PHARMACOKINETICS AND CLINICAL STUDIES ON SPARFLOXACIN
We performed basic and clinical studies on sparfloxacin (SPFX), a newly synthesized quinolone, and obtained the following results. 1. Effects of antacid (dried aluminium hydroxide gel, AL) and probenecid on the gastrointestinal absorption and renal excretion of SPFX were investigated by a cross-over...
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| Published in | CHEMOTHERAPY Vol. 39; no. Supplement4; pp. 234 - 244 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English Japanese |
| Published |
Japanese Society of Chemotherapy
1991
公益社団法人 日本化学療法学会 |
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| Online Access | Get full text |
| ISSN | 0009-3165 1884-5894 |
| DOI | 10.11250/chemotherapy1953.39.Supplement4_234 |
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| Abstract | We performed basic and clinical studies on sparfloxacin (SPFX), a newly synthesized quinolone, and obtained the following results. 1. Effects of antacid (dried aluminium hydroxide gel, AL) and probenecid on the gastrointestinal absorption and renal excretion of SPFX were investigated by a cross-over design in six healthy male volunteers. The subjects received orally 200mg of SPFX with and without 1g of AL or 1.5g of probenecid, and the time course of blood levels, urinary concentrations and urinary recovery of SPFX and its pharmacokinetic parameters were determined. SPFX concentrations in the samples were measured by the HPLC method. The obtained pharmacokinetic parameters for SPFX after each of the treatment were as follows: the Cmax, Tmax, T1/2 and AUC0→∞ for SPFX alone were 0.865μg/ml, 5.3h, 14.7h and 21.1μg·h/ml, respectively; those for co-administration with AL were 0.683μg/ml, 4.0h, 14.0h and 13.7μg·h/ml; and those for co-administration with probenecid were 0.810μg/ml, 3.5h, 15.7h and 20.1μg·h/ml. Gastrointestinal absorption of SPFX was inhibited by interaction with AL, but SPFX was the least inhibited among the new quinolones. 2. Twenty-three patients with respiratory infections, 5 with urinary tract infections and one with mastitis were treated orally at a daily dose of 100-300mg of SPFX for 3-4 days. The clinical results were excellent in 8 cases, good in 16 and poor in 5, giving the efficacy rate of 82.8%. We encountered adverse reactions to SPFX in two cases: vertigo, nausea and epigastric pain in one case, and fever and eosinophilia in another case. These adverse reactions disappeared shortly after completion of the treatment. There were no cases in which the administration of SPFX was discontinued due to adverse effects. |
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| AbstractList | We performed basic and clinical studies on sparfloxacin (SPFX), a newly synthesized quinolone, and obtained the following results. 1. Effects of antacid (dried aluminium hydroxide gel, AL) and probenecid on the gastrointestinal absorption and renal excretion of SPFX were investigated by a cross-over design in six healthy male volunteers. The subjects received orally 200mg of SPFX with and without 1g of AL or 1.5g of probenecid, and the time course of blood levels, urinary concentrations and urinary recovery of SPFX and its pharmacokinetic parameters were determined. SPFX concentrations in the samples were measured by the HPLC method. The obtained pharmacokinetic parameters for SPFX after each of the treatment were as follows: the Cmax, Tmax, T1/2 and AUC0→∞ for SPFX alone were 0.865μg/ml, 5.3h, 14.7h and 21.1μg·h/ml, respectively; those for co-administration with AL were 0.683μg/ml, 4.0h, 14.0h and 13.7μg·h/ml; and those for co-administration with probenecid were 0.810μg/ml, 3.5h, 15.7h and 20.1μg·h/ml. Gastrointestinal absorption of SPFX was inhibited by interaction with AL, but SPFX was the least inhibited among the new quinolones. 