依卡倍特钠与西咪替丁联合治疗与单用西咪替丁治疗胃溃疡的比较：前瞻性随机多中心研究。

Combination therapy of ecabet sodium and cimetidine compared with cimetidine alone for gastric ulcer: prospective randomized multicenter study.

作者信息

Murata Hiroaki, Kawano Sunao, Tsuji Shingo, Kamada Takenobu, Matsuzawa Yuuji, Katsu Kenichi, Inoue Kyouichi, Kobayashi Kenichi, Mitsufuji Syouji, Bamba Tadao, Kawasaki Hironaka, Kajiyama Gorou, Umegaki Eiji, Inoue Msasnori, Saito Ichimonji

机构信息

Department of Internal Medicine and Therapeutics, Osaka University Graduate School of Medicine, 1-7 Yamada-Oka, Suita-City, Osaka 565-0871, Japan.

出版信息

J Gastroenterol Hepatol. 2003 Sep;18(9):1029-33. doi: 10.1046/j.1440-1746.2003.03093.x.

DOI:10.1046/j.1440-1746.2003.03093.x

PMID:12911658

Abstract

BACKGROUND AND AIM

Little is known about the clinical efficacy of co-therapy of ecabet sodium, a mucoprotective agent, and a histamine H2-receptor antagonist. The aim of the present study was to assess its additive benefit in combination with cimetidine for gastric ulcer.

METHODS

In this prospective randomized study, after gastric ulcer was confirmed by endoscopy, 200 patients in 47 hospitals received either ecabet sodium 1 g b.i.d and cimetidine 400 mg b.i.d. (EC), or cimetidine 400 mg b.i.d. alone (C) for 8 weeks. Healing was examined by endoscopy at 4 and 8 weeks.

RESULTS

Of the intention-to-treat (ITT) population (EC, 103; C, 97), 181 patients comprised the per protocol (PP) analysis (EC, 93; C, 88). At 4 weeks, healing rates were significantly higher in the EC group (60%) than in the C group (36%) ( p < 0.01). At 8 weeks, those by the ITT and PP analyses were 82% (EC) versus 58% (C), and 90% (EC) versus 64% (C), respectively ( p < 0.01 and p < 0.001). Symptom relief rates (EC vs C) at 2, 4 and 8 weeks were 73%versus 47% ( p < 0.01), 89%versus 66% ( p < 0.001), and 97%versus 73% ( p < 0.001), respectively. Significant additive effects of ecabet sodium were observed in patients aged 60 years or older, with solitary and medium to large ulcer, and without smoking or drinking habits. No adverse effects were critical.

CONCLUSION

Ecabet sodium significantly augmented gastric ulcer healing and symptom relief by cimetidine, especially in the elderly.

摘要

背景与目的

关于黏膜保护剂依卡倍特钠与组胺H2受体拮抗剂联合治疗的临床疗效，人们了解甚少。本研究的目的是评估其与西咪替丁联合治疗胃溃疡的附加益处。

方法

在这项前瞻性随机研究中，经内镜确诊为胃溃疡后，47家医院的200例患者接受依卡倍特钠1g每日两次加西咪替丁400mg每日两次（EC组），或仅接受西咪替丁400mg每日两次（C组）治疗8周。在第4周和第8周通过内镜检查愈合情况。

结果

在意向性治疗（ITT）人群（EC组103例，C组97例）中，181例患者纳入符合方案（PP）分析（EC组93例，C组88例）。在第4周时，EC组的愈合率（60%）显著高于C组（36%）（p<0.01）。在第8周时，ITT分析和PP分析的愈合率分别为82%（EC组）对58%（C组），以及90%（EC组）对64%（C组）（p<0.01和p<0.001）。在第2周、第4周和第8周时的症状缓解率（EC组对C组）分别为73%对47%（p<0.01）、89%对66%（p<0.001）和97%对73%（p<0.001）。在60岁及以上、患有单发及中至大溃疡且无吸烟或饮酒习惯的患者中观察到依卡倍特钠有显著的附加效应。未出现严重不良反应。