New TB drugs for the treatment of children and adolescents with rifampicin-resistant TB in Mumbai, India
New TB drugs for the treatment of children and adolescents with rifampicin-resistant TB in Mumbai, India
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DOI：
10.5588/ijtld.20.0165
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发表时间：
2020-12-01
影响因子：
4
通讯作者：
Thakur, H. P.
中科院分区：
文献类型：
--
作者：
Das, M.;Mamnoon, F.;Thakur, H. P.
设置：目的：确定儿童和青少年的最终治疗结果、培养转化和治疗期间的不良事件（AE（0-19岁）耐利福平结核病（RR-TB）患者，在2014年9月至2020年1月期间接受了门诊免注射治疗，包括贝达喹啉（BDQ）和/或德拉马尼（DLM）。设计：这是一项回顾性队列研究的基础上审查常规收集的程序data.RESULTS：24例患者被纳入;中位年龄为15.5岁（最小值最大值3-19）和15（63%）是女性。没有人同时感染艾滋病毒。所有患者均对氟喹诺酮类药物耐药。12例接受BDQ和DLM治疗，11例接受DLM治疗，1例接受BDQ治疗。BDQ（n = 13）和DLM（n = 23）的中位暴露时间分别为82（IQR 80-93）和82（IQR 77-96）周。17例（94%）基线培养阳性的患者（n = 18）在治疗期间培养阴性;培养转换的中位时间为7周（IQR 5-11）。23例（96%）患者获得成功治疗结局：治愈（n = 16）或完成治疗（n = 7）; 1例死亡。11例（46%）患者发生了17次AE。12例严重不良事件中有2例与新药物相关（QTcF >500 ms）。结论：基于全球最大的接受新结核药物的儿童和青少年队列，本研究表明，在门诊基础上，含BDQ和/或DLM的免注射方案在儿童和青少年中有效且耐受性良好，应使这些弱势群体常规使用。
SETTING: Medecins Sans Frontieres (MSF) clinic in Mumbai, India.OBJECTIVE : To determine the final treatment outcomes, culture conversion and adverse events (AEs) during treatment among children and adolescents (0-19 years) with rifampicin-resistant tuberculosis (RR-TB) who received ambulatory injectable-free treatment, including bedaquiline (BDQ) and/or delamanid (DLM) during September 2014-January 2020.DESIGN: This was a retrospective cohort study based on review of routinely collected programme data.RESULTS : Twenty-four patients were included; the median age was 15.5 years (min-max 3-19) and 15 (63%) were females. None were HIV-coinfected. All had fluoroquinolone resistance. Twelve received treatment, including BDQ and DLM, 11 received DLM and one BDQ. The median exposure to BDQ (n = 13) and DLM (n = 23) was 82 (IQR 80-93) and 82 (IQR 77-96) weeks, respectively. Seventeen (94%) patients with positive culture at baseline (n = 18) had negative culture during treatment; median time for culture-conversion was 7 weeks (IQR 5-11). Twenty-three (96%) had successful treatment outcomes: cured (n = 16) or completed treatment (n = 7); one died. Eleven (46%) had 17 episodes of AEs. Two of 12 serious AEs were associated with new drugs (QTcF >500 ms).CONCLUSION: Based on one of the largest global cohorts of children and adolescents to receive new TB drugs, this study has shown that injectable-free regimens containing BDQ and/or DLM on ambulatory basis were effective and well-tolerated among children and adolescents and should be made routinely accessible to these vulnerable groups.