The American journal of gastroenterology · 1994
Risk factors for delayed healing of duodenal ulcers treated with famotidine and ranitidine.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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.
Reynolds J C, Schoen R E, Maislin G, Zangari G G
Аннотация
OBJECTIVES: 1) To validate risk factors for delayed healing of duodenal ulcers identified previously in a pilot study, and 2) To evaluate whether famotidine improves the rate of duodenal ulcer healing and pain relief, compared with ranitidine.
DESIGN: prospective, multicenter, double-observer-blinded, randomized trial.
SETTING: 594 patients with active duodenal ulcers seen in private practice offices, university based medical practices and Veterans Affairs hospital clinics.
INTERVENTIONS: Patients were randomly assigned to receive famotidine 40 mg or ranitidine 300 mg qhs.
MEASUREMENTS: Endoscopy was performed at entry and at 2, 4, and 8 wk after therapy or until complete ulcer healing. Seventeen patient variables, including demographic, past historical, presenting historical and endoscopic characteristics, were assessed for their relationship to healing.
RESULTS: After 4 wk of treatment, by a "per protocol" analysis, three risk factors for nonhealing were statistically significant: prior ulcer history [63.0% healed, compared to 77.9% with no history, p = 0.001, odds ratio for not healing (OR) = 2.1, 95% CI = 1.4-3.1]; ulcer size (61.6% of ulcers > or = 10 mm healed at 4 wk compared to 75.5% of smaller ulcers, p = 0.001, OR = 1.9, 95% CI = 1.3-2.8); and smoking (62% of smokers healed vs. 77.7% of nonsmokers, OR = 2.1, 95% CI = 1.4-3.1). The presence of multiple risk factors resulted in additive risk: for patients with no risk factors, 86.8% healed at 4 wk, with any one risk factor 76.8% healed, with two factors 63.0%, and with all three risk factors only 46.9% healed. Multiple risk factors also affected healing rates at 8 wk. Bleeding, alcohol use, and prior NSAID use did not influence ulcer healing. Although famotidine resulted in statistically significant faster ulcer healing when examined on an "intention-to-treat" basis, there were no differences between the drugs when examined on a "per protocol" basis. Patients treated with famotidine achieved more rapid pain relief than those treated with ranitidine.
CONCLUSIONS: 1) Smoking, prior ulcer history, and ulcer size > or = 10 mm exert independent risks for nonhealing of duodenal ulcers; 2) These risks are similar for both famotidine and ranitidine; 3) Patients with multiple risk factors for nonhealing may require more prolonged acid suppression therapy than patients who have no risks.
DESIGN: prospective, multicenter, double-observer-blinded, randomized trial.
SETTING: 594 patients with active duodenal ulcers seen in private practice offices, university based medical practices and Veterans Affairs hospital clinics.
INTERVENTIONS: Patients were randomly assigned to receive famotidine 40 mg or ranitidine 300 mg qhs.
MEASUREMENTS: Endoscopy was performed at entry and at 2, 4, and 8 wk after therapy or until complete ulcer healing. Seventeen patient variables, including demographic, past historical, presenting historical and endoscopic characteristics, were assessed for their relationship to healing.
RESULTS: After 4 wk of treatment, by a "per protocol" analysis, three risk factors for nonhealing were statistically significant: prior ulcer history [63.0% healed, compared to 77.9% with no history, p = 0.001, odds ratio for not healing (OR) = 2.1, 95% CI = 1.4-3.1]; ulcer size (61.6% of ulcers > or = 10 mm healed at 4 wk compared to 75.5% of smaller ulcers, p = 0.001, OR = 1.9, 95% CI = 1.3-2.8); and smoking (62% of smokers healed vs. 77.7% of nonsmokers, OR = 2.1, 95% CI = 1.4-3.1). The presence of multiple risk factors resulted in additive risk: for patients with no risk factors, 86.8% healed at 4 wk, with any one risk factor 76.8% healed, with two factors 63.0%, and with all three risk factors only 46.9% healed. Multiple risk factors also affected healing rates at 8 wk. Bleeding, alcohol use, and prior NSAID use did not influence ulcer healing. Although famotidine resulted in statistically significant faster ulcer healing when examined on an "intention-to-treat" basis, there were no differences between the drugs when examined on a "per protocol" basis. Patients treated with famotidine achieved more rapid pain relief than those treated with ranitidine.
CONCLUSIONS: 1) Smoking, prior ulcer history, and ulcer size > or = 10 mm exert independent risks for nonhealing of duodenal ulcers; 2) These risks are similar for both famotidine and ranitidine; 3) Patients with multiple risk factors for nonhealing may require more prolonged acid suppression therapy than patients who have no risks.