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New Budesonide Treatment Effective Against Eosinophilic Esophagitis in Children
By Scott Baltic
NEW YORK (Reuters Health) Nov 16 - A new therapy that uses budesonide in an oral viscous preparation appears to be safe and effective for eosinophilic esophagitis in young children, according to a study published in the October issue of the American Journal of Gastroenterology.
The precise causes of eosinophilic esophagitis remain unclear, and therapies are often complicated, particularly in children. In an earlier, pilot study, researchers used oral viscous budesonide to successfully treat two patients who had been unable to utilize fluticasone propionate.
The oral viscous budesonide is made by mixing a 0.5 mg Pulmicort Respule with 5 1g packets of sucralose (Splenda) to create a volume of 8-12 mL.
The current study, led by Dr. Ranjan Dohil, of the Children's Hospital of San Diego and the University of California, San Diego, was a retrospective analysis of 20 children with eosinophilic esophagitis (mean age 5.5 years, range 1.7 -- 17.6 years). Fourteen had asthma, eczema and/or allergic rhinitis, and 16 had evidence of food allergies. At least one prior therapy for eosinophilic esophagitis had failed just over half of these patients.
Eosinophilic esophagitis was diagnosed when at least 24 eosinophils/high power field (eos/hpf) were found in esophageal mucosal biopsies. The patients received oral viscous budesonide for 3 -- 4 months before follow-up endoscopy with biopsies. Initial dosage was 1 mg/day, though two patients initially and two more later received 2 mg/day.
Before oral viscous budesonide treatment, the mean highest eosinophil count for all patients, all sites, was 87 eos/hpf. Following treatment, it was 7 eos/hpf.
The baseline mean score on an eosinophilic esophagitis endoscopy scale (0 -- 8) developed for this study was 3.6 (range 1 -- 6), and after treatment with oral viscous budesonide this score fell to 0 in 12 children and improved in 19 of the 20.
Finally, symptom scores, based on a scale of 0 -- 14 used for children with acid-peptic disease, fell from a mean of 4.4 before therapy to a mean of 0.8 afterward (p < 0.0001).
No significant adverse events were seen.
\"We are very excited about oral viscous budesonide and hope that it will be one of the main therapeutic options for the treatment of eosinophilic esophagitis in the future,\" Dr. Dohil told Reuters Health. \"We have achieved a good therapeutic response with once-daily therapy, and the 'volume effect' of the liquid preparation results in good esophageal covering.\"
He said that this group of researchers will be undertaking larger clinical trials of oral viscous budesonide.
Am J Gastroenterol 2007;102:2271-2279. |
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发表于 2007-12-3 07:14:19