Vol.63 No.5 September 2015
Postmarketing surveillance for high-dose of injectable pazufloxacin mesilate 1,000 mg twice daily
1)Ohtsubokai Kitatama Hospital, 4-1-1 Chofugaoka, Chofu, Tokyo, Japan
(Past: Department of Infectious Disease, Tokyo Women's Medical University)
2)Department of Dermatology, School of Medicine, Teikyo University
3)Data Science and Administration Department, Toyama Chemical Co., Ltd.
Abstract
The clinical efficacy and safety of pazufloxacin (PZFX), an injectable fluoroquinolone antimicrobial agent, administered at the dose of 1,000 mg twice daily, were evaluated in patients with sepsis, severe or intractable respiratory infection, including pneumonia or secondary infection of chronic respiratory disease and pneumonia caused by Streptococcus pneumoniae, as postmarketing surveillance from November 2010 to March 2013.
A total of 312 patients was included in the efficacy analysis set and the efficacy rate was 83.8% (244/291 patients). When classified by the indication, the efficacy rate was 90.5% (57/63 patients) in patients with sepsis, 81.6% (160/196 patients) in patients with severe or intractable respiratory infection, including pneumonia and secondary infection of chronic respiratory disease, and 84.4% (27/32 patients) in patients with pneumonia caused by S. pneumoniae. The eradication rate was 97.9% (46/47 strains), and only 1 strain of Escherichia coli persisted.
In the safety analysis set which included 342 patients, adverse drug reactions were observed in 61 patients (84 events), corresponding to an incidence rate of adverse drug reactions of 17.8% (61/342 patients). The major adverse drug reactions were injection-site phlebitis (13 events), injection-site erythema (10 events), injection-site pain (8 events), and liver function test abnormal (6 events). Serious adverse drug reactions were observed in 8 patients (12 events), including disseminated intravascular coagulation, pancytopenia, shock, acute respiratory distress syndrome, and platelet count decreased (5 events in 1 patient), and pseudomembranous colitis, superinfection (bacteria change phenomenon), myocardial infarction, stress cardiomyopathy, drug eruption, pyrexia, and renal function test abnormal (1 event each). In regard to the important survey items, injection-site reactions were reported in 27 patients (37 events), all of which were non-serious adverse drug reactions. Recovery or remission was confirmed in most of the patients after treatment, such as change of the injection site or ice pack application.
From above findings, it was concluded that PZFX 1,000 mg administered twice daily is useful for patients with sepsis, severe or intractable respiratory infection, including pneumonia or secondary infection of chronic respiratory disease, and pneumonia caused by S. pneumoniae, as postmarketing surveillance.
Key word
pazufloxacin, postmarketing surveillance
Received
March 31, 2015
Accepted
July 2, 2015
Jpn. J. Chemother. 63 (5): 473-489, 2015
