Clinical evaluation of a quinolone antimicrobial drug, grepafloxacin, for oral use in surgical infections

The clinical effects of a newly developed quinolone antimicrobial drug for oral use, grepailoxacin (GPFX), on infectious diseases in the surgical field were investigated by 13 collaborating organizations and 4 related institutions throughout the country. The results were as follows. GPFX was adminis...

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Published inJapanese Journal of Chemotherapy Vol. 43; no. Supplement1; pp. 454 - 467
Main Author Shinagawa, Nagao
Format Journal Article
LanguageJapanese
Published Japanese Society of Chemotherapy 1995
公益社団法人 日本化学療法学会
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ISSN1340-7007
1884-5886
DOI10.11250/chemotherapy1995.43.Supplement1_454

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Abstract The clinical effects of a newly developed quinolone antimicrobial drug for oral use, grepailoxacin (GPFX), on infectious diseases in the surgical field were investigated by 13 collaborating organizations and 4 related institutions throughout the country. The results were as follows. GPFX was administered to 183 patients at a dose of 150-400 mg once or twice a day for 3 14 days. Eight patients were excluded or dropped out, leaving 177 patients to be evaluated for clinical effects. The efficacy rate was 85.9% in the patients with superficial purulent diseases, 66.7% in those with mastitis, 93.8% in those with periproctal abscess, 81.8% in those with secondary infections (19/23 for postoperative wound, 3/3 for wound, 1/1 for burn, and 4/6 for others), and 94.7% in those with cholecystitis and cholangitis. The total efficacy rate was 85.3%. The efficacy rate in 116 patients in whom bacteria were isolated before the start of administration was 85.3%. Eradication of bacteria could be assessed in 99 patients. The isolates were eradicated or superinfection was observed in 83 patients. The eradication rate was 83.8%. The eradication rate in the 170 strains whose eradication was confirmed was 91.7%(11/12 strains) for Staphylococcus aureus, 92.9%(13/14) for coagulase-negative staphylococci, 100%(13/13) for Staphylococcus epidermidis, 73.3%(11/15) for Escherichia coli and 100%(11/11) for Peptostreptococcus spp. The total rate was 86.5%(147/170). With regard to safety, slight and transient adverse reactions, mainly of bitter taste in the oral cavity, were observed in 7 of the 179 subjects. Abnormal change in s-GPT was observed in one patient on clinical laboratory tests. The above results suggest that GPFX is highly useful for infectious diseases in the surgical field.
AbstractList The clinical effects of a newly developed quinolone antimicrobial drug for oral use, grepailoxacin (GPFX), on infectious diseases in the surgical field were investigated by 13 collaborating organizations and 4 related institutions throughout the country. The results were as follows. GPFX was administered to 183 patients at a dose of 150-400 mg once or twice a day for 3 14 days. Eight patients were excluded or dropped out, leaving 177 patients to be evaluated for clinical effects. The efficacy rate was 85.9% in the patients with superficial purulent diseases, 66.7% in those with mastitis, 93.8% in those with periproctal abscess, 81.8% in those with secondary infections (19/23 for postoperative wound, 3/3 for wound, 1/1 for burn, and 4/6 for others), and 94.7% in those with cholecystitis and cholangitis. The total efficacy rate was 85.3%. The efficacy rate in 116 patients in whom bacteria were isolated before the start of administration was 85.3%. Eradication of bacteria could be assessed in 99 patients. The isolates were eradicated or superinfection was observed in 83 patients. The eradication rate was 83.8%. The eradication rate in the 170 strains whose eradication was confirmed was 91.7%(11/12 strains) for Staphylococcus aureus, 92.9%(13/14) for coagulase-negative staphylococci, 100%(13/13) for Staphylococcus epidermidis, 73.3%(11/15) for Escherichia coli and 100%(11/11) for Peptostreptococcus spp. The total rate was 86.5%(147/170). With regard to safety, slight and transient adverse reactions, mainly of bitter taste in the oral cavity, were observed in 7 of the 179 subjects. Abnormal change in s-GPT was observed in one patient on clinical laboratory tests. The above results suggest that GPFX is highly useful for infectious diseases in the surgical field.
