Müller P, Dammann H G, Marinis E, Simon B
Medizinische Universitätsklinik Heidelberg, Gastroenterologische Abteilung.
Z Rheumatol. 1989 Sep-Oct;48(5):243-5.
The gastroduodenal tolerability of tenoxicam vs diclofenac-Na was evaluated in a double-blind, parallel group study in 36 healthy male volunteers. The doses used were 20 mg tenoxicam vs 100 mg diclofenac-Na in a retard formulation daily over a period of 14 days. Gastric tolerability was assessed by using upper endoscopy. Gastroscopy was performed at base-line after the dosing period of 14 days and again after a follow-up period of 14 days without any treatment. The mucosal lesions were scored using modified Lanza criteria. In comparison to diclofenac-Na, tenoxicam was significantly better tolerated after a 14-day dosing period (mean gastric score: tenoxicam: 1.3 +/- 0.7; diclofenac-Na: 2.2 +/- 1.1 p = 0.0143). Both treatment groups had comparable scores at base-line and post-study assessments. Tenoxicam and diclofenac-Na were generally well tolerated. Only two volunteers reported intermittent lack of appetite, heartburn, and a feeling of pressure in the stomach. In summary, tenoxicam given as a 20 mg single oral morning dose over a 14-day period was significantly better tolerated than diclofenac 100 mg with regard to gastroduodenal mucosal damage.
在一项针对36名健康男性志愿者的双盲平行组研究中，评估了替诺昔康与双氯芬酸钠的胃十二指肠耐受性。使用的剂量为，替诺昔康每日20毫克，双氯芬酸钠缓释制剂每日100毫克，持续14天。通过上消化道内镜检查评估胃耐受性。在14天给药期结束后的基线期以及14天无任何治疗的随访期结束后进行胃镜检查。使用改良的兰扎标准对黏膜损伤进行评分。与双氯芬酸钠相比，替诺昔康在14天给药期后的耐受性明显更好（平均胃评分：替诺昔康：1.3±0.7；双氯芬酸钠：2.2±1.1，p = 0.0143）。两个治疗组在基线期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有间歇性食欲不振、烧心和胃部压迫感。总之，在14天内每日早晨单次口服20毫克替诺昔康，在胃十二指肠黏膜损伤方面的耐受性明显优于100毫克双氯芬酸钠。
