Kamiya Takeshi, Shikano Michiko, Kubota Eiji, Mizoshita Tsutomu, Wada Tsuneya, Tanida Satoshi, Kataoka Hiromi, Adachi Hiroshi, Hirako Makoto, Okuda Noriaki, Joh Takashi
Department of Medical Innovation, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
J Clin Biochem Nutr. 2017 Mar;60(2):130-135. doi: 10.3164/jcbn.16-106. Epub 2017 Feb 24.
The aims of this study were to compare the therapeutic effects of a proton pump inhibitor (PPI), rabeprazole (RPZ), and a prokinetic agent, itopride (ITO), and to investigate the role of PPI in the treatment strategy for Japanese functional dyspepsia (FD) patients. We randomly assigned 134 patients diagnosed by Rome III criteria to 4 weeks treatment with RPZ 10 mg/day ( = 69) or ITO 150 mg/day ( = 65). Dyspeptic symptoms were evaluated using FD scores at baseline and after 1, 2 and 4 weeks of treatment. We also divided subjects into predominantly epigastric pain syndrome (EPS) or postprandial distress syndrome (PDS), and evaluated the efficacy of RPZ and ITO respectively. RPZ showed a significant decrease in the Rate of Change (RC) in FD score within 1 week, which was maintained until after 4 weeks, with RPZ a significant effect compared with ITO at all evaluation points. In addition, RPZ showed a significant decrease in FD score in subjects with both EPS and PDS, whereas a significant decrease in the RC with ITO was only shown in those with predominant PDS. Acid-suppressive therapy with RPZ is useful for PDS as well EPS in Japanese FD patients (UMIN Clinical Trials Registry number: UMIN 000013962).
本研究旨在比较质子泵抑制剂雷贝拉唑（RPZ）和促动力药伊托必利（ITO）的治疗效果，并探讨质子泵抑制剂在日本功能性消化不良（FD）患者治疗策略中的作用。我们将134例符合罗马III标准诊断的患者随机分为两组，分别接受为期4周的治疗，一组服用10毫克/天的雷贝拉唑（n = 69），另一组服用150毫克/天的伊托必利（n = 65）。在基线以及治疗1周、2周和4周后，使用FD评分评估消化不良症状。我们还将受试者分为以胃脘痛综合征（EPS）为主或餐后不适综合征（PDS）为主的类型，并分别评估雷贝拉唑和伊托必利的疗效。雷贝拉唑在1周内FD评分的变化率（RC）显著降低，且这种降低一直持续到4周后，在所有评估点上，雷贝拉唑的效果均显著优于伊托必利。此外，雷贝拉唑在EPS和PDS患者中均使FD评分显著降低，而伊托必利仅在以PDS为主的患者中使RC显著降低。雷贝拉唑的抑酸治疗对日本FD患者的PDS和EPS均有效（UMIN临床试验注册号：UMIN 000013962）。
