European journal of gastroenterology & hepatology · 1995
Combination of ranitidine and cisapride in the treatment of reflux oesophagitis.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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McKenna C J, Mills J G, Goodwin C, Wood J R
Аннотация
OBJECTIVE: To compare the efficacy of treatment for 8 or 12 weeks with a combination of 150 mg ranitidine twice daily plus 20 mg cisapride twice daily with ranitidine 150 mg twice daily alone in patients with moderate-to-severe reflux oesophagitis.
DESIGN: A double-blind, randomized, parallel-group clinical trial.
SETTING: Forty-two out-patient centres in the UK, Germany, Ireland, Denmark and South Africa.
PATIENTS: A total of 344 symptomatic patients with endoscopically confirmed reflux oesophagitis (Hetzel grade 3 or 4) were randomly assigned to receive the study medication.
INTERVENTIONS: Patients underwent a follow-up endoscopy after 8 weeks' treatment. Healing was defined as Hetzel grade 0 or 1 upon endoscopy. Patients with unhealed oesophagitis continued their allocated treatment regimen for a further 4 weeks before undergoing a repeat endoscopy.
MAIN OUTCOME MEASURES: The primary efficacy analysis was based on a comparison of 12-week cumulative healing rates between the two groups.
RESULTS: A statistically significant difference (P = 0.015) in the cumulative healing rate was observed between patients given ranitidine plus cisapride (82%) and those given ranitidine alone (71%). Oesophagitis in patients who received the combination was twice as likely to heal as that in patients who received ranitidine alone.
CONCLUSION: A combination of 150 mg ranitidine twice daily and 20 mg cisapride twice daily is a safe and effective treatment for moderate-to-severe reflux oesophagitis and offers increased efficacy over ranitidine alone.
DESIGN: A double-blind, randomized, parallel-group clinical trial.
SETTING: Forty-two out-patient centres in the UK, Germany, Ireland, Denmark and South Africa.
PATIENTS: A total of 344 symptomatic patients with endoscopically confirmed reflux oesophagitis (Hetzel grade 3 or 4) were randomly assigned to receive the study medication.
INTERVENTIONS: Patients underwent a follow-up endoscopy after 8 weeks' treatment. Healing was defined as Hetzel grade 0 or 1 upon endoscopy. Patients with unhealed oesophagitis continued their allocated treatment regimen for a further 4 weeks before undergoing a repeat endoscopy.
MAIN OUTCOME MEASURES: The primary efficacy analysis was based on a comparison of 12-week cumulative healing rates between the two groups.
RESULTS: A statistically significant difference (P = 0.015) in the cumulative healing rate was observed between patients given ranitidine plus cisapride (82%) and those given ranitidine alone (71%). Oesophagitis in patients who received the combination was twice as likely to heal as that in patients who received ranitidine alone.
CONCLUSION: A combination of 150 mg ranitidine twice daily and 20 mg cisapride twice daily is a safe and effective treatment for moderate-to-severe reflux oesophagitis and offers increased efficacy over ranitidine alone.