title: The clinical efficacy and safety of a fluoroquinolone-containing regimen for pulmonary MAC disease.
abstract: Despite recent advances in chemotherapy, the treatment of pulmonary Mycobacterium avium complex (MAC) disease remains unsatisfactory. Judging from its MIC, fluoroquinolones including gatifloxacin (GFLX) are expected to demonstrate efficacy against MAC disease. However, there have been few clinical studies using fluoroquinolones. Therefore, a prospective study to evaluate the clinical efficacy and safety of a fluoroquinolone-containing regimen for the treatment of pulmonary MAC disease was conducted. In this trial, patients with pulmonary MAC disease received protocol-guided combined chemotherapy with rifampin (RFP) and ethambutol (EB) plus either GFLX or clarithromycin (CAM). Adult patients who fulfilled the criteria of the ATS definition of pulmonary MAC disease were enrolled in this study. The patients provided their informed consent, and treatments were administered for 1 year. Of 27 patients enrolled from three facilities, 14 patients were treated with the CAM-containing regimen and 13 patients were treated with the GFLX-containing regime. Four patients did not complete the 1-year treatment because of adverse events. Nine patients (64.3%) in the CAM group and 11 patients (84.6%) in the GFLX group achieved eradication of pathogens. Adverse events were observed more frequently in the GFLX group than in the CAM group. However, there were no severe adverse events in either group. The long-term results showed a similar relapse rate between the CAM and GFLX groups. The fluoroquinolone-containing regimen demonstrated both high efficacy and relative safety for pulmonary MAC disease that was similar to that of the CAM-containing regimen, which is considered to be the standard regimen.
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan. mfujita@fukuoka-u.ac.jp
authors.forename: Masaki
authors.initials: M
authors.lastname: Fujita
authors.forename: Akira
authors.initials: A
authors.lastname: Kajiki
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Tao
authors.forename: Masayuki
authors.initials: M
authors.lastname: Miyazaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ouchi
authors.forename: Eiji
authors.initials: E
authors.lastname: Harada
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ikegame
authors.forename: Takemasa
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Junji
authors.initials: J
authors.lastname: Uchino
authors.forename: Kentaro
authors.initials: K
authors.lastname: Watanabe
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nakanishi
mesh_terms: D000368:Aged; D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004977:Ethambutol / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects / Q000627:therapeutic use; D000077734:Gatifloxacin; D006801:Humans; D008171:Lung Diseases / Q000188:drug therapy* / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D015269:Mycobacterium avium Complex / Q000187:drug effects*; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy* / Q000382:microbiology; D012293:Rifampin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000995:Antitubercular Agents; D024841:Fluoroquinolones; D004977:Ethambutol; D017291:Clarithromycin; D000077734:Gatifloxacin; D012293:Rifampin