呼吸器感染症に対するBAY12-8039 (moxifloxacin) の第III相臨床試験

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  • Phase III clinical study of BAY 12-8039 (moxifloxacin) for respiratory tract infections

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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.<BR>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 11-2). The eradication rate was 100%(24/24) for Group I and 86.1%(31/36) for Group 11-2. The overall eradication rate was 91.7%(55/60). Good eradication rates were obtained in every diagnostic group.<BR>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.<BR>The above results suggested that 400mg of MFLX administered once daily should be clinically very useful in the treatment of respiratory tract infections.

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