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曲尼司特(Tracnil™)治疗多囊卵巢综合征皮肤表现患者的疗效与安全性:一项开放标签单臂研究。

Efficacy and Safety of Tracnil™ Administration in Patients with Dermatological Manifestations of PCOS: An Open-Label Single-Arm Study.

作者信息

Ramanan Ezhil Arasan, Ravi Sailatha, Anbu K R Radha, Michael Margaret

机构信息

Dr. VRE Research Laboratories, Chennai 600078, India.

Medlish Communications, Chennai 600078, India.

出版信息

Dermatol Res Pract. 2020 Mar 24;2020:7019126. doi: 10.1155/2020/7019126. eCollection 2020.

DOI:10.1155/2020/7019126
PMID:32256563
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7128037/
Abstract

Myo-inositol's role in improving acne by reducing hyperandrogenism has been demonstrated in PCOS patients. Inositol and associated molecules display inhibitory properties against 5- reductase, COX-2, and lipase enzymes in addition to their antimicrobial and anti-inflammatory properties. However, the role of myo-inositol is not well established in women patients with normal hormone levels but with clinical manifestations of PCOS. In this study, we evaluate the efficacy of Tracnil™, a combination of myo-inositol with folic acid and vitamin D3, in resolving acne in overweight women of menstruation age displaying normal hormone levels. It is a single-arm study conducted at 2 centers including 33 women with acne, hirsutism, and menstrual irregularities. Acne and hirsutism were assessed by manual lesion count, modified Cook's scale, and modified Ferriman-Gallwey hirsutism score (mFGHS). Hormone levels and safety parameters were assessed throughout the study. Our results show that Tracnil™ monotherapy could drastically reduce acne-related lesions of both inflammatory and noninflammatory types as quickly as 8 weeks. Additionally, it improves hirsutism and menstrual irregularities. Adverse reactions were negligible during the whole study period with no drastic side effects reflected by a modulatory effect on hormone levels. Despite the subjects having normal hormone levels, the acne treatment with myo-inositol and vitamin D3 shows improvement in hirsutism and regularization of menstrual cycle. Therefore, we attribute the mechanism of action of Tracnil™ to modulation of receptor sensitivity to sex hormones or other downstream processing events. Tracnil™ may be considered as a first-line treatment for dermatological manifestations of PCOS even in the absence of significant hormonal abnormalities. This treatment is practically implementable in a dermatologists's office practise.

摘要

肌醇在改善多囊卵巢综合征(PCOS)患者痤疮方面的作用已得到证实,其通过降低高雄激素血症起作用。肌醇及相关分子除了具有抗菌和抗炎特性外,还对5-还原酶、环氧化酶-2(COX-2)和脂肪酶具有抑制作用。然而,对于激素水平正常但有PCOS临床表现的女性患者,肌醇的作用尚未完全明确。在本研究中,我们评估了Tracnil™(一种肌醇与叶酸和维生素D3的组合)对月经年龄超重、激素水平正常且患有痤疮的女性患者治疗痤疮的疗效。这是一项在2个中心进行的单臂研究,纳入了33名患有痤疮、多毛症和月经不调的女性。通过手动计数皮损、改良库克量表和改良费里曼-盖尔韦多毛症评分(mFGHS)评估痤疮和多毛症。在整个研究过程中评估激素水平和安全参数。我们的结果表明,Tracnil™单一疗法可在8周内迅速大幅减少炎症性和非炎症性痤疮相关皮损。此外,它还能改善多毛症和月经不调。在整个研究期间,不良反应可忽略不计,对激素水平的调节作用未反映出严重副作用。尽管受试者激素水平正常,但用肌醇和维生素D3治疗痤疮可改善多毛症并使月经周期规律化。因此,我们将Tracnil™的作用机制归因于对性激素受体敏感性或其他下游加工事件的调节。即使在没有明显激素异常的情况下,Tracnil™也可被视为PCOS皮肤表现的一线治疗方法。这种治疗方法在皮肤科医生的门诊实践中切实可行。

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Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature.使用肌醇和叶酸治疗多囊卵巢综合征女性。新的临床数据及文献综述。
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