Lanza F L, Hubsher J A, Walker B R
J Clin Pharmacol. 1981 Apr;21(4):157-61. doi: 10.1002/j.1552-4604.1981.tb05694.x.
Oxaprozin, a new long-acting, antiinflammatory agent, and aspirin were compared utilizing gastroscopic evaluation and photography of the gastric mucosa in a double-blind, crossover study in normal volunteers. Submucosal hemorrhages or mucosal bleeding was observed in seven of eight subjects on aspirin and in only two of eight on oxaprozin (P = 0.061). Adverse effects were experienced by seven of eight subjects after the aspirin treatment period--tinnitus in five and gastrointestinal symptoms in four. Only one patient had mild diarrhea on oxaprozin. The incidence of adverse effects was found significantly higher with aspirin therapy (P less than 0.001). No laboratory abnormalities of clinical significance were attributed to either drug administration. Results after ten days of treatment show that oxaprozin in therapeutic dose levels (1200 mg once a day) produces significantly fewer changes in the gastric mucosa than aspirin (975 mg administered four times a day, total daily dose 3.9 Gm) in the same subjects, who received both drugs in this double-blind, crossover experiment with a four-week washout period between treatments.
在一项针对正常志愿者的双盲交叉研究中,使用胃镜评估和胃黏膜摄影术对新型长效抗炎药奥沙普秦与阿司匹林进行了比较。在服用阿司匹林的8名受试者中,有7人观察到黏膜下出血或黏膜出血,而服用奥沙普秦的8名受试者中只有2人出现这种情况(P = 0.061)。在阿司匹林治疗期后,8名受试者中有7人出现不良反应——5人出现耳鸣,4人出现胃肠道症状。只有1名患者在服用奥沙普秦时出现轻度腹泻。结果发现,阿司匹林治疗的不良反应发生率明显更高(P < 0.001)。两种药物给药均未出现具有临床意义的实验室异常情况。治疗10天后的结果表明,在该双盲交叉实验中,同一受试者在接受两种药物治疗且治疗间隔有4周洗脱期的情况下,治疗剂量水平的奥沙普秦(每日1次,1200 mg)对胃黏膜产生的变化明显少于阿司匹林(每日4次,每次975 mg,每日总剂量3.9 Gm)。