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瑞巴派特是一种具有胃保护和抗炎作用的药物,在日本人群中,它能在根除幽门螺杆菌的治疗后促进胃溃疡愈合:一项随机、双盲、安慰剂对照试验。

Rebamipide, a gastro-protective and anti-inflammatory drug, promotes gastric ulcer healing following eradication therapy for Helicobacter pylori in a Japanese population: a randomized, double-blind, placebo-controlled trial.

作者信息

Terano Akira, Arakawa Tetsuo, Sugiyama Toshiro, Suzuki Hidekazu, Joh Takashi, Yoshikawa Toshikazu, Higuchi Kazuhide, Haruma Ken, Murakami Kazunari, Kobayashi Kenzo

机构信息

Department of Gastroenterology, Dokkyo University School of Medicine, Tochigi, Japan.

出版信息

J Gastroenterol. 2007 Aug;42(8):690-3. doi: 10.1007/s00535-007-2076-2. Epub 2007 Aug 24.

Abstract

BACKGROUND

One week of Helicobacter pylori eradication therapy is insufficient for healing of gastric ulcers. We examined the efficacy of rebamipide in gastric ulcer healing following 1 week of eradication therapy in a randomized, double-blind, placebo-controlled trial.

METHODS

Patients with H. pylori-positive gastric ulcer were enrolled and received 1 week of eradication therapy, followed by 100 mg of rebamipide or placebo for 7 weeks. The primary end point was the gastric ulcer healing rate.

RESULTS

Of the 309 patients entered in the trial, 301 completed H. pylori eradication therapy; 154 patients took rebamipide, and 147 took placebo. The healing rate in the rebamipide group was higher than that in the placebo group in the per-protocol analysis-80.0% (104/130) versus 66.1% (82/124) [95% confidence interval (CI), 3.1-24.7; P = 0.013)-and in a full analysis-70.1% (108/154) versus 60.5% (89/147) (95% CI, -1.1 to 20.3; P = 0.080).

CONCLUSIONS

Compared with placebo, rebamipide significantly promoted gastric ulcer healing following 1 week of eradication therapy.

摘要

背景

一周的幽门螺杆菌根除治疗不足以治愈胃溃疡。我们在一项随机、双盲、安慰剂对照试验中研究了瑞巴派特在根除治疗1周后促进胃溃疡愈合的疗效。

方法

纳入幽门螺杆菌阳性胃溃疡患者,给予1周的根除治疗,随后给予100mg瑞巴派特或安慰剂,持续7周。主要终点是胃溃疡愈合率。

结果

在309例纳入试验的患者中,301例完成了幽门螺杆菌根除治疗;154例患者服用瑞巴派特,147例患者服用安慰剂。在意向性分析中,瑞巴派特组的愈合率高于安慰剂组,分别为80.0%(104/130)和66.1%(82/124)[95%置信区间(CI),3.1 - 24.7;P = 0.013];在全分析中,分别为70.1%(108/154)和60.5%(89/147)(95%CI,-1.1至20.3;P = 0.080)。

结论

与安慰剂相比,瑞巴派特在根除治疗1周后能显著促进胃溃疡愈合。

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