Department of Clinical Nursing, Shimane University Faculty of Medicine, Izumo City, Shimane, Japan.
Dig Dis Sci. 2012 Jun;57(6):1609-17. doi: 10.1007/s10620-012-2087-6. Epub 2012 Feb 26.
Reflux symptoms in patients with non-erosive reflux disease (NERD) cannot be easily controlled by treatment with proton pump inhibitors (PPI). The anti-inflammatory function of rebamipide may be effective for protecting the esophageal mucosa. This prospective randomized multicenter placebo-controlled study was performed to clarify the efficacy of rebamipide for NERD patients whose reflux symptoms were refractory to PPI treatment.
One hundred forty-nine patients were enrolled on the basis of a QUEST score of over 6 and absence of endoscopically proven esophageal mucosal breaks. All the patients were initially administered 15 mg of lansoprazole for 4 weeks, and the symptoms were then assessed using QUEST and GSRS. PPI-refractory patients were randomly assigned to administration of rebamipide or placebo t.i.d. for 4 weeks.
Three of the 149 patients were lost to follow-up, and 60 among the remaining 146 patients were found to be PPI-refractory. Among these PPI-refractory patients, 31 were randomly assigned to a rebamipide group and 29 to a placebo group. At the end of drug administration, the QUEST and GSRS scores did not differ between the rebamipide and placebo groups, although a significantly higher proportion of patients in the rebamipide group showed amelioration of abdominal pain and diarrhea.
Administration of rebamipide cannot effectively control reflux symptoms in NERD patients whose symptoms are refractory to PPI therapy.
非糜烂性反流病（NERD）患者的反流症状经质子泵抑制剂（PPI）治疗后难以得到有效控制。瑞巴派特的抗炎作用可能对保护食管黏膜有效。本前瞻性随机多中心安慰剂对照研究旨在明确瑞巴派特治疗对 PPI 治疗无效的 NERD 患者的疗效。
根据 QUEST 评分>6 分且无内镜证实的食管黏膜破损，纳入 149 例患者。所有患者最初均给予 15mg 兰索拉唑治疗 4 周，然后采用 QUEST 和 GSRS 评估症状。PPI 难治性患者随机分为瑞巴派特或安慰剂 tid 治疗 4 周。
149 例患者中有 3 例失访，146 例剩余患者中有 60 例被认为是 PPI 难治性患者。在这些 PPI 难治性患者中，31 例被随机分配到瑞巴派特组，29 例分配到安慰剂组。在药物治疗结束时，瑞巴派特组和安慰剂组的 QUEST 和 GSRS 评分无差异，尽管瑞巴派特组中腹痛和腹泻改善的患者比例显著更高。
在 PPI 治疗无效的 NERD 患者中，瑞巴派特不能有效控制反流症状。
