title: [Study on the safety and efficacy of sitafloxacin--results of the use-results survey].
abstract: 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.
authors.affiliation: Post Marketing Studies Management Department Daiichi Sankyo Co., Ltd.
authors.forename: Takuyuki
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Uchino
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yamaguchi
authors.forename: Sanae
authors.initials: S
authors.lastname: Yoshida
authors.forename: Megumi
authors.initials: M
authors.lastname: Takahashi
authors.forename: Hiroko
authors.initials: H
authors.lastname: Kodama
authors.forename: Satoko
authors.initials: S
authors.lastname: Hamajima
authors.forename: Rie
authors.initials: R
authors.lastname: Yonemochi
authors.forename: Sachiko
authors.initials: S
authors.lastname: Fujita
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takita
authors.forename: Naoki
authors.initials: N
authors.lastname: Yamanouchi
authors.forename: Tadamichi
authors.initials: T
authors.lastname: Suzuki
authors.forename: Tomoo
authors.initials: T
authors.lastname: Shiozawa
authors.forename: Fumie
authors.initials: F
authors.lastname: Yamaguchi
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012141:Respiratory Tract Infections / Q000188:drug therapy / Q000382:microbiology; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; C076246:sitafloxacin