Abstract
Ceftriaxone (CTRX), a newly developed antibiotic agent, was administered at 1,000mg intravenously twice a day for 5 days to 7 healthy volunteers aged 21 to 26, weighing 61 to 79kg (mean: 67.7kg). The fecal bacterial flora was examined and the fecal level of CTRX was determined before, on 3 and 5 days after starting the administration, and on 3, 5 and 10 days after terminating the administration. At the same time, various bacteria isolated from the collected fecal specimens were studied for the sensitivity to CTRX, CEZ, CMZ and CTX. Adverse reactions and influence on various clinical laboratory parameters of CTRX were also examined. The results were as follows.
1. Fecal bacterial flora:
Enterobacteriaceae was at the level of 105 to 108 cells/g (mean: 107 cells/g) before starting the administration. The bacteria were detected from none of the 7 subjects on 5 days after starting the administration and on 3 days after terminating the administration. On 10 days after terminating the administration, the bacteria were detected in 6 out of the 7 subjects at the level of 103 to 107 cells/g (mean: 107 cells/g). The level was the same as before starting the administration as a whole, but it had not been recovered to the initial level in any individual subject. With regard to other Gram-negative bacilli, P. aeruginosa which was isolated from none of the 7 subjects before starting the administration was detected at the level of 102 to 106 cells/g in 1 or 2 subjects on 3 days after starting, and on 3, 5 and 10 days after terminating the administration.
Concerning Gram-positive bacteria, Staphylococcus sp. was isolated at the level of 103 to 104 cells/g in 3 subjects before starting the administration. The detection rate was decreased after starting the administration; it was detected in 2 and 1 subjects on 3 and 5 days after starting the administration, respectively, and in 1 subject on 3 days after terminating the administration. Then the detection rate was gradually increased; i. e., in 3 and 5 subjects on 5 and 10 days after terminating the administration, respectively. The level became gradually higher from on 5 days after terminating the administration than before starting the administration. Enterococcus sp. was isolated at the level of 105 to 108 cells/g (mean: 107 cells, g) in all of the 7 subjects before starting the administration. It was not detected in 1 and 4 subjects on 3 and 5 days, respectively, after starting the administration. On 3, 5 and 10 days after terminating the administration, the bacteria were isolated at the level of 106 to 109 cells/g (mean: 108 cells/g) in all of the 7 subjects. The level was higher in 5, 5 and 4 subjects, respectively, than before starting the administration and there was no marked difference in 2 subjects.
There was no tendency observed in changes in the level of Micrococcus sp. Candida sp. was isolated at the level of 102 to 104 cells/g (mean: 104 cells/g) in 5 subjects before starting the administration. The bacteria were isolated in 6 cases on 3 days after starting the administration. The level was over 100-times as high as the level before starting the administration in 3 cases and there was no remarkable difference on 1 case. The similar tendency was observed also on 5 days after starting the administration and on 3 days after terminating the administration. On 5 days after terminating the administration, the bacteria were detected at the level of 102 to 106 cells/g (mean: 105 cells/g) in all of the 4 subjects; the level of bacteria was 10,000-times as high in 1 case, and 100-times as low in 1 case, as the level before starting the administration. There was no remarkable difference in 3 cases.
