Respiratory Epidemiology and Clinical Research Unit,Montreal Chest Institute, McGill University,Montreal, QC, Canada.
Eur Respir J. 2013 Sep;42(3):721-32. doi: 10.1183/09031936.00180612. Epub 2013 Jan 11.
Fixed-dose combination (FDC) formulations are currently recommended for the treatment of active tuberculosis (TB). We have conducted a systematic review to evaluate the risk of treatment failure or disease relapse, acquired drug resistance, bacterial conversion after 2 months of treatment, adverse events, adherence and treatment satisfaction associated with treatment of active TB using FDC or separate drug formulations. We searched four electronic databases for randomised controlled trials and cohort studies. Results from trials that directly compared FDC to separate drug formulations were pooled. Results from other studies were reported separately. We identified 2450 citations from which 15 controlled trials and four additional relevant studies were included. In the 15 trials there were no differences in acquired drug resistance, bacterial conversion after 2 months of treatment or adverse drug reactions with FDC or separate drug formulations. There was a trend toward higher risk of failure or relapse with FDC (pooled relative risk 1.28 (95% CI 0.99-1.7)). Based on individual study results, only one of two trials that assessed treatment satisfaction, and none of five that assessed patient adherence, favoured FDCs. Although FDC formulations simplify TB therapy, the current evidence does not indicate that these formulations improve treatment outcomes among patients with active TB.
固定剂量复方制剂（FDC）目前被推荐用于治疗活动性肺结核（TB）。我们进行了一项系统评价，以评估使用 FDC 或单独药物制剂治疗活动性 TB 时治疗失败或疾病复发、获得性耐药、治疗 2 个月后细菌转化、不良事件、依从性和治疗满意度的风险。我们在四个电子数据库中搜索了随机对照试验和队列研究。直接比较 FDC 与单独药物制剂的试验结果进行了汇总。其他研究的结果分别报告。我们从 2450 条引文中确定了 15 项对照试验和 4 项额外的相关研究。在 15 项试验中，FDC 或单独药物制剂的获得性耐药、治疗 2 个月后细菌转化或药物不良反应没有差异。FDC 的失败或复发风险呈上升趋势（汇总相对风险 1.28（95%CI 0.99-1.7））。基于个别研究结果，只有两项评估治疗满意度的试验中的一项，以及五项评估患者依从性的试验均不支持 FDC。尽管 FDC 制剂简化了 TB 治疗，但目前的证据表明，这些制剂并不能改善活动性 TB 患者的治疗结果。
