Veve Michael P, Kenney Rachel M, Aljundi Alisar M, Dierker Michelle S, Athans Vasilios, Shallal Anita B, Patel Nimish
Department of Pharmacy, Henry Ford Hospital, Detroit, Michigan, USA.
Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA.
Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0159624. doi: 10.1128/aac.01596-24. Epub 2025 Mar 4.
Non-tuberculosis mycobacteria (NTM) are extensively drug-resistant organisms that require long-term therapy. The study purpose was to quantify the incidence of and risk factors for antimycobacterial-associated adverse drug events (ADEs) in persons with NTM infections receiving outpatient therapy. A multicenter, retrospective cohort was performed of persons with NTM infections who received antimycobacterial treatment from 2013 to 2024. Inclusion criteria were age ≥18 years, ≥1 month of outpatient treatment, and ≥1 follow-up outpatient visit within 3 months of index encounter. complex and complex were excluded. The primary outcome was development of pre-specified treatment-related ADE or acute kidney injury (AKI), thrombocytopenia, and/or infection (CDI) through 12 months of therapy. Secondary outcomes included therapy discontinuation due to any treatment-related ADEs. Two hundred patients were included: 14% developed a pre-specified ADE. (29%) was the most common pathogen; most initial regimens included a macrolide (54%), systemic aminoglycoside (24%), β-lactam (24%), or tetracycline derivative (22%). The most common pre-specified ADEs were thrombocytopenia (9%), AKI (8%), and CDI (<1%). The median (IQR) time-to-ADE was 25 (18-38) days from initial outpatient regimen; patients who received aminoglycoside- or oxazolidinone-based therapies were more likely to develop a pre-specified ADE (adjOR, 3.9; 95% CI, 1.7-9.2). Therapy discontinuation due to any ADE occurred in 35% of patients; the median (IQR) time-to-any ADE was 32 (21-58) days. ADEs in persons with NTM infections are common and occur near the first month of outpatient treatment. Intensified monitoring and/or use of more tolerable antimycobacterial regimens early in treatment may be an appropriate approach to avoid harms.Treatment of non-tuberculosis mycobacteria is complicated by adverse drug events (ADEs). This work quantified the incidence and time course of pre-determined, clinically relevant ADEs (acute kidney injury, thrombocytopenia, and infection), which occurred in 14% of patients within 30 days of outpatient treatment.
非结核分枝杆菌（NTM）是广泛耐药的病原体，需要长期治疗。本研究的目的是量化接受门诊治疗的NTM感染患者中抗分枝杆菌相关不良药物事件（ADEs）的发生率及危险因素。对2013年至2024年接受抗分枝杆菌治疗的NTM感染患者进行了一项多中心回顾性队列研究。纳入标准为年龄≥18岁、门诊治疗≥1个月以及在首次就诊后3个月内至少有1次门诊随访。排除复杂……和复杂……。主要结局是在治疗12个月内出现预先指定的与治疗相关的ADE或急性肾损伤（AKI）、血小板减少症和/或艰难梭菌感染（CDI）。次要结局包括因任何与治疗相关的ADE而停药。共纳入200例患者：14%出现了预先指定的ADE。鸟分枝杆菌（29%）是最常见的病原体；大多数初始治疗方案包括大环内酯类（54%）、全身用氨基糖苷类（24%）、β-内酰胺类（24%）或四环素衍生物（22%）。最常见的预先指定的ADE是血小板减少症（9%）、AKI（8%）和CDI（<1%）。从初始门诊治疗方案开始计算，ADE发生的中位（四分位间距）时间为25（18 - 38）天；接受基于氨基糖苷类或恶唑烷酮类治疗的患者更有可能出现预先指定的ADE（调整后比值比，3.9；95%置信区间，1.7 - 9.2）。35%的患者因任何ADE而停药；出现任何ADE的中位（四分位间距）时间为32（21 - 58）天。NTM感染患者中的ADE很常见，且发生在门诊治疗的第一个月左右。在治疗早期加强监测和/或使用更耐受的抗分枝杆菌治疗方案可能是避免危害的合适方法。非结核分枝杆菌的治疗因不良药物事件（ADEs）而变得复杂。这项研究量化了预先确定的、临床相关的ADE（急性肾损伤、血小板减少症和艰难梭菌感染）的发生率和时间进程，这些事件在门诊治疗30天内发生在14%的患者中。
