FK 037の泌尿器科領域感染症に対する前期第II相試験成績

新しい注射用セフェム剤FK 037の泌尿器科領域感染症に対する臨床効果と安全性を予備的に検討した。対象は尿路に基礎疾患を有するカテーテル非留置の複雑性尿路感染症で, 15歳以上80歳未満の入院患者とした。用法・用量は1回0.5g (力価), 1.0g (力価) または2.0g (力価) を朝・夕の1日2回, 5~9日間点滴静注し, UTI薬効評価基準に従い臨床効果を判定した。UTI薬効評価基準に合致した32例における臨床効果は著効15例, 有効15例, 無効2例で有効率は93.8%であった。副作用は1例に発疹がみられ, 臨床検査値の異常変動は1例に軽度のGPT上昇が認められたのみであった。以上...

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Published inCHEMOTHERAPY Vol. 42; no. 9; pp. 1036 - 1047
Main Authors 熊本, 悦明, 斎藤, 功, 河田, 幸道, 守殿, 貞夫, 大森, 弘之, 熊澤, 淨一, 河村, 信夫
Format Journal Article
LanguageJapanese
Published 公益社団法人 日本化学療法学会 1994
Online AccessGet full text
ISSN0009-3165
1884-5894
DOI10.11250/chemotherapy1953.42.1036

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Abstract 新しい注射用セフェム剤FK 037の泌尿器科領域感染症に対する臨床効果と安全性を予備的に検討した。対象は尿路に基礎疾患を有するカテーテル非留置の複雑性尿路感染症で, 15歳以上80歳未満の入院患者とした。用法・用量は1回0.5g (力価), 1.0g (力価) または2.0g (力価) を朝・夕の1日2回, 5~9日間点滴静注し, UTI薬効評価基準に従い臨床効果を判定した。UTI薬効評価基準に合致した32例における臨床効果は著効15例, 有効15例, 無効2例で有効率は93.8%であった。副作用は1例に発疹がみられ, 臨床検査値の異常変動は1例に軽度のGPT上昇が認められたのみであった。以上の成績から, 本剤はグラム陽性菌からグラム陰性菌まで幅広い抗菌スペクトルを有しており, これを反映して臨床試験においても優れた効果を示し, 安全性も特に問題がないことから, 泌尿器科領域感染症に対して有用性が期待される薬剤であると考えられる。
AbstractList 新しい注射用セフェム剤FK 037の泌尿器科領域感染症に対する臨床効果と安全性を予備的に検討した。対象は尿路に基礎疾患を有するカテーテル非留置の複雑性尿路感染症で, 15歳以上80歳未満の入院患者とした。用法・用量は1回0.5g (力価), 1.0g (力価) または2.0g (力価) を朝・夕の1日2回, 5~9日間点滴静注し, UTI薬効評価基準に従い臨床効果を判定した。UTI薬効評価基準に合致した32例における臨床効果は著効15例, 有効15例, 無効2例で有効率は93.8%であった。副作用は1例に発疹がみられ, 臨床検査値の異常変動は1例に軽度のGPT上昇が認められたのみであった。以上の成績から, 本剤はグラム陽性菌からグラム陰性菌まで幅広い抗菌スペクトルを有しており, これを反映して臨床試験においても優れた効果を示し, 安全性も特に問題がないことから, 泌尿器科領域感染症に対して有用性が期待される薬剤であると考えられる。
Author 斎藤, 功
熊本, 悦明
河村, 信夫
熊澤, 淨一
河田, 幸道
守殿, 貞夫
大森, 弘之
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References 4) Mine Y, et al.: In vivo antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 88-98, 1993
21) Naide Y, et al.: Comparative study of cefpirome and ceftazidime in complicated urinary tract infections. Acta Urologica Japonica 37: 447-464, 1991 (in Japanese
16) Matsumoto T, Kumazawa J: Evaluation of drug efficacy for catheterized patients. Antibiot & Chemother 6: 2137-2144, 1990 (in Japanese
1) Mine, Y, et al.: In vitro antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 71-87, 1993
9) Yokota T, Suzuki E: A new, improved parenteral cephem antibiotic-FK 037, its in vitro antibacterial activity. Program and Abstracts No.853, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
2) Ohki H, Kawabata K, Okuda S, Kamimura T, Sakane K: FK 037, a new parenteral cephalosporin with a broad antibacterial spectrum. J Antibiot 46: 359-361, 1993
8) Mine Y, Sakamoto H, Hatano K, Higashi Y, Kamimura T, Matsumoto F, Kuwahara S: FK 037, a novel parenteral broad-spectrum cephalosporin: IV. Animal pharmacokinetics Program and Abstracts No.852, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
22) Kumazawa J, et al.: Dose-finding study of cefe. pime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 285-298, 1992 (in Japanese
5) Mine Y, Watanabe Y, Sakamoto H, Hatano K, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: I. In vitro antibacterial activity. Program and Abstracts No.849, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
20) Naide Y, et al.: Dose-finding study of HR810 (cefpirome) in complicated urinary tract infections. Chemotherapy (Tokyo) 39: 158-173, 1991 (in Javanese
25) Kumazawa J, et al.: Comparative study of cefclidin and ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 1435-1460, 1992 (in Japanese
3) Mine, Y, et al.: Excellent activity of FK 037, a novel parenteral broad-spectrum cephalosporin, against methicillin-resistant staphylococci. J Antibiot 46: 99-119, 1993
24) Kumazawa J, et al.: Clinical evaluation of cefclidin for the treatment of complicated urinary tract infections.-Dote-finding study using ceftazidime as a reference drug-.Nishinihon J Urol 54: 528-549, 1992 (in Japanese
