AUSTRALIAN CLINICAL-TRIALS OF OMEPRAZOLE IN THE MANAGEMENT OF REFLUX ESOPHAGITIS

被引:35
作者
DENT, J
机构
关键词
AUSTRALIA; PEPTIC ESOPHAGITIS; RANITIDINE; OMEPRAZOLE; MAINTENANCE THERAPY;
D O I
10.1159/000200521
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Two multicentre clinical trials of omeprazole in peptic oesophagitis were recently completed in Australia. In the first trial, omeprazole, 20 or 40 mg daily (n = 31), was compared with placebo (n = 32) in 63 patients. After 4 weeks, 81% of the omeprazole-treated patients were healed, as determined endoscopically, compared with 6% of the placebo-treated patients (p < 0.0001). When the two doses of omeprazole were compared, there was a significant therapeutic advantage for the 40 mg dose at 4 weeks but by 8 weeks there was no significant difference between the two doses. This study included a 6-month surveillance phase in 107 endoscopically healed patients after cessation of omeprazole therapy. By 6 months, erosive or ulcerative oesophagitis had recurred in 82% of these patients. In the second trial, 165 patients with erosive or ulcerative oesophagitis were first healed with omeprazole, 20 mg daily. Of these patients, 159 were then enrolled in a maintenance therapy trial and randomized to three groups: ranitidine, 150 mg b.i.d., omeprazole, 20 mg daily, or omeprazole weekend therapy (i.e. omeprazole, 20 mg daily, on Friday, Saturday and Sunday only). Patients were followed for a maximum period of 12 months or until relapse. Neither ranitidine nor weekend therapy with omeprazole was effective in maintaining patients remission. However, omeprazole, prazole, 20 mg daily, was a highly effective maintenance therapy with 89% of patients in remission after 12 months compared with only 25 and 32% for ranitidine and weekend omeprazole, respectively. All three regimens were well tolerated.
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页码:69 / 71
页数:3
相关论文
共 2 条
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    HETZEL, DJ
    DENT, J
    REED, WD
    NARIELVALA, FM
    MACKINNON, M
    MCCARTHY, JH
    MITCHELL, B
    BEVERIDGE, BR
    LAURENCE, BH
    GIBSON, GG
    GRANT, AK
    SHEARMAN, DJC
    WHITEHEAD, R
    BUCKLE, PJ
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