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泮托拉唑与雷尼替丁治疗反流性食管炎的对照试验。一项德国多中心研究的结果。

Comparative trial of pantoprazole and ranitidine in the treatment of reflux esophagitis. Results of a German multicenter study.

作者信息

Koop H, Schepp W, Dammann H G, Schneider A, Lühmann R, Classen M

机构信息

4th Department of Medicine (Gastroenterology), Municipal Hospital Berlin-Buch, Germany.

出版信息

J Clin Gastroenterol. 1995 Apr;20(3):192-5. doi: 10.1097/00004836-199504000-00005.

Abstract

In 249 patients with acute symptomatic reflux esophagitis grade II and III (Savary-Miller classification), we compared the efficacy and safety of pantoprazole, a newly developed proton pump inhibitor given at a once-daily dose of 40 mg, with a standard dose of the H2 receptor antagonist ranitidine (150 mg b.i.d.) in a randomized, double-blind, multicenter study. Complete healing was achieved after 4 and 8 weeks of therapy (protocol-correct) in 69 and 82% (pantoprazole) and 57 and 67% (ranitidine), respectively (p = 0.054 at 4 weeks and p < 0.01 at 8 weeks). The predominant symptoms of gastroesophageal reflux, i.e., heartburn and acid eructation, were more effectively reduced in pantoprazole- than in ranitidine-treated patients. The frequency of adverse events was low and did not differ between the two treatment groups. We conclude that pantoprazole is superior to ranitidine in the acute treatment of reflux esophagitis.

摘要

在一项随机、双盲、多中心研究中,我们对249例急性症状性II级和III级反流性食管炎(Savary-Miller分类)患者进行了比较,将每日一次服用40mg的新型质子泵抑制剂泮托拉唑与标准剂量的H2受体拮抗剂雷尼替丁(150mg,每日两次)的疗效和安全性进行对比。治疗4周和8周后(符合方案),泮托拉唑组分别有69%和82%实现完全愈合,雷尼替丁组分别为57%和67%(4周时p = 0.054,8周时p < 0.01)。与雷尼替丁治疗的患者相比,泮托拉唑治疗的患者中胃食管反流的主要症状,即烧心和反酸,得到了更有效的缓解。不良事件的发生率较低,且两组治疗组之间无差异。我们得出结论,在反流性食管炎的急性治疗中,泮托拉唑优于雷尼替丁。

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