Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
J Neurogastroenterol Motil. 2014 Apr 30;20(2):219-27. doi: 10.5056/jnm.2014.20.2.219.
BACKGROUND/AIMS: The drink test has been regarded as a surrogate marker of gastric accommodation. The aims of this study were to develop a novel nutrient drink test (NDT) protocol and investigate its potential for application to a clinical trial of functional dyspepsia (FD).
A novel NDT was designed, involving drinking 125 mL of nutrient 4 times at 5-minute intervals or until maximal tolerability. Healthy volunteers and patients with FD rated their symptoms every 5 minutes for 20 minutes in a developmental study. Patients with FD were enrolled in an open trial of itopride for 4 weeks. NDT was performed before and after treatment. Improvement of integrative symptoms score during NDT after treatment for more than 50% compared with baseline was de-fined as responder.
Total aggregate symptom scores, sum of symptom scores measured during NDT, were higher in FD patients (n = 40, 368.1 ± 245.3) than in controls (n = 19, 215.9 ± 171.2) (P = 0.018) in a developmental study. In an open trial of itopride, symp-tom scores measured during NDT decreased significantly at all time points after treatment in responders (n = 49), whereas did not in non-responders (n = 25). Total aggregate symptom score for NDT correlated significantly with integrative dyspeptic symptom score, sum of 8 symptom scores of NDI questionnaire, at baseline (r = 0.374, P = 0.001) and after treatment (r = 0.480, P ＜ 0.001).
Our novel NDT can quantify dyspeptic symptoms and reflected therapeutic effects of itopride treatment in a clinical trial of FD patients. This NDT can be used as an effective parameter in clinical trials or drug development programs for assessing effects of novel therapies on postprandial symptoms.
背景/目的：饮液试验已被视为胃容纳能力的替代标志物。本研究旨在开发一种新的营养饮液试验（NDT）方案，并探讨其在功能性消化不良（FD）临床试验中的应用潜力。
设计了一种新的 NDT，涉及在 5 分钟间隔内饮用 125 毫升营养物质 4 次，或直至最大耐受量。在开发研究中，健康志愿者和 FD 患者在 20 分钟内每 5 分钟对症状进行评分。FD 患者入组为期 4 周的伊托必利开放性试验。在治疗前后进行 NDT。与基线相比，治疗后 NDT 期间综合症状评分改善超过 50%定义为应答者。
在开发研究中，FD 患者（n = 40，368.1 ± 245.3）的总综合症状评分和 NDT 期间测量的症状总评分均高于对照组（n = 19，215.9 ± 171.2）（P = 0.018）。在伊托必利的开放性试验中，应答者（n = 49）在治疗后所有时间点的 NDT 期间症状评分均显著下降，而非应答者（n = 25）则无此变化。NDT 的总综合症状评分与 NDI 问卷 8 项症状评分的综合消化不良症状评分在基线时（r = 0.374，P = 0.001）和治疗后（r = 0.480，P ＜0.001）均显著相关。
我们的新型 NDT 可定量评估消化不良症状，并反映 FD 患者伊托必利治疗的疗效。这种 NDT 可作为临床试验或新药开发计划中评估新型疗法对餐后症状影响的有效参数。
