Morgan Hannah, Ndjeka Norbert, Hasan Tasnim, Gegia Medea, Mirzayev Fuad, Nguyen Linh N, Schumacher Samuel, Schlub Timothy E, Naidoo Kogieleum, Fox Greg J
Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
National Department of Health, Tuberculosis Control and Management Cluster, Pretoria, South Africa.
Clin Infect Dis. 2024 Jun 14;78(6):1698-1706. doi: 10.1093/cid/ciae145.
In 2019, the South African tuberculosis program replaced ethionamide with linezolid as part of an all-oral 9-month regimen. We evaluated treatment outcomes for patients assigned to regimens including linezolid in 2019 and ethionamide in 2017.
This retrospective cohort study included patients treated for multidrug-resistant/rifampicin-resistant tuberculosis throughout South Africa between 1 January and 31 December 2017 and 1 January to 31 December 2019. The cohort treated with a 9-month regimen containing ethionamide for four months, was compared with a cohort treated with a 9-month regimen containing linezolid for 2 months. The regimens were otherwise identical. Inverse probability weighting of propensity scores was used to adjust for potential confounding. A log-binomial regression model was used to estimate adjusted relative risk (aRR) comparing 24-month outcomes between cohorts including treatment success, death, loss to follow up, and treatment failure. Adverse event data were available for the linezolid cohort.
In total, 817 patients were included in the cohort receiving ethionamide and 4244 in the cohort receiving linezolid. No evidence for a difference was observed between linezolid and ethionamide regimens for treatment success (aRR = 0.96, 95% confidence interval [CI] .91-1.01), death (aRR = 1.01, 95% CI .87-1.17) or treatment failure (aRR = 0.87, 95% CI .44-1.75). Loss to follow-up was more common in the linezolid group, although estimates were imprecise (aRR = 1.22, 95% CI .99-1.50).
No significant differences in treatment success and survival were observed with substitution of linezolid for ethionamide as a part of an all-oral 9-month regimen. Linezolid is an acceptable alternative to ethionamide in this shorter regimen for treatment of multidrug-resistant/rifampicin-resistant tuberculosis.
2019年，南非结核病防治项目用利奈唑胺取代乙硫异烟胺，作为全口服9个月治疗方案的一部分。我们评估了2019年分配接受含利奈唑胺方案治疗的患者以及2017年分配接受含乙硫异烟胺方案治疗的患者的治疗结局。
这项回顾性队列研究纳入了2017年1月1日至12月31日以及2019年1月1日至12月31日期间在南非各地接受耐多药/利福平耐药结核病治疗的患者。将接受含乙硫异烟胺的9个月方案治疗4个月的队列与接受含利奈唑胺的9个月方案治疗2个月的队列进行比较。其他方面，两个方案相同。采用倾向评分的逆概率加权法来调整潜在的混杂因素。使用对数二项回归模型来估计调整后的相对风险（aRR），比较两个队列24个月的结局，包括治疗成功、死亡、失访和治疗失败。利奈唑胺队列有不良事件数据。
接受乙硫异烟胺治疗的队列共纳入817例患者，接受利奈唑胺治疗的队列共纳入4244例患者。在治疗成功（aRR = 0.96，95%置信区间[CI].91 - 1.01）、死亡（aRR = 1.01，95% CI.87 - 1.17）或治疗失败（aRR = 0.87，95% CI.44 - 1.75）方面，未观察到利奈唑胺方案和乙硫异烟胺方案之间存在差异。失访在利奈唑胺组更为常见，尽管估计值不太精确（aRR = 1.22，95% CI.99 - 1.50）。
作为全口服9个月方案的一部分，用利奈唑胺替代乙硫异烟胺后，在治疗成功和生存率方面未观察到显著差异。在这种较短的治疗耐多药/利福平耐药结核病的方案中，利奈唑胺是乙硫异烟胺的可接受替代药物。
