 and n = 313 received the capsaicin patch; n = 60 and n = 96 had a response after the first application, n = 33 and n = 68 after the second, and n = 11 and n = 43 after the third. Among patients without a ≥30% reduction in pain intensity at 3 months, in STRIDE and PACE, respectively, 23.3% and 28.1% achieved a ≥30% reduction at 6 months, increasing to 33.9% and 45.7% at 12 months. Similar results were obtained when a decrease of ≥50% was used as the responder definition. Progressive improvements in pain intensity in slower responders reached levels similar to those in early responders at month 12 and were accompanied by improvements in sleep, QOL, and patient satisfaction.

CONCLUSIONS

Although some patients with peripheral neuropathic pain experience rapid improvements with a single treatment of capsaicin 179 mg patch, some may require two or three treatments before an initial response is observed. Similar benefits for pain, sleep, and QOL can be achieved in early and late responders.

目的

研究辣椒素 179mg 贴剂在首次应用无应答者中重复应用的疗效。

设计

具有 52 周随访的两项前瞻性试验（STRIDE 和 PACE）的事后、按治疗分析。

设盲

开放性。

地点

多中心临床试验。

受试者

STRIDE：非糖尿病性神经病理性疼痛；PACE：有痛性糖尿病周围神经病变。

方法

根据达到平均疼痛强度降低≥30%所需的应用次数将患者分组（BPI-Q5 问题 5）。我们评估了平均疼痛强度（BPI-Q5）、平均“睡眠干扰”评分、患者变化总体印象、通过欧洲五维健康量表评估的生活质量（QOL）和自我评估治疗的变化。

结果

在 STRIDE 和 PACE 中，分别有 306 例和 313 例患者接受了辣椒素贴剂；首次应用后有 60 例和 96 例患者出现应答，第二次应用后有 33 例和 68 例患者出现应答，第三次应用后有 11 例和 43 例患者出现应答。在 3 个月时疼痛强度无≥30%降低的患者中，STRIDE 和 PACE 中分别有 23.3%和 28.1%在 6 个月时达到≥30%降低，在 12 个月时增加到 33.9%和 45.7%。当将降低≥50%作为应答定义时，也得到了相似的结果。较慢应答者的疼痛强度逐渐改善，在 12 个月时达到与早期应答者相似的水平，同时睡眠、QOL 和患者满意度也得到改善。