The purpose of this study was to assess the efficacy and safety of tosufloxacin tosilate hydrate fine granules (TFLX fine granules) for pediatric patients and to evaluate the position of TFLX fine granules in the treatment of community-acquired pneumonia (CAP) in children. The study was conducted in patients with CAP younger than 16 years of age who visited one of the 15 institutions between August 2010 and December 2012. The severity of infection was classified according to the severity assessment criteria in the Guidelines for the Management of Respiratory Infectious Diseases in Children in Japan 2007 (GL2007). We also examined the Guidelines for Management of Respiratory Infectious Diseases in Children in Japan 2011(GL2011), which were issued during the study, since the method for evaluation of the severity has greatly changed. The clinical efficacy, safety, and compliance of TFLX fine granules were evaluated based on the Criteria for Clinical Evaluation of Antibiotics in Pediatrics. A total of 104 patients were enrolled in the study. Of these patients, 102 were included in the safety analysis and 95 were included in the efficacy analysis. The overall efficacy rate was 94.7% (90/95) in patients with CAP, 97.7% (43/44) in patients with bacterial pneumonia, and 96.3% (26/27) in patients with mycoplasma pneumonia. The efficacy rate was 94.5% (69/73) in patients suspected of having antibiotic-resistant bacterial infections at the initial treatment and 100% (15/15) in patients with mycoplasma pneumonia who were suspected of having macrolide-resistant Mycoplasma pneumoniae infection. By the severity of infection based on the GL2007, the efficacy rate was 96.2% (25/26) in mild cases, 90.0% (27/30) in moderate cases, and 97.4% (38/39) in severe cases of pneumonia. Based on the GL2011, the efficacy rate was 97.7% (43/44) in mild, 92.2% (47/51) in moderate cases of pneumonia. The incidence of adverse drug reactions was 8.8% (9/102): diarrhoea (6.9%, 7/102) and abnormal laboratory values (2.0%, 2/102). No joint-related adverse drug reactions were noted. Overall, TFLX fine granules showed good efficacy and safety in children with CAP.
|ジャーナル||Japanese Journal of Chemotherapy|
|出版ステータス||Published - 2014 9 1|
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