Clinical efficacy of grepafloxacin in respiratory infections and its pharmacokinetics in sputum
We evaluated the clinical efficacy and safety of grepafloxacin (GPFX) in a phase 2 study in a total of seven patients with respiratory infections. GPFX was administered orally at a dose of 150 to 300mg daily. The time course of the serum and sputum concentrations was evaluated after administering a...
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| Published in | Japanese Journal of Chemotherapy Vol. 43; no. Supplement1; pp. 239 - 243 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
Japanese Society of Chemotherapy
1995
公益社団法人 日本化学療法学会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1340-7007 1884-5886 |
| DOI | 10.11250/chemotherapy1995.43.Supplement1_239 |
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| Abstract | We evaluated the clinical efficacy and safety of grepafloxacin (GPFX) in a phase 2 study in a total of seven patients with respiratory infections. GPFX was administered orally at a dose of 150 to 300mg daily. The time course of the serum and sputum concentrations was evaluated after administering a 300mg dose to one patient, and pharmacokinetic analysis was also performed. The subjects included one case each of bronchial asthma and diffuse panbronchiolitis, and five cases of bronchiectasis. Clinical response was good in three cases, fair in one and poor in two. Two strains of Haemophilus influenzae were eradicated, while three strains of Pseudomonas aeruginosa persisted in spite of their susceptibility to GPFX. One patient had headache and lumbago as well as chest discomfort four hours after taking GPFX. No abnormal laboratory findings were observed. The peak concentration of GPFX in sputum (four hours after administration) was 2.31μg/ml, almost two-fold that in serum, suggesting its efficacy in respiratory infections. |
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| AbstractList | We evaluated the clinical efficacy and safety of grepafloxacin (GPFX) in a phase 2 study in a total of seven patients with respiratory infections. GPFX was administered orally at a dose of 150 to 300mg daily. The time course of the serum and sputum concentrations was evaluated after administering a 300mg dose to one patient, and pharmacokinetic analysis was also performed. The subjects included one case each of bronchial asthma and diffuse panbronchiolitis, and five cases of bronchiectasis. Clinical response was good in three cases, fair in one and poor in two. Two strains of Haemophilus influenzae were eradicated, while three strains of Pseudomonas aeruginosa persisted in spite of their susceptibility to GPFX. One patient had headache and lumbago as well as chest discomfort four hours after taking GPFX. No abnormal laboratory findings were observed.The peak concentration of GPFX in sputum (four hours after administration) was 2.31μg/ml, almost two-fold that in serum, suggesting its efficacy in respiratory infections.
