OMEPRAZOLE IN THE LONG-TERM TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE - A DOUBLE-BLIND RANDOMIZED DOSE-FINDING STUDY

被引:57
作者
LAURSEN, LS
HAVELUND, T
BONDESEN, S
HANSEN, J
SANCHEZ, G
SEBELIN, E
FENGER, C
LAURITSEN, K
机构
[1] ODENSE UNIV HOSP,DEPT MED GASTROENTEROL,DK-5000 ODENSE,DENMARK
[2] ODENSE UNIV HOSP,DEPT PATHOL,DK-5000 ODENSE,DENMARK
关键词
DRUG THERAPY; OMEPRAZOLE; RANDOMIZED CONTROLLED TRIAL; RECURRENCE; REFLUX ESOPHAGITIS;
D O I
10.3109/00365529509101589
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background: Omeprazole is effective in the treatment of reflux oesophagitis, and it is important to determine the lower dose limit with still appropriate clinical efficacy. Methods: Patients with endoscopic oesophagitis grade 1-4 (N = 220) were randomized to double-blind treatment with 20 mg or 40 mg omeprazole daily for 4-8 weeks. Those healed after this initial treatment phase were re-randomized to double-blind treatment with 20 mg omeprazole daily (n = 67), 10 mg omeprazole daily (n = 68), or placebo (n = 33) for 6 months. Remission was defined as the absence of any endoscopic sign of oesophagitis. Results: Healing rates were increased with 40 mg omeprazole, the therapeutic gain compared with the 20-mg dose being 15% after 4 and 8 weeks. The proportion of patients in remission after 6 months was 59% with 20 mg omeprazole, 35% with 10 mg omeprazole, and 0% with placebo. Conclusion: Maintenance treatment with 10 mg omeprazole can prevent recurrence of oesophagitis in about one-third of patients with all grades of oesophagitis, and 20 mg omeprazole in about twice as many.
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页码:839 / 846
页数:8
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