1 Department of Respiratory Medicine, Tenryu Hospital, National Hospital Organization, Hamamatsu, Japan; and.
Ann Am Thorac Soc. 2014 Jan;11(1):23-9. doi: 10.1513/AnnalsATS.201308-266OC.
Patients with Mycobacterium avium complex pulmonary disease are frequently administered a combination of clarithromycin, ethambutol, and rifampicin. However, rifampicin is known to reduce the serum levels of clarithromycin. It remains unclear whether a reduction in clarithromycin serum levels influences the clinical outcome of the Mycobacterium avium complex pulmonary disease treatment regimen.
To compare a three-drug regimen (clarithromycin, ethambutol, and rifampicin) to a two-drug regimen (clarithromycin and ethambutol) for the treatment of Mycobacterium avium lung disease.
In a preliminary open-label study, we randomly assigned newly diagnosed, but as-yet untreated, patients with disease caused by Mycobacterium avium complex without HIV infection to either the three-drug or the two-drug regimen for 12 months. The primary endpoint was the conversion of sputum cultures to negative after 12 months of treatment. Patient data were analyzed using the intention-to-treat method.
Of 119 eligible patients, 59 were assigned to the three-drug regimen and 60 to the two-drug regimen. The rate of sputum culture conversion was 40.6% with the three-drug regimen and 55.0% with the two-drug regimen (difference, -14.4% [95% confidence interval, -32.1 to 3.4]). The incidence of adverse events leading to the discontinuation of treatment was 37.2 and 26.6% for the three-drug and the two-drug regimens, respectively.
This preliminary study suggests that treatment with clarithromycin and ethambutol is not inferior to treatment with clarithromycin, ethambutol, and rifampicin for Mycobacterium avium complex lung disease. Our findings justify a larger clinical trial to compare long-term clinical outcomes for the two treatment regimens. Clinical trial registered with http://www.umin.ac.jp/english/ (UMIN000002819).
患有鸟分枝杆菌复合群肺病的患者常采用克拉霉素、乙胺丁醇和利福平联合治疗。然而，利福平已知会降低克拉霉素的血清水平。目前尚不清楚克拉霉素血清水平的降低是否会影响鸟分枝杆菌复合群肺病治疗方案的临床结果。
比较三药方案（克拉霉素、乙胺丁醇和利福平）与两药方案（克拉霉素和乙胺丁醇）治疗鸟分枝杆菌肺病的疗效。
在一项初步的开放性标签研究中，我们将未经治疗且新近诊断为鸟分枝杆菌复合群感染但无 HIV 感染的患者随机分配至三药组或两药组，接受为期 12 个月的治疗。主要终点是治疗 12 个月后痰培养转为阴性。采用意向治疗法对患者数据进行分析。
在 119 例符合条件的患者中，59 例患者被分配至三药组，60 例患者被分配至两药组。三药组痰培养转阴率为 40.6%，两药组为 55.0%（差值为-14.4%[95%置信区间为-32.1 至 3.4]）。三药组和两药组因不良事件而停药的发生率分别为 37.2%和 26.6%。
这项初步研究表明，克拉霉素和乙胺丁醇治疗方案对于鸟分枝杆菌复合群肺病并不劣于克拉霉素、乙胺丁醇和利福平联合治疗方案。我们的研究结果支持开展一项更大规模的临床试验，以比较两种治疗方案的长期临床结局。临床试验在 http://www.umin.ac.jp/english/（UMIN000002819）上注册。
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