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高齢者における慢性呼吸器疾患の二次感染に対するgatifloxacin 1日200 mg投与の有用性の検討

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Title: 高齢者における慢性呼吸器疾患の二次感染に対するgatifloxacin 1日200 mg投与の有用性の検討
Other Titles: Evaluation of efficacy and safety of gatifloxacin for secondary infection in patients with chronic respiratory disease
Authors: 柳原, 克紀 / 東山, 康仁 / 泉川, 公一 / 大野, 秀明 / 宮崎, 義継 / 平潟, 洋一 / 河野, 茂 / Nagasaki Respiratory tract infection Treatment Society: NRTS
Authors (alternative): Yanagihara, Katsunori / Higashiyama, Yasuhito / Izumikawa, Koichi / Ohno, Hideaki / Miyazaki, Yoshitsugu / Hirakata, Yoichi / Kohno, Shigeru / Nagasaki Respiratory tract infection Treatment Society: NRTS
Issue Date: Jan-2006
Publisher: 日本化学療法学会 / Japanese Society of Chemotherapy
Citation: 日本化学療法学会雑誌, 54(1), pp.31-38; 2006
Abstract: ニューキノロン系抗菌薬gatifloxacin(GFLX)は,2002年6月に発売後,血糖値異常の副作用が報告され,2003年3月には糖尿病患者に禁忌となった。しかしながら,本薬剤の優れた抗菌力および喀痰・組織移行性からレスピラトリーキノロンとして日本呼吸器学会発刊(2003年)の「呼吸器感染症に関するガイドライン」成人気道感染症診療の基本的考え方にも推奨されている。また,肺炎球菌に対するGFLXのAUC/MICは200 mg×2回/日(400 mg/日)で74.4(29.0/0.39),100 mg×2回/日(200 mg/日)では35.9(14.0/0.39)および97.2(37.9/0.39:高齢者)である。これらの成績から,高齢者においては200 mg/日で治療可能と考えられた。 今回,慢性呼吸器疾患の二次感染を対象として,65歳以上の高齢者への200 mg/日投与が,非高齢者への400 mg/日投与と同等の有効性が認められるかどうかを比較検討した。 2004年11月から2005年3月までに長崎大学第二内科ならびに関連施設において,52例がエントリーされ,評価可能症例は32例であった。臨床効果は高齢者200 mg/日で87.0%(20/23例),非高齢者400 mg/日で88.9%(8/9例),全体で87.5%(28/32例)であった。原因菌の消長も考慮した最終評価判定でも,臨床効果と同等であった。また,安全性は有害事象が高齢者で1例,非高齢者で2例の計3例,臨床検査値異常が高齢者で2例,非高齢者で2例の計4例で,いずれも軽度であった。 高齢者慢性呼吸器疾患の二次感染に対して,GFLX 200 mg/日は,非高齢者400 mg/日と同等の有効性と安全性を有することが示唆された。 / The new quinolone antimicrobial drug gatifloxacin (GFLX) was reported to cause adverse effects in patients with abnormal blood sugar levels after it had been placed on the market (in Japan) in June 2002, and GFLX became counterindicated in diabetic patients in March 2003. Nevertheless, it is still recommended by the Japanese Respiratory Society guidelines as a "respiratory quinolone" because of its excellent antimicrobial activity and expectoration. Moreover, the AUC/MIC of GFLX for pneumococcus is 74.4 at 200 mg b.i.d. (400 mg/day) and 35.9 (age< 65years) and 97.2 (age>65 years) at 100 mg b.i.d. (200 mg/day). Based on these results, the treatment of senior citizens at a dose of 200 mg/day was thought to be feasible. Subsequently, a clinical study was undertaken to establish the efficacy of a GFLX dose of 200 mg/day for the treatment of secondary infections in senior citizens (age>65 years) chronic respiratory illnesses to determine if the effectiveness was equal to treat of 400 mg/day in non-senior citizens. Fifty-two patients were enrolled in this study, and 32 of these patients were evaluated between November 2004 and March 2005 at our university hospital or surrounding clinics. The clinical efficacy of GFLX was 87.0% (20/23) in senior citizens and 88.9% (8/9) non-senior citizens, for an overall efficacy of 87.5% (28/32). The bacteriological clinical efficacy of GFLX was concluded to be equivalent in both groups. Moreover, only three adverse events occurred: one in the senior citizen and two in the non-senior citizen group. These adverse events were generally mild in nature. Abnormal lab results were also seen in four patients: two in the senior citizen group and two in the non-senior citizen group. The present study suggests that GFLX at a dose of 200 mg/day is equally safe and effective as a dose of 400 mg/day for the treatment of secondary infections resulting from chronic respiratory disease in both senior citizens and non-senior citizens.
Keywords: gatifloxacin / chronic respiratory tract infection / elderly patient or senior citizen
URI: http://hdl.handle.net/10069/26668
ISSN: 13407007
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/26668

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