Steen H J, Scott E M, Stevenson M I, Black A E, Redmond A O, Collier P S
Royal Belfast Hospital for Sick Children, Queen's University of Belfast, UK.
J Antimicrob Chemother. 1989 Nov;24(5):787-95. doi: 10.1093/jac/24.5.787.
Twelve cystic fibrosis patients, aged over 18, who had developed an acute respiratory exacerbation and who had Pseudomonas species isolated from their sputum, were entered into a clinical trial involving ciprofloxacin. The dosage regimen was 100 mg iv followed by 500 mg twice daily orally if less than 40 kg in weight and 200 mg iv followed by 750 mg twice daily orally if greater than 40 kg. Ciprofloxacin was well tolerated with no major side effects, except in one patient who withdrew after onset of headaches and generalized aches and pains. Eleven of the 12 patients showed clinical improvement at the end of the treatment period as determined by weight gain, Shwachman Score, Chrispin Norman Score and pulmonary function tests. MICs of Pseudomonas species isolated from the sputum at the start of the trial were in the range 0.25-4 mg/l. During therapy, sensitivity of isolates decreased and did not return to starting levels at the end of a four week follow-up period. Pharmacokinetic parameters were similar to those reported for fasting healthy volunteers by other workers except for bioavailability which was reduced in the non-fasting patients.
12名年龄超过18岁、出现急性呼吸道加重且痰液中分离出假单胞菌属的囊性纤维化患者进入了一项涉及环丙沙星的临床试验。给药方案为：体重小于40kg者，静脉注射100mg，随后口服500mg，每日两次；体重大于40kg者，静脉注射200mg，随后口服750mg，每日两次。环丙沙星耐受性良好，无重大副作用，但有1例患者在出现头痛和全身酸痛后退出试验。根据体重增加、施瓦克曼评分、克里斯平·诺曼评分和肺功能测试，12例患者中有11例在治疗期结束时显示出临床改善。试验开始时从痰液中分离出的假单胞菌属的最低抑菌浓度在0.25 - 4mg/L范围内。治疗期间，分离菌株的敏感性降低，在四周随访期结束时未恢复到初始水平。除了非空腹患者的生物利用度降低外，药代动力学参数与其他研究人员报道的空腹健康志愿者的参数相似。
