High-dose Ciprofloxacin Working Group, Review Board for Unapproved Drugs of the Japanese Society of Chemotherapy

Hiroshige Mikamo, Akira Watanabe, Yoshio Takesue, Katsunori Yanagihara

    Research output: Contribution to journalReview articlepeer-review

    Abstract

    The Review Board for Unapproved Drugs of the Japanese Society of Chemotherapy established the High-dose Ciprofloxacin (CPFX) Working Group and conducted a nationwide survey on the usage of intravenous CPFX to investigate the need for high-dose administration to further improve the therapeutic efficacy and prevent the development of resistant strains. Of 1,888 institutions surveyed, 479 responded (response rate: 25.4%): 272 from institutions that have prescribed intravenous CPFX (Group A) and 207 from those that have not (Group B). In Group A, intravenous CPFX was most frequently prescribed for hospital-acquired pneumonia (75.4%), followed by community-acquired pneumonia (64.0%), sepsis (56.3%), and Legionnaire's disease (including pneumonia: 30.9%). Intravenous CPFX was prescribed as second-line therapy in 56% to 68% of the cases of these diseases, except for Legionnaire's disease and anthrax, and in 44% to 69% of severe cases. To the question of the need for high-dose administration of intravenous CPFX, 62.5% and 36.7% in Groups A and B answered "yes," 4.0% and 5.3% answered "no," and 32.7% and 56.0% answered "unclear," respectively. In Group A, significantly more physicians answered positively to the question of the need for high-dose administration than negatively, whether they were infection control doctors (ICD) or not (p = 0.005 in both subgroups). Likewise, significantly more infectious disease experts answered positively (p<0.001). In Group A,"increased efficacy based on the PK-PD theory" (86.7%) was the most common reason given for the response that "intravenous CPFX will be more often prescribed" if high-dose administration is approved. On the other hand,"no use of intravenous CPFX as first-line therapy" (54.0%) was the most common reason for "the frequency of prescriptions will not be affected." To the question regarding desirable daily dose, responses in Groups A and B were "800 mg" in 33.1% and 33.3% "900 mg" in 21.2% and 10.3%, "1,200 mg" in 33.9% and 36.8%, and "unclear" in 11.9% and 19.5%, respectively. The review board will perform a detailed analysis on the actual usage of intravenous CPFX based on the survey results and fully assess the need for high-dose administration based on the analysis results.

    Original languageEnglish
    Pages (from-to)210-222
    Number of pages13
    JournalJapanese Journal of Chemotherapy
    Volume60
    Issue number2
    Publication statusPublished - 2012 Mar

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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