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[Study on the safety and efficacy of sitafloxacin--results of the use-results survey].
Matsumoto, Takuyuki; Uchino, Kazuhiro; Yamaguchi, Hiroki; Yoshida, Sanae; Takahashi, Megumi; Kodama, Hiroko; Hamajima, Satoko; Yonemochi, Rie; Fujita, Sachiko; Takita, Atsushi; Yamanouchi, Naoki; Suzuki, Tadamichi; Shiozawa, Tomoo; Yamaguchi, Fumie.
Afiliación
  • Matsumoto T; Post Marketing Studies Management Department Daiichi Sankyo Co., Ltd.
Jpn J Antibiot ; 64(5): 319-37, 2011 Oct.
Article en Ja | MEDLINE | ID: mdl-22428215
Sitafloxacin (STFX, Gracevit 50 mg, fine granules 10%), a new quinolone antibacterial agent, was approved in January 2008, and the use-results survey was performed for 2 years from December 2008 to November 2010. In total, 3558 case cards were collected from 287 medical institutions and 3331 cases were subjected to a safety evaluation and 3225 were subjected to an efficacy evaluation. Incidence of adverse drug reactions (ADRs) was 4.44% (148/3331 cases). Major ADRs were diarrhea (55 cases) and hepatic function disorders (39 cases), and the incidences were 1.65% and 1.17%, respectively. Serious ADRs were observed in 5 cases (7 episodes); gastrointestinal haemorrhage, hepatic function abnormal, white blood cell count decreased, drug eruption, hypoglycemia, pneumonia, and superinfection in one case each. Efficacy rate was 92.9% (2997/3225 patients) in total with a range of 91.4 to 97.8% by type of infection such as respiratory tract and urinary tract. Eradication rate of indicated strains was 91.5% (808/883 strains) including Gram-positive bacteria at 92.3% (310/336 strains), Gram-negative bacteria at 90.7% (458/505 strains), anaerobes at 100.0% (28/28 strains) and atypical bacteria at 85.7% (12/14 strains). In conclusion, this use-results survey confirmed that STFX is a useful antibacterial agent with no serious problems in its safety profile and efficacy rates of over 90% against all infections.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Infecciones Bacterianas / Fluoroquinolonas / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Antibacterianos Tipo de estudio: Incidence_studies / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: Ja Revista: Jpn J Antibiot Año: 2011 Tipo del documento: Article Pais de publicación: Japón
Buscar en Google
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Infecciones Bacterianas / Fluoroquinolonas / Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos / Antibacterianos Tipo de estudio: Incidence_studies / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: Ja Revista: Jpn J Antibiot Año: 2011 Tipo del documento: Article Pais de publicación: Japón