氯法齐明
医学
利福平
肺病
分枝杆菌复合群
随机对照试验
重症监护医学
分枝杆菌
疾病
内科学
肺结核
皮肤病科
麻风病
病理
作者
Sanne M.H. Zweijpfenning,Rob E. Aarnoutse,Martin J. Boeree,Carlos Magis‐Rodríguez,Ralf Stemkens,Bram Geurts,Jakko van Ingen,Wouter Hoefsloot
出处
期刊:Chest
[Elsevier]
日期:2023-11-01
被引量:6
标识
DOI:10.1016/j.chest.2023.11.038
摘要
Abstract
Background
Retrospective studies have suggested clofazimine as an alternative for rifampicin in MAC-PD treatment. Research question
Is a treatment regimen consisting of clofazimine-ethambutol-macrolide non inferior to the standard treatment regimen (rifampicin-ethambutol-macrolide) in the treatment of M.avium complex pulmonary disease? Study design and Methods
In this single centre non-blinded clinical trial, we randomly assigned adult patients with MAC-PD in a 1:1 ratio to receive rifampicin or clofazimine as adjuncts to an ethambutol-macrolide backbone. The primary outcome was sputum culture conversion after six months of treatment. Results
Forty patients were assigned to receive either rifampicin (n=19) or clofazimine (n=21) ) next to ethambutol and a macrolide. After 6 months of treatment, both arms showed similar percentages of sputum culture conversion based on intention to treat analysis: 58% (11/19) for rifampicin; 62% (13/21) for clofazimine. Study discontinuation, mainly due to adverse events, was equal in both arms (26% vs 33%). Based on an on treatment analysis sputum culture conversion after 6 months of treatment was 79% in both groups. In the clofazimine arm, diarrhoea was more prevalent (76% vs 37%; p=0.012), while arthralgia was more frequent in the rifampicin arm (37% vs 5%; p=0.011). No difference in the frequency of QTc prolongation was seen between both groups. Interpretation
A clofazimine-ethambutol-macrolide regimen showed similar results to the standard rifampicin-ethambutol-macrolide regimen and should be considered in the treatment of MAC-PD. The frequency of adverse events was similar in both arms, but their nature was different. Individual patients characteristics and possible drug-drug interactions should be taken into consideration when choosing an antibiotic regimen for MAC-PD.
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