Alimentary pharmacology & therapeutics · 1997
Bismuth carbomer foam enemas for active chronic pouchitis: a randomized, double-blind, placebo-controlled trial.
Клиническое исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Tremaine W J, Sandborn W J, Wolff B G, Carpenter H A, Zinsmeister A R, Metzger P P
Аннотация
BACKGROUND: Bismuth carbomer liquid enemas are equivalent to mesalamine enemas for active distal ulcerative colitis.
AIMS: In this study, the efficacy and safety of bismuth carbomer foam enemas for active chronic pouchitis was determined in a placebo-controlled trial.
PATIENTS: Forty adult patients with active chronic pouchitis were randomly assigned into either concurrent therapy for pouchitis or no concurrent therapy. Topical corticosteroids and mesalamine were withdrawn prior to the study.
METHODS: Patients received either bismuth carbomer (270 mg elemental bismuth) (n = 20) or placebo (n = 20) foam enemas for 3 weeks. Clinical assessment was performed at baseline and at 3 weeks using the pouchitis disease activity index score which incorporates symptoms, endoscopy and histology. Serum bismuth concentrations were determined by atomic absorption spectrophotometry.
RESULTS: At 3 weeks nine of 20 patients (45%) in both the bismuth and placebo groups had improved. Ten patients discontinued prematurely because of worse diarrhoea (three in each group) or abdominal cramping after enema use (one from the bismuth group and three from the placebo group). No other side-effects were noted. Serum bismuth concentrations were negligible in all patients.
CONCLUSIONS: Bismuth carbomer foam enemas (270 mg bismuth) nightly for 3 weeks are safe but not efficacious for active chronic pouchitis.
AIMS: In this study, the efficacy and safety of bismuth carbomer foam enemas for active chronic pouchitis was determined in a placebo-controlled trial.
PATIENTS: Forty adult patients with active chronic pouchitis were randomly assigned into either concurrent therapy for pouchitis or no concurrent therapy. Topical corticosteroids and mesalamine were withdrawn prior to the study.
METHODS: Patients received either bismuth carbomer (270 mg elemental bismuth) (n = 20) or placebo (n = 20) foam enemas for 3 weeks. Clinical assessment was performed at baseline and at 3 weeks using the pouchitis disease activity index score which incorporates symptoms, endoscopy and histology. Serum bismuth concentrations were determined by atomic absorption spectrophotometry.
RESULTS: At 3 weeks nine of 20 patients (45%) in both the bismuth and placebo groups had improved. Ten patients discontinued prematurely because of worse diarrhoea (three in each group) or abdominal cramping after enema use (one from the bismuth group and three from the placebo group). No other side-effects were noted. Serum bismuth concentrations were negligible in all patients.
CONCLUSIONS: Bismuth carbomer foam enemas (270 mg bismuth) nightly for 3 weeks are safe but not efficacious for active chronic pouchitis.