摘要
AIM： To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia. METHODS： We performed a multi-center, prospective, randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-II criteria were enrolled from 7 centers. In the study group （115 patients）, 1.5 g ecabet sodium was given twice a day. In the control group （121 patients）, 400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3, 14, and 28 d after initiating the treatment. RESULTS： Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment, the rates of improvement in patients with dyspeptic symptoms were not different between two groups （77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P 〉 0.05）. Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups. There was no clinically significant adverse event in both groups.
瞄准：在减轻机能性消化不良的症状比较 ecabet 钠和 cimetidine。方法：我们执行了一个多中心，未来，使随机化，双 blinded 控制了试用在病人把 ecabet 钠和 cimetidine 的临床的功效与机能性消化不良作比较。二 -- 有完成 Rome-II 标准的消化不良的症状的 172 个病人从 7 个中心被注册。在学习组(115 个病人) ， 1.5 g ecabet 钠一天被给两次。在控制组(121 个病人) ， 400 mg cimetidine 一天被给两次。生命的质量的症状和参数在基线被分析，在开始治疗以后的 3， 14，和 28 d。结果：二 -- 136 个病人完成了临床的试用。在治疗的 4 wk 以后，在有消化不良的症状的病人的改进的率不在二个组之间是不同的(77.4% 在 ecabet 组织，分别地， 79.3% 在 cimetidine 组织 P > 0.05 ) 。同样，征兆的改进的率不在 3 d 和 14 d 是不同的。生命的质量的参数没在两个组在学习时期期间显著地变化。在两个组没有临床上重要的不利事件。结论：在有机能性消化不良的病人， ecabet 钠与 cimetidine 有类似的临床的功效。
