Alipanah N, Cattamanchi A, Menzies R, Hopewell P C, Chaisson R E, Nahid P
Curry International Tuberculosis Center, University of California San Francisco, San Francisco, California, USA.
Montreal Chest Institute, McGill University, Montreal, Quebec, Canada.
Int J Tuberc Lung Dis. 2016 Nov;20(11):1522-1528. doi: 10.5588/ijtld.16.0217.
Several recent trials evaluating 4-month fluoroquinolone (FQ) containing regimens found that none of the experimental regimens were non-inferior to standard 6-month therapy in treating patients with drug-susceptible pulmonary tuberculosis (PTB).
To answer whether FQ-containing duration-shortened regimens are non-inferior to standard therapy in the treatment of patients with non-cavitary PTB.
Systematic review of all randomized and quasi-randomized trials that substituted an FQ into standard therapy for less than 6 months' duration to treat drug-susceptible, non-cavitary PTB. Non-inferiority was based on a 6% margin of difference.
Of 4594 total participants in the three trials that met the inclusion criteria, 1066 patients had non-cavitary disease. The pooled difference in unfavorable outcomes was 5% (95%CI -3 to 13) in patients with non-cavitary disease treated with FQ-containing regimens vs. standard therapy. In subgroup analyses, the pooled difference in unfavorable outcomes was 1% (95%CI -3 to 5) when comparing the daily form of intervention regimen with standard therapy, and -1% (95%CI -5 to 4) between regimens replacing ethambutol (EMB) with an FQ and standard therapy. No difference in risk of adverse events was noted.
Daily administered 4-month regimens with substitution of EMB by an FQ may be non-inferior to standard therapy in patients with culture-confirmed, non-cavitary, drug-susceptible PTB.
最近几项评估含4个月氟喹诺酮(FQ)方案的试验发现,在治疗药物敏感型肺结核(PTB)患者时,没有一种试验方案不劣于标准的6个月治疗方案。
回答含FQ的缩短疗程方案在治疗非空洞型PTB患者时是否不劣于标准治疗方案。
对所有将FQ替代标准治疗方案少于6个月以治疗药物敏感型、非空洞型PTB的随机和半随机试验进行系统评价。非劣效性基于6%的差异幅度。
在符合纳入标准的三项试验的4594名总参与者中,1066名患者患有非空洞型疾病。与标准治疗相比,接受含FQ方案治疗的非空洞型疾病患者不良结局的合并差异为5%(95%CI -3至13)。在亚组分析中,将每日形式的干预方案与标准治疗进行比较时,不良结局的合并差异为1%(95%CI -3至5),用FQ替代乙胺丁醇(EMB)的方案与标准治疗之间为-1%(95%CI -5至4)。未观察到不良事件风险的差异。
对于培养确诊的、非空洞型、药物敏感型PTB患者,每日给予4个月疗程且用FQ替代EMB的方案可能不劣于标准治疗方案。