Department of Neurology, University Hospital Erlangen, Erlangen, Germany.
Curr Med Res Opin. 2013 Jun;29(6):673-83. doi: 10.1185/03007995.2013.792246. Epub 2013 Apr 25.
Reversible defunctionalisation of nociceptors by the TRPV1 agonist capsaicin in high concentration is an emerging new concept for the treatment of peripheral neuropathic pain.
The capsaicin 8% cutaneous patch with a long-lasting effect for up to 3 months after a single application is available in Germany by prescription since October 2010. The aim of this study was to monitor its usage and therapeutic performance in clinical practice.
Patients had a single patch application with up to 4 patches and were followed up after 7-14 days, 4, 8, and 12 weeks. Average pain intensity (NPRS-11), pain attacks, neuropathy symptoms, sleep parameters, quality of life, working capacity and concomitant neuropathic pain medication were assessed during at least two visits.
A total of 509 females (48.8%; effectiveness population N = 1044) and 531 males (50.9%) were included; the mean age was 61.2 ± 14.4 (SD) years. Postherpetic neuralgia was the most frequent diagnosis (31.9%), followed by postsurgical neuralgia (22.8%), post-traumatic neuropathy (12.4%), polyneuropathy (14.3%), and mixed pain syndromes (16.6%). Thirty and 50% responder rates were 42.7% and 23.7%, respectively, with a mean relative reduction of pain intensity during weeks 1-12 of 24.7% (1.1 SEM) and significant improvements in pain attacks, sleep duration and sleep quality, while the consumption of opioids and antiepileptics decreased significantly. In 106 patients (10.0%; safety population n = 1063) 146 adverse drug reactions (ADRs) were reported, mainly application site reactions (erythema, pain). A total of 27 serious ADRs were documented in 17 patients (1.6%).
Analgesic treatment of peripheral neuropathic pain with the capsaicin 8% cutaneous patch is safe and effective.
The study did not include a control group; therefore, a comparison of the results with that of therapeutic alternatives is not justified.
高浓度 TRPV1 激动剂辣椒素可逆失能伤害感受器是治疗周围神经性疼痛的新兴新概念。
自 2010 年 10 月以来，德国已通过处方提供一种单次应用后长达 3 个月长效的 8%辣椒素贴剂。本研究旨在监测其在临床实践中的使用和治疗效果。
患者最多应用 4 贴贴剂，在 7-14 天、4、8 和 12 周时进行随访。在至少两次就诊期间评估平均疼痛强度（NPRS-11）、疼痛发作、神经病变症状、睡眠参数、生活质量、工作能力和伴随的神经性疼痛药物。
共纳入 509 名女性（48.8%；有效人群 N=1044）和 531 名男性（50.9%），平均年龄为 61.2±14.4（SD）岁。最常见的诊断是带状疱疹后神经痛（31.9%），其次是手术后神经痛（22.8%）、创伤后神经病（12.4%）、多发性神经病（14.3%）和混合性疼痛综合征（16.6%）。30%和 50%应答率分别为 42.7%和 23.7%，在第 1-12 周，疼痛强度的平均相对缓解率为 24.7%（1.1 SEM），疼痛发作、睡眠持续时间和睡眠质量显著改善，而阿片类药物和抗癫痫药的消耗显著减少。在 106 名患者（10.0%；安全人群 n=1063）中报告了 146 起药物不良反应（ADR），主要为贴剂部位反应（红斑、疼痛）。在 17 名患者（1.6%）中记录了总共 27 起严重 ADR。
辣椒素 8%贴剂治疗周围神经性疼痛安全有效。
该研究未包括对照组；因此，不能将结果与治疗替代方案进行比较。
