Clinical characteristics and effectiveness of lansoprazole in Japanese patients with gastroesophageal reflux disease and dyspepsia
Clinical characteristics and effectiveness of lansoprazole in Japanese patients with gastroesophageal reflux disease and dyspepsia
复制标题
DOI：
10.1007/s00535-013-0812-3
复制
发表时间：
2014-04-01
影响因子：
6.3
通讯作者：
Haruma, Ken
中科院分区：
文献类型：
--
作者：
Kinoshita, Yoshikazu;Miwa, Hiroto;Haruma, Ken
胃食管反流病（GERD）患者除反流症状外，还常伴有消化不良症状。消化不良的治疗方案没有标准化。本研究的目的是阐明兰索拉唑对日本胃食管反流患者消化不良的治疗效果。纳入伴有消化不良的胃食管反流患者，用兰索拉唑15或30 mg治疗，每天1次，持续4周。治疗前和开始兰索拉唑治疗后2周和4周通过问卷调查评估反流和消化不良症状。在有效性分析集中（n = 12,653），研究入组时91.6%的患者报告了胃灼热。在研究开始时，餐后饱腹是最常见的消化不良症状，79%的入组患者报告了这一症状。兰索拉唑治疗4周后，75.7%的患者胃灼热症状得到改善，68.7%的患者餐后饱腹症状得到改善。低剂量和高剂量兰索拉唑治疗消化不良和反流症状的效果，在内镜确认的糜烂性食管炎患者中（60.1- 82.2%）比在非糜烂性反流疾病患者中（53.0- 73.3%）高出约10%。兰索拉唑耐受性良好。在这项大规模临床研究中，兰索拉唑能有效缓解胃食管反流患者的消化不良和反流症状。
Patients with gastroesophageal reflux disease (GERD) frequently have symptoms of dyspepsia in addition to reflux symptoms. Treatment options for dyspepsia are not standardized. The aim of this study was to clarify the therapeutic effect of lansoprazole on dyspepsia in Japanese patients with GERD.GERD patients with dyspepsia were enrolled and treated with lansoprazole 15 or 30 mg once daily for 4 weeks. Reflux and dyspeptic symptoms were assessed by questionnaires before treatment, and 2 and 4 weeks after the start of lansoprazole treatment.In the effectiveness analysis set (n = 12,653), heartburn was reported by 91.6 % of patients at study enrollment. Postprandial fullness was the most frequently reported dyspepsia symptom at the start of the study, reported by 79.0 % of enrolled patients. After 4 weeks of lansoprazole treatment, heartburn symptoms were improved in 75.7 % of patients and symptoms of postprandial fullness were improved in 68.7 % of patients. The therapeutic effect of low and high doses of lansoprazole on dyspepsia, as well as on reflux symptoms, was approximately 10 % higher in patients with endoscopy-confirmed erosive esophagitis (60.1-82.2 %), than in patients with non-erosive reflux diseases (53.0-73.3 %). Lansoprazole was well tolerated.In this large-scale clinical study, lansoprazole effectively relieved dyspepsia in addition to reflux symptoms in patients with GERD.