Azathioprine in severe adult atopic dermatitis: a double-blind, placebo-controlled, crossover trial
Azathioprine in severe adult atopic dermatitis: a double-blind, placebo-controlled, crossover trial
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DOI：
10.1046/j.1365-2133.2002.04989.x
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发表时间：
2002-08-01
影响因子：
10.3
通讯作者：
Graham-Brown, RAC
中科院分区：
文献类型：
--
作者：
Berth-Jones, J;Takwale, A;Graham-Brown, RAC
研究背景重度特应性皮炎（AD）的治疗方法有限。硫唑嘌呤常被用于治疗阿尔茨海默病，但尚无该药物的随机对照试验来证实其疗效。目的建立或反驳硫唑嘌呤治疗重度AD的疗效。探讨硫唑嘌呤在该患者群体中的安全性和耐受性。方法采用双盲、随机、安慰剂对照、交叉试验的方法，研究了硫唑嘌呤治疗成人重度AD患者的疗效。每组疗程为3个月。治疗是硫唑嘌呤2.5 mg kg（-1）天（-1）和匹配的安慰剂。采用SASSAD体征评分监测疾病活动度。此外，使用视觉模拟量表监测瘙痒、睡眠障碍和工作/白天活动中断的严重程度。记录不良事件并进行血液学和生化监测。结果纳入37例受试者，平均年龄38岁（17 ~ 73岁）。16例患者停药，12例接受硫唑嘌呤治疗，4例接受安慰剂治疗。硫唑嘌呤组SASSAD评分下降26%，安慰剂组下降3% （P < 0.01）。瘙痒、睡眠障碍和工作/白天活动中断都在积极治疗中得到显著改善，而安慰剂组则没有。硫唑嘌呤和安慰剂在工作/白天活动中断方面的平均改善差异显著（P < 0.02），但在瘙痒或睡眠障碍方面无显著差异。14例患者在硫唑嘌呤治疗期间出现胃肠道紊乱，其中4例因严重恶心和呕吐而停药。在硫唑嘌呤治疗期间，2例患者出现白细胞减少，8例患者出现肝酶紊乱。结论硫唑嘌呤是治疗重度AD的有效药物，但并不一定耐受良好。建议在治疗期间监测全血细胞计数和肝酶。
Background There is a limited range of treatments for severe atopic dermatitis (AD). Azathioprine has often been used but there has been no randomized controlled trial of this drug to confirm its efficacy in AD.Objectives To establish or refute the efficacy of azathioprine in severe AD. To investigate the safety and tolerability of azathioprine in this patient population.Methods We performed a double-blind, randomized, placebo-controlled, crossover trial of azathioprine in adult patients with severe AD. Each treatment period was of 3 months' duration. Treatments were azathioprine 2.5 mg kg(-1) day(-1) and matched placebo. Disease activity was monitored using the SASSAD sign score. In addition, severity of pruritus, sleep disturbance and disruption of work/daytime activity were monitored using visual analogue scales. Adverse events were recorded and haematological and biochemical monitoring was performed.Results Thirty-seven subjects were enrolled, mean age 38 years (range 17-73). Sixteen were withdrawn, 12 during azathioprine treatment and four during placebo treatment. The SASSAD score fell by 26% during treatment with azathioprine vs. 3% on placebo (P < 0.01). Pruritus, sleep disturbance and disruption of work/daytime activity all improved significantly on active treatment but not on placebo. The difference in mean improvement between azathioprine and placebo was significant for disruption of work/daytime activity (P < 0.02) but not for pruritus or sleep disturbance. Gastrointestinal disturbances were reported by 14 patients during azathioprine treatment and four were withdrawn as a result of severe nausea and vomiting. Leukopenia was observed in two patients and deranged liver enzymes in eight during treatment with azathioprine.Conclusions Azathioprine is an effective and useful drug in severe AD although it is not always well-tolerated. Monitoring of the full blood count and liver enzymes is advisable during treatment.