Abstract
A double-blind comparison of josamycin propionate granule for oral suspension (JM-P) and that of erythromycin ethylsuccinate (ES-EM) was performed on their efficacy and safety in the treatment of scarlet fever inpatients, and the following results were obtained.
1. A total of 159 patients was randomly assigned to two groups of almost equal size: 79 cases to JM-P and 80 to ES-EM groups. Among them, 8 cases medicated with JM-P (10%) and 11 with ES-EM (14%) were removed from analysis because of not filling prerequisites. Medication was 30 to 40 mg (potency) /kg per day for 7 days.
2. No item of background factors was significantly different (P> 0.05).
3. Global efficacy data showed no significant difference between the two groups (P> 0.05). The rate of improvement (excellent plus moderate) was 70% with JM-P and 58% with ES-EM. The rate would become 64% with JM-P (50 out of 78 cases) and 53% with ES-EM (40 out of 76), if 14 among 19 cases removed were taken into account, in which medication was earlier terminated by change to other drugs.
4. The rate of disappearance of pharyngeal streptococci before the 3rd day was 40% with JM-P (23 out of 57 cases) and 39% with ES-EM (19 out of 49), showing no significant difference between them (P>0.05).
The rate of detection of pharyngeal cocci after termination of drug administration was not significantly different between the groups (P>0.05).
5. The rate of defervescence was not significantly different between the two groups (P>0.05). Days for disappearance of eruption and of pharyngeal reddening suggested a trend favorable to JM-P.
6. Global evaluation was shown significantly correlated with the efficacy criteria selected: days for disappearance of pharyngeal streptococci, days for defervescence, days for disappearance of eruption and days for disappearance of pharyngeal reddening in the order cited, except for a nonsignificant correlation between global evaluation and days for disappearance of pharyngeal reddening in the ES-EM group.
7. Changes in ASLO and CRP values before and after medication were similar in both groups. However a slight trend favorable to JM-P was observed.
8. A case medicated with JM-P showed definite rise in SGOT and SGPT values, which did not reveal any clear correlation with medication. As to side effects, a case was encountered who complained a slight abdominal pain during medication of ES-EM.
