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西沙必利两种不同剂量方案治疗反流性食管炎:与雷尼替丁的双盲对照研究

Two different dose regimens of cisapride in the treatment of reflux oesophagitis: a double-blind comparison with ranitidine.

作者信息

Geldof H, Hazelhoff B, Otten M H

机构信息

Department of Internal Medicine, Ijsselland Hospital, Rotterdam, The Netherlands.

出版信息

Aliment Pharmacol Ther. 1993 Aug;7(4):409-15. doi: 10.1111/j.1365-2036.1993.tb00114.x.

Abstract

We conducted a double-blind study comparing two dosage regimens of a prokinetic drug, cisapride (10 mg q.d.s. and 20 mg b.d.), with a low dose of a H2-receptor antagonist (150 mg ranitidine b.d.) in the treatment of 155 patients with reflux oesophagitis as determined by endoscopy. The active treatment took 8 to 12 weeks depending on whether complete healing was found at endoscopy. Improvement in oesophagitis grades from baseline to endpoint was observed in 68% of patients in the 10 mg cisapride q.d.s. group, 83% in the cisapride 20 mg b.d. group and 81% in the ranitidine group (N.S.). At endpoint, the percentages of endoscopically cured patients with initial grades I or II were 52% for 10 mg cisapride q.d.s., 71% for 20 mg cisapride b.d. and 80% for ranitidine (N.S.). The proportional improvement of the overall reflux symptom score (60%) also showed no significant difference between the three groups. In the treatment of mild reflux oesophagitis (grades I and II) similar results can be expected from 20 mg cisapride b.d. and 150 mg ranitidine b.d. As the results of the two dosage regimens of cisapride were not different, the 20 mg twice daily regimen is preferred because it will improve patient compliance. It is concluded that in reflux oesophagitis grades I and II, the efficacy of 20 mg cisapride b.d. and 150 mg ranitidine b.d. are broadly similar.

摘要

我们进行了一项双盲研究,比较了促动力药物西沙必利的两种给药方案(10毫克每日四次和20毫克每日两次)与低剂量H2受体拮抗剂(150毫克雷尼替丁每日两次)对155例经内镜检查确诊为反流性食管炎患者的治疗效果。根据内镜检查是否发现完全愈合情况,积极治疗持续8至12周。10毫克西沙必利每日四次组68%的患者、西沙必利20毫克每日两次组83%的患者以及雷尼替丁组81%的患者(无统计学差异),食管炎分级从基线到终点均有改善。终点时,初始分级为I或II级的内镜治愈患者百分比,10毫克西沙必利每日四次组为52%,20毫克西沙必利每日两次组为71%,雷尼替丁组为80%(无统计学差异)。三组总体反流症状评分的比例改善(60%)也无显著差异。在治疗轻度反流性食管炎(I级和II级)时,预计20毫克西沙必利每日两次和150毫克雷尼替丁每日两次会有相似结果。由于西沙必利两种给药方案的结果无差异,所以每日两次20毫克的方案更可取,因为它会提高患者的依从性。结论是,在I级和II级反流性食管炎中,20毫克西沙必利每日两次和150毫克雷尼替丁每日两次的疗效大致相似。

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