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一项关于外用他克莫司治疗特应性皮炎患者瘙痒症的随机、开放标签、多中心试验。

A randomized, open-label, multicenter trial of topical tacrolimus for the treatment of pruritis in patients with atopic dermatitis.

作者信息

Takeuchi Satoshi, Saeki Hidehisa, Tokunaga Shoji, Sugaya Makoto, Ohmatsu Hanako, Tsunemi Yuichiro, Torii Hideshi, Nakamura Koichiro, Kawakami Tamihiro, Soma Yoshinao, Gyotoku Eiichi, Hide Michihiro, Sasaki Rikako, Ohya Yukihiro, Kido Makiko, Furue Masutaka

机构信息

Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

出版信息

Ann Dermatol. 2012 May;24(2):144-50. doi: 10.5021/ad.2012.24.2.144. Epub 2012 Apr 26.

DOI:10.5021/ad.2012.24.2.144
PMID:22577263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3346903/
Abstract

BACKGROUND

Pruritis caused by atopic dermatitis (AD) is not always well controlled by topical corticosteroid therapy, but use of tacrolimus often helps to soothe such intractable pruritis in clinical settings.

OBJECTIVE

To determine the anti-pruritic efficacy of topical tacrolimus in treating AD in induction and maintenance therapy.

METHODS

Prior to the study, patients were randomly allocated into two groups, induction therapy followed by tacrolimus monotherapy maintenance, and induction therapy followed by emollient-only maintenance. In the induction therapy, the patients were allowed to use topical tacrolimus and emollients in addition to a low dose (<10 g/week) of topical steroids. Patients showing relief from pruritis were allowed to proceed to maintenance therapy. Recurrence of pruritis in maintenance therapy was examined as a major endpoint.

RESULTS

Two-thirds of patients (44/68; 64.7%) showed relief from pruritis after induction therapy. Pruritis recurred in 23.8% (5/21) of the tacrolimus monotherapy group and in 100% (21/21) of the emollient group during maintenance period, a difference that was statistically significant.

CONCLUSION

Use of topical tacrolimus is effective in controlling pruritis of AD compared to emollient.

摘要

背景

特应性皮炎(AD)引起的瘙痒症并非总能通过局部使用皮质类固醇激素疗法得到有效控制,但在临床环境中,使用他克莫司通常有助于缓解此类难治性瘙痒。

目的

确定局部使用他克莫司在诱导治疗和维持治疗中治疗AD的止痒疗效。

方法

在研究开始前,患者被随机分为两组,一组采用诱导治疗后进行他克莫司单药维持治疗,另一组采用诱导治疗后仅使用润肤剂维持治疗。在诱导治疗中,患者除了可使用低剂量(<10克/周)的局部类固醇激素外,还可使用局部他克莫司和润肤剂。瘙痒症状缓解的患者可进入维持治疗阶段。维持治疗阶段瘙痒症的复发情况被作为主要终点进行检查。

结果

三分之二的患者(44/68;64.7%)在诱导治疗后瘙痒症状得到缓解。在维持治疗期间,他克莫司单药治疗组中有23.8%(5/21)的患者瘙痒症复发,而润肤剂组的复发率为100%(21/21),二者差异具有统计学意义。

结论

与润肤剂相比,局部使用他克莫司在控制AD瘙痒方面有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/76d5be2ccfaa/ad-24-144-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/b3bb23ea39ea/ad-24-144-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/14fad0c25f82/ad-24-144-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/81ccb8e1860c/ad-24-144-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/bbdf614a3b83/ad-24-144-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/76d5be2ccfaa/ad-24-144-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/b3bb23ea39ea/ad-24-144-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/14fad0c25f82/ad-24-144-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/81ccb8e1860c/ad-24-144-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/bbdf614a3b83/ad-24-144-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/3346903/76d5be2ccfaa/ad-24-144-g005.jpg

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