Kern K-U, Baust H, Hofmann W, Holzmüller R, Maihöfner C, Heskamp M-L
Institut für Schmerzmedizin/Schmerzpraxis Wiesbaden, Sonnenberger Str. 68, 65193, Wiesbaden, Deutschland,
Schmerz. 2014 Aug;28(4):374-83. doi: 10.1007/s00482-014-1441-3.
Post amputation pain presents a challenge for pain physicians and is often detrimental to the patient's quality of life.
A prospective 12-week non-interventional study (NIS) was conducted in Germany to obtain data on the effectiveness and safety of capsaicin 8 % cutaneous patches from real life use in patients with peripheral neuropathic pain. For the first time in a subgroup of amputees data on post amputation pain were collected. This article presents the results for patients who suffered from phantom limb pain (PLP), stump pain (SP) and combined phantom limb/stump pain (PLP/SP).
The analyses included 21 patients with post amputation pain (PLP: n = 10, SP: n = 4, PLP/SP: n = 7). The mean duration of pain (± standard deviation) was 12.8 ± 13.0 years for PLP, 23.1 ± 29.9 years for SP and 11.0 ± 15.8 years for PLP/SP. A single treatment with capsaicin 8 % cutaneous patches significantly reduced the average pain intensity over the observational period of 12 weeks. The mean numeric pain rating scale (NPRS) baseline score changed by - 2.4 for PLP with a standard error of the mean (SEM) of 0.4 (median: - 2.9, Q1: - 3.5, Q3: - 1.0), - 1.7 for SP (SEM: 0.8, median: - 1.1, Q1: - 2.9, Q3: - 0.5) and - 1.5 for PLP/SP (SEM: 0.6, median: - 2.0, Q1: - 2.3, Q3: 0) during weeks 1-12. The 30 % responder rates (i.e. ≥ 30 % reduction in pain, day 7/14 to week 12) were 70.0 % (PLP), 50.0 % (SP) and 28.6 % (PLP/SP). PLP and PLP/SP patients in particular, benefited from improvements in pain attacks, sleep duration and sleep quality and one patient (PLP/SP) reported an adverse drug reaction (increase of pain). Physicians rated the tolerability of the patch as very good or good in 90.5 % of patients. A poor tolerability was stated for none of the 21 amputees. Of the patients 80 % for PLP and 50 % for both SP and PLP/SP expressed the wish to receive retreatment with capsaicin 8 % patches.
Capsaicin 8 % cutaneous patches seem to be effective and safe for the treatment of post amputation pain, notably in patients suffering from phantom limb pain.
截肢后疼痛给疼痛科医生带来了挑战，且常常对患者的生活质量产生不利影响。
在德国进行了一项为期12周的前瞻性非干预性研究（NIS），以获取关于8%辣椒素皮肤贴片在周围神经性疼痛患者实际使用中的有效性和安全性的数据。首次在一个截肢亚组中收集了截肢后疼痛的数据。本文展示了患有幻肢痛（PLP）、残端痛（SP）以及合并幻肢/残端痛（PLP/SP）患者的研究结果。
分析纳入了21例截肢后疼痛患者（PLP：n = 10，SP：n = 4，PLP/SP：n = 7）。PLP的平均疼痛持续时间（±标准差）为12.8 ± 13.0年，SP为23.1 ± 29.9年，PLP/SP为11.0 ± 15.8年。在12周的观察期内，单次使用8%辣椒素皮肤贴片可显著降低平均疼痛强度。在第1 - 12周期间，PLP的平均数字疼痛评分量表（NPRS）基线得分变化为 - 2.4，平均标准误（SEM）为0.4（中位数： - 2.9，Q1： - 3.5，Q3： - 1.0）；SP为 - 1.7（SEM：0.8，中位数： - 1. / 1，Q1： - 2.9，Q3： - 0.5）；PLP/SP为 - 1.5（SEM：0.6，中位数： - 2.0，Q1： - 2.3，Q3：0）。30%的有效率（即疼痛减轻≥30%，从第7/14天到第12周）分别为70.0%（PLP）、50.0%（SP）和28.6%（PLP/SP）。尤其是PLP和PLP/SP患者在疼痛发作、睡眠时间和睡眠质量方面得到了改善，且有1例患者（PLP/SP）报告了药物不良反应（疼痛加剧）。医生对90.5%的患者的贴片耐受性评价为非常好或良好。21例截肢患者中无一例报告耐受性差。PLP患者中有80%以及SP和PLP/SP患者中有50%表示希望接受8%辣椒素贴片的再次治疗。
8%辣椒素皮肤贴片似乎对治疗截肢后疼痛有效且安全，尤其是对患有幻肢痛的患者。
