Verho M, Dagrosa E E, Usinger P, Grötsch H, Malerczyk V, Uchida M, Rangoonwala R
Pharmatherapeutica. 1985;4(5):306-13.
An open study was carried out in 12 male, healthy volunteers to investigate the renal tolerance of ofloxacin, a new, broad-spectrum oral antibacterial agent. Subjects received single doses of 300 mg and then repeated doses of 300 mg ofloxacin twice daily for 7 days. Urine was collected in several fractions during the study and the excretion of creatinine, alanine-aminopeptidase (AAP), gamma-glutamyl transferase (GGT) and n-acetyl-beta-glucose aminidase (NAG) was calculated in 12-hour fractions. Serum creatinine, beta 2-microglobulin concentrations and creatinine clearance were also determined. Based on the findings for the kidney enzymes AAP, GGT and NAG, renal tolerance was good. This was confirmed by creatinine clearance and serum beta 2-microglobulin values. Ofloxacin showed no nephrotoxic potential in this study.
对12名男性健康志愿者进行了一项开放性研究，以调查新型广谱口服抗菌剂氧氟沙星的肾脏耐受性。受试者单次服用300毫克，然后每日两次重复服用300毫克氧氟沙星，共7天。研究期间分几次收集尿液，并计算12小时时段内肌酐、丙氨酸氨基肽酶（AAP）、γ-谷氨酰转移酶（GGT）和N-乙酰-β-葡萄糖苷酶（NAG）的排泄量。还测定了血清肌酐、β2-微球蛋白浓度和肌酐清除率。根据肾脏酶AAP、GGT和NAG的检测结果，肾脏耐受性良好。肌酐清除率和血清β2-微球蛋白值证实了这一点。在本研究中，氧氟沙星未显示出肾毒性潜力。
