In the treatment of infectious diseases, it is very important to know the MIC of the antibiotics against the pathogenic bacteria and the distribution of the drug to the infected target tissues. This ...study investigated various body fluids and tissue concentration of Azthreonam, a new whole synthetic monocyclic β-lactam antibiotic, which in resistant to β-lactamase, and has a strongly specifically active against aerobic gram-negative bacteria including Pseudomonas aeruginosa. Azthreonam was administered intravenously before or during operation in a dose of 1g to 11 cases of biliary tract infection, 12 cases of acute appendicitis and 5 cases of others, and tissue specimens and body fluid samples were taken during the operation. The Azthreonam concentrations were determined bybioassay using E. coli NIHJ JC-2 as the test organism. The Azthreonam concentration in the common duct bile ranged from 3. 3 to 175. 0μg/ml at 18 to 112 minutes after intravenous bolus injection of 1g of Azthreonam. These level in the gall bladder bile showed 0.9 to 59.4μg/ml, and that in the gall bladder wall ranged from 0.8 to 17.2μg/g. These concentration in the infected appendix wall ranged from 0.8 to 18. 8μg at 0 to 226 minutes after injection. These level in the purulent ascites showed 5. 3 to 18. 8μg/ml. These values weresuperior to the MICs of almost all of the organisms which were isolated from these cases. For therapeutic purposes, Azthreonam was given in a daily dose of 1 g (1×1) to 4g (2×2) by intravenous drip infusion for 4 to 22 days to 43 cases (12 with biliary tract infection, 26 with acute diffuse or localized peritonitis and 5 with others). The clinical response was rated excellent in 10 cases, good in 27 cases, fair in 3 cases and poor in 3 cases (efficacy rate 86.0%). No adverse effect was observed in any of 43 patients. Therefore, Azthreonam appears to be very useful drug when used for chemotherapy of acute peritonitis, biliary tract infection and abdominal infectious diseases in surgical field.
A well-controlled comparative study was performed using ceftizoxime (CZX) as the control drug to objectively evaluate the efficacy, safety and usefulness of cefotaxime (CTX) in postoperative ...infections. Both antibiotics were administered intravenously by drip infusion at 2g/day in two divided doses, and the following results were obtained. 1. Overall clinical efficacy rates, based on assessment by the Efficacy Evaluation Committee, were 84.5%(60/71) in the CTX group and 75.7%(56/74) in the CZX group in postoperative wound infections (Trial A), and 73.7%(42/57) in the CTX group and 68.4%(39/57) in the CZX group in postoperative abdominal cavity infections and postoperative dead space infections (Trial B). No significant difference was found between the two treatment groups in either Trial A or Trial B. 2. Final overall improvement rates evaluated by the surgeons were 76.1%(54/71) in the CTX group and 74.3%(55/74) in the CZX group in Trial A, and 64.9%(37/57) in the CTX group and 57.9%(33/57) in the CZX group in Trial B. No significant difference was found between the two treatment groups in either Trial A or Trial B. 3. Bacteriological effectiveness was judged by the Efficacy Evaluation Committee. Pathogen eradication rates by case were 69.5%(41/59) in the CTX group and 52.6%(30/57) in the CZX group in Trial A, with CTX tending to be more effective. In Trial B, however, the rates were 52.2%(24/46) in the CTX group and 42.6%(20/47) in the CZX group, with no significant difference between the two treatment groups. The eradication rate by bacterial species based on the growth and decline of the bacteria clinically isolated before administration was 73.3%(66/90) in the CTX group and 56.8%(54/95) in the CZX group in Trial A, while, in Trial B, the rates were 51.4%(37/72) in the CTX group and 33.0%(31/94) the CZX group, the CTX group exhibiting statistically significant better results in both Trials A and B (P<0.05). 4. Side effects were not observed in the CTX group but were reported in 4 out of 150 cases (2.7%) in the CZX group. Abnormal laboratory findings were observed in 1.4%(2/144) of the cases in the CTX group and in 4.1%(6/147) of the cases in the CZX group. However, no significant differences were found between the two treatment groups either in side effects or abnormal laboratory findings. 5. The usefulness was judged by the surgeons to be 66.7%(46/71) in the CTX group and 58.3%(42/74) in the CZX group in Trial A, and 54.5%(30/55) in the CTX group and 42.3%(22/52) in the CZX group in Trial B, with no significant difference between the two treatment groups in either Trial A or Trial B. From the above results, CTX may be considered to be at least as highly useful as CZX in the treatment of postoperative infections.
A double blind group comparison study was performed to ascertain efficacy and safety of cefmenoxime (CMX, SCE-1365) as compared with cefotiam (CTM) in treatment of postoperative superficial purulent ...infections (hereafter called Trial A) and postoperative peritonitis and/or dead space infections (hereafter called Trial B). Patients received through i. v. drip infusion either 1 g unit of cefmenoxime or 1 g unit of cefotiam twice d day for 7 days and 14 days in Trial A and Trial B, respectively. The results obtained from 111 cases (Trial A) and 124 cases (Trial B) are as follows: 1. As for the clinical efficacy of Trial A, the effective rates were 92.3%(48/52) and 73.6%(39/53) for the CMX group and the CTM group, respectively; the CMX group showed a significantly better result. On the other hand, the effective rates of Trial B were 78.7%, (37/47) and 73. 6%(42/57) for the CMX group and the CTM group, respectively; no significant differences between the two preparations were observed. 2. As for the degree of overall improvement at the end of the treatment, the improvement rates were 76.9% and 71. 7% for the CMX group and the CTM group respectively in Trial A, and 76.6.% and 71.9% for the CMX group and the CTM group respectively in Trial B; although the improvement rates for the CMX groups were higher, significant differences were not observed. 3. When the overall improvement rates were examined for the whole period of treatment, the marked improvement rates for the CMX group were high after three days and five days in Trial A, and the manifestation of the efficacy of CMX was quicker than that of CTM. 4. As for the transition of survival rate of each target finding, the CMX group showed earlier eradications rate in discharge, fever and WBC in Trial A. In Trial B, the CTM group showed an earlier eradication rate in abdominal findings. However, significant differences were not observed in both cases. 5. As for side effects, it was noted in 1 case (0. 9%) of CMX group and 4 cases (3.3%) of CTM group; all of them were eruptions. As for abnormal laboratory findings, they were noted in 4 cases (3.5%) of CMX group and 5 cases (4.1%) of CTM group; all of them were those of hepatic functions. Significant differences were, however, not observed between the two preparation groups, in kind and frequency of manifestation of side effect, and in details and frequency of abnormal laboratory finding. As shown above, it was concluded that CMX is clearly a preparation of high usefulness for thetreatment of postoperative infections.
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