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目的 :确定塞来昔布对于经常服用稳定剂量甲氨喋呤 (MTX)治疗类风湿性关节炎 (RA)患者的肾脏清除率和血浆药代动力学方面的影响。方法 :选取 14例至少已服用MTX3个月 ,且每个星期的剂量稳定在 5～15mg ,有类风湿关节炎的成年妇女 ,随机给予塞来昔布 (2 0 0mg ,bid)或安慰剂单盲治疗 ,每一阶段 7d ,分二阶段交叉试验 ,研究MTX的药代动力学和肾脏平均清除率。结果 :当MTX和塞来昔布或安慰剂合用时 ,MTX的血浆药代动力学并没有显著改变。当单用MTX时 ,其肾脏平均清除率为 (7.98± 2 .18)L/h ;合用塞来昔布时 ,MTX清除率为 (7.94± 1.6 1)L/h ;合用安慰剂时为 (7.97± 1.19)L/h ,几乎没有改变。结论 :塞来昔布对MTX的药代动力学和肾脏清除率无显著影响 ,但在老年人和有肾功能损伤的患者中 ,需要进一步的研究和证实。
Objectives: To determine the effect of celecoxib on renal clearance and plasma pharmacokinetics in patients who regularly take a stable dose of methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). METHODS: Fourteen adult women with rheumatoid arthritis who had been on MTX for at least 3 months with a stable dose of 5-15 mg per week were randomized to either celecoxib (200 mg bid) or placebo Blind treatment, 7d for each phase, was divided into two phases of crossover trials to study the MTX pharmacokinetics and renal clearance average. RESULTS: The MTX plasma pharmacokinetics did not change significantly when MTX was administered with celecoxib or placebo. When MTX alone was used, the mean clearance rate of kidney was (7.98 ± 2.18) L / h, and the clearance rate of MTX was (7.94 ± 1.6 1) L / h when combined with celecoxib. 7.97 ± 1.19) L / h, with almost no change. CONCLUSION: Celecoxib has no significant effect on the pharmacokinetics and renal clearance of MTX, but further studies and confirmations are needed in the elderly and in patients with impaired renal function.