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吡美莫司乳膏(1%)治疗口周皮炎的疗效——40例患者的随机、双盲、赋形剂对照研究结果

Pimecrolimus cream (1%) efficacy in perioral dermatitis - results of a randomized, double-blind, vehicle-controlled study in 40 patients.

作者信息

Oppel T, Pavicic T, Kamann S, Bräutigam M, Wollenberg A

机构信息

Department of Dermatology and Allergy, Ludwig-Maximilians University, Munich, Germany.

出版信息

J Eur Acad Dermatol Venereol. 2007 Oct;21(9):1175-80. doi: 10.1111/j.1468-3083.2007.02191.x.

DOI:10.1111/j.1468-3083.2007.02191.x
PMID:17894701
Abstract

BACKGROUND

Perioral dermatitis (POD) is a common skin disease and difficult to treat. Pimecrolimus cream (1%) successfully controls atopic eczema.

OBJECTIVE

Our aim was to investigate its efficacy in POD.

STUDY DESIGN

Single-centre, randomized, double-blind, vehicle-controlled study including 40 POD patients with a 4-week treatment and a 4-week follow-up. Efficacy was assessed by a novel Perioral Dermatitis Severity Index (PODSI) and Finlay's Dermatology Life Quality Index (DLQI).

SETTING

Outpatient clinics of a large dermatological hospital in Munich, Germany.

RESULTS

During treatment, the PODSI was significantly lower in the pimecrolimus group compared with vehicle (P = 0.005-0.02) whereas at follow-up, no significant differences were observed. At week 2, the responder rates (> or = 50% PODSI improvement) were 50% with pimecrolimus cream (1%) and 25% with vehicle (P = 0.095). DLQI was improved in pimecrolimus group compared with vehicle.

CONCLUSION

Results suggest that pimecrolimus cream (1%) effectively treats acute-stage POD.

摘要

背景

口周皮炎(POD)是一种常见的皮肤病且难以治疗。1%吡美莫司乳膏可成功控制特应性皮炎。

目的

我们的目的是研究其对口周皮炎的疗效。

研究设计

单中心、随机、双盲、赋形剂对照研究,纳入40例口周皮炎患者,进行为期4周的治疗和4周的随访。通过一种新的口周皮炎严重程度指数(PODSI)和芬利皮肤病生活质量指数(DLQI)评估疗效。

地点

德国慕尼黑一家大型皮肤病医院的门诊。

结果

治疗期间,吡美莫司组的PODSI显著低于赋形剂组(P = 0.005 - 0.02),而在随访时,未观察到显著差异。在第2周时,1%吡美莫司乳膏组的缓解率(PODSI改善≥50%)为50%,赋形剂组为25%(P = 0.095)。与赋形剂组相比,吡美莫司组的DLQI有所改善。

结论

结果表明,1%吡美莫司乳膏可有效治疗急性期口周皮炎。

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