Müller P, Dammann H G, Leucht U, Simon B
Gastroenterologische Abteilung, Medizinische Universitätsklinik Heidelberg, Federal Republic of Germany.
Eur J Clin Pharmacol. 1989;36(4):419-21. doi: 10.1007/BF00558307.
The gastroduodenal tolerance of Tenoxicam and Diclofenac Na has been evaluated in a double-blind, parallel group study in 36 healthy male volunteers. The doses used were 20 mg Tenoxicam and 100 mg Diclofenac Na daily in a retard formulation for 14 days. Gastric tolerance was assessed by endoscopy, which was performed at base-line, after the 14 day dosing period and after a 14 day follow-up period without treatment. The mucosal lesions were scored using modified Lanza criteria. Tenoxicam was significantly better tolerated at the end of the 14 day dosing period (mean gastric score: Tenoxicam 1.3; Diclofenac Na 2.2). The two treatment groups had comparable scores at the base-line and post study assessments. Tenoxicam and Diclofenac Na were generally well tolerated. Only two volunteers reported intermittant lack of appetite, heartburn and a feeling of pressure in the stomach.
在一项针对36名健康男性志愿者的双盲平行组研究中，已对替诺昔康和双氯芬酸钠的胃十二指肠耐受性进行了评估。所使用的剂量为每日20毫克替诺昔康和100毫克双氯芬酸钠缓释制剂，持续14天。通过内镜检查评估胃耐受性，内镜检查在基线、14天给药期后以及14天无治疗随访期后进行。使用改良的兰扎标准对粘膜病变进行评分。在14天给药期结束时，替诺昔康的耐受性明显更好（平均胃评分：替诺昔康1.3；双氯芬酸钠2.2）。两个治疗组在基线和研究后评估中的评分相当。替诺昔康和双氯芬酸钠总体耐受性良好。只有两名志愿者报告间歇性食欲不振、烧心和胃部有压迫感。
