Dubertret L, Chastang C, Beylot C, Bazex J, Rognin C, Touraine R
Br J Dermatol. 1985 Sep;113(3):323-30. doi: 10.1111/j.1365-2133.1985.tb02085.x.
Extensive lesions on 36 patients with psoriasis were treated by Tigason, I mg/kg/day plus PUVA until skin clearance. A clinical score was calculated for each body area, and erythema, scaling, thickness and pruritus of the lesions were scored from 0 to 3. Skin clearing was defined as a clinical score less than 10% of the initial score. Double-blind maintenance treatment was then started. This was Tigason at half of the maximal dose tolerated during the clearing phase of the treatment v. placebo. Relapse of the disease was defined as the occurrence of a clinical score greater than 50% of the initial score. Among the 36 patients randomized, 20 received placebo and 16 received Tigason. Relapses increased quickly in the patients on placebo, but occurred in few patients treated by Tigason with 60% remaining clear after 1 year (P less than 0.05). Surprisingly, the kinetics of disappearance of the most frequent side effect, cheilitis, was the same in the Tigason group and in the placebo group. This double-blind randomized clinical trial shows that Tigason at low doses is an efficient and well-tolerated maintenance treatment of psoriasis.
对36例银屑病患者的广泛皮损采用银屑灵治疗，剂量为1mg/kg/天，联合补骨脂素紫外线A光化学疗法（PUVA）直至皮肤清除。计算每个身体部位的临床评分，对皮损的红斑、鳞屑、厚度和瘙痒程度从0至3进行评分。皮肤清除定义为临床评分低于初始评分的10%。然后开始双盲维持治疗。治疗方案为：银屑灵剂量为治疗清除阶段耐受的最大剂量的一半，与安慰剂进行对比。疾病复发定义为临床评分大于初始评分的50%。在随机分组的36例患者中，20例接受安慰剂治疗，16例接受银屑灵治疗。接受安慰剂治疗的患者复发迅速增加，但接受银屑灵治疗的患者复发较少，1年后60%的患者仍保持皮肤清除状态（P小于0.05）。令人惊讶的是，银屑灵组和安慰剂组中最常见的副作用唇炎消失的动力学情况相同。这项双盲随机临床试验表明，低剂量的银屑灵是一种有效且耐受性良好的银屑病维持治疗药物。
