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一项研究者发起的、双盲、赋形剂对照的初步研究:评估局部封包卤倍他索 0.05%软膏治疗银屑病的快速耐受情况。

An investigator-initiated, double-blind, vehicle-controlled pilot study: assessment for tachyphylaxis to topically occluded halobetasol 0.05% ointment in the treatment of psoriasis.

机构信息

Laboratory for Investigative Dermatology, Rockefeller University, New York, New York.

Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.

出版信息

J Am Acad Dermatol. 2014 Nov;71(5):954-959.e1. doi: 10.1016/j.jaad.2014.05.040. Epub 2014 Jun 11.

Abstract

BACKGROUND

Topical corticosteroids are the most common first-line treatment for psoriasis. Tachyphylaxis, a decreased response to treatment with repetitive application of the drug, is a controversial phenomenon associated with topical corticosteroid treatment.

OBJECTIVE

We sought to prove or disprove tachyphylaxis to occluded halobetasol 0.05% versus vehicle.

METHODS

Patients with plaque psoriasis were recruited to this study. The study involved 3 phases (1, 2A, and 2B) with each phase being separated by a treatment vacation period. In phases 1 and 2A, 2 plaques were randomized to either halobetasol 0.05% or vehicle ointment application. In phase 2B, halobetasol 0.05% was applied to both. Target Lesion Severity Scale was used for clinical assessment.

RESULTS

Twenty patients were enrolled. No difference in time to clearance (P=.88) or time to recurrence (P=.92) of the treated plaques was found between phases 1 and 2A. Percentage of improvement was higher in phase 2A compared with phase 1 (89.4%, P<.05 vs 71%, P<.05), as a result of reduction of vehicle effect. In phase 2B, a greater improvement was found for previously corticosteroid-treated plaques.

LIMITATIONS

Limitations are small sample size and 1 corticosteroid tested.

CONCLUSION

No evidence of tachyphylaxis to the topical corticosteroid halobetasol 0.05% ointment treatment in patients with plaque psoriasis was found.

摘要

背景

局部皮质类固醇是治疗银屑病最常用的一线药物。脱敏作用是指随着药物的重复应用,治疗反应降低,这是一种与局部皮质类固醇治疗相关的有争议的现象。

目的

我们旨在证明或反驳卤倍他索 0.05%封包治疗与赋形剂相比是否出现脱敏现象。

方法

本研究招募了斑块状银屑病患者。该研究包括 3 个阶段(1、2A 和 2B),每个阶段之间都有治疗假期。在第 1 阶段和第 2A 阶段,将 2 个斑块随机分配至卤倍他索 0.05%或赋形剂软膏治疗。在第 2B 阶段,两种药物均应用于所有斑块。采用靶皮损严重程度评分进行临床评估。

结果

共纳入 20 例患者。第 1 阶段和第 2A 阶段治疗斑块的清除时间(P=.88)或复发时间(P=.92)无差异。与第 1 阶段相比,第 2A 阶段的改善百分比更高(89.4%,P<.05 比 71%,P<.05),这是由于赋形剂作用降低所致。在第 2B 阶段,先前接受皮质类固醇治疗的斑块改善程度更大。

局限性

样本量小且仅测试了 1 种皮质类固醇。

结论

在斑块状银屑病患者中,卤倍他索 0.05%软膏治疗未发现局部皮质类固醇脱敏现象。

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