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Levofloxacin 注射剤の呼吸器感染症患者における安全性成績

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Title: Levofloxacin 注射剤の呼吸器感染症患者における安全性成績
Other Titles: Safety profile of intravenous levofloxacin (500 mg once a day)
Authors: 堀, 誠治 / 河野, 茂
Authors (alternative): Hori, Seiji / Kohno, Shigeru
Issue Date: May-2011
Publisher: 日本化学療法学会 / Japan Society of Chemotherapy
Citation: 日本化学療法学会雑誌, 59(S-1), pp.46-54; 2011
Abstract: Levofloxacin(LVFX)注射剤の安全性プロファイルを明らかにするため,日本人呼吸器感染症患者を対象とした2 つの臨床試験成績(342 例)を併合し,評価した。さらに,併合した成績より得られたLVFX注射剤の安全性プロファイルを,すでに報告されているLVFX 経口剤の呼吸器感染症患者を対象にした臨床試験成績(152 例)と比較した。注射剤での有害事象および副作用発現率は,72.8%(249 342 例)および48.0%(164 342 例)であった。注射剤で5% 以上に認められた副作用は,注射部位紅斑15.2%(52 342 例),ALT 増加10.2%(35 342 例),AST 増加8.5%(29 342 例),注射部位そう痒感6.7%(23 342 例),下痢5.0%(17 342 例),γ -GTP 増加5.0%(17 342 例)であった。有害事象および副作用発現率を経口剤と比較すると,いずれも注射剤で高い傾向であったが,注射剤で約2 割に認められた注射部位反応を除くと,注射剤の有害事象および副作用発現率は63.2%(216 342例)および33.6%(115 342 例)となり,経口剤の59.2%(90 152 例)および39.5%(60 152 例)と同程度であった。経口剤と比較すると,注射剤での特有な副作用として投与経路に起因した事象である注射部位反応が認められたが,その注射部位反応を除くと,LVFX 注射剤と経口剤の安全性プロファイルに大きな差はないと考えられた。 / We evaluated the intravenous levofloxacin safety profile (N=342), integrating two clinical studies in which intravenous levofloxacin at 500 mg once a day was administered to Japanese subjects with pneumonia and secondary infection of chronic respiratory disease. Furthermore, we compared the safety profile of intravenous levofloxacin to that of oral levofloxacin, reported elsewhere. Adverse events were observed in 72.8% and adverse drug reactions in 48.0%. Major adverse drug reactions (over 5%) were injection site erythema (15.2%), alanine aminotransferase increased (10.2%), aspartate aminotransferase increased (8.5%), injection site pruritus (6.7%), diarrhea (5.0%), and gamma-glutamyltransferase increased (5.0%). The incidence of adverse events and adverse drug reactions was slightly higher in intravenous levofloxacin. Systemic allergic reactions such as anaphylaxis were not observed. Excluding injection site reactions such as erythema or pruritis, the adverse event and adverse drug reaction incidence were 63.2% and 33.6%, similar to those reported for oral levofloxacin. Our results suggest that the intravenous levofloxacin safety profile, excluding injection site reactions, resembled that of oral levofloxacin and that intravenous levofloxacin can be used to treat of infectious diseases without special additional attention to adverse drug reactions.
Keywords: Levofloxacin injection / Respiratory tract infection / Safety profile
URI: http://hdl.handle.net/10069/25690
ISSN: 13407007
Relational Links: http://journal.chemotherapy.or.jp/abstract/059S10046_j.html
Rights: Copyright © 2011 日本化学療法学会
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/25690

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