Fosfomycin Na と Sulbenicillin Na の慢性気道感染症に対する薬効比較試験成績

抄録

In order to compare the therapeutic effects and side effects of fosfomycin Na (FOM) with those of sulbenicillin Na (SBPC), a comparative clincal trial has been carried out in 115 patients with chronic respiratory tract infections at 25 institutions in Japan. Each of the patients was assigned to either of the drugs at random. Both drugs were administered as intravenous infusions at a dosage of 2g twice daily for 14 days.
In each patient, on the basis of detailedly recorded subjective and objective symptoms, laboratory test results and chest X-ray film findings, committee members consisting of several physicians who had not been informed of the drug actually given to each patient made an assessment on the severity, therapeutic results, and presence or absence of side effects. Subsequently, the key code for the drug abministered to each patient was opened and statistical analysis was carried out by making a comparison between the two groups (one received FOM and the other SBPC) with respect to background factors, clinical effectiveness, bacteriological effectiveness, degree of improvement and observed side effects.
Out of the 115 cases originally admitted to the trial, 13 cases were excluded because of failure to observe the treating regimen initially established, leaving 102 cases (56 from FOM group and 46 from SBPC group) for analysis. It was indicated that regarding background factors there was no significance between the two groups except that more cases of SBPC group had highly accelerated ESR value and that there were more cases in FOM group which had infections due to Pseudomonas and mixed infections, both with significance.
The clinical effectiveness were classified as excellent in 5 and 7 cases in FOM and SBPC group, respectively, as good in 22 and 17 cases ; as fair in 8 and 11 cases, as poor in 21 and 14 cases ; and as undecided in 0 and 1 case, respectively, with no significance. In the bacteriological effectiveness and the degree of improvement, there was no significance which is of importance in a comparison of both drugs. In regard to the incidence of side effects no significance was observed.