Schifilliti Chiara, Cucinotta Lelio, Fedele Viviana, Ingegnosi Carmela, Luca Salvatore, Leotta Carmelo
Associazione MOV.I.S, Onlus di Giarre, Via Teatro 81, Giarre, 95014 Catania, Italy.
Pain Res Treat. 2014;2014:849623. doi: 10.1155/2014/849623. Epub 2014 Apr 2.
The present study evaluated the effectiveness of micronized palmitoylethanolamide (PEA-m) treatment in reducing the painful symptoms experienced by diabetic patients with peripheral neuropathy. PEA-m, a fatty acid amide of the N-acylethanolamine family, was administered (300 mg twice daily) to 30 diabetic patients suffering from painful diabetic neuropathy. Before treatment start, after 30 and 60 days the following parameters were assessed: painful symptoms of diabetic peripheral neuropathy using the Michigan Neuropathy Screening instrument; intensity of symptoms characteristic of diabetic neuropathic pain by the Total Symptom Score; and intensity of different subcategories of neuropathic pain by the Neuropathic Pain Symptoms Inventory. Hematological and blood chemistry tests to evaluate metabolic control and safety were also performed. Statistical analysis (ANOVA) indicated a highly significant reduction in pain severity (P < 0.0001) and related symptoms (P < 0.0001) evaluated by Michigan Neuropathy Screening instrument, Total Symptom Score, and Neuropathic Pain Symptoms Inventory. Hematological and urine analyses did not reveal any alterations associated with PEA-m treatment, and no serious adverse events were reported. These results suggest that PEA-m could be considered as a promising and well-tolerated new treatment for symptomatology experienced by diabetic patients suffering from peripheral neuropathy.
本研究评估了微粉化棕榈酰乙醇胺(PEA-m)治疗对减轻糖尿病周围神经病变患者疼痛症状的有效性。将PEA-m(一种N-酰基乙醇胺家族的脂肪酸酰胺)以每日两次、每次300毫克的剂量给予30名患有疼痛性糖尿病神经病变的糖尿病患者。在治疗开始前、治疗30天和60天后,评估以下参数:使用密歇根神经病变筛查工具评估糖尿病周围神经病变的疼痛症状;通过总症状评分评估糖尿病神经病理性疼痛特征症状的强度;通过神经病理性疼痛症状量表评估神经病理性疼痛不同亚类的强度。还进行了血液学和血液化学检测以评估代谢控制情况和安全性。统计分析(方差分析)表明,通过密歇根神经病变筛查工具、总症状评分和神经病理性疼痛症状量表评估,疼痛严重程度(P < 0.0001)和相关症状(P < 0.0001)有极显著降低。血液学和尿液分析未发现与PEA-m治疗相关的任何改变,也未报告严重不良事件。这些结果表明,PEA-m可被视为一种有前景且耐受性良好的新治疗方法,用于治疗糖尿病周围神经病变患者所经历的症状。