Balofloxacin: <I>in vitro</I> antibacterial activity, penetration into sputum and clinical effects on respiratory infectious diseases

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  • Balofloxacinの<I>invitro</I>抗菌力, 喀痰内移行ならびに呼吸器感染症における臨床評価

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Abstract

The antibacterial activity of a new quinolone drug, balofloxacin (BLFX), against clinical isolates and its clinical effects on respiratory infectious diseases were investigated. The following results were obtained.<BR>1. Antibacterial activity: Minimum inhibitory concentration (MIC) was determined, using the method established by the Japan Society of Chemotherapy, in 516 strains of 12 species. Levels of ofloxacin (OFLX), lomefloxacin (LFLX) and tosufloxacin (TFLX), which were simultaneously determined, were compared with those of BLFX. Ingeneral, BLFX was approximately equivalent to TFLX and superior to OFLX and LFLX by 2-5 test tubes in terms of activity against gram-positive bacteria. Although activity against gram-negative bacteria was slightly inferior to that of control drugs, adequate clinical efficacy was demonstrated by the results.<BR>2. Transfer to serum and sputum: The serum concentration peaked (1.22μg/ml) 2 hours after the oral administration of BLFX at a dose of 100 mg. The sputum concentration peaked (0.84μg/ml) 3-4 hours after administration. The maximum sputum concentration to maximum serum concentration ratio was 0.69.<BR>3. Clinical results: The clinical efficacy was rated as excellent in one, good in nine, fair in two and poor in one of 13 patients in whom the clinical effects could be evaluated (1 with acute bronchitis, 8 with chronic bronchitis, 3 with bronchiectasis, and 1 with secondary infection of chronic respiratory disease), for an efficacy rate of 76.9%(10/13). The drug was bacteriologically effective in 2/3 isolates (1/2 for Pseudomonas aeruginosa and 1/1 for Haemophilus influenzae). Headache was observed in one and nausea and vomiting were observed in one, of the 15 patients to whom BLFX was administered, and these symptoms were mild. No abnormal changes in clinical laboratory test values, likely to be attributable to administration, were observed in any of these patients.

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