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西沙必利和雷尼替丁单一疗法及联合疗法治疗单纯性胃溃疡的效果。

The effect of cisapride and ranitidine as monotherapies and in combination in the treatment of uncomplicated gastric ulceration.

作者信息

Stubberöd A, Glise H, Hallerbäck B, Solhaug J H

机构信息

Dept. of Surgery, Värnamo Hospital, Norway.

出版信息

Scand J Gastroenterol. 1995 Feb;30(2):106-10. doi: 10.3109/00365529509093246.

DOI:10.3109/00365529509093246
PMID:7732330
Abstract

BACKGROUND

Stimulation of gastric motility has been supposed to accelerate the healing of gastric ulcer. The combination of the prokinetic drug cisapride and the H2 blocker ranitidine was tested in the treatment of uncomplicated gastric ulcer.

METHODS

Cisapride, 20 mg twice daily (Cis), and ranitidine, 150 mg twice daily (Ran), were given as monotherapies and in the combination 20 mg cisapride and 150 mg ranitidine daily (Cis + Ran) for a maximum of 8 weeks. The study was multicentre, randomized, and double-blind.

RESULTS

A total of 197 patients were included. Healing rates in the per-protocol analysis after 4 and 8 weeks' treatment were 61%/84%, 52%/69%, and 61%/92% for the Cis + Ran (n = 56), Cis (n = 58), and Ran (n = 59) treatment groups. No statistically significant difference in healing rates was seen when comparing Cis + Ran with the monotherapies. Symptom relief at the end of treatment was significantly better in the Ran group than in the Cis + Ran group with regard to epigastric pain (p = 0.01) and vomiting (p = 0.05). Patients' global evaluation of treatment was in favour of Ran in comparison with Cis + Ran treatment (p = 0.04).

CONCLUSIONS

Combination of cisapride and ranitidine in the treatment of gastric ulcer did not enhance the healing rate or improve symptom relief in patients treated for uncomplicated gastric ulcer when compared with the monotherapies.

摘要

背景

胃动力刺激被认为可加速胃溃疡的愈合。本研究对促动力药物西沙必利与H2受体阻滞剂雷尼替丁联合治疗单纯性胃溃疡进行了测试。

方法

西沙必利,每日两次,每次20毫克(Cis),雷尼替丁,每日两次,每次150毫克(Ran),分别作为单一疗法给药,以及联合给药,即每日20毫克西沙必利与150毫克雷尼替丁(Cis + Ran),最长治疗8周。该研究为多中心、随机、双盲试验。

结果

共纳入197例患者。在符合方案分析中,治疗4周和8周后,Cis + Ran组(n = 56)、Cis组(n = 58)和Ran组(n = 59)的愈合率分别为61%/84%、52%/69%和61%/92%。将Cis + Ran与单一疗法比较时,愈合率无统计学显著差异。在治疗结束时,就上腹部疼痛(p = 0.01)和呕吐(p = 0.05)而言,Ran组的症状缓解明显优于Cis + Ran组。与Cis + Ran治疗相比,患者对治疗的总体评价更倾向于Ran(p = 0.04)。

结论

与单一疗法相比,西沙必利和雷尼替丁联合治疗胃溃疡并未提高单纯性胃溃疡患者的愈合率或改善症状缓解情况。

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