Gálvez Rafael, Navez Marie-Louise, Moyle Graeme, Maihöfner Christian, Stoker Malcolm, Ernault Etienne, Nurmikko Turo J, Attal Nadine
*Pain and Palliative Care Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain †Center for Pain Evaluation and Treatment, Saint Etienne Hospital, Saint Etienne, France #Center for the Treatment and Evaluation of Pain and INSERM U 987, Hôpital Ambroise Paré, Boulogne-Billancourt, France ‡Chelsea & Westminster NHS Foundation Trust, London ¶The Walton Centre NHS Foundation Trust, University of Liverpool, Clinical Sciences Centre, Liverpool, UK §Department of Neurology, General Hospital Fürth, Fürth, Germany ∥Astellas Pharma Europe B.V., Leiden, The Netherlands.
Clin J Pain. 2017 Oct;33(10):921-931. doi: 10.1097/AJP.0000000000000473.
To investigate the long-term safety and tolerability of capsaicin 8% patch repeat treatment in nondiabetic patients with peripheral neuropathic pain.
A prospective, open-label, observational study in patients with postherpetic neuralgia, posttraumatic or postsurgical nerve injury, HIV-associated distal sensory polyneuropathy, or other peripheral neuropathic pain, and average daily pain score ≥4, who received ≤6 capsaicin 8% patch treatments over 52 weeks according to clinical need (retreatment at 9 to 12 wk intervals). Sensory testing and analgesic effectiveness were assessed using "bedside tests" and Brief Pain Inventory (question 5).
Overall, 306 patients received treatment. Treatment-emergent adverse events (TEAEs) and drug-related TEAEs were reported by 252 (82.4%) and 207 (67.6%) patients. Application site pain was the most common drug-related TEAE (n=112, 36.6%); no drug-related serious TEAEs were reported. Sensory category shift analyses from baseline to end of study (EoS) in patients attending at least 2 sensory visits (n=278 for all tests except warm, n=277) found sensory deterioration/loss in at least 1 modality in 50.4% (n=140); deterioration/loss in 1, 2, 3, 4, or 5 modalities occurred in 26.6% (n=74), 14.0% (n=39), 5.8% (n=16), 2.5% (n=7), and 1.4% (n=4) cases. Newly emergent hyperesthesia or allodynia was apparent in 1.1% to 3.6% of the cases (depending on modality) by EoS. Between 25.2% and 32.0% of patients reported improvement in a sensory modality by EoS. Average daily pain was 6.6 and 4.7 at baseline and month 12.
Generally, capsaicin 8% patch repeat treatment over 52 weeks was well tolerated, with variable alteration in sensory function and minimal chance of complete sensory loss.
研究8%辣椒素贴片重复治疗非糖尿病性周围神经病理性疼痛患者的长期安全性和耐受性。
一项针对疱疹后神经痛、创伤后或术后神经损伤、HIV相关远端感觉性多发性神经病或其他周围神经病理性疼痛且平均每日疼痛评分≥4的患者的前瞻性、开放标签观察性研究，这些患者根据临床需要在52周内接受≤6次8%辣椒素贴片治疗（每隔9至12周重新治疗）。使用“床边检查”和简明疼痛量表（问题5）评估感觉测试和镇痛效果。
总体而言，306例患者接受了治疗。252例（82.4%）和207例（67.6%）患者报告了治疗中出现的不良事件（TEAE）和与药物相关的TEAE。用药部位疼痛是最常见的与药物相关的TEAE（n = 112，36.6%）；未报告与药物相关的严重TEAE。在至少参加2次感觉检查的患者中（除温热检查外所有检查n = 278，温热检查n = 277），从基线到研究结束（EoS）的感觉类别转换分析发现，50.4%（n = 140）的患者至少有一种感觉模式出现感觉恶化/丧失；1、2、3、4或5种感觉模式出现恶化/丧失的情况分别为26.6%（n = 74）、14.0%（n = 39）、5.8%（n = 16）、2.5%（n = 7）和1.4%（n = 4）。到EoS时，1.1%至3.6%的病例（取决于感觉模式）出现新的感觉过敏或异常性疼痛。到EoS时，25.2%至32.0%的患者报告某种感觉模式有所改善。基线时和第12个月时的平均每日疼痛评分分别为6.6和4.7。
总体而言，52周内重复使用8%辣椒素贴片治疗耐受性良好，感觉功能改变各异，完全感觉丧失的可能性极小。
