| نویسندگان | Farhad Seif 1 , Nastaran Amiri 2 , Majid Khoshmirsafa 3 , Saba Arshi 2 , Mohammad Nabavi 2 , Mohammad Hassan Bemanian 2 , Sima Shokri 2 , Azizollah Yousefi 4 , Banafshe Rajabian 5 , Fatemeh Mahjoob 6 , Nikoo Emtiazi 7 , Morteza Fallahpour 2 |
|---|---|
| نشریه | AIMS Allergy and Immunology |
| كد DOI/DOR | 10.3934/Allergy.2024010 |
| نوع مقاله | Full Paper |
| تاریخ انتشار | ۲۰۲۴ |
| رتبه نشریه | ISI |
| نوع نشریه | چاپی |
| کشور محل چاپ | ایران |
چکیده مقاله
Background
Eosinophilic esophagitis (EoE) is a chronic allergen/immune-mediated disease known by eosinophil infiltration into the esophagus. Topical steroids are used for its treatment. We investigated the efficacy, side effects, and symptom relapse after discontinuation of two budesonide forms in EoE patients.
Methods
In this prospective, dose-ranging, randomized trial, 35 EoE patients under 18 years who received two budesonide forms were assigned to low-dose oral respule (17 patients) and swallowed metered-dose inhaler (MDI) (18 patients) groups. Both groups received low-dose budesonide for eight weeks. Doses were doubled after the first eight weeks if symptom remission was not achieved, but the previous dose was continued for the next eight weeks for the subjects with symptom relief. At the end of week 16, budesonide was discontinued in all patients. The following outcomes were assessed: The primary outcome was symptom relief, assessed by Pediatric EoE Symptom Scores (PEESS®v2.0). Secondary outcomes included safety, side effects, and histological changes, based on repeated endoscopy at weeks 0, 8, 16, and 32.
Results
Non-response to low-dose treatment in the first eight weeks was observed in 2 cases (13.3%, 95% CI: 2.6%–35.2%) in the respule group and 7 cases (50.0%, 95% CI: 22.7%–77.3%) in the MDI group, indicating a significant difference between the groups (p = 0.033). In the 16th week, the treatment failure rate was 13.3% and 26.6% in the oral respule and swallowed MDI groups, respectively (p = 0.048). The therapeutic response during the 8th week was significantly higher in oral respule group than swallowed MDI group (OR = 8.418, p = 0.046).
Conclusion
This study indicates that the oral respule formulation of budesonide is more effective than the swallowed MDI in alleviating symptoms of eosinophilic esophagitis (EoE) in children. The oral respule not only resulted in a higher rate of symptom relief but also exhibited a better safety profile, with fewer incidents of oral thrush and adrenal suppression.