Fujimoto Kazuma, Hongo Michio
Department of Internal Medicine, Saga Medical School, Japan.
Intern Med. 2011;50(3):179-88. doi: 10.2169/internalmedicine.50.4238. Epub 2011 Feb 1.
The aim of this prospective clinical study was to evaluate the efficacy and safety of long-term proton pump inhibitor (PPI) treatment for two years in Japanese patients with reflux esophagitis (RE).
The efficacy and safety of two-year (104-week) treatment with rabeprazole (RPZ) 10 mg were studied in patients confirmed to have been cured of RE by PPI and who required long-term maintenance therapy with PPI. We performed serial endoscopy, checked gastroesophageal reflux disease (GERD) symptoms, adverse events, laboratory values and serum gastrin. We also monitored gastric mucosal histology, atrophy and polyps.
The endoscopic non-relapse rate for RE was 87.3% for the 104-week period. GERD symptoms improved based on the fact that the mean change from baseline in GERD symptom score after treatment was a negative value. Treatment was safe; and atrophy was found to have developed in virtually no cases. A few new benign fundic gland or hyperplastic polyps developed throughout the study, but no ECL carcinoids were found to have developed. Serum gastrin levels tended to increase up to 24 weeks, but there were no subsequent changes thereafter up to 104 weeks.
The results confirmed oral RPZ 10 mg to be effective for maintenance therapy in Japanese patients with RE. Although effects on the gastric mucosa were not ruled out, long-term use of RPZ was confirmed to be safe overall.
这项前瞻性临床研究的目的是评估长期使用质子泵抑制剂（PPI）对日本反流性食管炎（RE）患者进行两年治疗的疗效和安全性。
对已通过PPI治愈RE且需要长期PPI维持治疗的患者，研究使用10毫克雷贝拉唑（RPZ）进行两年（104周）治疗的疗效和安全性。我们进行了系列内镜检查，检查了胃食管反流病（GERD）症状、不良事件、实验室检查值和血清胃泌素。我们还监测了胃黏膜组织学、萎缩和息肉情况。
在104周期间，RE的内镜无复发率为87.3%。基于治疗后GERD症状评分相对于基线的平均变化为负值这一事实，GERD症状有所改善。治疗是安全的；几乎未发现萎缩情况。在整个研究过程中出现了一些新的良性胃底腺息肉或增生性息肉，但未发现有ECL类癌发生。血清胃泌素水平在24周前有升高趋势，但此后直至104周均无后续变化。
结果证实口服10毫克RPZ对日本RE患者的维持治疗有效。虽然不能排除对胃黏膜的影响，但长期使用RPZ总体上被证实是安全的。
