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Review
, 2013 (6), CD004795

Fluoroquinolones for Treating Tuberculosis (Presumed Drug-Sensitive)

Affiliations
Review

Fluoroquinolones for Treating Tuberculosis (Presumed Drug-Sensitive)

Lilia E Ziganshina et al. Cochrane Database Syst Rev.

Abstract

Background: Currently the World Health Organization only recommend fluoroquinolones for people with presumed drug-sensitive tuberculosis (TB) who cannot take standard first-line drugs. However, use of fluoroquinolones could shorten the length of treatment and improve other outcomes in these people. This review summarises the effects of fluoroquinolones in first-line regimens in people with presumed drug-sensitive TB.

Objectives: To assess fluoroquinolones as substitute or additional components in antituberculous drug regimens for drug-sensitive TB.

Search methods: We searched the Cochrane Infectious Diseases Group Specialized Register; CENTRAL (The Cochrane Library 2013, Issue 1); MEDLINE; EMBASE; LILACS; Science Citation Index; Databases of Russian Publications; and metaRegister of Controlled Trials up to 6 March 2013.

Selection criteria: Randomized controlled trials (RCTs) of antituberculous regimens based on rifampicin and pyrazinamide and containing fluoroquinolones in people with presumed drug-sensitive pulmonary TB.

Data collection and analysis: Two authors independently applied inclusion criteria, assessed the risk of bias in the trials, and extracted data. We used the risk ratio (RR) for dichotomous data and the fixed-effect model when it was appropriate to combine data and no heterogeneity was present. We assessed the quality of evidence using the GRADE approach.

Main results: We identified five RCTs (1330 participants) that met the inclusion criteria. None of the included trials examined regimens of less than six months duration. Fluoroquinolones added to standard regimensA single trial (174 participants) added levofloxacin to the standard first-line regimen. Relapse and treatment failure were not reported. For death, sputum conversion, and adverse events we are uncertain if there is an effect (one trial, 174 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for ethambutol in standard regimens Three trials (723 participants) substituted ethambutol with moxifloxacin, gatifloxacin, and ofloxacin into the standard first-line regimen. For relapse, we are uncertain if there is an effect (one trial, 170 participants, very low quality evidence). No trials reported on treatment failure. For death, sputum culture conversion at eight weeks, or serious adverse events we do not know if there was an effect (three trials, 723 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for isoniazid in standard regimens A single trial (433 participants) substituted moxifloxacin for isoniazid. Treatment failure and relapse were not reported. For death, sputum culture conversion, or serious adverse events the substitution may have little or no difference (one trial, 433 participants, low quality evidence for all three outcomes). Fluoroquinolines in four month regimensSix trials are currently in progress testing shorter regimens with fluoroquinolones.

Authors' conclusions: Ofloxacin, levofloxacin, moxifloxacin, and gatifloxacin have been tested in RCTs of standard first-line regimens based on rifampicin and pyrazinamide for treating drug-sensitive TB. There is insufficient evidence to be clear whether addition or substitution of fluoroquinolones for ethambutol or isoniazid in the first-line regimen reduces death or relapse, or increases culture conversion at eight weeks. Much larger trials with fluoroquinolones in short course regimens of four months are currently in progress.

Conflict of interest statement

GDAV is a co‐author on the trial report of Rustomjee 2008a.

Figures

Figure 1
Figure 1
Study flow diagram
Figure 2
Figure 2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figure 3
Figure 3
Forest plot of comparison: 2 Fluoroquinolone (F‐quinolone) substitution for ethambutol (E) in a standard six month regimen (HRZE), outcome: 2.2 Death from any cause (complete case analysis).
Figure 4
Figure 4
Forest plot of comparison: 2 Fluoroquinolone (F‐quinolone) substitution for ethambutol (E) in a standard six month regimen (HRZE), outcome: 2.4 Sputum culture conversion at eight weeks (complete case analysis).
Analysis 1.1
Analysis 1.1
Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome 1 Death from any cause.
Analysis 1.2
Analysis 1.2
Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome 2 TB‐related death.
Analysis 1.3
Analysis 1.3
Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome 3 Sputum culture conversion at 8 weeks.
Analysis 1.4
Analysis 1.4
Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome 4 Serious adverse events.
Analysis 1.5
Analysis 1.5
Comparison 1 Fluoroquinolones plus standard regimen (HRZE) versus standard regimen alone (HRZE), Outcome 5 Total number of people with adverse events.
Analysis 2.1
Analysis 2.1
Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome 1 Relapse.
Analysis 2.2
Analysis 2.2
Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome 2 Death from any cause.
Analysis 2.3
Analysis 2.3
Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome 3 TB‐related death.
Analysis 2.4
Analysis 2.4
Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome 4 Sputum culture conversion at 8 weeks.
Analysis 2.5
Analysis 2.5
Comparison 2 Fluoroquinolone substitution for ethambutol (E) in a standard six month regimen (HRZE), Outcome 5 Serious adverse events.
Analysis 3.1
Analysis 3.1
Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome 1 Death from any cause.
Analysis 3.2
Analysis 3.2
Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome 2 TB‐related death.
Analysis 3.3
Analysis 3.3
Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome 3 Sputum culture conversion at 8 weeks.
Analysis 3.4
Analysis 3.4
Comparison 3 Fluoroquinolone substitution for isoniazid (H) in a standard six month regimen (HRZE), Outcome 4 Serious adverse events.

Update of

  • Fluoroquinolones for Treating Tuberculosis
    LE Ziganshina et al. Cochrane Database Syst Rev (1), CD004795. PMID 18254061. - Review
    Only ciprofloxacin, ofloxacin, levofloxacin, sparfloxacin and moxifloxacin have been tested in randomized controlled trials for treating tuberculosis. We cannot recommend …

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