The clinical effects of a newly developed quinolone antimicrobial drug for oral use, grepailoxacin (GPFX), on infectious diseases in the surgical field were investigated by 13 collaborating organizations and 4 related institutions throughout the country. The results were as follows. GPFX was administered to 183 patients at a dose of 150-400 mg once or twice a day for 3 14 days. Eight patients were excluded or dropped out, leaving 177 patients to be evaluated for clinical effects.The efficacy rate was 85.9% in the patients with superficial purulent diseases, 66.7% in those with mastitis, 93.8% in those with periproctal abscess, 81.8% in those with secondary infections (19/23 for postoperative wound, 3/3 for wound, 1/1 for burn, and 4/6 for others), and 94.7% in those with cholecystitis and cholangitis. The total efficacy rate was 85.3%.The efficacy rate in 116 patients in whom bacteria were isolated before the start of administration was 85.3%. Eradication of bacteria could be assessed in 99 patients. The isolates were eradicated or superinfection was observed in 83 patients. The eradication rate was 83.8%. The eradication rate in the 170 strains whose eradication was confirmed was 91.7%(11/12 strains) for Staphylococcus aureus, 92.9%(13/14) for coagulase-negative staphylococci, 100%(13/13) for Staphylococcus epidermidis, 73.3%(11/15) for Escherichia coli and 100%(11/11) for Peptostreptococcus spp. The total rate was 86.5%(147/170).With regard to safety, slight and transient adverse reactions, mainly of bitter taste in the oral cavity, were observed in 7 of the 179 subjects. Abnormal change in s-GPT was observed in one patient on clinical laboratory tests.The above results suggest that GPFX is highly useful for infectious diseases in the surgical field. 新しく開発されたキノロン系経口抗菌薬grepafloxacin (GPFX) の外科領域感染症に対する臨床評価を目的として, 全国13基幹施設とその関連施設 (合計19施設) による共同研究を実施し, 以下の成績を得た。GPFXを150mg~400mg/日, 1~2回/日, 3~14日間投与を中心に183例に投与した。除外, 脱落8例を除いた177例を臨床効果判定対象症例とした。その臨床効果は, 浅在性化膿性疾患85.9%, 乳腺炎66.7%, 肛門周囲膿瘍93.8%, 二次感染81.8%(手術創19/23, 外傷3/3, 熱傷1/1, その他4/6), 胆嚢炎・胆管炎94.7%の有効率であり, 全体で85.3%であった。投与開始前菌分離症例116症例における分離菌別臨床効果は85.3%であった。有菌例のうち菌の消長を検討し得たのは99例であり, 投与前分離菌が消失あるいは菌交代した症例が合計83例で, その消失率は83.8%であった。また, 菌の消長が確認できた170株に対する消失率は, Staphylococms aurens91.7%(11/12株), coagulase-negative staphylococci92.9%(13/14株), Staphylococms epidermidis100%(13/13株), Eschenchia coli73.3%(11/15株), Peptostreptococcus spp.100%(11/11株), などであり, 全体では86.5%(147/170) であった。安全性に関しては, 評価対象179例中7例に口腔内苦味などを主とする軽度で一過性の副作用が認められた。また臨床検査値異常としてs-GPTの変動が1例認められた。以上の成績から, GPFXは外科領域感染症に有用性の高い薬剤であると考えられた。
Author Shinagawa, Nagao
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References 3) Imada T, Miyazaki S, Nishida M, Yamaguchi K and Goto S: In vitro and in vivo antibacterial activities of a new quinolone, OPC-17116. Antimicrob Agents Chemother 36: 573-579, 1992
4) Wakebe H and Mitsuhashi S: Comparative in vitro activities of a new quinolone OPC-17116, possessing potent activity against Gram-positive bacteria. Antimicrob Agents Chemother 36. 2185-2191, 1992
8) 日本化学療法学会: 最小発育阻止濃度 (MIC) 測定法再改訂について. Chemotherapy 29: 76-79, 1981
5) Uematsu T, Nagashima S, Takiguchi Y and Nakashima M: OPC-1711Q, a new quinolone: Phase I study. 31st ICAAC, abstract no.1481, Chicago, October, 1991
