Bardhan K D, Cherian P, Vaishnavi A, Jones R B, Thompson M, Morris P, Brooks A, D'Silva J, Gillon K R, Wason C, Patterson J, Polak J, Bishop A
Rotherham General Hospitals NHS Trust, Rotherham, UK.
Gut. 1998 Oct;43(4):458-64. doi: 10.1136/gut.43.4.458.
To investigate the efficacy of daily maintenance treatment with omeprazole 10 mg in reducing the relapse rate of healed erosive oesophagitis.
Three hundred patients with erosive oesophagitis (grade 2 or greater) received omeprazole 20 mg daily for 12 weeks, followed by 40 mg daily for a further 12 weeks if required. After healing, patients were randomised to double blind treatment with omeprazole 10 mg daily or placebo for up to 18 months. On relapse the treatment cycle was repeated.
The cumulative healing rate at 12 weeks in the initial healing period was 95%, and 96% and 98% on rehealing courses after relapse in the first and second maintenance periods respectively. After 12 weeks of treatment, 98% of patients were free from heartburn and 97% were free of all reflux related symptoms. Relapse in the subgroup of patients who relapsed in both maintenance periods was infrequent on omeprazole 20 mg daily: only 9% at two years. Gastrin concentrations rose above normal in one third of patients. One patient had linear hyperplasia of endocrine cells and another had micronodular hyperplasia. There were no side effects definitely attributable to omeprazole.
Maintenance treatment with omeprazole 10 mg daily keeps about 60% of patients with erosive oesophagitis in prolonged remission. Patients relapsing once are likely to do so again; they can subsequently be treated effectively with omeprazole 20 mg daily.
研究每日服用10毫克奥美拉唑进行维持治疗对降低愈合的糜烂性食管炎复发率的疗效。
300例糜烂性食管炎（2级或更严重）患者每日服用20毫克奥美拉唑，持续12周，必要时接下来的12周每日服用40毫克。愈合后，患者被随机分配接受双盲治疗，每日服用10毫克奥美拉唑或安慰剂，最长持续18个月。复发时重复治疗周期。
初始愈合期12周时的累积愈合率为95%，在第一个和第二个维持期复发后的再次愈合疗程中，愈合率分别为96%和98%。治疗12周后，98%的患者无烧心症状，97%的患者无所有反流相关症状。在两个维持期均复发的患者亚组中，每日服用20毫克奥美拉唑时复发很少见：两年时仅为9%。三分之一的患者胃泌素浓度升高超过正常水平。1例患者出现内分泌细胞线性增生，另1例患者出现微结节性增生。没有明确归因于奥美拉唑的副作用。
每日服用10毫克奥美拉唑进行维持治疗可使约60%的糜烂性食管炎患者长期缓解。复发过一次的患者可能会再次复发；随后他们可以每日服用20毫克奥美拉唑进行有效治疗。
