Indian Council of Medical Research-National Institute for Research in Tuberculosis, Chennai, India.
Central TB Division, Ministry of Health and Family Welfare, New Delhi, India.
Int J Tuberc Lung Dis. 2022 Nov 1;26(11):1033-1040. doi: 10.5588/ijtld.21.0701.
Patients with isoniazid (H, INH) resistant pulmonary TB but undetected rifampicin (R, RIF) resistance are treated with a 6-month regimen of levofloxacin-RIF-ethambutol-pyrazinamide (6LvxREZ) under India´s National TB Elimination Programme (NTEP). To describe the profile of and treatment outcomes in patients with pulmonary INH-resistant (INH) TB initiated on TB treatment, and identify factors associated with unfavourable treatment outcomes (died, failed, treatment changed, lost to follow-up). This was a retrospective analysis of NTEP database (Ni-kshay) on pulmonary INH TB patients initiated on treatment with "H mono/poly regimen" (6LvxREZ) between July 2019 and June 2020 with documented treatment outcomes. Proportions with 95% confidence interval (CI) was calculated and logistic regression analysis was performed. Of the 11,519 patients with pulmonary INH TB, 9,440 (82%) had treatment success (55.1% cured, 26.9% treatment completed). Unfavourable treatment outcome was observed in 1,901 (16.5%). Male sex, tobacco and alcohol use, HIV reactive status were associated with unfavourable treatment outcome. Patients with G mutations and resistance to fluoroquinolones were likely to have poor treatment outcomes. A levofloxacin-based regimen offers a treatment success rate of 82% in patients with pulmonary INH TB. Sex-specific strategies, interventions to address smoking and alcohol use, focus on HIV-reactive patients and optimising treatment regimens based on drug susceptibility should be considered for improving treatment outcomes.
印度国家结核病消除计划（NTEP）下，对异烟肼（H，INH）耐药但未检出利福平（R，RIF）耐药的肺结核患者采用左氧氟沙星-RIF-乙胺丁醇-吡嗪酰胺（6LvxREZ）6 个月方案治疗。本研究旨在描述根据印度国家结核病消除计划（NTEP）数据库（Ni-kshay），开始使用“H 单药/多药方案”（6LvxREZ）治疗的耐 INH 肺结核（INH）患者的特征和治疗结局，并确定与不良治疗结局（死亡、失败、治疗改变、失访）相关的因素。本研究对 2019 年 7 月至 2020 年 6 月期间开始接受“H 单药/多药方案”（6LvxREZ）治疗的耐 INH 肺结核患者的 NTEP 数据库（Ni-kshay）进行了回顾性分析，并记录了治疗结局。计算了比例及其 95%置信区间（CI），并进行了逻辑回归分析。在 11519 例耐 INH 肺结核患者中，9440 例（82%）治疗成功（55.1%治愈，26.9%治疗完成）。1901 例（16.5%）出现不良治疗结局。男性、吸烟和饮酒、HIV 阳性状态与不良治疗结局相关。存在 G 基因突变和对氟喹诺酮类药物耐药的患者可能治疗结局较差。基于左氧氟沙星的方案可为耐 INH 肺结核患者提供 82%的治疗成功率。应考虑制定针对男性的具体策略，采取干预措施解决吸烟和饮酒问题，重点关注 HIV 阳性患者，并根据药物敏感性优化治疗方案，以改善治疗结局。