11) 副島林造: 第37回日本化学療法学会西日本支部総会, 新薬シンポジウム. AM-833 (Fleroxacin), 和歌山, 1989
1) Neu H C, Fang W, Gu J and Chin N: In vitro activity of OPC-17116. Antimicrob Agents Chemother 36: 1310-1315, 1992
9) 嫌気性菌MIC測定法検討委員会: 嫌気性菌の最小発育阻止濃度 (MIC) 測定法. Chemotherapy 27: 559-560, 1979
12) 上野一恵, 原耕平, 河田幸道: 第38回日本化学療法学会西日本支部総会, 新薬シンポジウム. Spafloxacin (AT-4140), 岐阜, 1990
7) 谷村弘, 内山和久, 柏木秀夫, 堂西宏紀, 坂口聡: 新しいキノロン抗菌薬grepafloxacinの胆汁中移行, 胆嚢組織内濃度および外科感染症における臨床効果. 日化療会誌43 (S-1): 443-453, 1995
13) 斎藤厚: 第39回日本化学療法学会, 新薬シンポジウム. Levofloxacin (DR-3355), 大分, 1991
10) 第34回日本化学療法学会東日本支部総会, 新薬シンポジウム. T-3262, 東京, 1987
2) Sader H S, Erwin M E and Jones R N: In vitro activity of OPC-17116 compared to other broadspectrum fluoroquinolones. Eur J Clin Microbiol 11: 372-381, 1992
6) Akiyama H, Koike M, Nii S, Ohguro K and Odomi M: OPC-17116, an excellently tissue-penetrative new quinolone: Pharmacokinetic profiles in animals and antibacterial activities of metabolites. 31st ICAAC, abstract no.1477, Chicago, October, 1991
References_xml – reference: 7) 谷村弘, 内山和久, 柏木秀夫, 堂西宏紀, 坂口聡: 新しいキノロン抗菌薬grepafloxacinの胆汁中移行, 胆嚢組織内濃度および外科感染症における臨床効果. 日化療会誌43 (S-1): 443-453, 1995
– reference: 4) Wakebe H and Mitsuhashi S: Comparative in vitro activities of a new quinolone OPC-17116, possessing potent activity against Gram-positive bacteria. Antimicrob Agents Chemother 36. 2185-2191, 1992
– reference: 8) 日本化学療法学会: 最小発育阻止濃度 (MIC) 測定法再改訂について. Chemotherapy 29: 76-79, 1981
– reference: 12) 上野一恵, 原耕平, 河田幸道: 第38回日本化学療法学会西日本支部総会, 新薬シンポジウム. Spafloxacin (AT-4140), 岐阜, 1990
– reference: 6) Akiyama H, Koike M, Nii S, Ohguro K and Odomi M: OPC-17116, an excellently tissue-penetrative new quinolone: Pharmacokinetic profiles in animals and antibacterial activities of metabolites. 31st ICAAC, abstract no.1477, Chicago, October, 1991
– reference: 11) 副島林造: 第37回日本化学療法学会西日本支部総会, 新薬シンポジウム. AM-833 (Fleroxacin), 和歌山, 1989
– reference: 9) 嫌気性菌MIC測定法検討委員会: 嫌気性菌の最小発育阻止濃度 (MIC) 測定法. Chemotherapy 27: 559-560, 1979
– reference: 2) Sader H S, Erwin M E and Jones R N: In vitro activity of OPC-17116 compared to other broadspectrum fluoroquinolones. Eur J Clin Microbiol 11: 372-381, 1992
– reference: 3) Imada T, Miyazaki S, Nishida M, Yamaguchi K and Goto S: In vitro and in vivo antibacterial activities of a new quinolone, OPC-17116. Antimicrob Agents Chemother 36: 573-579, 1992
– reference: 1) Neu H C, Fang W, Gu J and Chin N: In vitro activity of OPC-17116. Antimicrob Agents Chemother 36: 1310-1315, 1992
– reference: 13) 斎藤厚: 第39回日本化学療法学会, 新薬シンポジウム. Levofloxacin (DR-3355), 大分, 1991
– reference: 10) 第34回日本化学療法学会東日本支部総会, 新薬シンポジウム. T-3262, 東京, 1987
– reference: 5) Uematsu T, Nagashima S, Takiguchi Y and Nakashima M: OPC-1711Q, a new quinolone: Phase I study. 31st ICAAC, abstract no.1481, Chicago, October, 1991
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Snippet The clinical effects of a newly developed quinolone antimicrobial drug for oral use, grepailoxacin (GPFX), on infectious diseases in the surgical field were...
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外科領域感染症
臨床効果
Title Clinical evaluation of a quinolone antimicrobial drug, grepafloxacin, for oral use in surgical infections
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