Klaber M R, Hutchinson P E, Pedvis-Leftick A, Kragballe K, Reunala T L, Van de Kerkhof P C, Johnsson M K, Molin L, Corbett M S, Downess N
Dermatology Department, Broomfield Hospital, Essex, U.K.
Br J Dermatol. 1994 Nov;131(5):678-83. doi: 10.1111/j.1365-2133.1994.tb04982.x.
The efficacy, tolerability and safety of calcipotriol solution and betamethasone 17-valerate solution were compared in a multicentre, prospective, randomized, double-blind, parallel group study. Four hundred and seventy-four patients with scalp psoriasis were recruited from six European countries and Canada. Following a 2-week washout period, either calcipotriol solution (50 micrograms/ml) or betamethasone 17-valerate solution (1 mg/ml) was applied twice daily for 4 weeks. After this time, patients who required no further active treatment were observed for relapse. Retreatment with calcipotriol was offered to those patients who relapsed, and who were originally in the calcipotriol-treated group. The two treatment groups were well matched at baseline. At the end of treatment, the proportion of patients who had 'cleared' or 'markedly improved' was statistically significantly greater in the betamethasone group (75%) than in the calcipotriol group (58%) (P < 0.001) (95% confidence interval of difference 25.3-->8.6). The decrease in total sign score (sum of scores for erythema, thickness and scaliness) at the end of treatment was also statistically significantly greater in the betamethasone group (61%) than the calcipotriol group (45%) (P < 0.001) (95% confidence interval of difference 9.7-->23.1). Adverse events were reported by 87 patients in the calcipotriol group, and 31 patients in the betamethasone group; the most common was lesional or perilesional irritation, which occurred significantly more frequently with calcipotriol (26%) than with betamethasone (8%) (P < 0.001). Fifteen patients (6%) in the calcipotriol group and four (1%) in the betamethasone group withdrew from the study because of adverse events or unacceptable treatment response (P = 0.017).(ABSTRACT TRUNCATED AT 250 WORDS)
在一项多中心、前瞻性、随机、双盲、平行组研究中，对卡泊三醇溶液和倍他米松17-戊酸酯溶液的疗效、耐受性和安全性进行了比较。从六个欧洲国家和加拿大招募了474例头皮银屑病患者。经过2周的洗脱期后，卡泊三醇溶液（50微克/毫升）或倍他米松17-戊酸酯溶液（1毫克/毫升）每天涂抹两次，持续4周。在此之后，对无需进一步积极治疗的患者进行复发观察。对那些复发且最初在卡泊三醇治疗组的患者提供卡泊三醇再治疗。两个治疗组在基线时匹配良好。治疗结束时，倍他米松组（75%）“清除”或“显著改善”的患者比例在统计学上显著高于卡泊三醇组（58%）（P<0.001）（差异的95%置信区间为25.3->8.6）。治疗结束时，倍他米松组总体征评分（红斑、厚度和鳞屑评分总和）的下降幅度（61%）在统计学上也显著大于卡泊三醇组（45%）（P<0.001）（差异的95%置信区间为9.7->23.1）。卡泊三醇组有87例患者报告了不良事件，倍他米松组有31例；最常见的是皮损或皮损周围刺激，卡泊三醇组（26%）出现的频率显著高于倍他米松组（8%）（P<0.001）。卡泊三醇组有15例患者（6%）和倍他米松组有4例患者（1%）因不良事件或不可接受的治疗反应退出研究（P=0.017）。（摘要截断于250字）