12) Goto S, Higashi 5, Miyazaki S, Kaneko Y, Yamaguchi K: FK 037, a New Parenteral Cephalosporin: In vitro and in vivo antibacterial activity. Program and Abstracts No.856, 31 at Interscience Conference on Antimicrobial Agents and Chemotherapy, 1991
15) Nakashima M, Uematsu T, Takiguchi Y, Obara M, Terakawa M: Pharmacokinetics and safety of FK 037 in healthy volunteers. Program and Abstracts, No.883, 33 rd Interscience Conference on Antimicrobial Agents and Chemotherapy, New Orleans, 1993
6) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Tawara S, Matsumoto F, Kuwahara S. FK 037, a novel parenteral broad-spectrum cephalosporin: II. In vivo antibacterial activity. Program and Abstracts No.850, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
23) Kumazawa J, et al.: Comparative study of cefepime vs ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 974-985, 1992 (in Japanese
13) Nishino T, Otsuki M, Nishihara Y: In vitro and in vivo antibacterial activities of FK 037, a new broad-spectrum cephalosporin. Program and Abstracts No.857, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
18) UTI Committee (Chairman: Ohkoshi M): Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (Third edition). Chemotherapy (Tokyo) 34: 408-441, 1986 (in Japanese
10) Inoue K, Hamana Y, Mitsuhashi S: In vitro antibacterial activity of FK 037, a new cephalosporin. Program and Abstracts No.854, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
11) Ueno K, Watanabe K, Kato N, Muto Y, Bandoh K, Oka M: Comparative in vitro activity of FK 037, a novel cephalosporin, and other related agents against anaerobic bacteria. Program and Abstracts No.855, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
19) Deputy Director, New Drugs Division Pharmaceutical Affairs Bureau Ministry of Health & Welfare Japan: General consideration for the clinical evaluation of new drugs. Clin Eval 20: 401-411, 1992 (in Japanese
7) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: III. Excellent activity against methicillin-resistant Staphylococci. Program and Abstracts No.851, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
17) Japan Society of Chemotherapy: A method for determining the minimum inhibitory concentration of antimicrobial agents (3 rd edition). Chemotherapy (Tokyo) 29: 76-79, 1981 (in Japanese
14) FK 037 Toxicology Studies-The Reports of Fujisawa Pharmaceutical Co. Ltd.
References_xml – reference: 1) Mine, Y, et al.: In vitro antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 71-87, 1993
– reference: 13) Nishino T, Otsuki M, Nishihara Y: In vitro and in vivo antibacterial activities of FK 037, a new broad-spectrum cephalosporin. Program and Abstracts No.857, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 4) Mine Y, et al.: In vivo antibacterial activity of FK 037, a novel parenteral broad-spectrum cephalosporin. J Antibiot 46: 88-98, 1993
– reference: 8) Mine Y, Sakamoto H, Hatano K, Higashi Y, Kamimura T, Matsumoto F, Kuwahara S: FK 037, a novel parenteral broad-spectrum cephalosporin: IV. Animal pharmacokinetics Program and Abstracts No.852, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 24) Kumazawa J, et al.: Clinical evaluation of cefclidin for the treatment of complicated urinary tract infections.-Dote-finding study using ceftazidime as a reference drug-.Nishinihon J Urol 54: 528-549, 1992 (in Japanese)
– reference: 21) Naide Y, et al.: Comparative study of cefpirome and ceftazidime in complicated urinary tract infections. Acta Urologica Japonica 37: 447-464, 1991 (in Japanese)
– reference: 14) FK 037 Toxicology Studies-The Reports of Fujisawa Pharmaceutical Co. Ltd.
