書誌事項
- タイトル別名
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- The efficacy and safety of cefteram pivoxil(CFTM-PI) fine granules at the maximum approved dosager in pediatric with respiratory tract infections
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We compared the efficacy and safety of cefteram pivoxil (CFTM-PI) fine granules at the maximum approved dosager and the frequency of adverse events comparied to a group of other oral cephems (CE group). Among children under 15 years of age who visited designated medical facilities from September 2005 to March 2006 and were diagnosed with laryngeal pharyngitis, tonsillitis, acute bronchitis, or pneumonia, 259 in the CFTM-PI fine granules group (median age: 4.2 years) and 108 in the CE group (45 administered cefcapene pivoxil, 49 cefditoren pivoxil, and 14 other agents)(median age: 3.5 years). CFTM-PI fine granules were administered at 18 mg/kg/day in 3 divided doses for, in principle, 5 days (or 7 days for pneumonia), and efficacy was evaluated by day 5 or day 7 for pneumonia. For the CE group, although the duration of administration was not predetermined, dosage was determined based on the approved dosage and dosage regimen. Adverse events were assessed at the end of administration.<BR>Duration of administration of CFTM-PI fine granules was 5.96±1.76 days and CE groups 6.27±1.94 days. In the CFTM-PI granules group, 223 cases were subjected to efficacy analysis; clinical efficacy was evaluated after 4.21±1.18 days, resulting in efficacy of 962%(128/133) for pharyngitis, 97.4%(38/39) for acute bronchitis, 97.4%(37/38) for tonsillitis, 97.4%(37/38) for tonsillstis, 100%(13/13) for pneumonia, and 96.9%(216/223) overall. Clinical efficacy for each major detected bacterium was 100%(28/28) for Streptococcus pneumoniae, 98.8%(85/86) for Streptococcus pyogenes, 95.0%(57/60) for Haemophilus influenzae, and 100%(24/24) for Moraxella (Branhamella) catarrhalis. Out of 28 strains of S. pneumoniae, 6 of PISP and 7 of PRSP were found, whereas 9 of BLNAR were found among 60 strains of H. influenzae. Organoleptic evaluation showed that 70.7%(183/259) of patients felt the drug was “easy to take”. Adverse events observed in all cases gastrointestinal symptoms and the incidence in CFTM-PI fine granules group was 5.4%(14/259) and in CE group 13.0%(14/108). For children under 3 years of age, the incidence of adverse reactions was 262% in the CE group and 9.4% in the CFTM-PI fine granules group, the latter being significantly lower than that in the CE group (p=0.0129).<BR>These findings suggest that a high dosage of CFTM-PI fine granules produces a sufficient therapeutic effect in children with respiratory tract infections and can be expected to be effective for treating infectious diseases caused by resistant bacteria.
収録刊行物
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- 日本化学療法学会雑誌
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日本化学療法学会雑誌 56 (4), 453-461, 2008
公益社団法人 日本化学療法学会
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詳細情報 詳細情報について
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- CRID
- 1390001206286351360
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- NII論文ID
- 130004298372
- 10022594807
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- NII書誌ID
- AN10472127
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- ISSN
- 18845886
- 13407007
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- 本文言語コード
- ja
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- データソース種別
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- JaLC
- CiNii Articles
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- 抄録ライセンスフラグ
- 使用不可