Clinical study of gatifloxacin in the treatment of male urethritis

The clinical efficacies of gatifloxacin LX, a new 8-methoxyquinolone, on male urethritis were investigated. The subjects were 45 patients with gonococcal urethritis, 7 withgonococcal-chlamydial urethritis, 75 with chlamydial urethritis and 44 with nongonococcal-nonchlamydial urethritis. GFLX was adm...

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Published inJapanese Journal of Chemotherapy Vol. 47; no. 11; pp. 786 - 793
Main Author Kawada, Yukimichi
Format Journal Article
LanguageJapanese
Published Japanese Society of Chemotherapy 1999
公益社団法人 日本化学療法学会
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ISSN1340-7007
1884-5886
DOI10.11250/chemotherapy1995.47.786

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Abstract The clinical efficacies of gatifloxacin LX, a new 8-methoxyquinolone, on male urethritis were investigated. The subjects were 45 patients with gonococcal urethritis, 7 withgonococcal-chlamydial urethritis, 75 with chlamydial urethritis and 44 with nongonococcal-nonchlamydial urethritis. GFLX was administered orally at a dose of 200 mg twice a day for 3 days to the patients with gonococcal urethritis, and for 7 to 14 days to those with chlamydial urethritis and nongonococcal-nonchlamydial urethritis. Thirty-six patients with gonococcal urethritis, 33 patients with chlamydial urethritis and 20 patients with nongonococcal-nonchlamydial urethritis were assessable according to the criteria of the Japanese UTI Committee. The overall clinical responses were excellent in 30 cases and moderate in 6 cases with gonococcal urethritis, excellent in 25 cases, moderate in 7 cases and poor in 1 case with chlamydial urethritis, and excellent in all cases with nongonococcal-nonchlamydial urethritis, showing an overall efficacy rate of 100%, 97.0%, and 100%, respectively. MIC90 of GFLX against 36 strains of Neisseria gonorrhoeae isolated in this study, was 0.063μg/mL, and its activity was 4-to 8-times higher than that of ciprofloxacin and ofloxacin, respectively. The incidence of clinical adverse reactions was 3.8%(6/160), and of laboratory adverse reactions 6.0%(5/83), and all adverse reactions were slight in degree. The results suggest that GFLX is an effective and safe drug in the treatment of both gonococcal and chlamydial urethritis.
AbstractList The clinical efficacies of gatifloxacin LX, a new 8-methoxyquinolone, on male urethritis were investigated. The subjects were 45 patients with gonococcal urethritis, 7 withgonococcal-chlamydial urethritis, 75 with chlamydial urethritis and 44 with nongonococcal-nonchlamydial urethritis. GFLX was administered orally at a dose of 200 mg twice a day for 3 days to the patients with gonococcal urethritis, and for 7 to 14 days to those with chlamydial urethritis and nongonococcal-nonchlamydial urethritis. Thirty-six patients with gonococcal urethritis, 33 patients with chlamydial urethritis and 20 patients with nongonococcal-nonchlamydial urethritis were assessable according to the criteria of the Japanese UTI Committee. The overall clinical responses were excellent in 30 cases and moderate in 6 cases with gonococcal urethritis, excellent in 25 cases, moderate in 7 cases and poor in 1 case with chlamydial urethritis, and excellent in all cases with nongonococcal-nonchlamydial urethritis, showing an overall efficacy rate of 100%, 97.0%, and 100%, respectively. MIC90 of GFLX against 36 strains of Neisseria gonorrhoeae isolated in this study, was 0.063μg/mL, and its activity was 4-to 8-times higher than that of ciprofloxacin and ofloxacin, respectively. The incidence of clinical adverse reactions was 3.8%(6/160), and of laboratory adverse reactions 6.0%(5/83), and all adverse reactions were slight in degree. The results suggest that GFLX is an effective and safe drug in the treatment of both gonococcal and chlamydial urethritis.
