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[法莫替丁对症治疗非糜烂性胃食管反流病。一项开放性多中心研究的结果]

[Symptomatic therapy with famotidine in non-erosive gastro-esophageal reflux. Results of an open multicenter study].

作者信息

Heckers H, Lübbecke F

机构信息

Zentrum für Innere Medizin, Justus-Liebig-Universität Giessen.

出版信息

Arzneimittelforschung. 1995 Apr;45(4):499-504.

PMID:7779150
Abstract

180 patients suffering from frequent heartburn and endoscopically normal oesophageal mucosa or mild non-erosive oesophagitis entered an open, multicentre study to evaluate the 6-week safety profile and efficacy on symptom relief of famotidine (CAS 76824-35-6, Pepdul mite), a potent and long-acting H2-receptor antagonist. By week 6 the cumulative percentage of patients with defined response, that is complete relief of heartburn in 5 days and only mild discomfort in the remaining 2 days of a week, reached 68.9%, whereas the cumulative percentage of patients with complete relief of heartburn within a week reached 52.7%. Throughout the evaluation period famotidine relieved nighttime heartburn better than daytime heartburn. More than 75% of the responders remained without recurrence. Even the non-responders experienced a 60-70% reduction of heartburn severity assessed using scores. Antacid consumption was reduced from 18 tablets (median) in week 0 to 5 tablets in week 6. 90% of the patients reported at week 6 excellent (67.2%) or moderate (22.8%) symptomatic improvement. No serious adverse events attributable to famotidine occurred. It is concluded that in patients with non-erosive gastro-oesophageal reflux disease famotidine therapy, 20 mg twice daily, is highly effective in reducing reflux disease symptoms.

摘要

180名经常出现烧心症状且食管黏膜内镜检查正常或患有轻度非糜烂性食管炎的患者参与了一项开放性多中心研究,以评估强效长效H2受体拮抗剂法莫替丁(CAS 76824 - 35 - 6,Pepdul mite)的6周安全性以及缓解症状的疗效。到第6周时,有明确反应的患者累积百分比,即一周内5天烧心完全缓解且其余2天仅有轻度不适,达到了68.9%,而一周内心烧心完全缓解的患者累积百分比达到了52.7%。在整个评估期间,法莫替丁缓解夜间烧心症状的效果优于白天烧心症状。超过75%的有反应者未复发。即使是无反应者,使用评分评估的烧心严重程度也降低了60 - 70%。抗酸剂的消耗量从第0周的18片(中位数)降至第6周的5片。90%的患者在第6周报告有极佳(67.2%)或中度(22.8%)的症状改善。未发生归因于法莫替丁的严重不良事件。得出的结论是,对于非糜烂性胃食管反流病患者,每日两次服用20毫克法莫替丁治疗在减轻反流病症状方面非常有效。

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