Terano Akira, Arakawa Tetsuo, Sugiyama Toshiro, Suzuki Hidekazu, Joh Takashi, Yoshikawa Toshikazu, Higuchi Kazuhide, Haruma Ken, Murakami Kazunari, Kobayashi Kenzo
Department of Gastroenterology, Dokkyo University School of Medicine, Tochigi, Japan.
J Gastroenterol. 2007 Aug;42(8):690-3. doi: 10.1007/s00535-007-2076-2. Epub 2007 Aug 24.
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.
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.
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).
Compared with placebo, rebamipide significantly promoted gastric ulcer healing following 1 week of eradication therapy.
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。
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。
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)。
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。