A multicenter open study was conducted to evaluate the clinical efficacy, safety and optimal effective dosage of FK 037 in chronic respiratory tract infections. 1. The total number of patients ...enrolled was 55, 3 of whom were judged to be “unkown” in the assessment of clinical efficacy. 2. The clinical efficacy in 52 patients was judged to be “excellent” in 14 and “good” in 34 an efficacy rate of 92.3%. The efficacy rates according to dosage were 90.0% at 0.5g×2/day, 93.1% at 1.0g×2/day and 92.3% at 2.0g×2/day. 3. The bacteriological effects in 31 patients were “eradicated” in 26, “decreased” in 3 and “unchanged” in 2, for an eradication rate of 83.9%. 4. As side effects, a small papule was observed in 1 patient, and abnormal laboratory findings were observed in 7 patients. From the above results, we concluded that 1.0g×2/day of FK 037 was useful in chronic respiratory tract infections.
Using the double-blind comparative trial method, we conducted a multicenter cooperative study at 52 institutions throughout Japan on the efficacy and the safety of cefotetan (CTT) at a dose of 2g/day ...and cefmetazole (CMZ) at a dose of 4g/day in treating bacterial pneumonia and other lower respiratory tract infections and achieved the following results. 1. The patients were classified according to severity of symptoms and based on the judgment of the committee, it was concluded that in regard to clinical efficacy CTT proved to be significantly superior to CMZ in bacterial pneumonia cases of moderate severity. Even in all cases, CTT tend to show a superior clinical effectiveness on cases moderate severity. No other significant differences in regard to clinical efficacy were observed between these 2 drugs either by the committee or the attending physicians. 2. An analysis of all cases accepted by the committee showed that CTT was significantly superior in effectively relieving fever, and CMZ was significantly superior in relieving cough symptom. 3. No significant difference was observed between 2 drugs in regard to bacteriological effectiveness. 4. No significant difference was observed between 2 drugs in regard to the nature or frequency of side effects or abnormal clinical laboratory findings. 5. No significant difference was observed between 2 drugs in regard to clinical usefulness. From the above findings we concluded that 2g/day of CTT was equal or superior in some cases to 4g/day of CMZ in the treatment of respiratory tract infections.
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