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左氧氟沙星与莫西沙星治疗耐多药结核病的比较。

Comparison of levofloxacin versus moxifloxacin for multidrug-resistant tuberculosis.

机构信息

1 Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

出版信息

Am J Respir Crit Care Med. 2013 Oct 1;188(7):858-64. doi: 10.1164/rccm.201303-0604OC.

Abstract

RATIONALE

Levofloxacin (LFX) and moxifloxacin (MXF) are the two most frequently recommended fluoroquinolones for treatment of patients with multidrug-resistant tuberculosis (MDR-TB). However, studies comparing the effectiveness of LFX and MXF among patients with MDR-TB are lacking.

OBJECTIVES

To compare the effectiveness of LFX and MXF in terms of culture conversion after 3 months of treatment for MDR-TB.

METHODS

In this prospective multicenter randomized open label trial, we randomly assigned 182 patients with MDR-TB (sensitive to LFX and MXF) to receive either LFX (750 mg/day; 90 patients) or MXF (400 mg/day; 92 patients) with a background drug regimen. The primary outcome was the proportion of patients who achieved sputum culture conversion at 3 months of treatment. Secondary outcomes were time to culture conversion and time to smear conversion, with data censored at 3 months, and the proportions of adverse drug reactions.

MEASUREMENTS AND MAIN RESULTS

At 3 months of treatment, 68 (88.3%) of the 77 patients in the LFX group and 67 (90.5%) of the 74 in the MXF group showed conversion to negative sputum cultures (odds ratio for LFX compared with MXF, 0.78; 95% confidence interval, 0.27-2.20). Adverse drug reactions were reported in six patients (7.7%) in the LFX group and four (5.2%) in the MXF group (P = 0.75).

CONCLUSIONS

The choice of LFX or MXF for treatment of patients with MDR-TB may not affect sputum culture conversion at 3 months of treatment. Clinical trial registered with www.clinicaltrials.gov (NCT 01055145).

摘要

背景

左氧氟沙星(LFX)和莫西沙星(MXF)是治疗耐多药结核病(MDR-TB)患者最常推荐的两种氟喹诺酮类药物。然而,缺乏比较 LFX 和 MXF 治疗 MDR-TB 患者疗效的研究。

目的

比较 LFX 和 MXF 在治疗 MDR-TB 患者 3 个月后培养转换方面的疗效。

方法

在这项前瞻性多中心随机开放标签试验中,我们将 182 例 MDR-TB (对 LFX 和 MXF 敏感)患者随机分为 LFX 组(750mg/天;90 例)或 MXF 组(400mg/天;92 例),并使用背景药物治疗。主要结局是治疗 3 个月时痰培养转阴的患者比例。次要结局是培养和涂片转阴时间,数据截止到 3 个月,并记录不良反应的比例。

测量和主要结果

在治疗 3 个月时,LFX 组 77 例患者中有 68 例(88.3%)和 MXF 组 74 例患者中有 67 例(90.5%)转为阴性痰培养(LFX 组与 MXF 组的比值比,0.78;95%置信区间,0.27-2.20)。LFX 组有 6 例(7.7%)和 MXF 组有 4 例(5.2%)患者报告药物不良反应(P = 0.75)。

结论

在治疗 MDR-TB 患者时,选择 LFX 或 MXF 可能不会影响治疗 3 个月时的痰培养转换。临床试验注册于 www.clinicaltrials.gov(NCT 01055145)。

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