■这项探索性病例对照研究旨在评估补充杜兴氏肌营养不良（DMD）年轻患者产生的1,3-1，-6β葡聚糖的影响。
■包括27名年龄在5-19岁患有DMD的男性受试者，对照组9例，治疗组18例，分别接受N-163β葡聚糖和常规治疗45天。在执行分析时，还考虑了类固醇的使用，那些没有服用类固醇(类固醇-ve)(对照，n=5；治疗，n=9),那些服用类固醇(类固醇+ve)(对照，n=4；治疗，n=9)。
■IL-6在治疗组中显示出明显的下降，尤其是N-163类固醇组。IL-13在两个治疗组中都有下降，TGF-β水平在治疗组中有显著下降，尤其是N-163类固醇组，(p<0.05)。与对照组相比,治疗组的肌营养不良蛋白水平增加高达32%。医学研究理事会（MRC）分级显示，治疗组18名患者中有12名（67％）的肌肉力量改善略有改善，对照组9名受试者中有4名（44％）。
■补充N-163β葡聚糖食品补充剂产生了有益的作用：炎症和纤维化标志物的显着减少，DMD受试者45天以上血清肌营养不良蛋白的增加和肌肉力量的轻微改善，因此，在验证后，这是DMD的潜在辅助治疗。
■该研究已在印度的临床试验注册中心注册，CTRI/2021/05/033346。5月5日登记,2021年。
UNASSIGNED: This exploratory case-control study is to evaluate the effects of supplementation of Aureobasidium pullulans-N-163 strain produced 1,3-1,- 6 beta glucan in young patients with Duchenne muscular dystrophy (DMD).
UNASSIGNED: Twenty-seven male subjects aged 5-19 years with DMD were included, nine in the control arm and 18 in the treatment arm to receive N-163 beta glucan along with conventional therapies for 45 days. While performing the analysis, steroid usage was also taken into consideration, those not administered steroids (Steroid -ve) (Control, n = 5; treatment, n = 9), those administered steroids (Steroid +ve) (Control, n = 4; treatment, n = 9).
UNASSIGNED: IL-6 showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group. IL-13 decreased in both treatment groups and TGF-β levels showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group, (p < 0.05). Dystrophin levels increased by up to 32% in the treatment groups compared to the control. Medical research council (MRC) grading showed slight improvement in muscle strength improvement in 12 out of 18 patients (67%) in the treatment group and four out of nine (44%) subjects in the control group.
UNASSIGNED: Supplementation with the N-163 beta glucan food supplement produced beneficial effects: a significant decrease in inflammation and fibrosis markers, increase in serum dystrophin and slight improvement in muscle strength in DMD subjects over 45 days, thus making this a potential adjunct treatment for DMD after validation.
UNASSIGNED: The study was registered in Clinical trials registry of India, CTRI/2021/05/033346. Registered on 5th May, 2021.
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