ＭＲＳＡ感染症患者に対するａｒｂｅｋａｃｉｎ　２００ｍｇ　１日１回投与の治療効果―臨床薬理試験―

DOI 被引用文献7件 参考文献30件
  • 相川 直樹
    慶應義塾大学医学部救急医学
  • 河野 茂
    長崎大学大学院医歯薬学総合研究科感染免疫学講座先進感染制御学分野
  • 賀来 満夫
    東北大学大学院医学系研究科内科病態学講座感染制御・検査診断学分野
  • 渡辺 彰
    東北大学加齢医学研究所抗感染症薬開発研究部門
  • 山口 惠三
    東邦大学医学部微生物・感染症学教室
  • 谷川原 祐介
    慶應義塾大学医学部薬剤部

書誌事項

タイトル別名
  • An open clinical study of arbekacin 200mg q.d. in patients infected with methicillin-resistant Staphylococcus aureus (MRSA)-A clinical pharmacology study-
  • A clinical pharmacology study
  • 臨床薬理試験

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抄録

A multi-center collaborative open clinical study was conducted in patients infected with methicillinresistant Staphylococcus aureus (MRSA) to determine the efficacy and safety of arbekacin (ABK) administered at a dosage regimen of 200mg q. d. and the relationship between efficacy/safety and blood ABK concentration (PIVPD).<BR>Effectiveness (clinical efficacy) against MRSA-caused pneumonia was 71.4% and eradication/decrease (bacteriological efficacy) was 46.2%, showing favorable results. We thus confirmed that the 200 mg q.d.regimen of ABK would be effective against MRSA-caused pneumonia. Evaluating pharmacokinetic parameters, mean Cmax and Ctrough values were 16.2μg/mL and 1.1μg/mL, respectively, and the elimination half-life was prolonged in patients with moderate to severe renal dysfunction. As a result of PK/PD analysis, it was estimated that the expected clinical effect could be obtained when the ratio of Cmax/MIC exceeded 7 or 8, but it was difficult to clarify the target value due to the small sample size.In safety evaluation, the incidence of adverse drug reactions related to subjective/objective findings was 15.8% and the incidence of adverse reactions related to abnormal laboratory findings was 36.8%, and no unknown adverse drug reactions were observed. As a serious adverse event, shock was noted in one patient, but the causal relationship to ABK was ruled out. When patients were categorized with Cmax by whether or not reaching 12μg/mL, regarded as a safety benchmark, the incidence of adverse drug reactions was not higher in patients with a Cmax of≥12μg/mL than in those with a Cmax of<12μg/mL. This was also the case when the trough concentration of 2μg/mL, was used as another safety benchmark.<BR>As mentioned above, high Cmax and excellent efficacy of ABK were achieved by the 200mg q. d. regimen, and the trough concentration was controlled at<2μg/mL., in many patients. The incidence of adverse drug reactions did not increase with this regimen.The usefulness of ABK 200mg q. d. was thus confirmed.

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