Kusunoki Hiroaki, Kusaka Masayasu, Kido Soichiro, Yamauchi Ryo, Fujimura Yoshinori, Watanabe Yasuyuki, Kobori Michio, Miwa Hiroto, Tomita Toshihiko, Kin Yongmin, Hori Kazutoshi, Tano Nobuo, Sugimoto Kenji, Nakamura Yoshihiro, Fujimoto Kazuma, Oza Noriko, Matsunobu Aki, Ono Naofumi, Fuyuno Seisuke, Kinoshita Yoshikazu, Adachi Kyoichi, Yuki Mika, Fujisawa Tomoo, Haruma Ken
Department of General Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki, 701-0192, Japan.
J Gastroenterol. 2009;44(4):261-70. doi: 10.1007/s00535-009-0003-4. Epub 2009 Mar 13.
The purpose of this study was to compare the efficacy of proton pump inhibitor (PPI) with H(2) receptor antagonist (H(2)RA) in treatment of upper abdominal symptoms.
This was a multi-center, open study conducted at 102 hospitals in Japan. Patients with reflux esophagitis received famotidine 10 mg twice daily for 2 weeks, then omeprazole 10 mg once daily for 2 weeks. Thereafter, patients were switched to famotidine 10 mg twice daily for a third 2-weekperiod, provided those with a medical condition agreed to continue the study. Patients evaluated the treatment response to each gastrointestinal symptom using a predefined patient questionnaire and gastrointestinal symptom rating scale (GSRS).
161 patients entered the study, of whom 8 were excluded from all analyses due to lack of participation following entry. Overall symptom improvement rate (n = 130) at week 4, after the 2-week omeprazole treatment, was 75.4% and this was significantly higher than that after the first 2-week famotidine treatment (41.5%) at week 2. In patients (n = 36) who completed 6 weeks of treatment, 2-week omeprazole treatment at week 4 showed a significantly higher overall symptom improvement rate compared with both the first 2-week and third 2-week famotidine treatments.
Omeprazole was superior to famotidine for treatment of upper abdominal symptoms in patients with reflux esophagitis, which suggested that gastric acid might be a cause not only of reflux symptoms, but also of ulcer symptoms and dysmotility symptoms such as epigastric pain and feeling of fullness in reflux esophagitis.
本研究旨在比较质子泵抑制剂(PPI)与H2受体拮抗剂(H2RA)治疗上腹部症状的疗效。
这是一项在日本102家医院进行的多中心开放性研究。反流性食管炎患者接受法莫替丁10毫克,每日两次,共2周,然后接受奥美拉唑10毫克,每日一次,共2周。此后,若病情允许,患者转用法莫替丁10毫克,每日两次,进行第三个为期2周的疗程。患者使用预先定义的患者问卷和胃肠道症状评分量表(GSRS)评估对每种胃肠道症状的治疗反应。
161例患者进入研究,其中8例因入组后未参与而被排除在所有分析之外。在为期2周的奥美拉唑治疗后的第4周,总体症状改善率(n = 130)为75.4%,显著高于第2周时为期2周的法莫替丁首次治疗后的改善率(41.5%)。在完成6周治疗的患者(n = 36)中,第4周为期2周的奥美拉唑治疗的总体症状改善率显著高于法莫替丁的首次2周治疗和第三次2周治疗。
在反流性食管炎患者中,奥美拉唑治疗上腹部症状优于法莫替丁,这表明胃酸可能不仅是反流症状的原因,也是反流性食管炎中溃疡症状和动力障碍症状(如胃痛和饱腹感)的原因。