Bergstermann H, Rüchardt A
Zentralkrankenhaus Gauting, Tuberkuloseabteilung, Germany.
Infection. 1997 Jul-Aug;25(4):227-32. doi: 10.1007/BF01713149.
Ciprofloxacin was used as an antituberculous drug in adult patients who could not tolerate standard regimens or had to be treated with alternative combinations for resistance problems. During October 1986 to December 1991, 241 patients received ciprofloxacin in two daily 500 mg doses administered under supervision at 8.30 a.m. and 5 p.m., respectively. This group of patients was submitted to retrospective analysis for tolerability and clinical as well as microbiological efficacy. In January 1992, a once daily regimen with 1,000 mg of ciprofloxacin was introduced in order to simplify drug administration together with the other combination partners and to take advantage of higher drug levels at the site of infection. These patients were followed prospectively for safety and efficacy. Until July 1993, 227 patients with smear-positive pulmonary tuberculosis were included in this open study. Comparative analysis was carried out for a selected group of patients who had remained smear and culture positive for more than 27 days after start of treatment. Fifty-four patients who had received ciprofloxacin twice daily and 35 patients on the once daily regimen were evaluable. Both regimens were equally well tolerated. The once daily regimen was associated with a trend towards earlier conversion to smear negativity and a significantly shorter time to culture negativity. Smears became negative on average within 84 days with the once daily and in 94 days with the twice daily schedule (p = 0.19). Culture negativity occurred at 60 and 76 days in the respective groups (p = 0.0013; log Rank test). Of the patients who received ciprofloxacin twice daily, 33% were still smear and culture positive 90 days after start of treatment compared to only 15% of the patients treated with the once daily schedule. We conclude that ciprofloxacin, given as a single daily dose of 1,000 mg is as safe as two 500 mg doses, more convenient to apply and probably more efficacious.
环丙沙星被用作无法耐受标准治疗方案或因耐药问题必须采用替代联合方案治疗的成年结核病患者的抗结核药物。1986年10月至1991年12月期间，241例患者接受环丙沙星治疗，每日分两次给药，每次500mg，分别于上午8:30和下午5:00在监督下服用。对该组患者进行了耐受性、临床及微生物学疗效的回顾性分析。1992年1月，引入了每日一次服用1000mg环丙沙星的方案，以便与其他联合用药伙伴一起简化给药方式，并利用感染部位更高的药物浓度。对这些患者进行了安全性和疗效的前瞻性随访。截至1993年7月，227例涂片阳性的肺结核患者被纳入这项开放性研究。对治疗开始后涂片和培养持续阳性超过27天的一组选定患者进行了比较分析。54例每日接受两次环丙沙星治疗的患者和35例接受每日一次方案治疗的患者可进行评估。两种方案的耐受性同样良好。每日一次方案有使痰涂片转阴时间更早的趋势，且培养转阴时间显著更短。每日一次方案组痰涂片平均在84天内转阴，每日两次方案组在94天内转阴（p = 0.19）。两组培养转阴时间分别为60天和76天（p = 0.0013；对数秩检验）。每日接受两次环丙沙星治疗的患者中，33%在治疗开始90天后痰涂片和培养仍为阳性，而每日一次方案治疗的患者中这一比例仅为15%。我们得出结论，每日单次服用1000mg环丙沙星与每日两次服用500mg一样安全，使用更方便，可能疗效也更好。
