Long-Term Treatment with Omeprazole for Refractory Reflux Esophagitis: Efficacy and Safety

作者：Elly C. Klinkenberg–Knol, Henk P. M. Festen, Jan B. M. J. Jansen, Cornelis B. H. W. Lamers, Frits Nelis, Pleun Snel, Anton Luckers, Cornelius P. M. Dekkers, Niilo Havu, Stephan G. M. Meuwissen · 发表于：Annals of Internal Medicine · 年份：1994 · DOI：10.7326/0003-4819-121-3-199408010-00001 · 被引用次数：429 · 研究领域：Gastroesophageal reflux and treatments、Potassium and Related Disorders、Gastrointestinal motility and disorders

OBJECTIVE: To evaluate the long-term efficacy and safety of omeprazole in patients with gastroesophageal reflux disease resistant to treatment with histamine-2 (H2)-receptor antagonists. DESIGN: Cohort analytic study with a mean follow-up of 48 months (range, 36 to 64 months). SETTING: Patients receiving ambulatory care from referral centers. PATIENTS: 91 patients with gastroesophageal reflux disease resistant to treatment with an H2-receptor antagonist but subsequently responsive to 40 mg of omeprazole daily. INTERVENTION: Open maintenance therapy consisting of 20 mg of omeprazole daily in 86 patients and 40 mg daily in 5 patients. OUTCOME MEASURES: Endoscopy to assess healing; side effects, laboratory values, fasting serum gastrin level, and gastric corpus biopsies to assess safety. RESULTS: Esophagitis recurred in 47% of the patients receiving 20 mg of omeprazole daily, but all rehealed after the dose was doubled. Seven of 40 patients (18%) had a second relapse after a mean follow-up time of 24 months (range, 9 to 36 months) that was successfully treated with a further 20-mg dose increment for a mean period of 36 months (range, 6 to 39 months). Median gastrin levels increased initially from 60 ng/L before study entry to 162 ng/L (P < 0.01) with treatment and reached a plateau during maintenance treatment. Very high gastrin levels (> 500 ng/L) were observed in a subgroup (11%) of patients. The incidence of micronodular hyperplasia increased from 2.5% of the patients at firs...