Schwœbel Valérie, Trébucq Arnaud, Kashongwe Zacharie, Bakayoko Alimata S, Kuaban Christopher, Noeske Juergen, Harouna Souleymane H, Souleymane Mahamadou B, Piubello Alberto, Ciza François, Fikouma Valentin, Gasana Michel, Ouedraogo Martial, Gninafon Martin, Van Deun Armand, Tagliani Elisa, Cirillo Daniela M, Koura Kobto G, Rieder Hans L
International Union Against Tuberculosis and Lung Disease, 68 boulevard Saint-Michel, 75006 Paris, France.
Kinshasa University School of Medicine, Kinshasa, Democratic Republic of Congo.
EClinicalMedicine. 2020 Feb 10;20:100268. doi: 10.1016/j.eclinm.2020.100268. eCollection 2020 Mar.
Treatment outcomes of the shorter regimen for rifampicin-resistant tuberculosis are not completely established. We report on these outcomes two years after treatment completion among patients enrolled in an observational cohort study in nine African countries.
1,006 patients treated with the nine-month regimen were followed every six months with sputum cultures up to 24 months after treatment completion. The risk of any unfavourable outcome, of failure and relapse, and of death during and after treatment was analysed according to patient's characteristics and initial drug susceptibility by Cox proportional hazard models.
Respectively 67.8% and 57.2% patients had >=1 culture result six months and 12 months after treatment completion. Fourteen relapses were diagnosed. The probability of relapse-free success was 79.3% (95% confidence interval [CI] 76.6-82.0%) overall, 80.9% (95% CI 78.0-84.0%) among HIV-negative and 72.5% (95% CI 66.5-78.9%) among HIV-infected patients. Initial fluoroquinolone (adjusted hazard ratio [aHR] 6.7 [95% CI 3.4-13.1]) and isoniazid resistance (aHR 9.4 [95% CI 1.3-68.0]) were significantly associated with increased risk of failure/relapse and of any unfavourable outcome.
The close to 80% relapse-free success indicates the good outcome of the regimen in low-and middle-income settings. Results confirm the lesser effectiveness of the regimen in patients with initial resistance to fluoroquinolones and support the use of high-dose isoniazid, but do not support exclusion of patients for resistance to drugs other than fluoroquinolones.
Expertise-France and Agence Française de Développement.
利福平耐药结核病短程治疗方案的治疗效果尚未完全明确。我们报告了在9个非洲国家开展的一项观察性队列研究中，患者完成治疗两年后的治疗效果。
1006例接受9个月治疗方案的患者在治疗完成后每6个月进行一次痰培养，随访至24个月。根据患者特征和初始药物敏感性，采用Cox比例风险模型分析治疗期间及治疗后出现任何不良结局、治疗失败和复发以及死亡的风险。
分别有67.8%和57.2%的患者在治疗完成后6个月和12个月时至少有1次培养结果。共诊断出14例复发。总体无复发生存率为79.3%（95%置信区间[CI]76.6 - 82.0%），HIV阴性患者为80.9%（95%CI 78.0 - 84.0%），HIV感染患者为72.5%（95%CI 66.5 - 78.9%）。初始氟喹诺酮耐药（校正风险比[aHR]6.7[95%CI 3.4 - 13.1]）和异烟肼耐药（aHR 9.4[95%CI 1.3 - 68.0]）与治疗失败/复发及任何不良结局风险增加显著相关。
接近80%的无复发生存率表明该方案在低收入和中等收入环境中取得了良好的治疗效果。结果证实该方案对初始氟喹诺酮耐药患者的有效性较低，并支持使用高剂量异烟肼，但不支持因对氟喹诺酮以外的药物耐药而排除患者。
法国专家协会和法国开发署。
