Treatment outcomes 24 months after initiating short, all-oral bedaquiline-containing or injectable-containing rifampicin-resistant tuberculosis treatment regimens in South Africa: a retrospective cohort study.
Treatment outcomes 24 months after initiating short, all-oral bedaquiline-containing or injectable-containing rifampicin-resistant tuberculosis treatment regimens in South Africa: a retrospective cohort study.
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在南非开始短期、全口服含贝达喹啉或含注射剂的利福平耐药结核病治疗方案后24个月的治疗结果：一项回顾性队列研究
DOI：
10.1016/s1473-3099(21)00811-2
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发表时间：
2022-07
影响因子：
56.3
通讯作者：
Menzies, Dick
中科院分区：
文献类型：
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作者：
Ndjeka, Norbert;Campbell, Jonathon R.;Meintjes, Graeme;Maartens, Gary;Schaaf, H. Simon;Hughes, Jennifer;Padanilam, Xavier;Reuter, Anja;Romero, Rodolfo;Ismail, Farzana;Enwerem, Martin;Ferreira, Hannetjie;Conradie, Francesca;Naidoo, Kogieleum;Menzies, Dick
需要对耐利福平结核病进行短期、安全的全口服治疗。我们比较了南非耐利福平结核病患者在开始治疗后24个月内接受短期、全口服贝达奎林方案(贝达奎林组)和短期、可注射方案(注射组)治疗的结果。对利福平耐药的结核病患者，年龄在18岁或以上，有资格在2017年1月1日至12月31日期间开始接受短期方案治疗，并在耐药结核病数据库(EDRWeb)中登记，使用贝达奎林或世卫组织推荐的9-12个月的可注射治疗方案，并已知年龄、性别、艾滋病毒状况和国家识别号，符合纳入研究的条件；接受利奈唑胺、碳青霉烯类、特利西酮或环丝氨酸、delamanid或对氨基水杨酸的患者被排除在外。贝达奎兰剂量为400毫克，每日一次，连续两周，然后每周三次，每次200毫克，共22周。为了比较方案，患者在HIV和ART状态、既往结核病治疗史、基线抗酸杆菌涂片和培养结果方面完全匹配，而倾向评分在年龄、性别、治疗省份和异烟肼敏感状态上匹配。我们做了二项线性回归来估计24个月结果的调整风险差(ARD)和95%的CI，其中包括：治疗成功(即治愈或治疗完成但没有复发证据)与所有其他结果、生存与死亡、无病生存与治疗失败或复发的生存、以及失去随访与所有其他结果。总体而言，2017年治疗的10152例耐利福平结核病患者中，1,387例(14%)符合纳入标准；贝达奎林组688例，注射组699例。治疗失败或复发4例(1%)，失访44例(6%)，死亡162例(24%)，而注射组分别为17例(2%)、87例(12%)和199例(28%)。在调整后的分析中，贝达奎林组的治疗成功率比注射组(70%比57%)高14%(95%可信区间8-20)，随访失败率(6%比12%)低4%(1-8)，无病生存率(99%比97%)高2%(0-5)。贝达奎林组治疗期间死亡风险降低8%(4~11)(17.0%比22.4%)，但治疗后死亡率差异无统计学意义。贝达奎林组患者在24个月时经历了显著更高的治疗成功率。这一发现支持在符合条件的患者中使用含有贝达奎兰的短期方案。世卫组织全球结核病规划。摘要的法文译本见补充资料部分。
There is a need for short and safe all-oral treatment of rifampicin-resistant tuberculosis. We compared outcomes up to 24 months after treatment initiation for patients with rifampicin-resistant tuberculosis in South Africa treated with a short, all-oral bedaquiline-containing regimen (bedaquiline group), or a short, injectable-containing regimen (injectable group). Patients with rifampicin-resistant tuberculosis, aged 18 years or older, eligible for a short regimen starting treatment between Jan 1 and Dec 31, 2017, with a bedaquiline-containing or WHO recommended injectable-containing treatment regimen of 9–12 months, registered in the drug-resistant tuberculosis database (EDRWeb), and with known age, sex, HIV status, and national identification number were eligible for study inclusion; patients receiving linezolid, carbapenems, terizidone or cycloserine, delamanid, or para-aminosalicylic acid were excluded. Bedaquiline was given at a dose of 400 mg once daily for two weeks followed by 200 mg three times a week for 22 weeks. To compare regimens, patients were exactly matched on HIV and ART status, previous tuberculosis treatment history, and baseline acid-fast bacilli smear and culture result, while propensity score matched on age, sex, province of treatment, and isoniazid-susceptibility status. We did binomial linear regression to estimate adjusted risk differences (aRD) and 95% CIs for 24-month outcomes, which included: treatment success (ie, cure or treatment completion without evidence of recurrence) versus all other outcomes, survival versus death, disease free survival versus survival with treatment failure or recurrence, and loss to follow-up versus all other outcomes. Overall, 1387 (14%) of 10152 patients with rifampicin-resistant tuberculosis treated during 2017 met inclusion criteria; 688 in the bedaquiline group and 699 in the injectable group. Four patients (1%) had treatment failure or recurrence, 44 (6%) were lost to follow-up, and 162 (24%) died in the bedaquiline group, compared with 17 (2%), 87 (12%), and 199 (28%), respectively, in the injectable group. In adjusted analyses, treatment success was 14% (95% CI 8–20) higher in the bedaquiline group than in the injectable group (70% vs 57%); loss to follow-up was 4% (1–8) lower in the bedaquiline group (6% vs 12%); and disease-free survival was 2% (0–5) higher in the bedaquiline group (99% vs 97%). The bedaquiline group had 8% (4–11) lower risk of mortality during treatment (17·0% vs 22·4%), but there was no difference in mortality post-treatment. Patients in the bedaquiline group experienced significantly higher rates of treatment success at 24 months. This finding supports the use of short bedaquiline-containing regimens in eligible patients. WHO Global TB Programme. For the French translation of the abstract see Supplementary Materials section.