The clinical efficacies of gatifloxacin LX, a new 8-methoxyquinolone, on male urethritis were investigated. The subjects were 45 patients with gonococcal urethritis, 7 withgonococcal-chlamydial urethritis, 75 with chlamydial urethritis and 44 with nongonococcal-nonchlamydial urethritis. GFLX was administered orally at a dose of 200 mg twice a day for 3 days to the patients with gonococcal urethritis, and for 7 to 14 days to those with chlamydial urethritis and nongonococcal-nonchlamydial urethritis. Thirty-six patients with gonococcal urethritis, 33 patients with chlamydial urethritis and 20 patients with nongonococcal-nonchlamydial urethritis were assessable according to the criteria of the Japanese UTI Committee. The overall clinical responses were excellent in 30 cases and moderate in 6 cases with gonococcal urethritis, excellent in 25 cases, moderate in 7 cases and poor in 1 case with chlamydial urethritis, and excellent in all cases with nongonococcal-nonchlamydial urethritis, showing an overall efficacy rate of 100%, 97.0%, and 100%, respectively. MIC90 of GFLX against 36 strains of Neisseria gonorrhoeae isolated in this study, was 0.063μg/mL, and its activity was 4-to 8-times higher than that of ciprofloxacin and ofloxacin, respectively. The incidence of clinical adverse reactions was 3.8%(6/160), and of laboratory adverse reactions 6.0%(5/83), and all adverse reactions were slight in degree. The results suggest that GFLX is an effective and safe drug in the treatment of both gonococcal and chlamydial urethritis. 8位メトキシ基を特徴とする新しいフルオロキノロン系抗菌薬gatinoxacin (GFLX) の男子尿道炎に対する臨床的検討を行った。淋菌性尿道炎45例, 淋菌性クラミジア性尿道炎7例, クラミジア性尿道炎75例および非淋菌・非クラミジア性尿道炎44例の計171例を対象として, GFLX 1回200mgを1日2回, 淋菌性尿道炎には3~7日間, 非淋菌性尿道炎には7~14日間投薬し, UTI薬効評価基準 (第3版) 追補にしたがって臨床効果を判定し, 以下の成績を得た。1. 投薬前に分離された淋菌36株に対するGFIILxのMlC90は0.063μg/mLであり, ciprofloxacinおよびofloxacinの4~8倍強い抗菌力を示した。2. 淋菌性尿道炎に対しては3日後において100%(36/36例) の有効率であった。3. 非淋菌性クラミジア性尿道炎に対しては7日後9790%(32/33例), 14日後100%(35/35例), 非淋菌・非クラミジア性尿道炎に対しては7日後83.3%(25/30例), 14日後100%(20/20例) の有効率であった。4. 副作用は, 160例中6例 (3.8%) に7件認められた。また, 臨床検査値の異常変動は83例中5例 (6.0%) に6件認められた。いずれも重篤なものではなく臨床上特に問題となるものはなかった。以上の成績より, 本剤は淋菌およびクラミジアに起因する男子尿道炎の治療において安全で有効性の高い薬剤と考えられた。
Author Kawada, Yukimichi
Author_FL 河田 幸道他
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公益社団法人 日本化学療法学会
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References 10) 国井乙彦・副作用判定基準検討委員会: 抗菌薬による治験症例における副作用, 臨床検査値異常の判定基準. Chomotherapy 39: 687-689, 1991
2) Wakabayashi E, Mitsuhashi S: In vitro antibacterial activity of AM-1155, a novel 6-fluoro- 8-methoxy quinolone. Antimicrob. Agents Chemother. 38: 594-601, 1994
11) Deguchi T, Yasuda M, Saito I, et al.: Quinoloneresistant Neisseria gonorrhoeae. J. Infect. Chemother. 3: 73-84, 1997
3) Nakashima M, Uematsu T, Kosuge K, et al.: Single-and multiple-dose pharmacokinetics of AM-1155, a new 6-fluoro-8-methoxy quinolone, in humans. Antimicrob. Agents Chemother. 39: 2635-2640, 1995
5) Deguchi T, Yasuda M, Nakano M, et al.: Comparison of in vitro antimicrobial activity of AM-1155 with those of tosufloxacin and fleroxacin against clinical isolates of Neisseria gonorrhoeae harboring quinolone resistance alterations in GyrA and ParC. Chemotherapy (Basel) 43: 239-244, 1997
