[Clinical studies of rokitamycin dry syrup on skin and soft tissue infections in the pediatric fields]

Abstract

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 cases. The average daily dose level used was 31.3 mg/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 10(6) 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 beta-lactam antibiotics including 3 different penicillins such as ampicillin (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 0.39 microgram/ml, and against no strains of S. aureus showed MIC values of higher than 25 micrograms/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.(ABSTRACT TRUNCATED AT 400 WORDS)