Rogalla K, Lange R, Panijel M
Drug Research Centre, Bayer AG, Wuppertal, Germany.
Int J Clin Pharmacol Res. 1992;12(3):133-8.
A randomized, three-way crossover study by gastroscopic examination in 24 healthy male volunteers was performed to compare the gastric tolerance of a single dose of buffered or unbuffered acetylsalicylic acid. Gastroscopic assessment was made two hours after administration of the buffered (800 mg ASA) or unbuffered (500 mg ASA) tablets taken with 200 ml of water. Mucosal changes were rare and of a minor nature. Only two volunteers in the unbuffered ASA group presented minor changes (erythema and oedema). No pathological changes were observed after the buffered ASA. Subjective adverse reactions, e.g. epigastric complaints, were reported by four volunteers in the unbuffered group and by two in the buffered group. Based on the limited number and the minor extent of visible changes, statistical tests did not appear to be warranted. The results indicate that buffered ASA is better tolerated.
对24名健康男性志愿者进行了一项通过胃镜检查的随机三向交叉研究,以比较单剂量缓冲或未缓冲阿司匹林的胃耐受性。在服用200毫升水冲服的缓冲(800毫克阿司匹林)或未缓冲(500毫克阿司匹林)片剂两小时后进行胃镜评估。黏膜变化很少且程度较轻。未缓冲阿司匹林组只有两名志愿者出现轻微变化(红斑和水肿)。服用缓冲阿司匹林后未观察到病理变化。未缓冲组有四名志愿者报告了主观不良反应,如中上腹不适,缓冲组有两名志愿者报告了主观不良反应。基于可见变化的数量有限和程度较轻,似乎没有必要进行统计检验。结果表明,缓冲阿司匹林的耐受性更好。