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一种新型生物活性从螺旋藻中提取具有多功能特性显示了对甲真菌病临床疗效和癣感染;对其他皮肤状况及其影响

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AMYCOT®是一种生物活性提取来自的螺旋藻(Arthrospira最大值),藻青菌,常用的食品补充几个世纪以来一直由墨西哥的阿兹特克文明和非洲的部落。AMYCOT®通过专有的过程产生丰富的生物活性。复杂混合物包含多种分子已知有抗真菌活性以及独特的活动针对甲壳素,细胞壁成分存在于广泛的真菌包括酵母。的真菌的财产AMYCOT®支持电子显微镜研究表明测试真菌几天后破裂以及体外区抑制真菌和酵母菌对各种研究。临床体外研究包括使用的体外三维人体表皮模型表明,AMYCOT®无毒和non-allergenic刺激皮肤细胞生长特性。此外,生物活性提取显示抗炎活动通过减少分泌il - 1α,中央对皮肤炎症细胞因子(未发表的结果)。以前的非盲研究由独立调查人员证实疗效的AMYCOT®等多种皮肤真菌感染癣、甲癣(2;未发表的结果)。为了进一步证实这些研究,单中心、随机、双盲、安慰剂对照临床研究在印度。AMYCOT®被制定为乳液(8% AMYCOT®)治疗甲真菌病和霜(12% AMYCOT®)对癣感染。 The study’s sample size was determined from a previous study on a cream and lotion that observed an 81% cure rate for the experimental drugs and an assigned 10% IGA response of ‘cleared’ or ‘excellent’ for the placebo group using a two-group Fisher’s-exact test of equal proportions. Based on these assumptions, there is over 95% power to detect a significant difference between the treatment and placebo groups with 14 subjects per group (28 subjects overall) at 5% level of significance, and assuming a 20% dropout rate. From screening 50 potential patients, a total of 28 patients, 18 with tinea and 10 with onychomycosis were randomized in a ratio of 1:1 to treatment or placebo group. All were positive for all three parameters constituting mycological cure, which was assessed, was assessed by potassium hydroxide (KOH) smear, fungal culture and live spore count. Clinical cure was defined as Investigator global assessment (IGA) response of ‘cleared’ (100% improvement) or ‘excellent’ (>90% improvement). At the end of treatment, all three parameters were negative in the treatment arm, while KOH smear was positive in all subjects, and culture and live spore count were positive in six of them in the placebo arm. The treatments showed a significant improvement in all three parameters.

Leodevico L Ilag (Vic)

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