부산대학교 도서관

The clinical efficacy and safety of Enoxacin (AT-2266, ENX) were compared with those of cefaclor (CCL) in 188 patients with chronic respiratory tract infections (chronic RTI) and those with exacerbated acute infections by a double-blind study at 40 institutions in Japan. Patients over 16 years old with apparent clinical signs and symptoms were administered ENX or CCL orally for 14 days at a daily dose of 3 tablets or capsules (ENX: on tablet contains 200 mg of ENX; CCL: on capsule contains 250 mg of CCL). The parameters assessed were clinical efficacy, bacteriological response, rate of improvement of clinical signs and symptoms, appearance of side effect, abnormal loboratory findings and clinical usefulness.1. Clinical efficacy was analysed statistically 166 patients (88 administered ENX., 78 administered CCL) and 22 patients out of a total of 188 patients were excluded. Side effects were also analysed in 179 patients (ENX: 96, CCL 83) in whom judgement was possible.2. On the basis of committee judgement the overall clinical efficacy rates for all the cases were 56.8% for ENX and 62.8% for CCL, those for chronic RTI were 56.3% for ENX and 62.7% for CCL. No significant difference was observed between the two drug groups.In the evaluation of clinical efficacy by the doctor, the overall efficacy ratesin all the cases were 56.8% for ENX and 55.1% for CCL, those for chronic RTI were 56.3% for ENX and 56.0% for CCL. No significant difference was observed between the two drug groups.3. The bacteriological eradicated rate of causative organisms was 54.2% out of 48 patients treated with ENX and 50.9% out of 60 treated with CCL and there was no significant differences between the two groups. At showed an eradication rate of 18.2% in S. pneumoniae and that of 84.6% in H influenzae, while the corresponding rates for CCL were 71.4% in S. pneumoniae and 63.2% in H.influenzae. The ENX group was superior to the CCL group in the bacteriological response in H influenzae among causative organisms (p<0.10) and the CCL group was superior to the ENX group in S. pneumoniae (p<0.05).4. With respect to the rate of improvement of clinical signs and symptoms the ENX group was superior to the CCL group in the improvement for sputum volume five days after treatment (p<0.05).5. The incidence of side effects was 11.5% for ENX and 2.4% for CCL. The ENX group displayed significantly higher rate of side effects than the CCL group. Abnormal laboratory findings were observed at the rate of 19.7% for ENX and 14.1% for CC1, without significant differences between the two groups.6. Regarding usefulness as judged by committtee members the respective rate for the ENX group and CCL group were 53.3% and 62.8% and usefulnss as judged by the doctor in charge those were 45.7% for ENX and 48.7% for CCL. These assessements showed no significant differences between the two.From the above results it was concluded that ENX is an equal useful drug to CCL for the treatment of chronic RTI caused by gram negative bacteria.