Behar J, Roufail W, Thomas E, Keller F, Dernbach W, Tesler M A
J Clin Gastroenterol. 1987;9 Suppl 1:23-30. doi: 10.1097/00004836-198709011-00006.
Eighty-four patients who were endoscopically confirmed to have healed duodenal ulcers were entered into this 1-year, double-blind, placebo-controlled trial of sucralfate, 1g twice daily, in the prevention of duodenal ulcer recurrence. Patients remained in the study until recurrence of ulceration was endoscopically confirmed. Sixty-one patients could be evaluated for efficacy of treatment. Within 6 months, 23 of 31 placebo patients (74%) and 6 of 30 sucralfate patients (20%) had ulcer recurrence. At 12 months, 25 of 31 placebo patients (80%) and 8 of 30 receiving sucralfate (27%) had ulcer recurrence. The lower rate of ulcer recurrence in patients receiving sucralfate was significant (p = 0.0001). Survival curves also showed that sucralfate was significantly more effective in preventing relapse (p = 0.0001). Three patients were judged as experiencing drug-related side effects, two of which were in the placebo group. The results indicate that sucralfate is significantly more effective than placebo in the prevention of recurrence of duodenal ulcer disease.
84例经内镜检查证实十二指肠溃疡已愈合的患者进入了这项为期1年的硫糖铝双盲、安慰剂对照试验，硫糖铝剂量为每日2次，每次1g，用于预防十二指肠溃疡复发。患者持续参与研究，直至内镜检查证实溃疡复发。61例患者可对治疗效果进行评估。6个月内，31例安慰剂组患者中有23例（74%）出现溃疡复发，30例硫糖铝组患者中有6例（20%）出现溃疡复发。12个月时，31例安慰剂组患者中有25例（80%）出现溃疡复发，30例接受硫糖铝治疗的患者中有8例（27%）出现溃疡复发。接受硫糖铝治疗的患者溃疡复发率较低，差异有统计学意义（p = 0.0001）。生存曲线也显示硫糖铝在预防复发方面显著更有效（p = 0.0001）。3例患者被判定出现与药物相关的副作用，其中2例在安慰剂组。结果表明，硫糖铝在预防十二指肠溃疡疾病复发方面显著优于安慰剂。
