Bergstrom Kendra Gail, Arambula Karina, Kimball Alexa Boer
Department of Dermatology, Stanford University, California 94305-5334, USA.
Cutis. 2003 Nov;72(5):407-11.
For topical medications commonly used to treat dermatologic conditions, outcomes may be affected by the choice of delivery vehicles. The aim of this study was to compare quality of life (QOL), effectiveness, user satisfaction, and cost-effectiveness of 2 clobetasol regimens for the treatment of psoriasis over 14 days. In a single-blind design, 32 patients randomized into 2 groups applied either clobetasol foam 0.05% to the skin and scalp or combination clobetasol cream 0.05% to the skin and clobetasol solution 0.05% to the scalp. Psoriasis severity was measured using the standardized Psoriasis Area and Severity Index (PASI) and self-administered PASI (SAPASI). QOL was assessed via the EuroQoL-5D (EQ-5D) questionnaire and Dermatology Life Quality Index (DLQI). Cost-effectiveness was measured by the amount of medication used per body surface area (BSA) treated and by cost per point improvement in PASI score. In this study, a foam formulation performed better than a cream/solution combination by several measures. A greater absolute improvement in psoriasis severity was seen in the group using the foam than in the group using the cream/solution (mean decrease in PASI=5.0 vs 3.3, P=.05). The PASI score in the foam group decreased by 41% versus 35% in the cream/solution group (P=.17). In scalp psoriasis, the group using the foam had greater improvement in both absolute (P=.03) and percentage (P=.03) terms and than the solution group. When measuring global QOL, foam users had a significantly greater increase in EQ-5D than those using the cream/solution in absolute (P=.05, P=.02) and percentage (P=.04, P=.02) terms (first and second survey components, respectively). Differences in improvement of skin-specific QOL, quantified by DLQI scores between groups, were suggested but not statistically significant. Patients using foam spent less time applying medication compared with previous topical medications (P<.001). No significant difference in cost was appreciated between foam and cream/solution over the period after controlling for BSA (8.18 dollars vs 7.05 dollars per percentage BSA affected, P=.30).
对于常用于治疗皮肤病的局部用药，治疗效果可能会受到给药载体选择的影响。本研究的目的是比较两种氯倍他索治疗方案在14天内治疗银屑病的生活质量（QOL）、有效性、用户满意度和成本效益。在单盲设计中，32例患者随机分为两组，一组将0.05%氯倍他索泡沫剂涂抹于皮肤和头皮，另一组将0.05%氯倍他索乳膏涂抹于皮肤，0.05%氯倍他索溶液涂抹于头皮。使用标准化的银屑病面积和严重程度指数（PASI）和自我管理的PASI（SAPASI）来测量银屑病严重程度。通过欧洲五维健康量表（EQ-5D）问卷和皮肤病生活质量指数（DLQI）评估生活质量。通过每治疗单位体表面积（BSA）使用的药物量和PASI评分每改善一分的成本来衡量成本效益。在本研究中，通过多项指标衡量，泡沫剂型的表现优于乳膏/溶液组合剂型。使用泡沫剂的组在银屑病严重程度上的绝对改善幅度大于使用乳膏/溶液的组（PASI平均下降=5.0对3.3，P=.05）。泡沫剂组的PASI评分下降了41%，而乳膏/溶液组为35%（P=.17）。在头皮银屑病中，使用泡沫剂的组在绝对（P=.03）和百分比（P=.03）方面的改善均大于使用溶液的组。在测量总体生活质量时，使用泡沫剂的患者在EQ-5D上的绝对（P=.05，P=.02）和百分比（P=.04，P=.02）增加均显著大于使用乳膏/溶液的患者（分别为第一次和第二次调查部分）。两组之间通过DLQI评分量化的皮肤特异性生活质量改善存在差异，但无统计学意义。与之前的局部用药相比，使用泡沫剂的患者涂抹药物的时间更短（P<.001）。在控制BSA后，泡沫剂和乳膏/溶液在成本上无显著差异（每受影响的百分比BSA为8.18美元对7.05美元，P=.30）。
