부산대학교 도서관

A comparative clinical study of cefaclor with cephalexin was carried out by randomized double blind techniques in order to compare the clinical efficacy, side effects and usefulness in treatment of 239patients with acute and chronic bronchitis.In the cephalexin group, cephalexin was orally administered four times a day at a daily dosage of 1, 000mg for 3 to 10 days. In the cefaclor group, cefaclor was orally administered three times a day at a daily dosage of 750mg for 3 to 10 days and one capsule of placebo was also given every evening in order to keep the blindness of the administration.Statistical comparisons between the two drugs were made in 159 patients with acute bronchitis and 78 patients with chronic bronchitis. Two patients were excluded from the statistical evaluation due to deviations from the protocol.In the case of acute bronchitis, characteristics of the population, sex and age, severity of infection and causative organisms before treatment were similar in each treatment group and no significantdifference could be found between the two groups, except for a higher tendency of complications with pulmonary tuberculosis and higher positive CRP in the cefaclor group.No significant difference was seen in the clinical effectiveness obtained in acute bronchitis between the two drugs. Excellent and good clinical responses were obtained in 57 (74%) of 77 patients of the cefaclor group and in 64 (78%) of 82 patients of the cephalexin group. Regarding the degree of improvement of cough on the 7th day, the cephalexin group showed a superior tendency (p<0.10) to the cefaclor group. On the other hand, the cefaclor group showed a superior tendency (p<0.10) to the cephalexin group in degrees of improvement of rales on the 5th day and final day of administration.In contrast, backgrounds of the population of chronic bronchitis were quite similar in each group and all items compared showed no significant difference between the two groups.The clinical effectiveness in chronic bronchitis obtained with cefaclor showed superior tendency (p<0.10) to that with cephalexin. Excellent and good clinical responses were obtained in 28 (67%) of 42 patients of the cefaclor group and in 17 (47%) of 36 patients of the cephalexin group. Regarding the degree of improvement of sputum, treatment with cefaclor showed a superior tendency (p<0.10) to that with cephalexin on the 7th day. At the same time, the degrees of improvement of CRP and ESR treated with cefaclor were significantly superior (p<0.05) to those with cephalexin. In addition, on the final day of treatment, the degree of improvement of cough in the cefaclor group showed a superior tendency (p<0.10) to that in the cephalexin group.No statistically significant difference could be found in the occurrence of side effects or abnormal clinical laboratory findings between the two groups.According to the judgement by investigators in charge, no significant difference was seen in clinical usefulness in acute bronchitis between the two drugs.In the patients with chronic bronchitis, the judgements of clinical usefulness in the cefaclor group was significantly superior (p<0.05) to that in the cephalexin group