Hudson N, Murray F E, Cole A T, Turnbull G M, Lettis S, Hawkey C J
Department of Therapeutics, University Hospital, Nottingham, UK.
Aliment Pharmacol Ther. 1993 Oct;7(5):515-21. doi: 10.1111/j.1365-2036.1993.tb00127.x.
The aim of this study was to investigate the protective action of a new compound, ranitidine bismuth citrate, in the prevention of aspirin-induced acute mucosal injury to the upper gastrointestinal tract of healthy human volunteers. In a double-blind randomized three-way cross-over study 24 male volunteers received placebo, 900 mg aspirin or 900 mg aspirin and 800 mg ranitidine bismuth citrate at 12-h intervals for nine doses with a 2-week wash-out period between each treatment. The median (interquartile range) number of erosions seen at endoscopy when ranitidine bismuth citrate was given with aspirin (1 [0-4]) was significantly lower than aspirin alone (24 [16-32]) (P < 0.001) and not significantly different from either baseline or placebo (0 [0-2]). These findings were similarly reflected in the effects on microbleeding following the ninth dose: 12.1 (7.1-21.0) microL/10 min following aspirin alone compared to levels with placebo of 1.2 (0.4-2.9), and with aspirin and ranitidine bismuth citrate of 1.6 (0.8-2.6) (P < 0.005). Ranitidine bismuth citrate conferred substantial protection from aspirin-induced injury to the gastric and duodenal mucosa as determined by both endoscopic assessment and microbleeding rates, reducing injury to placebo levels.
本研究旨在探讨一种新化合物枸橼酸铋雷尼替丁对健康人类志愿者上消化道阿司匹林诱导的急性黏膜损伤的预防作用。在一项双盲随机三交叉研究中，24名男性志愿者每隔12小时接受安慰剂、900毫克阿司匹林或900毫克阿司匹林加800毫克枸橼酸铋雷尼替丁，共服用9剂，每次治疗之间有2周的洗脱期。在内镜检查中，当枸橼酸铋雷尼替丁与阿司匹林一起服用时观察到的糜烂中位数（四分位间距）为1（0-4），显著低于单独服用阿司匹林时的24（16-32）（P<0.001），与基线或安慰剂（0[0-2]）无显著差异。这些结果同样反映在第九剂后对微出血的影响上：单独服用阿司匹林后为12.1（7.1-21.0）微升/10分钟，而安慰剂组为1.2（0.4-2.9），阿司匹林加枸橼酸铋雷尼替丁组为1.6（0.8-2.6）（P<0.005）。通过内镜评估和微出血率确定，枸橼酸铋雷尼替丁对阿司匹林诱导的胃和十二指肠黏膜损伤具有显著保护作用，将损伤降低至安慰剂水平。
