类黄酮和欧米茄3的基于欧米茄的复杂性对肌肉营养不良治疗的有益作用

clementina sitzia sitzia

营养化合物可以exti-anti-infi-infi-anti-antiflamant和antiflamporation和anti-antflamporation和ant-anti-anti-anti-anti-oxidixic效果。由于这些事件加剧了肌肉营养不良的病理生理学，因此我们研究了营养补充营养不良患者的辅助治疗，低成本和易于给药途径。 Moreover, this treatment could represent an alternative therapeutic strategy for dystrophic patients who do not respond to corticosteroid treatment.A 24 weeks randomized double-blind placebo-controlled clinical study was aimed at evaluating the safety and efficacy of daily oral administration of flavonoids- and omega3-based natural supplement (FLAVOMEGA) in patients affected by muscular dystrophy with recognized muscle inflammation.We screened 60 patients诊断为Duchenne（DMD），Facioscapulohumeral（FSHD）和肢体腰围肌营养不良症（LGMD）。使用计算机生成的随机分配序列，我们以2：1：1的比例（DMD：FSHD：LGMD）将患者分层为两个治疗组之一：连续Flavomega，连续安慰剂。在29名患者中，只有24例完成了这项研究：15例接受了Flavomega，14个安慰剂。Flavomega的耐受性良好，没有报告不良事件。重要的在LGMD和FSHD受试者中观察到了6分钟步行距离（6MWD；二次疗效终点）和等速膝关节伸展（= 0.039）（= 0.039）的治疗差异（= 0.033）（= 0.033）（= 0.039）（初级疗效端点）。 Serum CK levels (secondary efficacy endpoint) decreased in all FLAVOMEGA treated groups with significant difference in DMD subjects (= 0.039).Although the small number of patients and the wide range of disease severity among patients reduced statistical significance, we obtained an optimal profile of safety and tolerability for the compound, showing valuable data of efficacy in primary and secondary endpoints.NCT03317171 Retrospectively registered 25/10/2017。