A randomized trial of itraconazole in allergic bronchopulmonary aspergillosis.
A randomized trial of itraconazole in allergic bronchopulmonary aspergillosis.
复制标题
DOI：
10.1056/nejm200003163421102
复制
发表时间：
2000-03-16
影响因子：
158.5
通讯作者：
Reuman, P
中科院分区：
文献类型：
--
作者：
Stevens, DA;Schwartz, HJ;Reuman, P
背景：变应性支气管肺曲霉病是一种可从急性期进展为慢性的超敏反应性疾病。主要的治疗是全身性皮质类固醇激素，但从非对照研究的数据表明，伊曲康唑，口服抗真菌剂，可能是一个有效的administrative therapeutic.Methods：我们进行了一项随机，双盲试验的治疗与伊曲康唑200毫克，每日两次或安慰剂16周的患者谁符合免疫和肺功能的标准，皮质类固醇依赖性过敏性支气管肺曲霉菌病。缓解定义为皮质类固醇剂量减少至少50%，血清IgE浓度降低至少25%，以及以下之一：运动耐量或肺功能试验改善至少25%，或肺浸润消退或消失。在试验的第二个开放标签部分，所有患者每天接受200 mg伊曲康唑，持续16周。结果：伊曲康唑组28例患者中有13例（46%）有反应，而安慰剂组27例患者中有5例（19%，P=0.04）。两组不良事件发生率相似。在随后的开放标签阶段，12的33名患者谁没有反应在双盲阶段（36%）有反应，谁在双盲阶段的试验有反应的患者没有复发。结论：对于糖皮质激素依赖性过敏性支气管肺曲霉病患者，除了伊曲康唑可以导致改善的条件，而不增加毒性。（N Engl J Med 2000;342：756-62.）（C）2000年，马萨诸塞州医学会。
Background: Allergic bronchopulmonary aspergillosis is a hypersensitivity disorder that can progress from an acute phase to chronic disease. The main treatment is systemic corticosteroids, but data from uncontrolled studies suggest that itraconazole, an orally administered antifungal agent, may be an effective adjunctive therapy.Methods: We conducted a randomized, double-blind trial of treatment with either 200 mg of itraconazole twice daily or placebo for 16 weeks in patients who met immunologic and pulmonary-function criteria for corticosteroid-dependent allergic bronchopulmonary aspergillosis. A response was defined as a reduction of at least 50 percent in the corticosteroid dose, a decrease of at least 25 percent in the serum IgE concentration, and one of the following: an improvement of at least 25 percent in exercise tolerance or pulmonary-function tests or resolution or absence of pulmonary infiltrates. In a second, open-label part of the trial, all the patients received 200 mg of itraconazole per day for 16 weeks.Results: There were responses in 13 of 28 patients in the itraconazole group (46 percent), as compared with 5 of 27 patients in the placebo group (19 percent, P=0.04). The rate of adverse events was similar in the two groups. In the subsequent open-label phase, 12 of the 33 patients who had not had a response during the double-blind phase (36 percent) had responses, and none of the patients who had a response in the double-blind phase of the trial had a relapse.Conclusions: For patients with corticosteroid-dependent allergic bronchopulmonary aspergillosis, the addition of itraconazole can lead to improvement in the condition without added toxicity. (N Engl J Med 2000;342:756-62.) (C)2000, Massachusetts Medical Society.