Baldi F, Morselli-Labate A M, Cappiello R, Ghersi S
Department of Gastroenterology, S. Orsola Hospital, Bologna, Italy.
Am J Gastroenterol. 2002 Jun;97(6):1357-64. doi: 10.1111/j.1572-0241.2002.05666.x.
For the long term maintenance treatment of reflux esophagitis several strategies have been proposed with the aim of reducing the daily dosage or the frequency of drug administration. However, the available clinical studies are scarce and are often not controlled or conducted on a reduced number of cases. We aimed to compare the efficacy of two doses of lansoprazole (15 mg once daily and 30 mg on alternate days) in maintaining endoscopic healing and symptom relief over a 6-month period.
One hundred thirty-seven patients with Savary-Miller grades I-III reflux esophagitis healed after an 8-wk treatment with lansoprazole (30 mg daily) were divided into two main groups for a 6-month maintenance therapy period: lansoprazole, 15 mg once daily (group 15qd) and lansoprazole, 30 mg on alternate days (group 30qod). These two main groups were further subdivided according to the time of drug administration; morning (15qdm and 30qodm) and evening (15qde and 30qode). Each patient underwent esophagogastroduodenoscopy before entry into the study, after 8 wk of acute therapy, and after 6 months of maintenance therapy; 24-h esophageal-gastric pH monitoring was performed at baseline and during the last week of maintenance therapy.
At the end of the maintenance period the recurrence of esophagitis was observed in 12.1% of group 15qd patients and in 19.0% of group 30qod patients, without significant differences between the two groups. The frequency of patients without reflux symptoms after the 6-month period was the same for both groups; however, a significant increase of heartburn was observed in group 30qod patients (from 12.1% to 28.6%, p = 0.007). The time of drug administration (morning and evening) had no influence on the outcome of treatment. Both regimens significantly reduced esophageal acid exposure time and increased the median 24-h gastric pH.
Both long term lansoprazole regimens are equally effective in preventing the recurrence of esophagitis, independent of the modality of drug administration. The daily administration seems to have a better effect on the prevention of symptom recurrence.
对于反流性食管炎的长期维持治疗,已提出多种策略,旨在减少每日药物剂量或给药频率。然而,现有的临床研究较少,且往往缺乏对照或病例数较少。我们旨在比较两种剂量的兰索拉唑(每日一次15毫克和隔日一次30毫克)在6个月期间维持内镜下愈合和缓解症状的疗效。
137例经兰索拉唑(每日30毫克)8周治疗后Savary-Miller I - III级反流性食管炎愈合的患者被分为两个主要组进行为期6个月的维持治疗:每日一次15毫克兰索拉唑(15qd组)和隔日一次30毫克兰索拉唑(30qod组)。这两个主要组再根据给药时间进一步细分;早晨(15qdm和30qodm)和晚上(15qde和30qode)。每位患者在进入研究前、急性治疗8周后以及维持治疗6个月后均接受食管胃十二指肠镜检查;在基线和维持治疗的最后一周进行24小时食管-胃pH监测。
在维持期末,15qd组12.1%的患者和30qod组19.0%的患者出现食管炎复发,两组之间无显著差异。6个月后两组无反流症状患者的频率相同;然而,30qod组患者烧心频率显著增加(从12.1%增至28.6%,p = 0.007)。给药时间(早晨和晚上)对治疗结果无影响。两种方案均显著降低了食管酸暴露时间并提高了24小时胃pH中位数。
两种长期兰索拉唑方案在预防食管炎复发方面同样有效,与给药方式无关。每日给药似乎对预防症状复发效果更好。