Study on the safety and efficacy of sitafloxacin at a dose of 100mg once a day —Results of the use-results survey—

DOI Web Site
  • HORI SEIJI
    Department of Infectious Diseases and Infection Control, Jikei University School of Medicine
  • UCHINO KAZUHIRO
    Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited
  • MATSUMOTO TAKUYUKI
    Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited
  • YAMAGUCHI HIROKI
    Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited
  • TAKAHASHI MEGUMI
    Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited
  • HAMAJIMA SATOKO
    Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited
  • NUKUI KAORI
    Post-Marketing Regulatory Affairs Department, Daiichi Sankyo Company, Limited
  • EDA HISANO
    Pharmacovigilance Department, Daiichi Sankyo Company, Limited
  • SHIINA AKIKO
    Pharmacovigilance Department, Daiichi Sankyo Company, Limited
  • TAKITA ATSUSHI
    Clinical Data and Biostatistics Department, Daiichi Sankyo Company, Limited
  • YAMANOUCHI NAOKI
    Clinical Data and Biostatistics Department, Daiichi Sankyo Company, Limited
  • MIZUNO MASAMI
    Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited
  • OKUTANI YUKIHIRO
    Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited

Bibliographic Information

Other Title
  • 使用実態下におけるsitafloxacin 100mg1日1回投与の安全性・有効性
  • シヨウ ジッタイ カ ニ オケル sitafloxacin100mg1ニチ 1カイ トウヨ ノ アンゼンセイ ・ ユウコウセイ

Search this article

Description

<p>Sitafloxacin (STFX, Gracevit® 50mg, fine granules 10%), an oral quinolone antibacterial agent, was approved additionally for administration at a dose of 100mg/day was performed from December 2011 to May 2013. In total, 1,186 case cards were collected from 226 medical institutions and 1,089 cases were subjected to a safety evaluation and 1,069 were subjected to an efficacy evaluation.</p><p>The incidence of adverse drug reactions (ADRs) was 2.11% (23/1,089cases) and no serious ADR’s were observed. The major ADR was diarrhea at 1.10% (12/1,089 cases). Of these 12 cases, 10 cases developed symptoms within 4 days of treatment. All of them, except one case that could not be followed up, either recovered or improved.</p><p>Nonsteroidal anti-inflammatory drugs of the phenyl acetate and propionate types, which require caution when coadministered with STFX, were uses concomitantly by 17.6% (192/1,089 cases) of patients but no central nervous system ADRs were observed.</p><p>The overall efficacy rate was 96.4% (1,030/1,069 cases) and by types of infections, it was 97.0% (387/399 cases) for respiratory tract infections, 96.7% (353/365 cases) for urinary tract infections, 94.7% (36/38 cases) for gynecological infections, 92.3% (132/143 cases) for otorhinolaryngological infections, 98.4% (122/124 cases) for dental and oral surgical infections. The efficacy rate in every category of site of infections exceeded 90%.</p><p>The overall eradication rate was 94.4% (185/196 strains) including Gram-positive bacteria at 95.4% (62/65 strains), Gram-negative bacteria at 92.2% (92/102 strains), anaerobes at 100.0% (11/11 strains) and atypical bacteria at 100.0% (18/18 strains).</p><p>In conclusion, this use-results survey confirmed that STFX 100mg/day is an effective administration with no serious problems in its safety profile and efficacy rate of over 90% in every category of site of infection.</p>

Journal

Details 詳細情報について

Report a problem

Back to top