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他克莫司 0.1% 软膏治疗甲银屑病:一项随机对照开放性研究。

Tacrolimus 0.1% ointment in nail psoriasis: a randomized controlled open-label study.

机构信息

Department of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.

出版信息

J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1003-6. doi: 10.1111/j.1468-3083.2012.04642.x. Epub 2012 Jul 13.

DOI:10.1111/j.1468-3083.2012.04642.x
PMID:22788697
Abstract

BACKGROUND

Despite recent advances in the treatment of psoriasis, the therapeutic options for nail psoriasis are very limited, particularly when this is the only manifestation of the disease.

OBJECTIVE

We performed a randomized controlled open-label study to assess the efficacy and safety of a topical treatment with tacrolimus 0.1% ointment in nail psoriasis.

METHODS

In each patient, tacrolimus 0.1% ointment was prescribed for application only on the affected nails of a randomly selected hand for 12 weeks, whereas nails of the other hand did not receive any treatment. Severity of nail psoriasis was evaluated using the Nail Psoriasis Severity Index (NAPSI) score.

RESULTS

We enrolled 21 consecutive psoriatic patients. At week 12, a statistically significant (P < 0.001) improvement was obtained in the treated hands with respect to the hands used as control (NAPSI score absolute change 13.0 and 3.0 respectively). Each of the enrolled patients concluded the period of treatment, but one patient was withdrawn from tacrolimus application after 9 weeks because of the appearance of acute paronychia.

DISCUSSION

Our study showed that tacrolimus 0.1% ointment may be an efficacious and safe therapeutic opportunity in the treatment of nail psoriasis. Our data should be confirmed by a double-blind study with a larger sample of patients.

摘要

背景

尽管银屑病的治疗方法近年来有所进步,但指甲银屑病的治疗选择非常有限,尤其是当这种疾病只有指甲表现时。

目的

我们进行了一项随机对照开放性标签研究,以评估他克莫司 0.1%软膏治疗指甲银屑病的疗效和安全性。

方法

在每位患者中,他克莫司 0.1%软膏仅被规定用于随机选择的一只手上受影响的指甲,为期 12 周,而另一只手的指甲则不接受任何治疗。指甲银屑病严重程度使用指甲银屑病严重指数(NAPSI)评分进行评估。

结果

我们共纳入了 21 例连续的银屑病患者。在第 12 周,治疗组相对于对照组(NAPSI 评分绝对值变化分别为 13.0 和 3.0),手部指甲的严重程度有统计学显著(P < 0.001)改善。每个患者都完成了治疗期,但有 1 例患者在 9 周后因急性甲沟炎而停止使用他克莫司。

讨论

我们的研究表明,他克莫司 0.1%软膏可能是治疗指甲银屑病的一种有效且安全的治疗选择。我们的数据需要通过一项包含更大样本量患者的双盲研究来进一步证实。

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