Ranitidine effectively relieves symptoms in a subset of patients with functional dyspepsia.
Ranitidine effectively relieves symptoms in a subset of patients with functional dyspepsia.
复制标题
雷尼替丁可有效缓解部分功能性消化不良患者的症状。
DOI：
10.3109/00365529708996530
复制
发表时间：
1997
影响因子：
1.9
通讯作者：
K. Ulshagen
中科院分区：
文献类型：
--
作者：
Per G. Farup;S. Wetterhus;M. Osnes;K. Ulshagen
背景
酸分泌抑制剂对大多数功能性消化不良患者的价值不确定，但可能对一个子集有效。该试验的目的是比较雷尼替丁与安慰剂在选定的患者亚组中的效果。
方法
226例功能性消化不良患者被纳入一项双盲多交叉（MCO）试验。6周后，计算范围为0-5的效应评分（Xs）。然后根据他们的评分将他们分层，并随机分配到雷尼替丁或安慰剂的4周双盲治疗组。在100 mm视觉模拟量表上对总体症状进行评分，评分的变化（以毫米为单位）是主要效果指标。
结果
206名患者完成了研究。雷尼替丁和安慰剂对“反应者”（76名MCO期后X值为4-5的患者）的影响分别为28 mm和5 mm（P < 0.001），对所有患者的影响分别为19 mm和12 mm（P < 0.03）。在“无应答者”（130例MCO期后X为0-3的患者）中未观察到任何影响。在过去4周内给予雷尼替丁的患者的临床改善在统计学上显著不同，与无应答者相比，应答者更有利。我们无法根据人口统计学、症状和体征描述应答者的特征。
结论
雷尼替丁对功能性消化不良患者有良好的临床显著疗效。
BACKGROUND
Acid secretion inhibitors are of dubious value to most patients with functional dyspepsia but might be effective in a subset. The aims of the trial were to compare the effect of ranitidine with that of placebo in selected subsets of patients.
METHODS
Two hundred and twenty-six patients with functional dyspepsia were included in a double-blind multi-crossover (MCO) trial. After 6 weeks an effect score (Xs) with a range of 0-5 was calculated. They were then stratified in accordance with their score and randomized to 4 weeks' double-blind treatment with ranitidine or placebo. Overall symptoms were scored on a 100-mm visual analogue scale, and the change in score (measured in millimetres) was the primary effect measure.
RESULTS
Two hundred and six patients completed the study. The effect of ranitidine and placebo in the 'responders' (76 patients with Xs of 4-5 after the MCO period) was 28 mm and 5 mm, respectively (P < 0.001), and in all patients 19 mm and 12 mm, respectively (P < 0.03). No effect was seen in 'nonresponders' (130 patients with Xs of 0-3 after the MCO period). The clinical improvement, as judged by the patients given ranitidine during the last 4-week period was statistically significantly different in favour of responders compared with nonresponders. We were unable to characterize the responders on the basis of demographics, symptoms, and signs.
CONCLUSIONS
Ranitidine has a good and clinically significant effect in a subset of patients with functional dyspepsia.