Department of Neurosciences, Unit of Clinical Pharmacology. School of Medicine, Federico II University, Via S. Pansini 5, 80131 Naples, Italy.
J Clin Pharmacol. 2010 May;50(5):576-80. doi: 10.1177/0091270009347869. Epub 2010 Jan 20.
This study investigates the potential pharmacokinetic interactions between an antimicrobial agent, moxifloxacin, and 2 immunosuppressant drugs, cyclosporine and tacrolimus, in kidney transplant recipients. Twenty-two kidney transplant patients needing antibiotic therapy for urinary tract infections are enrolled. Eleven patients are under cyclosporine treatment and the other 11 patients are under tacrolimus treatment. Because the urinary tract infections are caused by gram-negative aerobes sensitive to moxifloxacin, this antibiotic is administered by oral route at a dose of 400 mg/d for 1 week; in each patient pharmacokinetic studies are carried out before and at the seventh day of therapy. For both immunosuppressors, none of the pharmacokinetic parameters investigated show statistically significant differences between values obtained before and during treatment with moxifloxacin. In fact, the concentration-time profiles of monoclonal cyclosporine, polyclonal cyclosporine, and tacrolimus are not significantly different before and during the antimicrobial therapy. The results of the present study rule out interference of moxifloxacin with both cyclosporine and tacrolimus kinetics and indicate that the concomitant administration of the fluoroquinolone and cyclosporine or tacrolimus does not require modifications of the dosages of 2 immunosuppressant drugs.
本研究旨在探讨抗菌药物莫西沙星与两种免疫抑制剂环孢素和他克莫司在肾移植受者中的潜在药代动力学相互作用。本研究共纳入 22 例因尿路感染而需要接受抗生素治疗的肾移植患者。其中 11 例患者接受环孢素治疗,11 例患者接受他克莫司治疗。由于尿路感染是由对莫西沙星敏感的革兰氏阴性需氧菌引起的,因此该抗生素通过口服途径给药,剂量为 400mg/d,疗程为 1 周;在每个患者中,在治疗前和第 7 天进行药代动力学研究。对于两种免疫抑制剂,在所研究的药代动力学参数中,莫西沙星治疗前后的值均无统计学差异。事实上,单克隆环孢素、多克隆环孢素和他克莫司的浓度-时间曲线在抗菌治疗前后并无显著差异。本研究结果排除了莫西沙星对环孢素和他克莫司动力学的干扰,并表明氟喹诺酮类药物与环孢素或他克莫司同时使用时,不需要调整两种免疫抑制剂的剂量。