Farup P G, Hovde O, Torp R, Wetterhus S
Dept. of Medicine, Gjøvik County Hospital, Norway.
Scand J Gastroenterol. 1999 Jun;34(6):575-9. doi: 10.1080/003655299750026029.
The effect of acid secretion inhibitors in patients with functional dyspepsia (FD) is equivocal. One previous trial showed an effect in patients with a characteristic gastro-oesophageal reflux pattern. This double-blind trial compares the number of reflux episodes in responders and non-responders to omeprazole.
Twenty-four patients (men/women, 11:13; mean age, 49 years) with FD were included; those with reflux as the main symptom were excluded. An upper endoscopy and a 24-h oesophageal pH measurement were performed before randomization to treatment with 10-20 mg omeprazole or placebo for 4 weeks. Patients who at questioning considered themselves to have achieved sufficient relief of dyspeptic symptoms after 4 weeks were characterized as responders.
The number of responders in the omeprazole and placebo groups was 8 of 14 (57%) and 2 of 10 (20%), respectively (P = 0.07). The mean number of reflux episodes at the 24-h oesophageal pH measurement in responders and non-responders to omeprazole was 57 and 25, respectively (P < 0.003). In the omeprazole group the number of responders was 0 of 5 (0%) in those with < 32 reflux episodes and 8 of 9 (89%) in those with > 32 reflux episodes (P < 0.003).
Patients with FD responding to omeprazole were characterized by many reflux episodes.
酸分泌抑制剂对功能性消化不良（FD）患者的疗效尚不明确。此前一项试验显示，其对具有典型胃食管反流模式的患者有效。本双盲试验比较了对奥美拉唑有反应者和无反应者的反流发作次数。
纳入24例FD患者（男/女，11:13；平均年龄49岁）；排除以反流为主要症状的患者。在随机接受10 - 20 mg奥美拉唑或安慰剂治疗4周之前，进行了上消化道内镜检查和24小时食管pH值测量。在询问时认为自己在4周后消化不良症状得到充分缓解的患者被归类为有反应者。
奥美拉唑组和安慰剂组的有反应者分别为14例中的8例（57%）和10例中的2例（20%）（P = 0.07）。在24小时食管pH值测量中，对奥美拉唑有反应者和无反应者的反流发作平均次数分别为57次和25次（P < 0.003）。在奥美拉唑组中，反流发作次数< 32次的患者中有反应者为5例中的0例（0%），反流发作次数> 32次的患者中有反应者为9例中的8例（89%）（P < 0.003）。
对奥美拉唑有反应的FD患者的特点是反流发作次数较多。
