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Abstract：
Infections due to nontuberculous mycobacteria (NTM) continue to increase in prevalence, leading to problematic clinical outcomes. Omadacycline (OMC) is an aminomethylcycline antibiotic with FDA orphan drug and fast-track designations for pulmonary NTM infections, including Mycobacteroides abscessus (MAB). This multicenter retrospective study across 16 U.S. medical institutions from January 2020 to March 2023 examined the long-term clinical success, safety, and tolerability of OMC for NTM infections. The cohort included patients aged ≥18 yr, who were clinically evaluable, and` had been treated with OMC for ≥3 mo without a previous diagnosis of cystic fibrosis. The primary outcome was 3 mo clinical success, with secondary outcomes including clinical improvement and mortality at 6- and 12 mo, persistence or reemergence of infection, adverse effects, and reasons for OMC utilization. Seventy-five patients were included in this analysis. Most patients were female (48/75, 64.0%) or Caucasian (58/75, 77.3%), with a median (IQR) age of 59 yr (49-67). Most had NTM pulmonary disease (33/75, 44.0%), skin and soft tissue disease (19/75, 25.3%), or osteomyelitis (10/75, 13.3%), and Mycobacterium abscessus (60/75, 80%) was the most commonly isolated NTM pathogen. The median (IQR) treatment duration was 6 mo (4 - 14), and the most commonly co-administered antibiotic was azithromycin (33/70, 47.1%). Three-month clinical success was observed in 80.0% (60/75) of patients, and AEs attributable to OMC occurred in 32.0% (24/75) of patients, leading to drug discontinuation in 9.3% (7/75).
摘要：
由非结核分枝杆菌（NTM）引起的感染患病率继续增加，导致有问题的临床结果。Omadacycline（OMC）是一种氨基甲基环素抗生素，具有FDA孤儿药和用于肺部NTM感染的快速治疗名称，包括分枝杆菌脓肿（MAB）。这项从2020年1月至2023年3月在美国16家医疗机构进行的多中心回顾性研究检查了长期临床成功。安全,OMC对NTM感染的耐受性。该队列包括年龄≥18岁的患者，可以临床评估的人，并且'接受OMC治疗≥3个月，以前没有诊断为囊性纤维化。主要结果是3个月临床成功，次要结局包括6个月和12个月的临床改善和死亡率，感染的持续或复发，不利影响，以及OMC使用的原因。75名患者纳入本分析。大多数患者为女性（48/75，64.0%）或白种人（58/75，77.3%），年龄中位数（IQR）为59岁（49-67岁）。大多数人患有NTM肺病（33/75，44.0%），皮肤和软组织疾病（19/75，25.3%），或骨髓炎（10/75，13.3%），脓肿分枝杆菌（60/75，80％）是最常见的NTM病原体。中位（IQR）治疗时间为6个月（4-14），最常见的联合使用抗生素是阿奇霉素（33/70，47.1％）。在80.0%(60/75)的患者中观察到三个月的临床成功,32.0%(24/75)的患者发生归因于OMC的不良事件，导致9.3%(7/75)停药。
