Ruan Qiaoling, Liu Qihui, Sun Feng, Shao Lingyun, Jin Jialin, Yu Shenglei, Ai Jingwen, Zhang Bingyan, Zhang Wenhong
Emerg Microbes Infect. 2016 Feb 24;5(2):e12. doi: 10.1038/emi.2016.12.
Moxifloxacin (MOX) and gatifloxacin (GAT) have exhibited promising mycobactericidal activity, and a number of clinical trials have been conducted in recent decades to compare the treatment efficacy of MOX-containing and/or GAT-containing regimens with the standard regimen. The aim of this meta-analysis for clinical trials of MOX- or GAT-containing regimens was to evaluate their treatment efficacy and safety in initial therapy for drug-sensitive tuberculosis (TB). Databases were searched for randomized controlled trials, and nine studies with 6980 patients were included. We found that fluoroquinolone substitution for isoniazid or ethambutol in short-course regimens might result in more frequent unfavorable treatment outcomes compared with the standard regimen-in particular, an increased incidence of relapse. In a per-protocol analysis, MOX-containing regimens had slightly higher rates of sputum culture conversion at two months than the standard regimen (RR 1.08, 95% CI 1.04-1.11, P <0.001); there was no significant difference in the rate of sputum conversion between the GAT-containing regimens and the standard regimen (RR 1.13, 95% CI 0.96-1.33, P = 0.13). There were no significant differences in the incidence of death from any cause, including TB, nor were there serious adverse events between the MOX- or GAT-containing regimens and the standard regimen. In conclusion, MOX or GAT might not have the ability to shorten treatment duration in the initial therapy for tuberculosis despite the non-inferiority or even slightly better efficacy in the early phase of treatment compared with the standard regimen. Furthermore, it is safe to include MOX or GAT in initial TB treatment.
莫西沙星(MOX)和加替沙星(GAT)已显示出有前景的杀分枝杆菌活性,并且在最近几十年进行了多项临床试验,以比较含MOX和/或含GAT方案与标准方案的治疗效果。这项针对含MOX或GAT方案的临床试验的荟萃分析的目的是评估它们在初治药物敏感结核病(TB)中的治疗效果和安全性。检索数据库以查找随机对照试验,纳入了9项研究共6980例患者。我们发现,在短程方案中用氟喹诺酮替代异烟肼或乙胺丁醇可能比标准方案导致更频繁的不良治疗结果,特别是复发率增加。在符合方案分析中,含MOX方案在两个月时痰培养转阴率略高于标准方案(RR 1.08,95%CI 1.04-1.11,P<0.001);含GAT方案与标准方案之间的痰转阴率无显著差异(RR 1.13,95%CI 0.96-1.33,P = 0.13)。在含MOX或GAT方案与标准方案之间,包括TB在内的任何原因导致的死亡率以及严重不良事件均无显著差异。总之,尽管与标准方案相比,MOX或GAT在治疗早期具有非劣效性甚至疗效略好,但它们可能没有能力缩短结核病初治的疗程。此外,在结核病初治中使用MOX或GAT是安全的。