– reference: 18) UTI Committee (Chairman: Ohkoshi M): Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (Third edition). Chemotherapy (Tokyo) 34: 408-441, 1986 (in Japanese)
– reference: 16) Matsumoto T, Kumazawa J: Evaluation of drug efficacy for catheterized patients. Antibiot & Chemother 6: 2137-2144, 1990 (in Japanese)
– reference: 7) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: III. Excellent activity against methicillin-resistant Staphylococci. Program and Abstracts No.851, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 9) Yokota T, Suzuki E: A new, improved parenteral cephem antibiotic-FK 037, its in vitro antibacterial activity. Program and Abstracts No.853, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 12) Goto S, Higashi 5, Miyazaki S, Kaneko Y, Yamaguchi K: FK 037, a New Parenteral Cephalosporin: In vitro and in vivo antibacterial activity. Program and Abstracts No.856, 31 at Interscience Conference on Antimicrobial Agents and Chemotherapy, 1991
– reference: 22) Kumazawa J, et al.: Dose-finding study of cefe. pime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 285-298, 1992 (in Japanese)
– reference: 20) Naide Y, et al.: Dose-finding study of HR810 (cefpirome) in complicated urinary tract infections. Chemotherapy (Tokyo) 39: 158-173, 1991 (in Javanese)
– reference: 6) Mine Y, Watanabe Y, Sakamoto H, Kamimura T, Tawara S, Matsumoto F, Kuwahara S. FK 037, a novel parenteral broad-spectrum cephalosporin: II. In vivo antibacterial activity. Program and Abstracts No.850, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 17) Japan Society of Chemotherapy: A method for determining the minimum inhibitory concentration of antimicrobial agents (3 rd edition). Chemotherapy (Tokyo) 29: 76-79, 1981 (in Japanese)
– reference: 11) Ueno K, Watanabe K, Kato N, Muto Y, Bandoh K, Oka M: Comparative in vitro activity of FK 037, a novel cephalosporin, and other related agents against anaerobic bacteria. Program and Abstracts No.855, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 5) Mine Y, Watanabe Y, Sakamoto H, Hatano K, Kamimura T, Matsumoto F, Kuwahara S: FK 037, A novel parenteral broad-spectrum cephalosporin: I. In vitro antibacterial activity. Program and Abstracts No.849, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 10) Inoue K, Hamana Y, Mitsuhashi S: In vitro antibacterial activity of FK 037, a new cephalosporin. Program and Abstracts No.854, 31 st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, 1991
– reference: 15) Nakashima M, Uematsu T, Takiguchi Y, Obara M, Terakawa M: Pharmacokinetics and safety of FK 037 in healthy volunteers. Program and Abstracts, No.883, 33 rd Interscience Conference on Antimicrobial Agents and Chemotherapy, New Orleans, 1993
– reference: 2) Ohki H, Kawabata K, Okuda S, Kamimura T, Sakane K: FK 037, a new parenteral cephalosporin with a broad antibacterial spectrum. J Antibiot 46: 359-361, 1993
– reference: 23) Kumazawa J, et al.: Comparative study of cefepime vs ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 974-985, 1992 (in Japanese)
– reference: 19) Deputy Director, New Drugs Division Pharmaceutical Affairs Bureau Ministry of Health & Welfare Japan: General consideration for the clinical evaluation of new drugs. Clin Eval 20: 401-411, 1992 (in Japanese)
– reference: 25) Kumazawa J, et al.: Comparative study of cefclidin and ceftazidime for the treatment of complicated urinary tract infections. Nishinihon J Urol 54: 1435-1460, 1992 (in Japanese)
– reference: 3) Mine, Y, et al.: Excellent activity of FK 037, a novel parenteral broad-spectrum cephalosporin, against methicillin-resistant staphylococci. J Antibiot 46: 99-119, 1993
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Snippet 新しい注射用セフェム剤FK 037の泌尿器科領域感染症に対する臨床効果と安全性を予備的に検討した。対象は尿路に基礎疾患を有するカテーテル非留置の複雑性尿路感染症で, 15歳以上80歳未満の入院患者とした。用法・用量は1回0.5g (力価), 1.0g (力価) または2.0g (力価) を朝・夕の1日2回,...
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Title FK 037の泌尿器科領域感染症に対する前期第II相試験成績
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