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超强效外用糖皮质激素的全身风险最新进展

Update on the Systemic Risks of Superpotent Topical Steroids.

作者信息

Nakamura Mio, Abrouk Michael, Zhu Henry, Farahnik Benjamin, Koo John, Bhutani Tina

出版信息

J Drugs Dermatol. 2017 Jul 1;16(7):643-648.

Abstract

INTRODUCTION: The potential for systemic effects due to percutaneous absorption of superpotent topical steroids has been a longstanding concern. The Food and Drug Administration currently recommends limiting the use of superpotent topical steroids to 50g per week for 2 or 4 consecutive weeks depending on the formulation, which is mostly based on the exact duration with which phase 3 clinical trials were allowed to be conducted per the FDA. This article reviews all published clinical incidence of adrenal adverse effects in the medical literature, specifically Cushing's syndrome (CS) and pathologic adrenal suppression (PAAS), to try to ascertain a more realistic limit for the safe use of superpotent topical steroids as it pertains to its potential systemic effects.

METHODS: Literature search was conducted using PubMed. Only cases of CS and PAAS secondary to the use of Class I superpotent topical steroids were included. Pediatric cases and full articles unavailable in English were excluded.

RESULTS: There were a total of 14 cases of CS and 5 cases of subsequent PAAS found in the current literature.

DISCUSSION: From our review of these cases, if the amount used per week is within FDA guidelines, it appears that patients needed to use superpotent topical steroids for far greater than 2 or 4 weeks to develop CS or PAAS. CS did not necessarily predict occurrence of PAAS, but in all cases CS appeared to be a prerequisite for developing PAAS. All cases of CS and all but one case of PAAS were reversible. If excessive amount of greater than 50g per week is avoided, it appears that superpotent topical steroids may be safe to use consecutively for months, perhaps even years, without causing systemic effects.

J Drugs Dermatol. 2017;16(7):643-648.

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摘要

引言

超强效外用糖皮质激素经皮吸收产生全身效应的可能性一直备受关注。美国食品药品监督管理局(FDA)目前建议,根据制剂情况,将超强效外用糖皮质激素的使用限制为每周50克,连续使用2周或4周,这主要是基于FDA允许进行3期临床试验的确切时长。本文回顾了医学文献中所有已发表的肾上腺不良反应的临床发生率,特别是库欣综合征(CS)和病理性肾上腺抑制(PAAS),以试图确定与超强效外用糖皮质激素潜在全身效应相关的更现实的安全使用限度。

方法

使用PubMed进行文献检索。仅纳入使用I类超强效外用糖皮质激素继发CS和PAAS的病例。排除儿科病例和无法获取英文全文的文章。

结果

在当前文献中总共发现14例CS病例和5例随后发生的PAAS病例。

讨论

通过对这些病例的回顾,如果每周使用量在FDA指南范围内,似乎患者需要使用超强效外用糖皮质激素远超过2周或4周才会发生CS或PAAS。CS不一定预示PAAS的发生,但在所有病例中,CS似乎是发生PAAS的先决条件。所有CS病例以及除1例之外的所有PAAS病例都是可逆的。如果避免每周使用超过50克的过量药物,似乎超强效外用糖皮质激素可以连续安全使用数月,甚至数年而不产生全身效应。

《药物皮肤学杂志》。2017年;16(7):643 - 648。

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