書誌事項
- タイトル別名
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- 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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説明
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.
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 (3), 299-312, 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
- 1390282681263558912
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- NII論文ID
- 130004298365
- 10021192591
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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