Ketchem Corey J, Reed Craig C, Stefanadis Zoe, Dellon Evan S
Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Chapel Hill Compounding Pharmacy, Chapel Hill, NC, USA.
Dis Esophagus. 2021 Jul 12;34(7). doi: 10.1093/dote/doaa120.
No approved medication exists for the treatment of eosinophilic esophagitis (EoE) in the United States, which forces patients to utilize off-label drugs and/or create their own formulations. We assessed the efficacy of a standardized compounded fluticasone suspension. To do this, we performed a retrospective cohort study identifying all EoE patients treated with compounded fluticasone. Compounded fluticasone was prescribed during routine clinical care and dispensed by a specialty compounding pharmacy. Clinical data were extracted from medical records. Outcomes (symptomatic, endoscopic, and histologic) were assessed after the initial and last compounded fluticasone treatment in our system. There were 27 included patients (mean age 34.2; 67% male; 96% white) treated for a mean length of 5.4 ± 4.4 months. The majority (89%) previously utilized dietary elimination or topical corticosteroids, and many (75%) had primary non-response or secondary loss of response to these treatments. After starting compounded fluticasone, symptoms and endoscopic findings improved [dysphagia (89 vs. 56%, P = 0.005), food impaction (59 vs. 4%, P = 0.003), heartburn (26 vs. 4%, P = 0.01), chest pain (26 vs. 8%, P = 0.05), white plaques (63 vs. 32%; P = 0.005), furrows (81 vs. 60%; P = 0.06), and edema (15 vs. 4%; P = 0.16)]. The median of the peak eosinophil counts decreased from 52 to 37 eos/hpf (P = 0.10) and 35% of patients achieved <15 eos/hpf. In conclusion, compounded fluticasone provided a significant improvement in symptoms and endoscopic findings, with more than a third achieving histologic response in a treatment refractory EoE population. Compounded fluticasone should be considered as an EoE management option.
在美国,尚无获批用于治疗嗜酸性粒细胞性食管炎(EoE)的药物,这迫使患者使用未获批准的药物和/或自行配制药物。我们评估了一种标准化复方氟替卡松混悬液的疗效。为此,我们开展了一项回顾性队列研究,纳入所有接受复方氟替卡松治疗的EoE患者。复方氟替卡松是在常规临床护理期间开具的,并由一家专业配制药房配药。临床数据从病历中提取。在我们的系统中,对首次和末次复方氟替卡松治疗后的结局(症状、内镜检查和组织学)进行评估。纳入27例患者(平均年龄34.2岁;67%为男性;96%为白人),平均治疗时长为5.4±4.4个月。大多数患者(89%)此前采用过饮食排除法或局部使用皮质类固醇,许多患者(75%)对这些治疗原发无反应或继发反应丧失。开始使用复方氟替卡松后,症状和内镜检查结果有所改善[吞咽困难(89%对56%,P=0.005)、食物嵌塞(59%对4%,P=0.003)、烧心(26%对4%,P=0.01)、胸痛(26%对8%,P=0.05)、白色斑块(63%对32%;P=0.005)、皱襞(81%对60%;P=0.06)和水肿(15%对4%;P=0.16)]。嗜酸性粒细胞峰值计数的中位数从52降至37个嗜酸性粒细胞/高倍视野(P=0.10),35%的患者嗜酸性粒细胞计数<15个/高倍视野。总之,复方氟替卡松显著改善了症状和内镜检查结果,在难治性EoE患者群体中,超过三分之一的患者实现了组织学反应。复方氟替卡松应被视为EoE的一种治疗选择。