Harper J I, Ahmed I, Barclay G, Lacour M, Hoeger P, Cork M J, Finlay A Y, Wilson N J, Graham-Brown R A, Sowden J M, Beard A L, Sumner M J, Berth-Jones J
Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London WC1N 3JH, UK.
Br J Dermatol. 2000 Jan;142(1):52-8. doi: 10.1046/j.1365-2133.2000.03241.x.
Cyclosporin (CyA) has been shown to be highly effective and well tolerated in the short-term treatment of severe childhood atopic dermatitis; however, there is limited experience in its longer-term use. The aim of this study was to compare multiple short courses of CyA with continuous therapy for 1 year, with respect to efficacy, safety, tolerability and quality of life. Children aged 2-16 years, with a diagnosis of severe atopic dermatitis refractory to topical steroid therapy, were randomly assigned to receive short course therapy (multiple courses of 12 weeks) or continuous therapy. The starting dose and maximum dose for all patients was 5 mg/kg per day. Disease activity was monitored using the Six Area Six Sign Atopic Dermatitis score and the 'Rule of Nines' area score. Pruritus, sleep disturbance and irritability were measured using visual analogue scales, and topical therapy was monitored. Safety measurements included monitoring of serum creatinine, blood pressure and adverse events. Forty patients were included in the efficacy analysis, 21 of whom were randomized to the short course group (of whom six were withdrawn) and 19 to the continuous group (of whom five were withdrawn). Significant improvements were seen in all efficacy parameters at every time-point. There were no significant differences between groups, although the improvement was more consistent in the continuous arm. In the short course arm, 7 out of 21 patients could be managed by at least two short courses. The remaining 14 patients includes 12 who could not be controlled by at least two short courses, one patient who failed to return after week 12 and another patient who was withdrawn at week 4 due to an adverse event. Quality of life improved for both the children and their families. Tolerability was considered good or very good in at least 80% of the patients at week 12 and at the end of the study. No clinically significant change was seen in mean serum creatinine and no change was seen in mean blood pressure in either group. CyA is effective in controlling severe atopic dermatitis in children over a 1-year period and is well tolerated. More consistent control is achieved with continuous treatment; however, short course therapy was adequate for some patients, indicating that treatment should be tailored to the individual patient's needs. Short course treatment may produce prolonged remission in some cases and reduce the cumulative exposure to the drug.
环孢素（CyA）已被证明在重度儿童特应性皮炎的短期治疗中疗效显著且耐受性良好；然而，其长期使用的经验有限。本研究的目的是比较多次短期使用CyA与持续治疗1年在疗效、安全性、耐受性和生活质量方面的差异。年龄在2至16岁、诊断为对局部类固醇治疗无效的重度特应性皮炎患儿被随机分配接受短期疗程治疗（多个12周疗程）或持续治疗。所有患者的起始剂量和最大剂量均为每日5mg/kg。使用六区域六体征特应性皮炎评分和“九分法”面积评分监测疾病活动度。使用视觉模拟量表测量瘙痒、睡眠障碍和易怒情况，并监测局部治疗。安全性测量包括监测血清肌酐、血压和不良事件。40名患者纳入疗效分析，其中21名随机分配至短期疗程组（其中6名退出），19名分配至持续治疗组（其中5名退出）。在每个时间点，所有疗效参数均有显著改善。两组之间无显著差异，尽管持续治疗组的改善更为一致。在短期疗程组中，21名患者中有7名至少通过两个短期疗程得到控制。其余14名患者包括12名至少经过两个短期疗程仍无法控制的患者、1名在第12周后未复诊的患者以及另1名因不良事件在第4周退出的患者。儿童及其家庭的生活质量均有所改善。在第12周和研究结束时，至少80%的患者耐受性良好或非常好。两组的平均血清肌酐均未见临床显著变化，平均血压也未见变化。CyA在1年期间有效控制儿童重度特应性皮炎，且耐受性良好。持续治疗能实现更持续的控制；然而，短期疗程治疗对部分患者足够，这表明治疗应根据个体患者的需求进行调整。短期疗程治疗在某些情况下可能产生长期缓解并减少药物的累积暴露。
