Elad, Sharon and Zeevi, Itai and Finke, Juergen and Koldehoff, Michael and Schwerdtfeger, Rainer and Wolff, Daniel and Mohrbacher, Ralf and Levitt, Michael and Greinwald, Roland and Shapira, Michael Y. (2012) Improvement in Oral Chronic Graft-versus-Host Disease with the Administration of Effervescent Tablets of Topical Budesonide-An Open, Randomized, Multicenter Study. BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 18 (1). pp. 134-140. ISSN 1083-8791,
Full text not available from this repository. (Request a copy)Abstract
Chronic graft-versus-host disease (cGVHD) frequently involves oral tissues. Although the mucosal changes may be painful and impair oral function, there is currently no topical therapy available for oral cGVHD that has been proven to work in an evidence-based manner. The aims of this study were to (1) assess the response of patients with oral cGVHD to various doses of a new topical budesonide formulation; (2) evaluate the efficacy and safety of the new topical budesonide formulation in these patients. An open, randomized, multicenter phase II pilot study with 4 treatment arms differing in application frequency and duration was performed. Response to treatment was scored by the clinician and patient using several scales. Oral cGVHD improved in all patients, with a median reduction of 70%. Pain reduction was similar in all study arms. The rate of objective improvement (defined as >= 50%) was not significantly different among the 4 study arms. The safety profile was satisfactory. Topical budesonide mouthwash (3 mg/10 mL) improved oral cGVHD in all patients when applied for 5 or 10 minutes, 2 or 3 times daily. The response was similar in all treatment arms. Safety analysis supported a dosing schedule of 3 mg of budesonide 3 times a day for 10 minutes. Biol Blood Marrow Transplant 18: 134-140 (2012) (C) 2012 American Society for Blood and Marrow Transplantation
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CONSENSUS DEVELOPMENT PROJECT; WORKING GROUP-REPORT; CLINICAL-TRIALS; CRITERIA; VALIDATION; THERAPY; CARE; Graft-versus-host disease; Oral; Chronic; Mucosa; Budesonide; Topical; Steroid |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 25 May 2020 08:33 |
| Last Modified: | 25 May 2020 08:33 |
| URI: | https://pred.uni-regensburg.de/id/eprint/19500 |
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