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      Meta-analysis on Effectiveness and Safety of Moxifloxacin in Treatment of Multidrug Resistant Tuberculosis in Adults

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          Abstract

          Background:

          Moxifloxacin, a fourth generation fluoroquinolone, which has good antibacterial activity against both Gram-positive cocci and Gram-negative bacteria. To date, there are no meta-analysis to evaluate the efficacy and safety of moxifloxacin for multi-drug resistant tuberculosis (MDR-TB) treatment. This meta-analysis to explore the efficacy and safety of the moxifloxacin in treatment of MDR-TB in adults.

          Methods:

          Databases of PubMed, Embase, Embase, Ovid, and Google Scholar databases were investigated for eligible literatures from their establishments to August, 2019. Included studies were selected according to precise eligibility criteria: MDR-TB confirmed by the clinical diagnostic criteria (at least 2 or more first-line drugs resistant to isoniazid and rifampicin). Study design was limited to retrospective studies, randomized controlled trials, or prospective cohort studies; the control group was treated with other drugs or no moxifloxacin. Statistical analysis was performed by RevMan 5.3 software.

          Results:

          Eight studies with a total of 1447 patients were finally eligible for the final systematic review and meta-analysis. Moxifloxacin regimen was related to a significantly elevated treatment success rate compared with levofloxacin or conventional therapy regimen (OR = 1.94; 95% CI = 1.16–3.25, P = .01). No significant difference of sputum culture conversion rate (OR = 1.15; 95% CI = 0.82–1.60; P = 0.43) was found between 2 groups. In addition, there was no significant difference in the increased risks of gastrointestinal trouble (OR = 1.28; 95% CI = 0.98–1.68; P = .05), hepatotoxicity (OR = 0.91; 95% CI = 0.64–1.30; P = .6), dermatologic abnormalities (OR = 1.11; 95% CI = 0.74–1.67; P = .62), and vision change (OR = 1.47; 95% CI = 0.74–2.89; P = .27) between the moxifloxacin-containing regimens and control group.

          Conclusions:

          This meta-analysis revealed that the addition of moxifloxacin to the recommended regimen significantly improved the rate of treatment success in the treatment of MDR-TB, with no additional adverse moxifloxacin events.

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          Most cited references 28

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          Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis.

          Moxifloxacin has potent activity against Mycobacterium tuberculosis in vitro and in a mouse model of antituberculosis (TB) chemotherapy, but data regarding its activity in humans are limited. Our objective was to compare the antimicrobial activity and safety of moxifloxacin versus isoniazid during the first 8 weeks of combination therapy for pulmonary TB. Adults with sputum smear-positive pulmonary TB were randomly assigned to receive either moxifloxacin 400 mg plus isoniazid placebo, or isoniazid 300 mg plus moxifloxacin placebo, administered 5 days/week for 8 weeks, in addition to rifampin, pyrazinamide, and ethambutol. All doses were directly observed. Sputum was collected for culture every 2 weeks. The primary outcome was negative sputum culture at completion of 8 weeks of treatment. Of 433 participants enrolled, 328 were eligible for the primary efficacy analysis. Of these, 35 (11%) were HIV positive, 248 (76%) had cavitation on baseline chest radiograph, and 213 (65%) were enrolled at African sites. Negative cultures at Week 8 were observed in 90/164 (54.9%) participants in the isoniazid arm, and 99/164 (60.4%) in the moxifloxacin arm (P = 0.37). In multivariate analysis, cavitation and enrollment at an African site were associated with lower likelihood of Week-8 culture negativity. The proportion of participants who discontinued assigned treatment was 31/214 (14.5%) for the moxifloxacin group versus 22/205 (10.7%) for the isoniazid group (RR, 1.35; 95% CI, 0.81, 2.25). Substitution of moxifloxacin for isoniazid resulted in a small but statistically nonsignificant increase in Week-8 culture negativity.
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            Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary tuberculosis.

            Moxifloxacin has promising preclinical activity against Mycobacterium tuberculosis, but has not been evaluated in multidrug treatment of tuberculosis in humans. To compare the impact of moxifloxacin versus ethambutol, both in combination with isoniazid, rifampin, and pyrazinamide, on sputum culture conversion at 2 mo as a measure of the potential sterilizing activity of alternate induction regimens. Adults with smear-positive pulmonary tuberculosis were randomized in a factorial design to receive moxifloxacin (400 mg) versus ethambutol given 5 d/wk versus 3 d/wk (after 2 wk of daily therapy). All doses were directly observed. The primary endpoint was sputum culture status at 2 mo of treatment. Of 336 patients enrolled, 277 (82%) were eligible for the efficacy analysis, 186 (67%) were male, 175 (63%) were enrolled at African sites, 206 (74%) had cavitation on chest radiograph, and 60 (22%) had HIV infection. Two-month cultures were negative in 71% of patients (99 of 139) treated with moxifloxacin versus 71% (98 of 138) treated with ethambutol (p = 0.97). Patients receiving moxifloxacin, however, more often had negative cultures after 4 wk of treatment. Patients treated with moxifloxacin more often reported nausea (22 vs. 9%, p = 0.002), but similar proportions completed study treatment (88 vs. 89%). Dosing frequency had little effect on 2-mo culture status or tolerability of therapy. The addition of moxifloxacin to isoniazid, rifampin, and pyrazinamide did not affect 2-mo sputum culture status but did show increased activity at earlier time points.
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              Adverse events in the treatment of multidrug-resistant tuberculosis: results from the DOTS-Plus initiative.

              Adverse events associated with second-line drugs have been mentioned as obstacles in the management of multidrug-resistant tuberculosis (MDR-TB). Data on adverse events were collected from five DOTS-Plus sites in Estonia, Latvia, Peru (Lima), the Philippines (Manila) and the Russian Federation (Tomsk Oblast). The results show that among 818 patients enrolled on MDR-TB treatment only 2% of patients stopped treatment, but 30% required removal of the suspected drug(s) from the regimen due to adverse events. The study shows that adverse events are manageable in the treatment of MDR-TB in resource-limited settings provided that standard management strategies are applied.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                19 June 2020
                19 June 2020
                : 99
                : 25
                Affiliations
                [a ]Department of Tuberculosis, Tianjin Haihe Hospital
                [b ]Tianjin Institute of Respiratory Diseases
                [c ]TCM Key Research Laboratory for Infectious Disease Prevention for State Administration of Traditional Chinese Medicine
                [d ]Department of Dermatology & STD, The Third Central Hospital of Tianjin
                [e ]Tianjin Key Laboratory of Artificial Cell
                [f ]Artificial Cell Engineering Technology Research Center of Public Health Ministry, Tianjin, China.
                Author notes
                []Correspondence: Yanmin Guan, Department of Tuberculosis, Tianjin Haihe Hospital; Tianjin Institute of Respiratory Diseases; TCM Key Research Laboratory for Infectious Disease Prevention for State Administration of Traditional Chinese Medicine, Tianjin, 300350, China (e-mail: guanyanmin@ 123456126.com ), Yong Liu, Department of Dermatology and STD, The Third Central Hospital of Tianjin, Tianjin Key Laboratory of Artificial Cell, Tianjin, China; Artificial Cell Engineering Technology Research Center of Public Health Ministry, Tianjin 300170, China (e-mail: liuyongtj@ 123456163.com ).
                Article
                MD-D-19-09150 20648
                10.1097/MD.0000000000020648
                7310829
                32569195
                Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0

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