2. Twenty-three patients with respiratory infections, 5 with urinary tract infections and one with mastitis were treated orally at a daily dose of 100-300mg of SPFX for 3-4 days. The clinical results were excellent in 8 cases, good in 16 and poor in 5, giving the efficacy rate of 82.8%. We encountered adverse reactions to SPFX in two cases: vertigo, nausea and epigastric pain in one case, and fever and eosinophilia in another case. These adverse reactions disappeared shortly after completion of the treatment. There were no cases in which the administration of SPFX was discontinued due to adverse effects. We performed basic and clinical studies on sparfloxacin (SPFX), a newly synthesized quinolone, and obtained the following results.1. Effects of antacid (dried aluminium hydroxide gel, AL) and probenecid on the gastrointestinal absorption and renal excretion of SPFX were investigated by a cross-over design in six healthy male volunteers.The subjects received orally 200mg of SPFX with and without 1g of AL or 1.5g of probenecid, and the time course of blood levels, urinary concentrations and urinary recovery of SPFX and its pharmacokinetic parameters were determined. SPFX concentrations in the samples were measured by the HPLC method. The obtained pharmacokinetic parameters for SPFX after each of the treatment were as follows: the Cmax, Tmax, T1/2 and AUC0→∞ for SPFX alone were 0.865μg/ml, 5.3h, 14.7h and 21.1μg·h/ml, respectively; those for co-administration with AL were 0.683μg/ml, 4.0h, 14.0h and 13.7μg·h/ml; and those for co-administration with probenecid were 0.810μg/ml, 3.5h, 15.7h and 20.1μg·h/ml. Gastrointestinal absorption of SPFX was inhibited by interaction with AL, but SPFX was the least inhibited among the new quinolones.2. Twenty-three patients with respiratory infections, 5 with urinary tract infections and one with mastitis were treated orally at a daily dose of 100-300mg of SPFX for 3-4 days. The clinical results were excellent in 8 cases, good in 16 and poor in 5, giving the efficacy rate of 82.8%. We encountered adverse reactions to SPFX in two cases: vertigo, nausea and epigastric pain in one case, and fever and eosinophilia in another case.These adverse reactions disappeared shortly after completion of the treatment. There were no cases in which the administration of SPFX was discontinued due to adverse effects. 新しく開発された合成抗菌剤のsparfloxacinについて基礎的ならびに臨床的検討を行い, 以下の成績を得た。1. Sparfloxacinの胃腸管吸収に及ぼす制酸剤 (乾燥水酸化アルミニウムゲル) およびprobenecidの影響を, 6名の健常成人男子志願者を対象にcross-over法により検討した。Sparfloxacin 200mg単独服用時の最高血中濃度は0.865μg/ml, 最高血中濃度到達時間は5.3時間, 血中消失半減期は14.7時間, 血中濃度曲線下面積は21.1μg・h/mlであり.制酸剤1.0g同時併用時では各々0.683μg/ml, 4.0時間, 14.0時間, 13.7μg・h/ml, probenecid 1.5g併用時では各々0.810μg/ml, 3.5時間, 15.7時間, 20.1μg・h/mlであった。制酸剤併用時においてsparfloxacinの吸収阻害が認められたが, その程度は最高血中濃度で22%, 血中濃度曲線下面積で35%の低下であり, 既存のキノロン系抗菌剤と比較して弱かった。2. 呼吸器感染症23例, 尿路感染症5例, 乳腺炎1例の計29例に対して, sparfloxacinを1日100～300mg, 3～14日間経口投与した。臨床効果は著効8例, 有効16例, 無効5例で, 有効率82.8%の成績を得た。副作用として眩量+嘔気+心窩部痛, 発熱+好酸球増多を各1例に認めたが投与中止例はなく, かつ治療終了後はいずれも消退した。 |
| Author | Shimada, Jingoro Shiba, Kohya Sakai, Osamu Kaji, Masanobu Imai, Takeo Hori, Seiji Saito, Atsushi Matsumoto, Fumio Yoshida, Masaki Hojo, Toshio |
| Author_FL | 加地 正伸 松本 文夫 柴 孝也 酒井 紀 今井 健郎 吉田 正樹 堀 誠治 斎藤 篤 嶋田 甚五郎 北条 敏夫 |
| Author_FL_xml | – sequence: 1 fullname: 嶋田 甚五郎 – sequence: 2 fullname: 斎藤 篤 – sequence: 3 fullname: 柴 孝也 – sequence: 4 fullname: 北条 敏夫 – sequence: 5 fullname: 加地 正伸 – sequence: 6 fullname: 堀 誠治 – sequence: 7 fullname: 吉田 正樹 – sequence: 8 fullname: 酒井 紀 – sequence: 9 fullname: 今井 健郎 – sequence: 10 fullname: 松本 文夫 |
