Phase III clinical study of BAY 12-8039 (moxifloxacin) for respiratory tract infections
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Accession number;06A0013878
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| Title;Phase III clinical study of BAY 12-8039 (moxifloxacin) for respiratory tract infections |
| Author;
KOBAYASHI HIROYUKI
(Kyorin Univ., School of Medicine, JPN)
AOKI NOBUKI
(Niigata-shi Shakai Jigyo Kyokai Shinrakuen Byoin, JPN)
NIKI YOSHIHITO
(Kawasaki Medical School, JPN)
WATANABE AKIRA
(Res. Inst. Tuberculosis and Cancer, Tohoku Univ.)
KAWAI SHIN
(Kyorin Univ., School of Medicine, JPN)
ODAGIRI SHIGEKI
(Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center, JPN)
KONO SHIGERU
(Nagasaki Univ., Grad. Sch.)
YAMAGUCHI KEIZO
(Toho Univ., School of Med.)
SAITO ATSUSHI
(Univ. of Ryukyus, Grad. Sch.)
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Journal Title;Japanese Journal of Chemotherapy
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Journal Code:F0608A
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ISSN:1340-7007
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VOL.53;NO.Supplement 3;PAGE.47-59(2005)
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| Figure&Table&Reference;FIG.1, TBL.9, REF.26 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy and safety of BAY 12-8039 (moxifloxacin: MFLX), a novel new quinolone compound, were evaluated in patient with respiratory tract infections. Patients were treated for 7 days with MFLX 400 mg once daily. The clinical efficacy rate was 98.3% (57/58 cases) for acute upper respiratory tract infections (Group I), 100% (26/26) for atypical pneumonia (Group II-1) and 87.7% (57/65) for secondary infections (or acute exacerbation) in patient with chronic respiratory tract diseases (Group II-2). The eradication rate was 100% (24/24) for Group I and 86.1% (31/36) for Group II-2. The overall eradication rate was 91.7% (55/60). Good eradication rates were obtained in every diagnostic group. The incidence of adverse drug reactions were noted in 32.5% (65 cases) of all patients. Adverse drug reactions were most commonly observed in digestive organs in 20.0% (40 cases). The most common adverse drug reactions were abnormal liver function tests and diarrhea, and their incidence rate was 8.5% (17 cases) and 5.5% (11 cases), respectively. The above results suggested that 400 mg of MFLX administered once daily should be clinically very useful in the treatment of respiratory tract infections. (author abst.) |
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