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莫西沙星作为治疗肺结核的替代或附加治疗药物。

Moxifloxacin as an alternative or additive therapy for treatment of pulmonary tuberculosis.

机构信息

School of Pharmacy, Temple University, Philadelphia, PA, USA.

出版信息

Ann Pharmacother. 2011 Nov;45(11):1439-44. doi: 10.1345/aph.1Q299. Epub 2011 Oct 11.

Abstract

OBJECTIVE

To evaluate clinical studies on the role of moxifloxacin in the treatment of pulmonary tuberculosis (TB).

DATA SOURCES

A literature search was conducted using MEDLINE (1960-July 2011). Key search terms were moxifloxacin, BAY 12-8039, fluoroquinolones, and TB. References of review articles and of a Cochrane Review were also evaluated.

STUDY SELECTION AND DATA EXTRACTION

All articles published in English were evaluated. Prospective studies that evaluated the use of moxifloxacin in addition to or in substitution for first-line TB therapies were reviewed and included. Case series and retrospective studies were excluded.

DATA SYNTHESIS

Four 8-week clinical trials were included. All had comparator regimens containing standard doses of rifampin, isoniazid, ethambutol, and pyrazinamide. Two evaluated the substitution of moxifloxacin for ethambutol, 1 evaluated the substitution of moxifloxacin for isoniazid, and 1 studied the addition of moxifloxacin to a standard regimen. The dose of moxifloxacin was 400 mg daily in all studies, but dosing frequency differed from 3 to 7 days per week. All used culture conversion at 8 weeks as the primary end point, although they collected cultures at different times. Only 1 study found a significant difference in time to culture conversion at 8 weeks. One study found no significant difference at any point during the study. The other 2 studies found a significant difference in time to culture conversion at 4 and 6 weeks. In all trials, moxifloxacin was well tolerated, with nausea being the only significant adverse effect reported compared to the other arms of the studies.

CONCLUSIONS

Although it cannot be stated definitively, available evidence suggests that moxifloxacin appears to be as effective as ethambutol and is possibly as effective as isoniazid in the treatment of pulmonary TB. Given the generally poor second-line options for the treatment of TB, moxifloxacin is an attractive option as an alternative drug in TB treatment.

摘要

目的

评估莫西沙星在治疗肺结核(TB)中的作用的临床研究。

资料来源

使用 MEDLINE(1960 年-2011 年 7 月)进行文献检索。主要检索词为莫西沙星、BAY 12-8039、氟喹诺酮类药物和 TB。还评估了综述文章和 Cochrane 综述的参考文献。

研究选择和数据提取

评估了所有以英文发表的文章。综述了并包括了评估莫西沙星在一线 TB 治疗中加用或替代治疗的前瞻性研究。排除了病例系列和回顾性研究。

数据综合

共纳入四项 8 周临床试验。所有研究均采用包含标准剂量利福平、异烟肼、乙胺丁醇和吡嗪酰胺的对照方案。两项研究评估了莫西沙星替代乙胺丁醇,一项研究评估了莫西沙星替代异烟肼,一项研究研究了莫西沙星添加到标准方案中的作用。所有研究中莫西沙星的剂量均为每日 400mg,但用药频率为每周 3 至 7 天不等。所有研究均以 8 周时的培养转换作为主要终点,但采集培养物的时间不同。只有一项研究发现 8 周时培养转换时间有显著差异。一项研究在研究过程中的任何时间均未发现显著差异。另外两项研究在 4 周和 6 周时发现培养转换时间有显著差异。在所有试验中,莫西氟沙星耐受性良好,与研究其他组相比,只有恶心是唯一显著的不良反应。

结论

尽管不能明确,但现有证据表明,莫西沙星似乎与乙胺丁醇一样有效,并且可能与异烟肼一样有效治疗肺结核。鉴于二线治疗 TB 的选择通常较差,莫西沙星作为 TB 治疗的替代药物是一种有吸引力的选择。

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