Oral Viscous Budesonide Is Effective in Children With Eosinophilic Esophagitis in a Randomized, Placebo-Controlled Trial
Oral Viscous Budesonide Is Effective in Children With Eosinophilic Esophagitis in a Randomized, Placebo-Controlled Trial
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DOI：
10.1053/j.gastro.2010.05.001
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发表时间：
2010-08-01
期刊：
影响因子：
29.4
通讯作者：
Aceves, Seema
中科院分区：
文献类型：
--
作者：
Dohil, Ranjan;Newbury, Robert;Aceves, Seema
背景与目的：嗜酸性食管炎(EoE)是由摄入/吸入性变应原引起的免疫反应引起的。如果在粘膜活检中检测到15个嗜酸性粒细胞/高倍视野(Eos/HPF)，则认为该诊断。尚未进行安慰剂对照研究来评估口服粘性布地奈德(OVB)的安全性和有效性。方法：将EoE患儿随机分为OVB组(n=15)和安慰剂组(n=9)。身高5英尺的患者每天分别接受1 mg和2 mg的OVB治疗。所有患者均接受兰索拉唑治疗。疗程为3个月，随后进行重复的内窥镜检查和活检。如果患者的嗜酸性粒细胞峰值计数=20 Eos/HPF，则将其归类为应答者。对基线和治疗后的症状、内窥镜和组织学特征进行评分。结果：13名(86.7%)服用OVB的儿童(P<；.0001)和没有接受安慰剂的儿童(P=.3)被归类为应答者。服用OVB的患者治疗前后的平均峰值嗜酸性粒细胞计数分别为66.7和4.8 Eos/HPF(P=0.0001)，而服用安慰剂的患者分别为83.9和65.6 Eos/HPF(P=0.3)。在服用OVB的组中，近端(P=.002)、中段(P=.0003)和远端(P=.001)食道嗜酸粒细胞增多症的基准值显著降低。在OVB治疗后，与基线相比，平均症状(P=.0007)、内窥镜检查(P=.0005)和组织学评分(P=.0035)显著改善。结论：OVB是治疗儿童EoE全食道疾病的有效方法。OVB可改善症状、内窥镜和组织学特征。质子泵抑制剂单一治疗不能明显改善食管嗜酸性粒细胞增多症或EoE症状。
BACKGROUND & AIMS: Eosinophilic esophagitis (EoE) is caused by immunologic reactions to ingested/inhaled allergens. The diagnosis is considered if >= 15 eosinophils per high-powered field (eos/hpf) are detected in mucosal biopsies. Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB). METHODS: Children with EoE were randomly assigned to groups that were given OVB (n = 15) or placebo (n = 9). Patients = 5 feet tall received 1 mg and 2 mg OVB daily, respectively. All patients received lansoprazole. Duration of treatment was 3 months, followed by repeat endoscopy and biopsies. Patients were classified as responders if their peak eosinophil counts were = 20 eos/hpf. Baseline and post-treatment symptoms and endoscopic and histologic features were scored. RESULTS: Thirteen (86.7%) children given OVB (P < .0001) and none who received placebo (P = .3) were classified as responders. Mean pre-/post-treatment peak eosinophil counts were 66.7 and 4.8 eos/hpf, respectively, in the group given OVB (P < .0001); they were 83.9 and 65.6 eos/hpf, respectively, in the group given placebo (P = .3). In the group given OVB, there were significant reductions from baseline values in proximal (P = .002), mid (P = .0003), and distal (P = .001) esophageal eosinophilia. After OVB therapy, compared with baseline, the mean symptom (P = .0007), endoscopy (P = .0005), and histology scores improved (P = .0035) significantly. CONCLUSIONS: OVB is an effective treatment of pan-esophageal disease in children with EoE. OVB improves symptoms and endoscopic and histologic features. Proton pump inhibitor single therapy did not significantly improve esophageal eosinophilia or symptoms of EoE.