Anslow J A, Balm T K, Hooper J W, Szego P, Wagner G S
Pharmacology. 1985;30(1):40-4. doi: 10.1159/000138048.
This study involved a randomized parallel groups comparison of the effects of aspirin formulated as enteric-coated granules (25 subjects) or as buffered tablets (26 subjects) with that of a lactose placebo (5 subjects), on the gastric and duodenal mucosa, as determined by endoscopic examination 2 h after a fasting single 975-mg dose. A grading scale of 0 (no damage) to 4 (severe damage) was used. The granule formulation produced a statistically significant (p less than 0.05) lower severity (mean 0.40 +/- 0.58 vs. 3.00 +/- 0.94) and incidence (36% of subjects vs. 100%) of gastric lesions than the buffered aspirin formulation. None of the lesions produced by the granule formulation or the placebo was considered clinically significant by the blinded endoscopist, whereas 17 subjects on the buffered formulation (65%) had clinically meaningful stomach damage. The incidence of duodenal lesions was minimal and comparable for the two formulations.
本研究采用随机平行组比较的方法，在空腹单次服用975毫克剂量药物2小时后，通过内镜检查，观察肠溶颗粒剂型阿司匹林（25名受试者）、缓冲片剂剂型阿司匹林（26名受试者）以及乳糖安慰剂（5名受试者）对胃和十二指肠黏膜的影响。使用0（无损伤）至4（严重损伤）的分级量表。与缓冲阿司匹林剂型相比，颗粒剂型导致的胃损伤严重程度（平均0.40±0.58 vs. 3.00±0.94）和发生率（36%的受试者 vs. 100%）在统计学上有显著差异（p小于0.05）。颗粒剂型或安慰剂产生的损伤在盲法内镜检查中均不被认为具有临床意义，而使用缓冲剂型的17名受试者（65%）出现了具有临床意义的胃损伤。两种剂型的十二指肠损伤发生率均极低且相当。
