Clinical efficacy of temafloxacin in respiratory infections and its pharmacokinetics in sputum
We evaluated the clinical efficacy and safety of temafloxacin (TMFX) in a phase II study in a total of twelve patients with respiratory infections. TMFX was administered orally at a dose of 300mg twice daily in most cases. The time course of the serum and sputum concentrations was evaluated after ad...
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| Published in | CHEMOTHERAPY Vol. 41; no. Supplement5; pp. 361 - 368 |
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| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English Japanese |
| Published |
Japanese Society of Chemotherapy
1993
公益社団法人 日本化学療法学会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0009-3165 1884-5894 |
| DOI | 10.11250/chemotherapy1953.41.Supplement5_361 |
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| Abstract | We evaluated the clinical efficacy and safety of temafloxacin (TMFX) in a phase II study in a total of twelve patients with respiratory infections. TMFX was administered orally at a dose of 300mg twice daily in most cases. The time course of the serum and sputum concentrations was evaluated after administering a single 300mg dose to two patients with copious mucopurulent sputum, and pharmacokinetic analysis was also performed. The subjects included one case each of pneumonia, mycoplasmal pneumonia, infected bullae, diffuse panbronchiolitis, and eight cases of bronchiectasis. Clinical response was good in eight cases, fair in two and poor in two. The overall clinical response rate was 67%. Two strains of Haemophilus influenzae were eradicated. Two of the 3 strains of Pseudomonas aeruginosa persisted and one decreased. No adverse effects were observed. The average peak concentration of TMFX in serum was 3.53μg/ml and in sputum 3.72μg/ml. The mean sputum/serum concentration ratio was 106%. The pharmacokinetic parameters in sputum were very similar to those in serum. The results indicate that TMFX penetrates into bronchial secretions well and is useful in the treatment of respiratory infections. |
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| AbstractList | We evaluated the clinical efficacy and safety of temafloxacin (TMFX) in a phase II study in a total of twelve patients with respiratory infections. TMFX was administered orally at a dose of 300mg twice daily in most cases. The time course of the serum and sputum concentrations was evaluated after administering a single 300mg dose to two patients with copious mucopurulent sputum, and pharmacokinetic analysis was also performed. The subjects included one case each of pneumonia, mycoplasmal pneumonia, infected bullae, diffuse panbronchiolitis, and eight cases of bronchiectasis. Clinical response was good in eight cases, fair in two and poor in two. The overall clinical response rate was 67%. Two strains of Haemophilus influenzae were eradicated. Two of the 3 strains of Pseudomonas aeruginosa persisted and one decreased. No adverse effects were observed. The average peak concentration of TMFX in serum was 3.53μg/ml and in sputum 3.72μg/ml. The mean sputum/serum concentration ratio was 106%. The pharmacokinetic parameters in sputum were very similar to those in serum. The results indicate that TMFX penetrates into bronchial secretions well and is useful in the treatment of respiratory infections. We evaluated the clinical efficacy and safety of temafloxacin (TMFX) in a phase II study in a total of twelve patients with respiratory infections. TMFX was administered orally at a dose of 300mg twice daily in most cases. The time course of the serum and sputum concentrations was evaluated after administering a single 300mg dose to two patients with copious mucopurulent sputum, and pharmacokinetic analysis was also performed. The subjects included one case each of pneumonia, mycoplasmal pneumonia, infected bullae, diffuse panbronchiolitis, and eight cases of bronchiectasis. Clinical response was good in eight cases, fair in two and poor in two. The overall clinical response rate was 67%. Two strains of Haemophilus influenzae were eradicated. Two of the 3 strains of Pseudomonas aeruginosa persisted and one decreased. No adverse effects were observed.The average peak concentration of TMFX in serum was 3.53μg/ml and in sputum 3.72μg/ml. The mean sputum/serum concentration ratio was 106%. The pharmacokinetic parameters in sputum were very similar to those in serum. The results indicate that TMFX penetrates into bronchial secretions well and is useful in the treatment of respiratory infections. 呼吸器感染症12例にtemafloxacin (TMFX) を投与し, その臨床効果と安全性を検討した。対象は肺炎, マイコプラズマ肺炎, 感染性嚢胞各1例, 気道感染症9例であった。気道感染症の内訳は気管支拡張症8例, びまん性汎細気管支炎1例であった。投与量は100mgないし300mgを1日2ないし3回投与した。臨床効果は, 12例中有効8例, やや有効2例, 無効2例で有効率は67%であった。細菌学的効果は, Haemophilus influenzae 2株は消失, Pseudomonas aeruginosa 3株中1株減少, 2株は存続した。ブドウ糖非発酵菌1株も存続した。副作用, 臨床検査値異常はみられなかった。びまん性汎細気管支炎2例において本剤の血清・喀痰中の薬動力学的検討を行った。本剤300mg1回投与後の薬動力学的パラメータは, 血清およひ喀痰中で類似しており, 本剤は喀痰中に血清とほぼ同一相で移行していると考えられた。TMFXの喀痰中移行は良好であり, 呼吸器感染症に対する有効性が示唆された。 |
| Author | Nakamori, Yoshitaka Tanimoto, Hiroichi Nakatani, Tatsuo Narui, Kouji Nakata, Koichiro Tsuboi, Eiyasu Sugi, Hiroko |
| Author_FL | 中谷 龍王 中田 紘一郎 坪井 永保 中森 祥隆 杉 裕子 谷本 普一 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: 杉 裕子 – sequence: 7 fullname: 谷本 普一 |
| Author_xml | – sequence: 1 fullname: Tanimoto, Hiroichi organization: The Fourth Department of Internal Medicine, The Jikei University, School of Medicine – sequence: 1 fullname: Nakatani, Tatsuo organization: Division of Respiratory diseases, Toranomon Hospital – 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: Nakata, Koichiro organization: Division of Respiratory diseases, Toranomon Hospital – sequence: 1 fullname: Tsuboi, Eiyasu organization: Division of Respiratory diseases, Toranomon Hospital – sequence: 1 fullname: Sugi, Hiroko organization: Department of Clinical Laboratory, Toranomon Hospital |
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| References | 2) 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: 1990, 中外医学社, 1990 4) 中谷龍王, 坪井永保, 成井浩司, 蝶名林直彦, 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sparfloxacinの効果および喀痰中の薬動力学的検討. Chemotherapy 39 (S-4): 245-249, 1991 3) 中谷龍王, 成井浩司, 野口昌幸, 蝶名林直彦, 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fleroxacinの効果および喀痰中濃度の検討. Chemotherapy 38 (S-2): 396-402, 1990 1) 那須勝, 熊澤淨一: 第39回日本化学療法学会西日本支部総会, 新薬シンポジウム, Temafloxacin (TA-167), 大分, 1991 |
| References_xml | – reference: 1) 那須勝, 熊澤淨一: 第39回日本化学療法学会西日本支部総会, 新薬シンポジウム, Temafloxacin (TA-167), 大分, 1991 – reference: 2) 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: 1990, 中外医学社, 1990 – reference: 4) 中谷龍王, 坪井永保, 成井浩司, 蝶名林直彦, 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sparfloxacinの効果および喀痰中の薬動力学的検討. Chemotherapy 39 (S-4): 245-249, 1991 – reference: 3) 中谷龍王, 成井浩司, 野口昌幸, 蝶名林直彦, 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fleroxacinの効果および喀痰中濃度の検討. Chemotherapy 38 (S-2): 396-402, 1990 |
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| Title | Clinical efficacy of temafloxacin in respiratory infections and its pharmacokinetics in sputum |
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