title: [Study on the safety and efficacy of sitafloxacin at a dose of 100 mg once a day--results of the use-results survey].
abstract: Sitafloxacin (STFX, Gracevit 50 mg, fine granules 10%), an oral quinolone antibacterial agent, was approved additionally for administration at a dose of 100 mg once a day in August 2011. A use-results survey on STFX 100 mg/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. The incidence of adverse drug reactions (ADRs) was 2.11% (23/1,089 cases) and no serious ADRs 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. Nonsteroidal anti-inflammatory drugs of the phenyl acetate and propionate types, which require caution when coadministered with STFX, were used concomitantly by 17.6% (192/1,089 cases) of patients but no central nervous system ADRs were observed. 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 infection exceeded 90%. 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% (94/102 strains), anaerobes at 100.0% (11/11 strains) and atypical bacteria at 100.0% (18/18 strains). In conclusion, this use-results survey confirmed that STFX 100 mg/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.
authors.forename: Seiji
authors.initials: S
authors.lastname: Hori
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Uchino
authors.forename: Takuyuki
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yamaguchi
authors.forename: Megumi
authors.initials: M
authors.lastname: Takahashi
authors.forename: Satoko
authors.initials: S
authors.lastname: Hamajima
authors.forename: Kaori
authors.initials: K
authors.lastname: Nukui
authors.forename: Hisano
authors.initials: H
authors.lastname: Eda
authors.forename: Akiko
authors.initials: A
authors.lastname: Shiina
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takita
authors.forename: Naoki
authors.initials: N
authors.lastname: Yamanouchi
authors.forename: Masami
authors.initials: M
authors.lastname: Mizuno
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Okutani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001424:Bacterial Infections / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; C076246:sitafloxacin