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首页> 外文期刊>Clinical and experimental allergy : >A double-blind, placebo-controlled trial of montelukast in adult atopic eczema.
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A double-blind, placebo-controlled trial of montelukast in adult atopic eczema.

机译：孟鲁司特治疗成人特应性湿疹的双盲，安慰剂对照试验。

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BACKGROUND: Montelukast is an antagonist of cys-leukotriene receptors used mainly in the treatment of asthma- and seasonal-allergic rhinitis. Initial reports concerning the use of montelukast in atopic dermatitis (AD) have been encouraging, although not consistent. OBJECTIVES: We have undertaken a randomized, double-blind, parallel-group, placebo-controlled trial to investigate further the efficacy of montelukast in the treatment of atopic eczema. METHODS: Following a screening visit, subjects received placebo treatment for 2 weeks in a single-blind phase, followed after visit 2 by an 8-week, double-blind period of treatment with montelukast 10 mg daily or placebo. Subjects were patients aged 16-60 years under our care for treatment of AD of moderate severity, defined by a six-area, six-sign atopic dermatitis (SASSAD) score in the range 12-50. Response to treatment was assessed by investigators and by subjects using a seven-point scale, with response defined as marked improvement or better. In addition, the SASSAD score was used to monitor the severity of clinical signs. The proportion of skin involved was estimated and visual analogue scales were used to record the severity of pruritus and sleep disturbance. Topical corticosteroid usage was recorded using a five-point scale. Adverse events were recorded. RESULTS: Sixty subjects were recruited and 54 completed the study. The treatment groups were well matched for disease severity at baseline (SASSAD scores were 25 and 29 in the montelukast and placebo groups, respectively). There were no significant differences between the treatment groups in any of the parameters used to assess treatment response. The improvement in mean SASSAD score from baseline (visit 2) to the end of treatment was marginally superior in the placebo group, 1.41 points on montelukast vs. 1.76 on placebo, a difference of 0.35 (95% confidence interval -6.1 to 6.8). Adverse events were generally of a mild nature except for a brief septicaemic illness in one subject receiving montelukast. CONCLUSIONS: The data do not support previous reports of efficacy of montelukast in treatment of AD.
机译：背景：孟鲁司特是cys-白三烯受体的拮抗剂，主要用于治疗哮喘和季节性变应性鼻炎。关于孟鲁司特用于特应性皮炎（AD）的初步报道令人鼓舞，尽管不一致。目的：我们进行了一项随机，双盲，平行组，安慰剂对照的试验，以进一步研究孟鲁司特治疗特应性湿疹的疗效。方法：筛选访问后，受试者在单盲阶段接受安慰剂治疗2周，然后在访问2后接受每日10 mg孟鲁司特或安慰剂的8周双盲治疗期。受试者为16-60岁的患者，在我们的护理下接受中度严重度AD的治疗，这由六个区域，六个体征的特应性皮炎（SASSAD）评分定义为12-50。研究者和受试者使用七点量表评估对治疗的反应，反应定义为明显改善或更好。此外，SASSAD评分用于监测临床体征的严重性。估计涉及皮肤的比例，并使用视觉模拟量表记录瘙痒和睡眠障碍的严重程度。使用五点量表记录局部使用皮质类固醇激素的情况。记录不良事件。结果：招募了60名受试者，其中54名完成了研究。在基线时，治疗组的疾病严重程度非常匹配（孟鲁司特和安慰剂组的SASSAD评分分别为25和29）。在用于评估治疗反应的任何参数上，治疗组之间没有显着差异。从基线（第2次访问）到治疗结束，SASSAD平均评分的改善在安慰剂组中稍好，孟鲁司特为1.41分，安慰剂组为1.76分，相差0.35（95％置信区间-6.1至6.8）。不良事件一般是轻微的，除了一名接受孟鲁司特的受试者发生短暂的败血病。结论：数据不支持孟鲁司特治疗AD的先前报道。

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