Koirala S, Shah N P, Pyakurel P, Khanal M, Rajbhandari S K, Pun T, Shrestha B, Maharjan B, Karki S, Koirala S, Tamang K B, Roggi A, Kumar A M V, Ortuño-Gutiérrez N
Damien Foundation, Kathmandu, Nepal.
National TB Control Center, Bhaktapur, Nepal.
Public Health Action. 2021 Nov 1;11(Suppl 1):38-45. doi: 10.5588/pha.21.0041.
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.
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.
This was a cohort study involving secondary programme data.
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.
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.
九个耐多药结核病中心,其中一些由达米安基金会在尼泊尔提供支持,该国80%以上的耐多药/利福平耐药结核病(MDR/RR-TB)患者在此接受治疗。
评估2018年1月至2019年12月登记的MDR/RR-TB患者采用9至12个月短程治疗方案(STR)的接受情况、有效性和安全性。
这是一项涉及二级项目数据的队列研究。
631例患者中,301例(48.0%)开始并持续接受STR治疗。不符合开始/继续STR治疗条件的主要原因是基线耐药或接触二线药物(62.0%)、接触广泛耐药结核病(XDR-TB)或准广泛耐药结核病(pre-XDR-TB)患者(7.0%)以及STR药物不可用(6.0%)。治疗成功率为79.6%;治疗失败的结果包括死亡(12.0%)、失访(5.3%)、治疗失败(2.7%)和未评估(0.7%)。治疗失败的结果与HIV阳性和患者年龄≥55岁显著相关,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)。6个月和12个月的治疗后复发率分别为0.5%和2.4%。15.3%的患者出现严重不良事件(SAE)——肝毒性和耳毒性最为常见。
STR的接受程度适中,治疗成功率高,治疗后复发率低。为了正确检测和管理SAE,可考虑加强药物警戒。二线药物快速诊断检测的可用性对于正确的患者管理至关重要。