一项关于布地奈德口腔崩解片诱导治疗嗜酸性食管炎安全性和有效性的回顾性真实世界研究。

A retrospective real-world study on the safety and efficacy of budesonide orodispersible tablets for the induction therapy of eosinophilic oesophagitis.

作者信息

Geow Rachel, Arena Gina, Siah Chiang, Picardo Sherman

机构信息

UWA Medical School, The University of Western Australia, Perth, Australia, 17 Monash Avenue, Nedlands 6009, Australia.

UWA Medical School, The University of Western Australia, Perth, Australia.

出版信息

Therap Adv Gastroenterol. 2024 Oct 16;17:17562848241290346. doi: 10.1177/17562848241290346. eCollection 2024.

Abstract

BACKGROUND

An orodispersible form of budesonide has recently been approved for the targeted treatment of eosinophilic oesophagitis in the United Kingdom, Europe, Australia, Canada and the United States, following favourable results from a randomised controlled trial. This is the first dedicated real-world study exploring the safety and efficacy of budesonide orodispersible tablets for induction therapy in the treatment of eosinophilic oesophagitis while providing insights into its management.

OBJECTIVES

The primary objective was histologic remission, defined as less than 5 eosinophils per high-powered field. The secondary objectives included histologic response (>50% reduction in peak eosinophil count), clinical remission (complete resolution of symptoms documented on clinic letters), clinical response (improvements in symptoms as reported on clinical letters), endoscopic remission (Endoscopic Reference Score (EREFS) score = 0), and endoscopic response (improvement in EREFS score). The EREFS scores were calculated based on the severity and presence of rings, longitudinal furrows, strictures, oedema and exudates on endoscopic images. Adverse events and safety profiles were also recorded.

DESIGN

A multicentre cohort study examining the effectiveness of 1 mg, twice daily, budesonide orodispersible tablet induction therapy for the treatment of eosinophilic oesophagitis.

METHODS

Ethics approval was obtained through the Western Australia Health: Governance, Evidence, Knowledge, Outcomes system for assessment of Audit and Quality Activities. The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines.

RESULTS

A total of 43 patients (29 males, 14 females; median age 39) were recruited. Forty-one patients were included in the analysis. After induction therapy, 30 patients (73%) achieved histologic remission, and 35 patients (85%) demonstrated histologic response. Thirty-nine patients (95%) achieved clinical response, and 28 patients (68%) achieved clinical remission. An endoscopic response was seen in 37 patients (90%), and 16 patients (39%) achieved endoscopic remission. No significant adverse events were identified.

CONCLUSION

Budesonide orodispersible tablet is an effective induction therapy for eosinophilic oesophagitis, as evidenced by its high histologic remission rate and favourable safety profile.

摘要

背景

在一项随机对照试验取得良好结果后,布地奈德的口腔崩解剂型最近在英国、欧洲、澳大利亚、加拿大和美国被批准用于嗜酸性粒细胞性食管炎的靶向治疗。这是第一项专门的真实世界研究,旨在探索布地奈德口腔崩解片诱导治疗嗜酸性粒细胞性食管炎的安全性和有效性,同时深入了解其治疗方法。

目的

主要目标是组织学缓解,定义为每高倍视野嗜酸性粒细胞少于5个。次要目标包括组织学反应(峰值嗜酸性粒细胞计数减少>50%)、临床缓解(临床信函记录的症状完全缓解)、临床反应(临床信函报告的症状改善)、内镜缓解(内镜参考评分(EREFS)=0)和内镜反应(EREFS评分改善)。EREFS评分是根据内镜图像上环形、纵向皱襞、狭窄、水肿和渗出物的严重程度及存在情况计算得出的。还记录了不良事件和安全性概况。

设计

一项多中心队列研究,考察每日两次、每次1毫克布地奈德口腔崩解片诱导治疗嗜酸性粒细胞性食管炎的有效性。

方法

通过西澳大利亚卫生:治理、证据、知识、结果系统获得伦理批准,用于评估审计和质量活动。该研究遵循了加强流行病学观察性研究报告指南。

结果

共招募了43例患者(29例男性,14例女性;中位年龄39岁)。41例患者纳入分析。诱导治疗后,30例患者(73%)实现组织学缓解,35例患者(85%)表现出组织学反应。39例患者(95%)实现临床反应,28例患者(68%)实现临床缓解。37例患者(90%)出现内镜反应,16例患者(39%)实现内镜缓解。未发现显著不良事件。

结论

布地奈德口腔崩解片是嗜酸性粒细胞性食管炎的一种有效诱导治疗药物,其高组织学缓解率和良好的安全性概况证明了这一点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc23/11483688/127973c7d285/10.1177_17562848241290346-fig1.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索