Methotrexate for recurrent chronic rhinosinusitis with nasal polyps: A randomized, controlled, phase 2 clinical trial.
chronic rhinosinusitis
clinical trial methotrexate
methylprednisolone
mometasone furoate
nasal polyps
phase 2
Journal
International forum of allergy & rhinology
ISSN: 2042-6984
Titre abrégé: Int Forum Allergy Rhinol
Pays: United States
ID NLM: 101550261
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
revised:
06
12
2022
received:
08
08
2022
accepted:
22
12
2022
medline:
24
8
2023
pubmed:
29
12
2022
entrez:
28
12
2022
Statut:
ppublish
Résumé
This randomized, controlled, open-label, phase 2 clinical trial aimed to assess the efficacy and safety of low-dose methotrexate as maintenance therapy for recurrent postoperative chronic rhinosinusitis with nasal polyps (CRSwNPs). Forty-one patients with CRSwNPs who experienced postoperative polyp recurrence(s) were randomly divided into three groups to receive one of the following treatments for 8 weeks: daily intranasal mometasone furoate monohydrate 200 mcg (control [intranasal corticosteroids (INCS)] arm, n = 13]); daily per oral methylprednisolone 8 mg (oral corticosteroids [OCS] arm, n = 14); and once weekly per oral 10 mg methotrexate (MTX arm, n = 14). All patients were assessed at three clinical visits according to the Lund-Kennedy endoscopic grading system (LKES), visual analog scale (VAS), Turkish version of the Sinonasal Outcome Test-22 (SNOT-22), peak nasal inspiratory flow (PNIF), butanol olfactory threshold test (BuOT), serum total IgE level, presence of peripheral eosinophilia, serum biochemical assays, and adverse events. All efficacy outcome measures significantly improved in all three groups, except for the nonrecovery of peripheral eosinophilia in the INCS group. There was no significant difference among the groups in terms of LKES scores. Scores for the Turkish version of the SNOT-22, PNIF, BuOT, and serum IgE levels were also similar among the groups. However, total VAS scores recovered significantly better in the INCS group than in the MTX group. Serum biochemical assays remained normal in all groups. Adverse events were minor and observed only in the OCS group. Low-dose MTX was a safe and effective maintenance therapy for patients with recurrent postoperative CRSwNPs.
Substances chimiques
Methotrexate
YL5FZ2Y5U1
Adrenal Cortex Hormones
0
Immunoglobulin E
37341-29-0
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1592-1602Informations de copyright
© 2022 ARS-AAOA, LLC.
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