| Author_xml | – sequence: 1 fullname: Saito, Atsushi organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Hojo, Toshio organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Shimada, Jingoro organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Kaji, Masanobu organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Hori, Seiji organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Imai, Takeo organization: Department of Internal Medicine, Kanagawa Prefectural Nursing and Hygiene School Hospital – sequence: 1 fullname: Sakai, Osamu organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Shiba, Kohya organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Yoshida, Masaki organization: The Second Department of Internal Medicine, The Jikei University School of Medicine – sequence: 1 fullname: Matsumoto, Fumio organization: Department of Internal Medicine, Kanagawa Prefectural Nursing and Hygiene School Hospital |
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| References | 5) 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, Sparfloxacin (AT-4140), 岐阜, 1990 7) 山口俊和, 横川真喜子, 橋爪孝典, 馬場政子, 松岡信男, 関根豊: Sparfloxacinのラット, イヌ, サルにおける体内動態. 薬物動態6: 33-41, 1991 11) Grasela T H, Schentag J J, Sedman A J, Wilton J H, Thomas ID J, Schultz R W, Lebsack M E and Kinkel A W: Inhibition of enoxacin absorption by antacids or ranitidine. Antimicrob Agents Chemother 33: 815-617, 1989 15) Wingender W, Beermann D, Forster D, Graefe K-H and Kuhlmann J: Interactions of ciprofloxacin with food intake and drugs. Proceedings of the 1 st International Ciprofloxacin Workshop. eds. by Neu HC and Weuta H, pp136-140, Extra Medica, Amsterdam, 1986 12) Misiak P, Toothaker R, Lebsack M, Sedman A and Colburn W: The effect of dosing-time intervals on the potential pharmacokinetic interaction between oral enoxacin and oral antacid. 28th ICAAC, Astr. No.1441, Los Angeles, Oct.23, 1988 10) 宍戸春美, 松本慶蔵, 永武毅, 田淵純宏: 新キノロン剤NY-198の胃腸管吸収に関する研究-Crossover法による制酸剤の影響ならびに胃切除患者の吸収におけるofloxacinとの比較. Chemotherapy 36 (S-2): 256-264, 1988 2) Nakamura S, et al.: In vitro and in vivo antibacterial activities of AT a new broad-spectrum quinolone. Antimicrob Agents Chemother 33: 1167-4173, 1989 4) Nakamura S, Kurobe N, Ohue T, Hashimoto M and Shimizu M: Pharmacokinetics of a novel quinolone, AT-4140, in animals. Antimicrob Agents Chemother 34. 89-93, 1990 13) Shimada J, Yamaji T, Ueda Y, Uchida H, Kusajima H and Irikura T: Mechanism of renal excretion of AM-715, a new quinolone carboxylic acid derivative, in rabbits, dogs, and humans. Antimicrob Agents Chemother 23: 1-7, 1983 16) 山口俊和, 横川真喜子, 関根豊: Sparfloxacinの腎排泄機序. 薬物動態6: 61-65, 1991 3) Kojima T, Inoue M and Mitsuhashi S: In vitro activity of AT-4140 against clinical bacterial isolates. Antimicrob Agents Chemother 33: 1980-1988, 1989 14) 加地正伸, 他: NY-198にかんする臨床的研究. Chemotherapy 36 (S-2): 513-526, 1988 1) Miyamoto T, et al.: Synthesis and structure-activity relationships of 5-substituted 6, 8-difluoroquinolones, including sparfloxacin, a new quinolone antibacterial agent with improved potency. J Med Chem 33: 1645-1656, 1990 9) 柴孝也, 他: 健常人におけるFleroxacinの胃腸管吸収に及ぼす制酸剤の影響. Chemotherapy 38 (S-2): 344-349, 1990 6) Hori S, Shimada J, Saito A, Sakai O and Matsuda M: Effect of AT-4140, a newly synthesized quinolone, on γ-aminobutylic acid (GABA) receptor binding, comparative study of convulsive activity of new quinolones. 29th ICAAC, Astr. No.1203, Houston, Sep.20, 1989 8) Shiba K, Saito A, Miyahara T, Tachizawa H and Fujimoto T: Effect of aluminum hydroxide, an antacid, on the pharmacokinetics of new quinolones in humans. 15th International Congress of Chemotherapy, Astr. No.247, Istanbul, July 19, 1987 |
