Gudjónsson H, Oddsson E, Björnsson S, Gunnlaugsson O, Theodors A, Jónasson T A, Bonnevie O, Thjodleifsson B
Dept. of Medicine, National University Hospital, Reykjavík, Iceland.
Scand J Gastroenterol. 1993 Nov;28(11):969-72. doi: 10.3109/00365529309098293.
The object of this study was to assess the efficacy of sucralfate in the treatment of non-ulcer dyspepsia (NUD). The diagnosis of NUD was made by exclusion. All patients underwent an upper gastrointestinal endoscopy and abdominal ultrasound, and blood tests were done as clinically indicated. Patients with a history of peptic ulcer disease were not included. Symptomatic assessment was made at the beginning and at the end of the study. The patients registered their most prominent dyspeptic symptoms and whether they improved, were unchanged, or worsened. The study was double-blind. Placebo or 1 g sucralfate four times daily was given for 3 weeks. Over a 2-year period 104 patients were included in the study; 56 received sucralfate and 48 placebo. Nine patients were excluded because of poor compliance or side effects, six from the sucralfate group and three from the placebo group. The sucralfate and placebo groups were comparable with regard to symptom and clinical variables. Global assessment of symptoms showed that in the sucralfate group 34 improved (68%), 11 were unchanged, and 5 were worse. In the placebo group 31 improved (69%), 11 were unchanged, and 3 were worse. There was no statistically significant difference between the groups. The 3-week course of sucralfate in patients with NUD did not show symptomatic improvement over placebo.
本研究的目的是评估硫糖铝治疗非溃疡性消化不良（NUD）的疗效。NUD通过排除法诊断。所有患者均接受了上消化道内镜检查和腹部超声检查，并根据临床指征进行了血液检查。有消化性溃疡病史的患者未纳入研究。在研究开始和结束时进行症状评估。患者记录其最突出的消化不良症状以及症状是改善、未改变还是恶化。该研究为双盲研究。给予安慰剂或每日4次、每次1 g硫糖铝，持续3周。在2年期间，104名患者纳入研究；56名接受硫糖铝治疗，48名接受安慰剂治疗。9名患者因依从性差或出现副作用而被排除，硫糖铝组6名，安慰剂组3名。硫糖铝组和安慰剂组在症状和临床变量方面具有可比性。症状的总体评估显示，硫糖铝组中34名患者症状改善（68%），11名未改变，5名恶化。安慰剂组中31名患者症状改善（69%），11名未改变，3名恶化。两组之间无统计学显著差异。NUD患者使用硫糖铝进行3周疗程治疗，与安慰剂相比，未显示出症状改善。