呼吸器感染症7例にgrepafloxacin (GPFX) を投与し, その臨床効果と安全性を検討した。対象は全例気道感染症であり, その内訳は気管支拡張症5例 (うち1例はKartagener症候群), 気管支喘息びまん性汎細気管支炎各1例であった。投与量は100mgないし300mgを1日1～2回投与した。臨床効果は, 6例中有効3例, やや有効1例, 無効2例であった。細菌学的効果は, Haemophitus influenzae 2株は消失, Pseudmonas aemginosa 3株は存続した。1例で投与4時間目に頭痛・腰痛・胸部不快感が出現したが, 30分で消失した。本剤による副作用と思われた。臨床検査値異常は見られなかった。Kartagener症候群の1例で本剤の血清・喀痰中の薬動力学的検討を行なった。300mg投与後の最高濃度到達時間は血清では3時間, 喀痰中では4時間であり, ピーク値はそれぞれ1.18μg/ml, 2.31μg/mlであった。喀痰中最高濃度の血清中最高濃度に対する比率は196%であった。GPFXは血清の約2倍の濃度で喀痰中に移行しており, 呼吸器感染症における有用性が示唆された。 We evaluated the clinical efficacy and safety of grepafloxacin (GPFX) in a phase 2 study in a total of seven patients with respiratory infections. GPFX was administered orally at a dose of 150 to 300mg daily. The time course of the serum and sputum concentrations was evaluated after administering a 300mg dose to one patient, and pharmacokinetic analysis was also performed. The subjects included one case each of bronchial asthma and diffuse panbronchiolitis, and five cases of bronchiectasis. Clinical response was good in three cases, fair in one and poor in two. Two strains of Haemophilus influenzae were eradicated, while three strains of Pseudomonas aeruginosa persisted in spite of their susceptibility to GPFX. One patient had headache and lumbago as well as chest discomfort four hours after taking GPFX. No abnormal laboratory findings were observed. The peak concentration of GPFX in sputum (four hours after administration) was 2.31μg/ml, almost two-fold that in serum, suggesting its efficacy in respiratory infections. |
| Author | Nakatani, Tatsuo Narui, Kouji Nakata, Koichiro Tsuboi, Eiyasu Nakamori, Yoshitaka Inagawa, Hiroko |
| Author_FL | 中谷 龍王 稲川 裕子 中田 紘一郎 坪井 永保 中森 祥隆 成井 浩司 |
| Author_FL_xml | – sequence: 1 fullname: 中谷 龍王 – sequence: 2 fullname: 坪井 永保 – sequence: 3 fullname: 成井 浩司 – sequence: 4 fullname: 中森 祥隆 – sequence: 5 fullname: 中田 紘一郎 – sequence: 6 fullname: 稲川 裕子 |
| Author_xml | – sequence: 1 fullname: Narui, Kouji organization: Division of Respiratory Diseases, Toranomon Hospital – sequence: 1 fullname: Nakamori, Yoshitaka organization: Division of Respiratory Diseases, Toranomon Hospital – sequence: 1 fullname: Inagawa, Hiroko organization: Department of Clinical Laboratory, Toranomon Hospital – sequence: 1 fullname: Nakatani, Tatsuo organization: Division of Respiratory Diseases, Toranomon Hospital – sequence: 1 fullname: Tsuboi, Eiyasu organization: Division of Respiratory Diseases, Toranomon Hospital – sequence: 1 fullname: Nakata, Koichiro organization: Division of Respiratory Diseases, Toranomon Hospital |
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| References | 5) 松本慶蔵: 抗生物質, 抗菌剤の血中濃度と喀痰中, 気道分泌物中濃度. Annual Review呼吸器, P123, 中外医学社, 東京, 1990 2) 中谷龍王, 坪井永保, 成井浩司, 中森祥隆, 中田紘一郎, 杉裕子, 谷本普一: 呼吸器感染症におけるtemafloxacinの効果および喀痰中の薬動力学的検討. Chemotherapy 39 (S-4): 245-249, 1993 4) Taira K, Koga H and Kohno S: Accumulation of a newly developed fluoroquinolone, OPC-17116, by human polymorphonuclear leukocytes. J Antimicrob Chemother 37: 1877-1881, 1993 1) 守殿貞夫, 副島林造: 第41回日本化学療法学会, 西日本支部総会, 新薬シンポジウム. Grepanoxacin (OPC-17116), 神戸, 1993 3) 中谷龍王: 抗菌薬の体内動態検討の意義; 呼吸器感染症より. 化学療法の領域 10: 425-432, 1994 |
| References_xml | – reference: 5) 松本慶蔵: 抗生物質, 抗菌剤の血中濃度と喀痰中, 気道分泌物中濃度. Annual Review呼吸器, P123, 中外医学社, 東京, 1990 – reference: 1) 守殿貞夫, 副島林造: 第41回日本化学療法学会, 西日本支部総会, 新薬シンポジウム. Grepanoxacin (OPC-17116), 神戸, 1993 – reference: 3) 中谷龍王: 抗菌薬の体内動態検討の意義; 呼吸器感染症より. 化学療法の領域 10: 425-432, 1994 – reference: 2) 中谷龍王, 坪井永保, 成井浩司, 中森祥隆, 中田紘一郎, 杉裕子, 谷本普一: 呼吸器感染症におけるtemafloxacinの効果および喀痰中の薬動力学的検討. Chemotherapy 39 (S-4): 245-249, 1993 – reference: 4) Taira K, Koga H and Kohno S: Accumulation of a newly developed fluoroquinolone, OPC-17116, by human polymorphonuclear leukocytes. J Antimicrob Chemother 37: 1877-1881, 1993 |
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| Title | Clinical efficacy of grepafloxacin in respiratory infections and its pharmacokinetics in sputum |
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