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替诺昔康与吡罗昔康在正常健康男性志愿者中引起的粪便失血比较。

A comparison of faecal blood loss caused by tenoxicam and piroxicam in normal healthy male volunteers.

作者信息

Bird H A, Hill J, Haw W M, Dixon J S, Harris P A, Wright V

出版信息

Curr Med Res Opin. 1985;9(8):524-8. doi: 10.1185/03007998509109629.

Abstract

Faecal blood loss arising from tenoxicam at a dose of 20 mg/day was compared to that arising from piroxicam at a dose of 20 mg/day in a double-blind, parallel comparative study in 12 healthy male volunteers. Faecal blood loss was measured for a 1-week run-in on placebo, during 4 weeks of treatment and for a 2-week post-treatment period in both groups. Plasma levels for tenoxicam and piroxicam confirmed good compliance in all subjects. Mean blood loss during the placebo run-in period was 0.35 ml/day. Mean blood loss during treatment with tenoxicam was 0.84 ml/day and with piroxicam 0.81 ml/day. There was no significant difference between these measurements. On cessation of treatment, faecal blood loss continued both in the tenoxicam group (mean 1.30 ml/day) and piroxicam group (mean 1.41 ml/day). The difference between these was not statistically significant. No significant haematological or biochemical abnormality resulted from either of the two trial drugs during the period of the study. Urinalysis and NAG/creatinine ratio also remained unaltered in both treatment groups.

摘要

在一项针对12名健康男性志愿者的双盲平行对照研究中,比较了每日剂量为20毫克的替诺昔康与每日剂量为20毫克的吡罗昔康引起的粪便失血情况。在两组中,均在服用安慰剂的1周导入期、4周治疗期以及治疗后2周期间测量粪便失血量。替诺昔康和吡罗昔康的血浆水平证实所有受试者均依从性良好。安慰剂导入期的平均失血量为每天0.35毫升。替诺昔康治疗期间的平均失血量为每天0.84毫升,吡罗昔康治疗期间为每天0.81毫升。这些测量结果之间无显著差异。治疗停止后,替诺昔康组(平均每天1.30毫升)和吡罗昔康组(平均每天1.41毫升)的粪便失血仍在继续。两者之间的差异无统计学意义。在研究期间,两种试验药物均未导致显著的血液学或生化异常。两个治疗组的尿液分析及NAG/肌酐比值也均未改变。

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