Gudjónsson H, Oddsson E, Thjodleifsson B
Department of Medicine, Landspítalinn, National Hospital, Reykjavík, Iceland.
Digestion. 1994;55(6):395-8. doi: 10.1159/000201171.
The objective of the study was to assess whether sucralfate can prevent or diminish short-term nonsteroidal anti-inflammatory drug (NSAID)-induced damage in the stomach and duodenum. Sixteen healthy subjects were randomly treated for 7 days with sucralfate 2 g b.d. or placebo in a double-blind cross-over manner. Naproxen 500 mg b.d. was given on days 3-7. Gastrointestinal endoscopy was performed before and after each treatment period. Mucosal damage was measured by counting erosions, submucosal hemorrhages or ulcers on a fixed point scale of 0-4 for stomach and duodenum separately. The mean posttreatment injury score in the stomach was 2.13 +/- 1.51 and 2.0 +/- 0.97 for the placebo and sucralfate periods, respectively (p = 0.72). The possibility of type II error was 7%. In the duodenum, the injury score was 1.69 +/- 1.08 and 1.06 +/- 0.93 for the placebo and sucralfate periods, respectively (p = 0.08). The possibility of type II error was 37%. Sucralfate has no efficacy as a prophylactic agent against short-term NSAID-induced gastroduodenal injury.
本研究的目的是评估硫糖铝是否能预防或减轻短期非甾体抗炎药（NSAID）引起的胃和十二指肠损伤。16名健康受试者以双盲交叉方式随机接受硫糖铝2g，每日2次或安慰剂治疗7天。在第3 - 7天给予萘普生500mg，每日2次。在每个治疗期前后进行胃肠内镜检查。通过分别对胃和十二指肠在0 - 4的固定评分量表上计数糜烂、黏膜下出血或溃疡来测量黏膜损伤。安慰剂组和硫糖铝组治疗后胃的平均损伤评分为分别为2.13±1.51和2.0±0.97（p = 0.72）。II型错误的可能性为7%。在十二指肠中，安慰剂组和硫糖铝组的损伤评分为分别为1.69±1.08和1.06±0.93（p = 0.08）。II型错误的可能性为37%。硫糖铝作为预防短期NSAID引起的胃十二指肠损伤的药物没有疗效。
