Hentschel E, Schütze K, Dufek W
Scand J Gastroenterol Suppl. 1983;83:31-5.
Seventy-two outpatients with endoscopically diagnosed duodenal ulcer were studied in a 4-6 week randomised, single-blind trial comparing sucralfate (1 g tds 2 h after each meal and 1 g nocte) with cimetidine (200 mg tds and 400 mg nocte). Endoscopy was performed after 4 weeks and was repeated at 6 weeks if healing was not achieved at 4 weeks. Ulcer pain and antacid consumption were recorded in a diary by patients. Twenty-three of 35 (65.7%) sucralfate-treated patients and 27 of 37 (73.0%) cimetidine-treated patients had complete ulcer healing after 4 weeks. The overall healing rates after 6 weeks for the sucralfate and cimetidine groups were 91.4% (32 of 35 patients) and 83.8% (31 of 37 patients), respectively. Neither difference was statistically significant. Pain relief and antacid consumption were similar in both groups. Nausea was reported by 4 patients in the sucralfate group and two requested withdrawal because of this complaint. Hematological and biochemical parameters were not affected by treatment with either sucralfate or cimetidine. We conclude that sucralfate is safe and as effective as cimetidine in the treatment of duodenal ulcer.
对72例经内镜诊断为十二指肠溃疡的门诊患者进行了一项为期4 - 6周的随机、单盲试验,比较硫糖铝(每餐饭后2小时服用1g,每日3次,睡前服用1g)和西咪替丁(每日3次,每次200mg,睡前400mg)的疗效。4周后进行内镜检查,若4周未愈合,则在6周时重复检查。患者通过日记记录溃疡疼痛情况和抗酸剂服用量。硫糖铝治疗组35例患者中有23例(65.7%)在4周后溃疡完全愈合,西咪替丁治疗组37例患者中有27例(73.0%)在4周后溃疡完全愈合。硫糖铝组和西咪替丁组6周后的总体愈合率分别为91.4%(35例患者中的32例)和83.8%(37例患者中的31例)。两组间差异均无统计学意义。两组的疼痛缓解情况和抗酸剂服用量相似。硫糖铝组有4例患者报告恶心,其中2例因该症状要求退出试验。硫糖铝或西咪替丁治疗均未影响血液学和生化指标。我们得出结论,硫糖铝在治疗十二指肠溃疡方面安全且与西咪替丁疗效相当。