6) Miyashita N, Niki Y, Kishimoto T, et al.: In vitro and in vivo activities of AM-1155, a new fluoroquinolone, against Chlamydia spp. Antimicrob. Agents Chemother. 41: 1331-1334, 1997
9) UTI研究会 (代表大越正秋): UTI薬効評価基準 (第3版) 追補. Chemotherapy 39: 894-932, 1991
4) 國西芳治, 永田美由紀, 緒方寛史, 他: Gatifloxacinのモルモットおよびマウスにおける光毒性試験. 薬理と治療26: 1651-1654. 1998
12) Deguchi T, Komeda H, Yasuda M, et al.: Mycoplasma genitalium in non-gonococcal urethritis. Int. J. STD AIDS 8: 144-148, 1995
8) 日本化学療法学会: 最小発育阻止濃度 (MIC) 測定法再改定について. Chemotherapy 29: 76-79, 1981
1) Hosaka M, Yasue T, Fukuda H, et al.: In vitro and in vivo antibacterial activities of AM-1155, a new 6-fluoro-8-methoxy quinolone. Antimiaob. Agents Chemother. 36: 2108-2117, 1992
7) 河田幸道, 熊本悦明, 折笠精一, 他: 泌尿器科領域感染症に対するgatifloxacinの後期第II相臨床試験. 日化療会誌47 (Sr2): 308-322, 1999
References_xml – reference: 2) Wakabayashi E, Mitsuhashi S: In vitro antibacterial activity of AM-1155, a novel 6-fluoro- 8-methoxy quinolone. Antimicrob. Agents Chemother. 38: 594-601, 1994
– reference: 3) Nakashima M, Uematsu T, Kosuge K, et al.: Single-and multiple-dose pharmacokinetics of AM-1155, a new 6-fluoro-8-methoxy quinolone, in humans. Antimicrob. Agents Chemother. 39: 2635-2640, 1995
– reference: 9) UTI研究会 (代表大越正秋): UTI薬効評価基準 (第3版) 追補. Chemotherapy 39: 894-932, 1991
– reference: 4) 國西芳治, 永田美由紀, 緒方寛史, 他: Gatifloxacinのモルモットおよびマウスにおける光毒性試験. 薬理と治療26: 1651-1654. 1998
– reference: 8) 日本化学療法学会: 最小発育阻止濃度 (MIC) 測定法再改定について. Chemotherapy 29: 76-79, 1981
– reference: 6) Miyashita N, Niki Y, Kishimoto T, et al.: In vitro and in vivo activities of AM-1155, a new fluoroquinolone, against Chlamydia spp. Antimicrob. Agents Chemother. 41: 1331-1334, 1997
– reference: 5) Deguchi T, Yasuda M, Nakano M, et al.: Comparison of in vitro antimicrobial activity of AM-1155 with those of tosufloxacin and fleroxacin against clinical isolates of Neisseria gonorrhoeae harboring quinolone resistance alterations in GyrA and ParC. Chemotherapy (Basel) 43: 239-244, 1997
– reference: 1) Hosaka M, Yasue T, Fukuda H, et al.: In vitro and in vivo antibacterial activities of AM-1155, a new 6-fluoro-8-methoxy quinolone. Antimiaob. Agents Chemother. 36: 2108-2117, 1992
– reference: 11) Deguchi T, Yasuda M, Saito I, et al.: Quinoloneresistant Neisseria gonorrhoeae. J. Infect. Chemother. 3: 73-84, 1997
– reference: 7) 河田幸道, 熊本悦明, 折笠精一, 他: 泌尿器科領域感染症に対するgatifloxacinの後期第II相臨床試験. 日化療会誌47 (Sr2): 308-322, 1999
– reference: 12) Deguchi T, Komeda H, Yasuda M, et al.: Mycoplasma genitalium in non-gonococcal urethritis. Int. J. STD AIDS 8: 144-148, 1995
– reference: 10) 国井乙彦・副作用判定基準検討委員会: 抗菌薬による治験症例における副作用, 臨床検査値異常の判定基準. Chomotherapy 39: 687-689, 1991
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Snippet The clinical efficacies of gatifloxacin LX, a new 8-methoxyquinolone, on male urethritis were investigated. The subjects were 45 patients with gonococcal...
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gatifloxacin
男子尿道炎
臨床的検討
Title Clinical study of gatifloxacin in the treatment of male urethritis
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