Rokitamycin (RKM) dry syrup, a newly developed macrolide antibiotic, was administered to children with ages between 6 months and 15 years and 10 months suffering from skin and soft tissue infections including 41 cases of impetigo, one case of staphylococcal scalded skin syndrome (SSSS) and 2 cases of subcutaneous abscess totalling 44 oases. The average daily dose level used was 31.3mg/kg divided into 3 or 4 doses, for an average of 6 days of treatment. MICs of 4 different macrolide antibiotics including RKM, erythromycin (EM), josamycin (JM) and midecamycin acetate (MDM acetate) were determined against 32 bacterial strains isolated from these cases including 30 strains of Staphylococcus aureus and 2 strains of Streptococcus pyogenes. The inoculum level used was 106 cells/ml. Among these strains of bacteria, 20 strains of
S. aureus and 1 strain of
S. pyogenes were also used, at the same inoculum size, for the determination of MICs of 4 β-lactam antibiotics including 3 different penicillins such as ampiciIlin (ABPC), methicillin (DMPPC) and cloxacillin (MCIPC) and cefaclor (CCL), a cephem antibiotic. RKM was then evaluated through the above treatment for its clinical efficacy, bacteriological effects, side effects and effects on laboratory test values. Obtained results are summarized as follows.
1. Activities of drugs tested were compared to each other. MIC90 of RKM against
S. aureus averaged 0.39μg/ml, and against no strains of
S. aureus showed MIC values of higher than 25μg/ml, thus, the antibacterial activity of RKM against
S. aureus was the highest among the 8 drugs tested. The activity of MCIPC was next highest followed by that of DMPPC. MIC determination was done on only 2 strains, or, for some drugs, only one strain, of
S. pyogenes, and RKM showed activities somewhat lower than ABPC and EM, and similar to JM and CCL within the limited testing.
2. Clinical efficacies of RKM determined by doctors in charge were 97.6% in the 41 cases of impetigo, with good or excellent efficacies were observed, 100% in the single case of SSSS and the 2 cases of subcutaneous abscess. Thus an overall efficacy on the 44 cases was rated very high, at 97.7%.
3. Clinical efficacy rating according to accumulated scores was determinable in 37 cases including all the 3 diseases on the third day of treatment with an efficacy rate of 89.2%. Ratings were determinable on the fifth and the seventh days of treatment in 24 and 21 cases, respectively, with all the cases judged good or excellent. From these results, it seemed that 5 days or longer treatment with a daily dose level of 20 to 40mg/kg divided into 3 or 4 doses would be required to obtain an overall efficacy rate above 90%.
4. For the determination of bacteriological effectiveness, effects of drugs on 2 species of bacteria were evaluated individually with 1 case of mixed infection. Twenty four out of 36 cases of
S. aureus infections were evaluable with a bacterial eradication rate of 79.2%. Both of the 2 cases of
S. pyogenes infection were evaluable with bacterial eradication observed in both cases, thus, the overall eradication rate was 80.8%. If those cases from which
S. aureus had been isolated but samples for bacteriological examination became unavailable because symtoms of infection had disappeared early were included in the efficacy rating as cases of the causative organisms being eradicated, eradication would be considered to have occurred in 33 cases out of 38, thus the eradication rate would be 86.8%, which would be quite high.
5. No side effect was observed in any of the cases. No refusal of the drug occurred, either. In a few cases examined before and after the treatment with RKM for a comparison of laboratory test values, no abnormal changes were observed.
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