Ziganshina L E, Vizel A A, Squire S B
Clinical Pharmacology and Pharmacotherapy, Kazan State Medical Academy for Postgraduate Medical Education, 11 Mushtari Street, 420012, 14-15 Malaya Krasnaya Street, 420015, Kazan, Tatarstan, Russia, 420012.
Cochrane Database Syst Rev. 2005 Jul 20(3):CD004795. doi: 10.1002/14651858.CD004795.pub2.
Fluoroquinolones are sometimes used to treat multiple-drug-resistant and drug-sensitive tuberculosis. The effects of fluoroquinolones in tuberculosis regimens need to be assessed.
To assess fluoroquinolones as additional or substitute components to antituberculous drug regimens for drug-sensitive and drug-resistant tuberculosis.
We searched the Cochrane Infectious Diseases Group Specialized Register (April 2005), CENTRAL (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to April 2005), EMBASE (1974 to April 2005), LILACS (1982 to April 2005), Science Citation Index (1940 to April 2005), and Russian database (1988 to April 2005). We also scanned reference lists of all identified studies and contacted researchers.
Randomized controlled trials of antituberculous regimens containing fluoroquinolones in people diagnosed with bacteriologically positive (sputum smear or culture) pulmonary tuberculosis.
Two authors independently applied inclusion criteria, assessed methodological quality, and extracted data. We used relative risk (RR) for dichotomous data, weighted mean difference (WMD) for continuous data (both with 95% confidence intervals (CI)), and the random-effects model if we detected heterogeneity and appropriate to combine data.
Ten trials (1178 participants) met the inclusion criteria. No statistically significant difference was found in trials substituting ciprofloxacin or ofloxacin for first-line drugs in relation to cure (89 participants, 2 trials), treatment failure (388 participants, 3 trials), or clinical or radiological improvement (216 participants, 2 trials). Substituting ciprofloxacin into first-line regimens in drug-sensitive tuberculosis led to a higher incidence of relapse (RR 7.17, 95% CI 1.33 to 38.58; 384 participants, 3 trials) and longer time to sputum culture conversion (WMD 0.50 months, 95% CI 0.18 to 0.82; 168 participants, 1 trial), although this was confined to HIV-positive participants. Adding or substituting levofloxacin to basic regimens in drug-resistant areas had no effect. A comparison of sparfloxacin versus ofloxacin added to regimens showed no statistically significant difference in cure (184 participants, 2 trials), treatment failure (149 participants, 2 trials), or total number of adverse events (253 participants, 3 trials).
AUTHORS' CONCLUSIONS: Only ciprofloxacin, ofloxacin, levofloxacin, and sparfloxacin have been tested in randomized controlled trials for treating tuberculosis. We cannot recommend ciprofloxacin in treating tuberculosis. Trials of newer fluoroquinolones for treating tuberculosis are needed. No difference has been demonstrated between sparfloxacin and ofloxacin in drug-resistant tuberculosis.
氟喹诺酮类药物有时用于治疗耐多药和药物敏感型结核病。需要评估氟喹诺酮类药物在结核病治疗方案中的效果。
评估氟喹诺酮类药物作为药物敏感型和耐药型结核病抗结核药物方案的附加或替代成分的效果。
我们检索了Cochrane传染病组专业注册库（2005年4月）、CENTRAL（Cochrane图书馆2005年第1期）、MEDLINE（1966年至2005年4月）、EMBASE（1974年至2005年4月）、LILACS（1982年至2005年4月）、科学引文索引（1940年至2005年4月）以及俄罗斯数据库（1988年至2005年4月）。我们还浏览了所有已识别研究的参考文献列表并联系了研究人员。
对诊断为痰涂片或培养细菌学阳性的肺结核患者使用含氟喹诺酮类药物的抗结核治疗方案进行的随机对照试验。
两位作者独立应用纳入标准、评估方法学质量并提取数据。对于二分数据，我们使用相对危险度（RR），对于连续数据使用加权均数差（WMD）（两者均带有95%置信区间（CI）），如果检测到异质性且适合合并数据，则使用随机效应模型。
10项试验（1178名参与者）符合纳入标准。在将环丙沙星或氧氟沙星替代一线药物的试验中，在治愈（89名参与者，2项试验）、治疗失败（388名参与者，3项试验）或临床或影像学改善（216名参与者，2项试验）方面未发现统计学上的显著差异。在药物敏感型结核病的一线治疗方案中加入环丙沙星会导致复发率更高（RR 7.17，95% CI 1.33至38.58；384名参与者，3项试验）以及痰培养转阴时间更长（WMD 0.50个月，95% CI 0.18至0.82；168名参与者，1项试验），不过这仅限于HIV阳性参与者。在耐药地区的基本治疗方案中添加或替代左氧氟沙星没有效果。将司帕沙星与添加到治疗方案中的氧氟沙星进行比较，在治愈（184名参与者，2项试验）、治疗失败（149名参与者，2项试验）或不良事件总数（253名参与者，3项试验）方面未发现统计学上的显著差异。
在治疗结核病的随机对照试验中仅对环丙沙星、氧氟沙星、左氧氟沙星和司帕沙星进行了测试。我们不推荐使用环丙沙星治疗结核病。需要开展新型氟喹诺酮类药物治疗结核病的试验。在耐药型结核病中，司帕沙星和氧氟沙星之间未显示出差异。
