Überall Michael A, Simanski Christian, Zellnig Mike, Eerdekens Mariëlle, Engelen Sylvia, Heine Myriam, Percot Fabienne, Freitas Rita, Guerra Lucia Garcia, Quandel Tamara
Institute of Neurological Sciences, Nuremberg, Germany.
Department Foot & Ankle Surgery, Member of the Chair for Orthopaedic and Trauma Surgery, GFO-Clinic Mettmann South, St. Martinus Hospital Langenfeld, University Witten/Herdecke, Campus Cologne Merheim, Cologne, Germany.
Pain Ther. 2025 Jun 15. doi: 10.1007/s40122-025-00752-4.
Peripheral neuropathic pain after nerve injury (PNI) caused by surgery or trauma can severely impact daily life. The high-concentration capsaicin patch (HCCP, 179 mg) is a topical therapy approved for peripheral neuropathic pain, including PNI. This study utilizes data from the German Pain e-Registry (GPeR) to investigate the real-world effectiveness of HCCP in managing PNI across multiple treatments over 1 year.
CASPAR is a retrospective, non-interventional cohort study investigating patients with peripheral neuropathic pain treated with HCCP. The present analysis included 499 patients with PNI who received ≥ 1 HCCP with ≥ 12 months of follow-up. Key measures included pain intensity, quality of life (QoL), affective distress, sleep disturbances, and overall functioning. Furthermore, analgesic use and adverse events associated with HCCP treatment were evaluated.
The mean average daily pain intensity (API) decreased from 52.5 mm on the visual analog scale (VAS) at baseline to 21.5 mm at month 12 in patients receiving four HCCPs. At month 12, a ≥ 30% reduction in API was observed in 25.8%, 44.9%, 85.3%, and 97.8% of patients receiving one, two, three, and four HCCP treatments, respectively. Significant improvements were also noted in physical and mental QoL, sleep, mood, and daily functioning. Patients receiving three or four HCCP treatments maintained pain relief and symptom improvements over the 12-month period, whereas those who discontinued treatment after one or two treatments experienced symptom rebound. In addition, repeated HCCP treatments were associated with a marked reduction in concomitant analgesic use and an increase in days of normal activities. Adverse events were mild-to-moderate application-site reactions, consistent with the well-established safety profile of HCCP.
HCCP treatment is associated with reductions in pain intensity and improvements in sleep, mood, and overall QoL in patients with PNI. These benefits are amplified with continued treatment and are accompanied by reduced use of concomitant analgesics and more days of usual activities, although a direct causal relationship cannot be confirmed within the context of this observational study.
EU PAS number: EUPAS1000000106.
手术或创伤引起的神经损伤后周围神经性疼痛（PNI）会严重影响日常生活。高浓度辣椒素贴剂（HCCP，179毫克）是一种被批准用于治疗包括PNI在内的周围神经性疼痛的局部治疗方法。本研究利用德国疼痛电子注册库（GPeR）的数据，调查HCCP在1年多的多种治疗中管理PNI的真实效果。
CASPAR是一项回顾性、非干预性队列研究，调查接受HCCP治疗的周围神经性疼痛患者。本分析纳入了499例接受≥1次HCCP治疗且随访时间≥12个月的PNI患者。关键指标包括疼痛强度、生活质量（QoL）、情感困扰、睡眠障碍和整体功能。此外，还评估了与HCCP治疗相关的镇痛药物使用情况和不良事件。
接受四次HCCP治疗的患者，其平均每日疼痛强度（API）从基线时视觉模拟量表（VAS）上的52.5毫米降至第12个月时的21.5毫米。在第12个月时，接受一、二、三、四次HCCP治疗的患者中，分别有25.8%、44.9%、85.3%和97.8%的患者API降低了≥30%。在身体和心理QoL、睡眠、情绪和日常功能方面也有显著改善。接受三次或四次HCCP治疗的患者在12个月期间维持了疼痛缓解和症状改善，而那些在接受一或两次治疗后停药的患者出现了症状反弹。此外，重复使用HCCP治疗与伴随镇痛药物使用的显著减少以及正常活动天数的增加有关。不良事件为轻度至中度的用药部位反应，与HCCP既定的安全性特征一致。
HCCP治疗可降低PNI患者的疼痛强度，并改善其睡眠、情绪和整体QoL。这些益处随着持续治疗而增强，同时伴随镇痛药物使用的减少和更多正常活动天数，尽管在本观察性研究的背景下无法确认直接的因果关系。
欧盟PAS编号：EUPAS1000000106。
