Safroneeva Ekaterina, Straumann Alex, Coslovsky Michael, Zwahlen Marcel, Kuehni Claudia E, Panczak Radoslaw, Haas Nadine A, Alexander Jeffrey A, Dellon Evan S, Gonsalves Nirmala, Hirano Ikuo, Leung John, Bussmann Christian, Collins Margaret H, Newbury Robert O, De Petris Giovanni, Smyrk Thomas C, Woosley John T, Yan Pu, Yang Guang-Yu, Romero Yvonne, Katzka David A, Furuta Glenn T, Gupta Sandeep K, Aceves Seema S, Chehade Mirna, Spergel Jonathan M, Schoepfer Alain M
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Swiss EoE Research Group, Praxis Römerhof, Olten, Switzerland; Division of Gastroenterology and Hepatology, University Hospital Basel, Basel, Switzerland.
Gastroenterology. 2016 Mar;150(3):581-590.e4. doi: 10.1053/j.gastro.2015.11.004. Epub 2015 Nov 14.
BACKGROUND & AIMS: It is not clear whether symptoms alone can be used to estimate the biologic activity of eosinophilic esophagitis (EoE). We aimed to evaluate whether symptoms can be used to identify patients with endoscopic and histologic features of remission.
Between April 2011 and June 2014, we performed a prospective, observational study and recruited 269 consecutive adults with EoE (67% male; median age, 39 years old) in Switzerland and the United States. Patients first completed the validated symptom-based EoE activity index patient-reported outcome instrument and then underwent esophagogastroduodenoscopy with esophageal biopsy collection. Endoscopic and histologic findings were evaluated with a validated grading system and standardized instrument, respectively. Clinical remission was defined as symptom score <20 (range, 0-100); histologic remission was defined as a peak count of <20 eosinophils/mm(2) in a high-power field (corresponds to approximately <5 eosinophils/median high-power field); and endoscopic remission as absence of white exudates, moderate or severe rings, strictures, or combination of furrows and edema. We used receiver operating characteristic analysis to determine the best symptom score cutoff values for detection of remission.
Of the study subjects, 111 were in clinical remission (41.3%), 79 were in endoscopic remission (29.7%), and 75 were in histologic remission (27.9%). When the symptom score was used as a continuous variable, patients in endoscopic, histologic, and combined (endoscopic and histologic remission) remission were detected with area under the curve values of 0.67, 0.60, and 0.67, respectively. A symptom score of 20 identified patients in endoscopic remission with 65.1% accuracy and histologic remission with 62.1% accuracy; a symptom score of 15 identified patients with both types of remission with 67.7% accuracy.
In patients with EoE, endoscopic or histologic remission can be identified with only modest accuracy based on symptoms alone. At any given time, physicians cannot rely on lack of symptoms to make assumptions about lack of biologic disease activity in adults with EoE. ClinicalTrials.gov, Number: NCT00939263.
尚不清楚仅依据症状能否用于评估嗜酸性粒细胞性食管炎(EoE)的生物学活性。我们旨在评估症状是否可用于识别具有内镜及组织学缓解特征的患者。
2011年4月至2014年6月期间,我们开展了一项前瞻性观察性研究,在瑞士和美国连续招募了269例成年EoE患者(男性占67%;中位年龄39岁)。患者首先完成经过验证的基于症状的EoE活动指数患者报告结局工具,然后接受食管胃十二指肠镜检查并采集食管活检样本。内镜及组织学检查结果分别采用经过验证的分级系统和标准化工具进行评估。临床缓解定义为症状评分<20(范围0 - 100);组织学缓解定义为高倍视野下嗜酸性粒细胞峰值计数<20个/mm²(相当于约<5个嗜酸性粒细胞/中位高倍视野);内镜缓解定义为无白色渗出物、中度或重度环、狭窄,或皱襞与水肿并存。我们采用受试者工作特征分析来确定用于检测缓解的最佳症状评分临界值。
在研究对象中,111例处于临床缓解状态(41.3%),79例处于内镜缓解状态(29.7%),75例处于组织学缓解状态(27.9%)。当症状评分作为连续变量时,内镜缓解、组织学缓解以及联合(内镜和组织学缓解)缓解的患者检测曲线下面积值分别为分别为0.67、0.60和0.67。症状评分为20时,识别内镜缓解患者的准确率为65.1%,识别组织学缓解患者的准确率为62.1%;症状评分为为15时,识别两种类型缓解患者的准确率为67.7%。
在EoE患者中,仅依据症状识别内镜或组织学缓解的准确率仅为中等。在任何给定时间,医生不能仅依据无症状就推断成年EoE患者不存在生物学疾病活动。ClinicalTrials.gov编号:NCT00939263。