Department of Gastroenterology, Moriguchi Keijinkai Hospital, Moriguchi, Osaka, Japan.
World J Gastroenterol. 2012 Apr 7;18(13):1517-24. doi: 10.3748/wjg.v18.i13.1517.
To compare efficacy of proton pump inhibitors (PPIs) with H(2)-receptor antagonists (H(2)RAs) plus prokinetics (Proks) for dysmotility-like symptoms in functional dyspepsia (FD).
Subjects were randomized to receive open-label treatment with either rabeprazole 10 mg od (n = 57) or famotidine 10 mg bid plus mosapride 5 mg tid (n = 57) for 4 wk. The primary efficacy endpoint was change (%) from baseline in total dysmotility-like dyspepsia symptom score. The secondary efficacy endpoint was patient satisfaction with treatment.
The improvement in dysmotility-like dyspepsia symptom score on day 28 was significantly greater in the rabeprazole group (22.5% ± 29.2% of baseline) than the famotidine + mosapride group (53.2% ± 58.6% of baseline, P < 0.0001). The superior benefit of rabeprazole treatment after 28 d was consistent regardless of Helicobacter pylori status. Significantly more subjects in the rabeprazole group were satisfied or very satisfied with treatment on day 28 than in the famotidine + mosapride group (87.7% vs 59.6%, P = 0.0012). Rabeprazole therapy was the only significant predictor of treatment response (P < 0.0001), defined as a total symptom score improvement ≥ 50%.
PPI monotherapy improves dysmotility-like symptoms significantly better than H(2)RAs plus Proks, and should be the treatment of first choice for Japanese FD.
比较质子泵抑制剂（PPIs）与 H2 受体拮抗剂（H2RAs）加促动力药（Proks）治疗功能性消化不良（FD）动力障碍样症状的疗效。
受试者随机接受兰索拉唑 10mg 每日一次（n=57）或法莫替丁 10mg 每日两次加莫沙必利 5mg 每日三次（n=57）的开放标签治疗，疗程为 4 周。主要疗效终点是总动力障碍样消化不良症状评分从基线的变化（%）。次要疗效终点是患者对治疗的满意度。
在第 28 天，兰索拉唑组（基线的 22.5%±29.2%）的动力障碍样消化不良症状评分改善明显大于法莫替丁+莫沙必利组（基线的 53.2%±58.6%，P<0.0001）。28 天后，兰索拉唑治疗的优势无论幽门螺杆菌状态如何均一致。第 28 天，兰索拉唑组有更多的患者对治疗满意或非常满意（87.7%比 59.6%，P=0.0012）。兰索拉唑治疗是治疗反应（定义为总症状评分改善≥50%）的唯一显著预测因素（P<0.0001）。
PPI 单药治疗可显著改善动力障碍样症状，优于 H2RAs 加 Proks，应成为日本 FD 的首选治疗方法。
