Housman Tamara Salam, Keil Kimberly A, Mellen Beverly G, McCarty Martha A, Fleischer Alan B, Feldman Steven R
Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA.
J Am Acad Dermatol. 2003 Jul;49(1):79-82. doi: 10.1067/mjd.2003.417.
It was discovered that Skin Cap (Cheminova Internacional S.A., Madrid, Spain), an over-the-counter psoriasis therapy with zinc pyrithione, contained clobetasol propionate and it was withdrawn from the market by the US Food and Drug Administration review. Some suggested that there might be a synergistic effect of zinc pyrithione with clobetasol propionate.
We sought to evaluate the efficacy of clobetasol propionate 0.05% foam with and without the coadministration of a topical 0.25% zinc pyrithione spray in treating psoriasis involving sites other than the scalp.
We conducted a randomized, double-blind, right/left study of patients with mild to moderate, generally symmetric, plaque-type psoriasis. Patients were assigned to treatment with clobetasol propionate foam on all psoriatic lesions and then randomly assigned to use zinc pyrithione spray to either the right or left side of their body (vehicle spray to be applied to the opposite side). There was a 2-week treatment phase (visits at baseline, week 1, and week 2) and a follow-up phase (visit at week 4), and all treatments were administered twice daily for 2 weeks. The primary outcome measure was the change from baseline to week 2 in the composite score of the signs of psoriasis (erythema, scaling, plaque thickness) for symmetric target lesions.
A total of 25 patients were enrolled; 24 completed the trial and 1 was lost to follow up. Of those who completed the study, 63% (15 of 24) were men, and the mean age (+/-SD) was 50 years (+/-12.2). After 2 weeks of therapy, the average decline in the composite score was 3.5 (+/-1.8) for monotherapy (clobetasol propionate foam and vehicle) and, similarly, 3.3 (+/-1.8) for clobetasol propionate foam plus zinc pyrithione spray (P =.5).
Zinc pyrithione spray does not appear to enhance the efficacy of clobetasol propionate foam after 2 weeks of therapy.
已发现非处方银屑病治疗药物皮肤帽(西班牙马德里的Chemínova Internacional S.A.公司生产),其含有的吡啶硫酮锌中含有丙酸氯倍他索,该产品已被美国食品药品监督管理局审查后撤出市场。有人认为吡啶硫酮锌与丙酸氯倍他索可能存在协同作用。
我们旨在评估0.05%丙酸氯倍他索泡沫单独使用以及联合外用0.25%吡啶硫酮锌喷雾剂治疗非头皮部位银屑病的疗效。
我们对轻度至中度、一般对称的斑块型银屑病患者进行了一项随机、双盲、右侧/左侧对照研究。患者所有银屑病皮损均接受丙酸氯倍他索泡沫治疗,然后随机分配在身体右侧或左侧使用吡啶硫酮锌喷雾剂(对侧使用赋形剂喷雾剂)。有一个为期2周的治疗阶段(在基线、第1周和第2周就诊)和一个随访阶段(在第4周就诊),所有治疗均每日给药两次,持续2周。主要结局指标是对称目标皮损的银屑病体征(红斑、鳞屑、斑块厚度)综合评分从基线到第2周的变化。
共纳入25例患者;24例完成试验,1例失访。完成研究的患者中,63%(24例中的15例)为男性,平均年龄(±标准差)为50岁(±12.2)。治疗2周后,单一疗法(丙酸氯倍他索泡沫和赋形剂)的综合评分平均下降3.5(±1.8),同样,丙酸氯倍他索泡沫加吡啶硫酮锌喷雾剂的综合评分平均下降3.3(±1.8)(P = 0.5)。
治疗2周后,吡啶硫酮锌喷雾剂似乎并未增强丙酸氯倍他索泡沫的疗效。