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1%吡美莫司乳膏与2%酮康唑乳膏治疗脂溢性皮炎的开放性、随机、前瞻性对照研究

An open, randomized, prospective, comparative study of topical pimecrolimus 1% cream and topical ketoconazole 2% cream in the treatment of seborrheic dermatitis.

作者信息

Koc Erol, Arca Ercan, Kose Osman, Akar Ahmet

机构信息

Department of Dermatology, School of Medicine, Gulhane Military Medical Academy, Ankara, Turkey.

出版信息

J Dermatolog Treat. 2009;20(1):4-9. doi: 10.1080/09546630802286993.

DOI:10.1080/09546630802286993
PMID:18677657
Abstract

BACKGROUND

Seborrheic dermatitis (SD) is a chronic inflammatory disorder that mainly affects the seborrheic region. While ketoconazole is often used, pimecrolimus has been used successfully in SD.

OBJECTIVE

To compare the efficacy and tolerability of pimecrolimus in comparison with ketoconazole in the treatment of SD.

METHODS

A total of 48 patients with SD were included in the study. Patients were randomized into two groups: 23 and 25 patients in the pimecrolimus and ketoconazole groups, respectively. Clinical measures were assessed by erythema, scaling and infiltration, which were evaluated using a four-point scale (0 to 3) at 2, 6, and 12 weeks.

RESULTS

Of these 48 patients, 38 completed the study (18 and 20 patients in the pimecrolimus and ketoconazole groups, respectively). The mean percentage decrease in clinical severity scores from baseline to the last follow-up period was 86.2% and 86.1% in the pimecrolimus and ketoconazole groups, respectively. Both pimecrolimus and ketoconazole were effective in SD. Differences between the two groups were not statistically significant. Side effects were observed more frequently with pimecrolimus than with ketoconazole and this difference was statistically significant.

CONCLUSION

Our study showed that pimecrolimus had a comparable efficacy profile with that of ketoconazole, but side effects appeared more frequently in the pimecrolimus group than in the ketoconazole group.

摘要

背景

脂溢性皮炎(SD)是一种主要影响脂溢部位的慢性炎症性疾病。虽然酮康唑经常被使用,但吡美莫司已成功用于治疗脂溢性皮炎。

目的

比较吡美莫司与酮康唑治疗脂溢性皮炎的疗效和耐受性。

方法

本研究共纳入48例脂溢性皮炎患者。患者被随机分为两组:吡美莫司组23例,酮康唑组25例。通过红斑、脱屑和浸润情况评估临床指标,在第2、6和12周使用四点量表(0至3)进行评估。

结果

这48例患者中,38例完成了研究(吡美莫司组和酮康唑组分别为18例和20例)。从基线到最后随访期,吡美莫司组和酮康唑组临床严重程度评分的平均下降百分比分别为86.2%和86.1%。吡美莫司和酮康唑治疗脂溢性皮炎均有效。两组之间的差异无统计学意义。吡美莫司组比酮康唑组更频繁地观察到副作用,且这种差异具有统计学意义。

结论

我们的研究表明,吡美莫司与酮康唑具有相当的疗效,但吡美莫司组比酮康唑组更频繁地出现副作用。

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