DOUBLE-BLIND, CONTROLLED, CROSSOVER STUDY OF CYCLOSPORINE IN ADULTS WITH SEVERE REFRACTORY ATOPIC-DERMATITIS
DOUBLE-BLIND, CONTROLLED, CROSSOVER STUDY OF CYCLOSPORINE IN ADULTS WITH SEVERE REFRACTORY ATOPIC-DERMATITIS
复制标题
DOI：
10.1016/0140-6736(91)90134-b
复制
发表时间：
1991-07-20
期刊：
影响因子：
168.9
通讯作者：
CAMP, RDR
中科院分区：
文献类型：
--
作者：
SOWDEN, JM;BERTHJONES, J;CAMP, RDR
少数患者在成年后仍然受到异位性皮炎的严重影响，尽管接受了全身性类固醇、硫唑嘌呤和光化学疗法的治疗。33名患者参加了一项双盲、安慰剂对照、交叉研究，以评估环孢菌素（5 mg/kg/天）在患有严重难治性特应性皮炎的成人中的疗效和安全性。每组治疗8周，其中一组（n = 16）接受安慰剂，然后接受环孢菌素，另一组（n = 17）接受环孢菌素，然后接受安慰剂。每两周评估一次疾病活动、疾病程度、睡眠和瘙痒、局部类固醇使用和不良事件。皮炎的程度和活动性均显著改善（p < 0.001），疾病的主观测量也是如此。20名接受环孢菌素治疗的患者报告了不良事件，而8名接受安慰剂治疗的患者报告了不良事件，尽管没有患者需要退出研究。环孢菌素治疗导致平均血清尿素、肌酐和胆红素浓度升高，但仅胆红素升高显著（p = 0.001）。我们的研究结果证实，环孢素是一种安全有效的短期治疗严重，难治性特应性皮炎。
A few patients remain severely affected by atopic dermatitis into adult life despite treatment with systemic steroids, azathioprine, and photochemotherapy. 33 patients took part in a double- blind, placebo-controlled, crossover study to assess the efficacy and safety of cyclosporin (5 mg/kg per day) in adults with severe refractory atopic dermatitis. Treatments were given for eight weeks each with one group (n = 16) receiving placebo followed by cyclosporin and another (n = 17) receiving cyclosporin and then placebo. Disease activity, extent of disease, sleep and itch, topical steroid use, and adverse events were assessed every two weeks. Both extent and activity of dermatitis were significantly improved (p < 0.001 ) as were subjective measures of disease. 20 patients receiving cyclosporin reported adverse events compared with 8 taking placebo, although no patient required withdrawal from the study. Cyclosporin therapy led to an increase in the mean serum urea, creatinine, and bilirubin concentrations, although only the rise in bilirubin was significant (p = 0.001 ). Our results confirm that cyclosporin is a safe and effective short-term treatment for severe, refractory atopic dermatitis.