Paladini Antonella, Varrassi Giustino, Bentivegna Giuseppe, Carletti Sandro, Piroli Alba, Coaccioli Stefano
Department of MESVA, School of Medicine, University of L'Aquila, L'Aquila, Italy.
Paolo Procacci Foundation, Rome, Italy.
Pain Res Treat. 2017;2017:1486010. doi: 10.1155/2017/1486010. Epub 2017 Aug 10.
This observational study was designed to evaluate the efficacy of ultramicronized palmitoylethanolamide (um-PEA) (Normast®) administration, as add-on therapy for chronic pain, in the management of pain-resistant patients affected by failed back surgery syndrome.
A total of 35 patients were treated with tapentadol (TPD) and pregabalin (PGB). One month after the start of standard treatment, um-PEA was added for the next two months. Pain was evaluated by the Visual Analogue Scale (VAS) at the time of enrollment () and after one (), two (), and three () months.
After the first month with TDP + PGB treatment only, VAS score decreased significantly from 5.7 ± 0.12 at the time of enrollment () to 4.3 ± 0.11 () ( < 0.0001); however, it failed to provide significant subjective improvement in pain symptoms. Addition of um-PEA led to a further and significant decrease in pain intensity, reaching VAS scores of 2.7 ± 0.09 () and 1.7 ± 0.11 (, end of treatment) ( < 0.0001) without showing any side effects.
This observational study provides evidence, albeit preliminary, for the efficacy and safety of um-PEA (Normast) as part of a multimodal therapeutic regimen in the treatment of pain-resistant patients suffering from failed back surgery syndrome.
本观察性研究旨在评估超微化棕榈酰乙醇胺（um-PEA，商品名Normast®）作为慢性疼痛附加治疗药物，用于治疗腰椎手术失败综合征所致疼痛耐受患者的疗效。
共有35例患者接受了曲马多（TPD）和普瑞巴林（PGB）治疗。在标准治疗开始1个月后，添加um-PEA并持续治疗2个月。在入组时（）、1个月后（）、2个月后（）和3个月后（），采用视觉模拟评分法（VAS）评估疼痛情况。
仅接受TPD + PGB治疗1个月后，VAS评分从入组时（）的5.7±0.12显著降至4.3±0.11（）（<0.0001）；然而，疼痛症状的主观改善并不显著。添加um-PEA后，疼痛强度进一步显著降低，VAS评分在2个月时（）降至2.7±0.09，治疗结束时（）降至1.7±0.11（<0.0001），且未出现任何副作用。
本观察性研究为um-PEA（Normast）作为多模式治疗方案的一部分，用于治疗腰椎手术失败综合征所致疼痛耐受患者的疗效和安全性提供了初步证据。
