DOSE-FINDING STUDY OF GATIFLOXACIN, A NEW ORAL QUINOLONE, IN CHRONIC RESPIRATORY TRACT INFECTION
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- Saito Atsushi
- Department of General Internal Medicine, The Jikei University School of Medicine, Kashiwa Hospital
Bibliographic Information
- Other Title
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- 慢性気道感染症に対するgatifloxacinの用量設定試験
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Abstract
We performed a double-blind, randomized, multi-center dose-finding study of gatifloxacin (GFLX) to determine the optimal dose regimen for chronic respiratory tract infections. The daily dosage of vatifloxacin was 100 mg b.i.d.(Group L), 150 mg b.i.d.(Group M), or 200 mg b. i. d.(Group H).<BR>The results were as follows:<BR>1. Clinical efficacy was evaluated in 104 cases. The clinical efficacy rates (excellent or good) in Groups L, M, and H were 97.1%(33/34), 87.5%(28/32), and 94.7%(36/38), respectively, with no significant differences among the groups. “Excellent” response rates were 5.9%(2/34) in Group L, 6.3%(2/32) in Group M, and 21.1%(8/34) in Group H, significantly higher than the former two.<BR>2. Bacteriological efficacy was evaluated in 59 cases of identified bacteria.Eradication rates in Groups L, M, and H were 75.0%(18/24), 76.5%(13/17), and 72.2%(13/18), respectively, with no significant differences among the groups.<BR>3.Side effects were evaluated in 114 cases; 5.1%(2/39) in Group L, 2.9%(1/35) in Group M, and 7.5%(3/40) in Group H.Laboratory test findings were evaluated in 106 cases, and the incidences of abnormal findings were 14.7%(5/34) in Group L, 0%(0/34) in Group M, and 5.3%(2/38) in Group H.<BR>4.Clinical usefulness was evaluated in 107 cases.The usefulness rates (very useful or useful) were 94.3%(33/35) in Group L, 84.9%(28/33) in Group M, and 92.3%(36/39) in Group H.<BR>These results indicate that no significant differences in clinical or bacteriological efficacy among the three dosage groups were found, and that there were no dose-dependent side effects or abnormal laboratory findings, nor dose-related differences in type or severity of side effects. However, since clinical efficacy rates in bronchiectasis-related infections and in moderate-type infections were significantly higher in Group H, as well as the clinical “excellent” rating, the daily dosage of 200 mg b. i. d. of gatifloxacin is considered optimal for treatment of chronic respiratory tract infections.
Journal
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- Japanese Journal of Chemotherapy
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Japanese Journal of Chemotherapy 47 (Supplement2), 419-437, 1999
Japanese Society of Chemotherapy
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Keywords
Details 詳細情報について
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- CRID
- 1390282681267527040
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- NII Article ID
- 10008029460
- 130004297971
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- NII Book ID
- AN10472127
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- ISSN
- 18845886
- 13407007
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed