Ｃｅｆｄｉｔｏｒｅｎ　ｐｉｖｏｘｉｌの市販後の特別調査とその調査精度に関する検証

DOI 被引用文献11件 参考文献11件

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  • Postmarketing special investigation and its verification of precision for cefditoren pivoxil.

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We verified in the special investigation on the pathological relation to penicillin-resistant Streptococcus pneumoniae (PRSP) and β-lactamase negative ampicillin-resistant (BLNAR) Haemohilus influenzae in clinical practice after introduction of cefditren pivoxil (CDTR-PI; brand names: Meiact® Tablets 100, Meiact® Fine Granules). We also studied shedding of the 2 bacterial strains and the distribution of their susceptibilities to various antibacterial agents before and after treatment with CDTR-PI and judgment of the clinical response made medical doctor. The significance of S. pneumoniae and H.influenzae isolated from the epipharynx was examined. We found that S. pneumoniae and H. influenzae isolated in this investigation resided mainly in the epipharynx of infants less than 1 year old to 2 or 3 years, and that they were associated with acute respiratory infection and acute otitis media. These bacterial strains, including PRSP and BLNAR, were eliminated or decreased in the epipharynx shortly after the start of CDTR-PI. They easily invaded the epipharynx again, however settled down, and proliferated there when the plasma drug concentration decreased to a trough level. Bacterial strains repeated this cycle, and some cases are likely to lead to persistent or repeated upper respiratory tract infection or otitis media. Infants nursery or nursery school and their siblings are likely to be of high risk, as suggested by a number of medical experts. The susceptibilities of S. pneumoniae and H.influenzae isolated before and after treatment with CDTR-PI to antibacterial agents were measured. In comparison of the distribution of MICs, the MICs of a variety of β-lactam antibiotics shifted slightly to higher resistance depending on their affinity for PBPs of bacterial strains. Bacteriological testing for the epipharynx is necessary to identify causative bacteria for acute respiratory tract infection in children and following acute otitis media. It is essential to know the type of resistant bacteria for selection of appropriate antibacterial agents considering persistent and repeated infection caused by PRSP and BLNAR H.influenzae. The investigation on drug-resistant genes by polymerase chain reaction has provided very useful information. It also suggested the importance of microscopical examination by gram staining for the shedding of bacteria in the epipharynx at least 2 to 3 days and 10 days after the start of treatment with antibacterial agents in infection associated with flora in the epipharynx. In the judgment of clinical response medical dictor, clinical findings in the pharynx, tonsil, or tympanic membrane, and the characteristics of nasal or middle ear discharge were focused on. The relationship between these findings and microscopic findings of the epipharynx and the number of bacteria detected there was analyzed by multivariate analysis, and a significant relationship detected.

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