Budesonide Is Effective in Adolescent and Adult Patients With Active Eosinophilic Esophagitis
Budesonide Is Effective in Adolescent and Adult Patients With Active Eosinophilic Esophagitis
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DOI：
10.1053/j.gastro.2010.07.048
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发表时间：
2010-11-01
期刊：
影响因子：
29.4
通讯作者：
Simon, Hans-Uwe
中科院分区：
文献类型：
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作者：
Straumann, Alex;Conus, Sebastien;Simon, Hans-Uwe
背景与目的：嗜酸性食管炎(EoE)是一种以组织致密的嗜酸性粒细胞增多为特征的慢性食管炎性疾病，对质子泵抑制剂治疗无效。EoE影响所有年龄段，但最常见的是20岁至50岁之间的个人。外用皮质类固醇对儿童EoE患者有效，但在成人患者中未见皮质类固醇对照研究的报道。方法：我们进行了一项随机、双盲、安慰剂对照试验，以评估口服布地奈德(1 mg，每日2次，共15天)对青少年和成人EoE活动期患者的疗效。对治疗前和治疗后的疾病活动性进行临床、内窥镜和组织学评估。主要终点是减少食道上皮中嗜酸粒细胞的平均数量(每高倍视野的数量[HPF]=食道嗜酸细胞负载)。食道活检和血液样本分别用免疫荧光和免疫分析方法分析炎症和治疗反应的生物标志物。结果：在15天的疗程中，服用布地奈德的患者食道上皮中的嗜酸性粒细胞数量显著减少(从68.2降至5.5/HPF；P<；0.0001)，但在安慰剂组中无显著差异(从62.3降至56.5/HPF；P=.48)。与服用安慰剂的患者相比，服用布地奈德的患者吞咽困难评分显著改善(5.61比2.22；P<；0.0001)。根据内窥镜检查，服用布地奈德的患者白色渗出物和红色皱纹被逆转。布地奈德，但不是安慰剂，也减少了上皮细胞的凋亡和食道的分子重塑事件；没有观察到严重的不良事件。结论：15天的布地奈德疗程耐受性好，在青少年和成人EoE活动期患者的组织学和临床缓解方面非常有效。
BACKGROUND & AIMS: Eosinophilic esophagitis (EoE) is a chronic inflammatory disease of the esophagus characterized by dense tissue eosinophilia; it is refractory to proton pump inhibitor therapy. EoE affects all age groups but most frequently individuals between 20 and 50 years of age. Topical corticosteroids are effective in pediatric patients with EoE, but no controlled studies of corticosteroids have been reported in adult patients. METHODS: We performed a randomized, double-blind, placebo-controlled trial to evaluate the effect of oral budesonide (1 mg twice daily for 15 days) in adolescent and adult patients with active EoE. Pretreatment and posttreatment disease activity was assessed clinically, endoscopically, and histologically. The primary end point was reduced mean numbers of eosinophils in the esophageal epithelium (number per high-power field [hpf] = esophageal eosinophil load). Esophageal biopsy and blood samples were analyzed using immunofluorescence and immunoassays, respectively, for biomarkers of inflammation and treatment response. RESULTS: A 15-day course of therapy significantly decreased the number of eosinophils in the esophageal epithelium in patients given budesonide (from 68.2 to 5.5 eosinophils/hpf; P < .0001) but not in the placebo group (from 62.3 to 56.5 eosinophils/hpf; P = .48). Dysphagia scores significantly improved among patients given budesonide compared with those given placebo (5.61 vs 2.22; P < .0001). White exudates and red furrows were reversed in patients given budesonide, based on endoscopy examination. Budesonide, but not placebo, also reduced apoptosis of epithelial cells and molecular remodeling events in the esophagus; no serious adverse events were observed. CONCLUSIONS: A 15-day course of treatment with budesonide is well tolerated and highly effective in inducing a histologic and clinical remission in adolescent and adult patients with active EoE.