Bosso J A
University of Utah College of Pharmacy, Salt Lake City.
Am J Med. 1989 Nov 30;87(5A):123S-127S. doi: 10.1016/0002-9343(89)90040-5.
In order to evaluate the clinical efficacy and safety of oral ciprofloxacin in the treatment of acute pulmonary exacerbations of cystic fibrosis and trace the possible development of resistance over time, three trials were conducted. In an open-label, uncontrolled trial, 25 courses of ciprofloxacin were administered to 16 patients. Efficacy and safety were assessed based on changes in short-term clinical scores, white blood cell counts, Pseudomonas aeruginosa counts in sputum, pulmonary function tests, and standard serum chemistries and urinalysis that were performed before therapy, weekly during therapy, at the end of therapy, and at a seven-day follow-up visit after therapy. In an open-label, randomized, controlled study, the efficacy and tolerance of oral ciprofloxacin were compared with those of intravenous tobramycin and azlocillin. In another study, the rate of susceptibility of P. aeruginosa isolated from cystic fibrosis patients during more than two years of clinical use was determined. In the uncontrolled trial, ciprofloxacin therapy was associated with clinical improvement in most cases with changes in short-term clinical score and forced expiratory volume in one second being statistically significant (p less than 0.05). Twenty-five patients were entered in the controlled trial with 12 patients in each treatment group being evaluable. The groups were comparable based on admitting demographic and disease characteristics, and no differences in therapeutic response or side effects were noted between the two treatments (p greater than 0.5). Bacterial susceptibility to ciprofloxacin has remained relatively stable over time. Based on these results as well as those from similar evaluations, ciprofloxacin appears to be efficacious in the treatment of acute pulmonary exacerbations in adults with cystic fibrosis, producing responses similar to those observed with standard intravenous antibiotic therapy.
为了评估口服环丙沙星治疗囊性纤维化急性肺部加重的临床疗效和安全性，并追踪随时间推移可能出现的耐药性发展情况，进行了三项试验。在一项开放标签、非对照试验中，对16例患者给予了25个疗程的环丙沙星治疗。根据治疗前、治疗期间每周、治疗结束时以及治疗后7天随访时进行的短期临床评分、白细胞计数、痰液中铜绿假单胞菌计数、肺功能测试以及标准血清化学和尿液分析的变化来评估疗效和安全性。在一项开放标签、随机、对照研究中，将口服环丙沙星的疗效和耐受性与静脉注射妥布霉素和阿洛西林进行了比较。在另一项研究中，测定了在两年多临床使用期间从囊性纤维化患者中分离出的铜绿假单胞菌的药敏率。在非对照试验中，环丙沙星治疗在大多数病例中与临床改善相关，短期临床评分和一秒用力呼气量的变化具有统计学意义（p小于0.05）。25例患者进入对照试验，每个治疗组有12例患者可进行评估。根据入院时的人口统计学和疾病特征，两组具有可比性，两种治疗在治疗反应或副作用方面未发现差异（p大于0.5）。随着时间的推移，细菌对环丙沙星的敏感性一直保持相对稳定。基于这些结果以及类似评估的结果，环丙沙星似乎对治疗成年囊性纤维化患者的急性肺部加重有效，产生的反应与标准静脉抗生素治疗观察到的反应相似。
