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M. Iborra B. Beltrn A. Fernndez‐Clotet A. Gutirrez B. Antolín J.M. Huguet R. De Francisco O. Merino D. Carpio S. García‐Lpez F. Mesonero P. Navarro R. Ferreiro‐Iglesias A.Y. Carbajo M. Rivero J.P. Gisbert M.C. Piero‐Prez D. Monfort L. Bujanda M.F. García‐Sepulcre A. Martín‐Cardona F. Caete C. Taxonera E. Domnech P. Nos 《Alimentary pharmacology & therapeutics》2019,50(3):278-288
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Marisa Iborra Belén Beltrán Agnes Fernández-Clotet Eva Iglesias-Flores Pablo Navarro Montserrat Rivero Ana Gutiérrez Mónica Sierra-Ausin Francisco Mesonero Rocío Ferreiro-Iglesias Joaquín Hinojosa Xavier Calvet Beatriz Sicilia Carlos González-Muñoza Beatriz Antolín María González-Vivo Ana Y. Carbajo Santiago García-López Albert Martín-Cardona Gerard Surís María Dolores Martin-Arranz Ruth de Francisco Fiorella Cañete Eugeni Domènech Pilar Nos GETECCU group 《Alimentary pharmacology & therapeutics》2020,52(6):1017-1030
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P. STÅL R. BEFRITS A. RÖNNBLOM Å. DANIELSSON O. SUHR D. STÅHLBERG A. BRINKBERG LAPIDUS R. LÖFBERG 《Alimentary pharmacology & therapeutics》2010,31(3):387-395
Aliment Pharmacol Ther 31 , 387–395
Summary
Background The cholera toxin B subunit ameliorates experimentally induced colitis in mice. In humans, cholera toxin B subunit has never been tested in the treatment of Crohn’s disease (CD). Aim To evaluate the safety and efficacy of treatment with recombinant cholera toxin B subunit of patients with CD. Methods An open‐label, multicentre, nonrandomized trial including 15 patients with mild/moderate CD. Patients received an oral solution of 5 mg recombinant cholera toxin B subunit three times weekly for 2 weeks. Reduction in CD Activity Index (CDAI) with >100 between baseline and days 15, 29, 42 and 70 defined clinical response. Patients with CDAI score ≤150 were defined as being in remission. Results A significant decrease in CDAI score was observed. Response rates were 40% in the full analysis set and 42% in the per protocol analysis. Two patients receiving adjuvant treatment after day 29 were excluded, after which 40% were in remission at 4 weeks and 30% at 8 weeks post‐treatment. Mild side effects (arthralgia, headache and pruritus) were seen in 33% of patients. Conclusions Treatment with recombinant cholera toxin B subunit was safe. Approximately 40% of patients with active CD responded to treatment. Randomized studies are needed to establish the clinical efficacy of recombinant cholera toxin B subunit. 相似文献19.