Katz H I, Lindholm J S, Weiss J S, Shavin J S, Morman M, Bressinck R, Cornell R, Pariser D M, Pariser R J, Weng W
Minnesota Clinical Study Center, Fridley, USA.
Clin Ther. 1995 May-Jun;17(3):390-401. doi: 10.1016/0149-2918(95)80104-9.
This 2-week, randomized, multicenter, investigator-blinded, parallel-group study was conducted to compare the efficacy and safety of augmented betamethasone dipropionate 0.05% lotion and clobetasol propionate 0.05% solution in the treatment of moderate-to-severe scalp psoriasis among 197 (193 assessable) healthy adult patients with at least 20% scalp-surface involvement. The patients received one of two treatments applied twice a day for 2 weeks. Signs and symptoms were evaluated at baseline, after 3 days (day 4), and after weeks 1 (day 8) and 2 (day 15) of treatment. As early as 3 days after treatment, scaling and induration were improved significantly faster by betamethasone dipropionate than by clobetasol propionate. Both treatments also reduced erythema and pruritus. Patients receiving betamethasone dipropionate had a significantly greater mean percent improvement in total sign/symptom scores (P < or = 0.015) at all visits and better mean global clinical response scores at the early visits (days 4 and 8) (P < or = 0.017). At the end of the study, only mild disease was present in both groups. Adverse events were reported by 34.0% and 36.4% of patients receiving betamethasone dipropionate and clobetasol propionate, respectively. All events were transient, most were mild and local, and no discontinuations resulted. The effects of treatment on the hypothalamic-pituitary-adrenal axis were not measured. In conclusion, augmented betamethasone dipropionate lotion and clobetasol propionate solution were equally effective, but betamethasone dipropionate lotion provided a faster onset of relief for scaling and induration, which may enhance patient compliance and patient satisfaction with treatment.
这项为期2周的随机、多中心、研究者设盲、平行组研究旨在比较0.05%倍他米松二丙酸酯洗剂和0.05%丙酸氯倍他索溶液在197例(193例可评估)头皮受累面积至少达20%的健康成年中重度头皮银屑病患者中的疗效和安全性。患者接受两种治疗之一,每天涂抹两次,持续2周。在基线、治疗3天后(第4天)以及治疗第1周(第8天)和第2周(第15天)对体征和症状进行评估。早在治疗3天后,倍他米松二丙酸酯改善脱屑和硬结的速度明显快于丙酸氯倍他索。两种治疗均能减轻红斑和瘙痒。接受倍他米松二丙酸酯治疗的患者在所有访视时总体征/症状评分的平均改善百分比显著更高(P≤0.015),在早期访视(第4天和第8天)时平均整体临床反应评分更好(P≤0.017)。研究结束时,两组均仅存在轻度疾病。接受倍他米松二丙酸酯和丙酸氯倍他索治疗的患者分别有34.0%和36.4%报告了不良事件。所有事件均为短暂性,大多数为轻度且局限于局部,未导致停药。未测量治疗对下丘脑-垂体-肾上腺轴的影响。总之,倍他米松二丙酸酯洗剂和丙酸氯倍他索溶液疗效相当,但倍他米松二丙酸酯洗剂在缓解脱屑和硬结方面起效更快,这可能会提高患者的依从性和对治疗的满意度。