| References_xml | – reference: 2) Nakamura S, et al.: In vitro and in vivo antibacterial activities of AT a new broad-spectrum quinolone. Antimicrob Agents Chemother 33: 1167-4173, 1989 – reference: 6) Hori S, Shimada J, Saito A, Sakai O and Matsuda M: Effect of AT-4140, a newly synthesized quinolone, on γ-aminobutylic acid (GABA) receptor binding, comparative study of convulsive activity of new quinolones. 29th ICAAC, Astr. No.1203, Houston, Sep.20, 1989 – reference: 10) 宍戸春美, 松本慶蔵, 永武毅, 田淵純宏: 新キノロン剤NY-198の胃腸管吸収に関する研究-Crossover法による制酸剤の影響ならびに胃切除患者の吸収におけるofloxacinとの比較. Chemotherapy 36 (S-2): 256-264, 1988 – reference: 1) Miyamoto T, et al.: Synthesis and structure-activity relationships of 5-substituted 6, 8-difluoroquinolones, including sparfloxacin, a new quinolone antibacterial agent with improved potency. J Med Chem 33: 1645-1656, 1990 – reference: 8) Shiba K, Saito A, Miyahara T, Tachizawa H and Fujimoto T: Effect of aluminum hydroxide, an antacid, on the pharmacokinetics of new quinolones in humans. 15th International Congress of Chemotherapy, Astr. No.247, Istanbul, July 19, 1987 – reference: 11) Grasela T H, Schentag J J, Sedman A J, Wilton J H, Thomas ID J, Schultz R W, Lebsack M E and Kinkel A W: Inhibition of enoxacin absorption by antacids or ranitidine. Antimicrob Agents Chemother 33: 815-617, 1989 – reference: 13) Shimada J, Yamaji T, Ueda Y, Uchida H, Kusajima H and Irikura T: Mechanism of renal excretion of AM-715, a new quinolone carboxylic acid derivative, in rabbits, dogs, and humans. Antimicrob Agents Chemother 23: 1-7, 1983 – reference: 14) 加地正伸, 他: NY-198にかんする臨床的研究. Chemotherapy 36 (S-2): 513-526, 1988 – reference: 15) Wingender W, Beermann D, Forster D, Graefe K-H and Kuhlmann J: Interactions of ciprofloxacin with food intake and drugs. Proceedings of the 1 st International Ciprofloxacin Workshop. eds. by Neu HC and Weuta H, pp136-140, Extra Medica, Amsterdam, 1986 – reference: 7) 山口俊和, 横川真喜子, 橋爪孝典, 馬場政子, 松岡信男, 関根豊: Sparfloxacinのラット, イヌ, サルにおける体内動態. 薬物動態6: 33-41, 1991 – reference: 9) 柴孝也, 他: 健常人におけるFleroxacinの胃腸管吸収に及ぼす制酸剤の影響. Chemotherapy 38 (S-2): 344-349, 1990 – reference: 3) Kojima T, Inoue M and Mitsuhashi S: In vitro activity of AT-4140 against clinical bacterial isolates. Antimicrob Agents Chemother 33: 1980-1988, 1989 – reference: 12) Misiak P, Toothaker R, Lebsack M, Sedman A and Colburn W: The effect of dosing-time intervals on the potential pharmacokinetic interaction between oral enoxacin and oral antacid. 28th ICAAC, Astr. No.1441, Los Angeles, Oct.23, 1988 – reference: 16) 山口俊和, 横川真喜子, 関根豊: Sparfloxacinの腎排泄機序. 薬物動態6: 61-65, 1991 – reference: 4) Nakamura S, Kurobe N, Ohue T, Hashimoto M and Shimizu M: Pharmacokinetics of a novel quinolone, AT-4140, in animals. Antimicrob Agents Chemother 34. 89-93, 1990 – reference: 5) 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, Sparfloxacin (AT-4140), 岐阜, 1990 |
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| Snippet | We performed basic and clinical studies on sparfloxacin (SPFX), a newly synthesized quinolone, and obtained the following results. 1. Effects of antacid (dried... We performed basic and clinical studies on sparfloxacin (SPFX), a newly synthesized quinolone, and obtained the following results.1. Effects of antacid (dried... |
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| SubjectTerms | Probenecid Sparfloxacin 制酸剤 吸収 臨床 |
| Title | PHARMACOKINETICS AND CLINICAL STUDIES ON SPARFLOXACIN |
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