S Koirala, N P Shah, P Pyakurel, M Khanal, S K Rajbhandari, T Pun, B Shrestha, B Maharjan, S Karki, S Koirala, K B Tamang, A Roggi, A M V Kumar, N Ortuño-Gutiérrez
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Key reasons for ineligibility to start/continue STR were baseline resistance or exposure to second-line drugs (62.0%), contact with extensively drug-resistant TB (XDR-TB) or pre-XDR-TB (7.0%) patients and unavailability of STR drugs (6.0%). Treatment success was 79.6%; unsuccessful outcomes were death (12.0%), lost to follow-up (5.3%), failure (2.7%) and not evaluated (0.7%). Unsuccessful outcomes were significantly associated with HIV positivity and patient age ⩾55 years, with adjusted relative risk of respectively 2.39 (95% CI 1.52-3.77) and 3.86 (95% CI 2.30-6.46). Post-treatment recurrence at 6 and 12 months was respectively 0.5% and 2.4%. Serious adverse events (SAEs) were seen in 15.3% patients - hepatotoxicity and ototoxicity were most common.</p><p><strong>Conclusion: </strong>STR had a modest uptake, high treatment success and low post-treatment recurrence. For proper detection and management of SAEs, improving pharmacovigilance might be considered. 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引用次数: 0
摘要
环境:九个耐药结核病中心,其中一些得到了尼泊尔达米安基金会的支持,超过80%的耐多药/耐利福平结核病(MDR/RR-TB)患者在这些中心接受治疗:评估2018年1月至2019年12月登记的MDR/RR-TB患者对9-12个月短期治疗方案(STR)的接受情况、有效性和安全性:这是一项涉及二级计划数据的队列研究:在 631 名患者中,301 人(48.0%)开始并继续接受 STR 治疗。不符合开始/继续 STR 的主要原因是基线耐药或接触过二线药物(62.0%)、接触过广泛耐药结核病(XDR-TB)或前 XDR-TB 患者(7.0%)以及无法获得 STR 药物(6.0%)。治疗成功率为 79.6%;失败率为死亡(12.0%)、失去随访(5.3%)、失败(2.7%)和未评估(0.7%)。不成功的结果与 HIV 阳性和患者年龄 ⩾55 岁明显相关,调整后的相对风险分别为 2.39 (95% CI 1.52-3.77) 和 3.86 (95% CI 2.30-6.46)。治疗后6个月和12个月的复发率分别为0.5%和2.4%。15.3%的患者出现了严重不良事件(SAE)--肝毒性和耳毒性最为常见:结论:STR 的使用率不高,治疗成功率高,治疗后复发率低。为了正确检测和处理 SAE,可以考虑改进药物警戒。提供二线药物的快速诊断测试对于正确管理患者至关重要。
High success and low recurrence with shorter treatment regimen for multidrug-resistant TB in Nepal.
Setting: Nine drug-resistant TB centres, some of them supported by Damien Foundation in Nepal where >80% of multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) patients are treated.
Objective: To assess the uptake, effectiveness and safety of the 9-12-month shorter treatment regimen (STR) in MDR/RR-TB patients registered from January 2018 to December 2019.
Design: This was a cohort study involving secondary programme data.
Results: Of 631 patients, 301 (48.0%) started and continued STR. Key reasons for ineligibility to start/continue STR were baseline resistance or exposure to second-line drugs (62.0%), contact with extensively drug-resistant TB (XDR-TB) or pre-XDR-TB (7.0%) patients and unavailability of STR drugs (6.0%). Treatment success was 79.6%; unsuccessful outcomes were death (12.0%), lost to follow-up (5.3%), failure (2.7%) and not evaluated (0.7%). Unsuccessful outcomes were significantly associated with HIV positivity and patient age ⩾55 years, with adjusted relative risk of respectively 2.39 (95% CI 1.52-3.77) and 3.86 (95% CI 2.30-6.46). Post-treatment recurrence at 6 and 12 months was respectively 0.5% and 2.4%. Serious adverse events (SAEs) were seen in 15.3% patients - hepatotoxicity and ototoxicity were most common.
Conclusion: STR had a modest uptake, high treatment success and low post-treatment recurrence. For proper detection and management of SAEs, improving pharmacovigilance might be considered. Availability of rapid diagnostic test for second-line drugs is crucial for correct patient management.
期刊介绍:
Launched on 1 May 2011, Public Health Action (PHA) is an official publication of the International Union Against Tuberculosis and Lung Disease (The Union). It is an open access, online journal available world-wide to physicians, health workers, researchers, professors, students and decision-makers, including public health centres, medical, university and pharmaceutical libraries, hospitals, clinics, foundations and institutions. PHA is a peer-reviewed scholarly journal that actively encourages, communicates and reports new knowledge, dialogue and controversy in health systems and services for people in vulnerable and resource-limited communities — all topics that reflect the mission of The Union, Health solutions for the poor.