rokitamycin and Acute-Disease

Because Campylobacter jejuni is most frequently identified as a causative organism of bacterial enteritis in pediatrics, a study was done to evaluate the clinical efficacy against Campylobacter enteritis and the safety of a macrolide antibiotic, rokitamycin (RKM). In case of acute enteritis, RKM was used in a form of dry syrup at a dose level of approximately 30 mg (in potency)/kg body weight and its efficacy and safety were compared to those of fosfomycin (FOM) dry syrup which is currently in use at a dose level of 60 mg (in potency)/kg. Both drugs were administered, as a rule, in 3 divided daily dose (RKM before meal and FOM after meal) for 5 consecutive days. Comparisons of the drugs were made using a well-controlled method. Obtained results are summarized as follows. 1. No significant differences in background factors of the 2 drug groups were apparent, hence it was deemed that no obstacles existed in making comparative studies of the 2 groups with regard to their efficacies and safeties. 2. Overall efficacy rate against Campylobacter enteritis was 100% in the RKM group with a rate of excellent efficacy of 91.3% and the former was 94.4% in the FOM group with the latter of 72.2%. Though the RKM group apparently showed higher rates by 5.6% and 19.1%, respectively, for overall and excellent efficacies, they were not statistically significant as both drugs showed good efficacies. When acute cases of enteritis other than those caused by Campylobacter were included in the analysis, overall efficacy rates and rates of excellent efficacy were, respectively, 97.6% and 85.7% for the RKM group and 88.6% and 68.2% for the FOM group, thus RKM showed higher efficacy rates by 9.0% and 17.5%, respectively. These differences were deemed statistically significant using the U-test. 3. Numbers of days required for most of the major symptoms to subside were 3 days or less for the group for which RKM was used against Campylobacter enteritis. Similar results were observed for the FOM group also. In cases of acute enteritis due to other causes than Campylobacter, slower recoveries were observed for both the RKM and the FOM groups than in Campylobacter enteritis cases, with the latter group slower than the former. In cases of puruloid stool, the recovery in the RKM group was significantly faster by U-test than the FOM group, and a similar trend was observed overall. 4. Bacteriologically, the eradication rate of Campylobacter in the RKM group was very good at 91.3% with the FO

Topics: Acute Disease; Administration, Oral; Age Factors; Campylobacter fetus; Campylobacter Infections; Child; Child, Preschool; Clinical Trials as Topic; Dosage Forms; Enteritis; Female; Fosfomycin; Humans; Infant; Male; Miocamycin; Multicenter Studies as Topic

Clinical efficacy and safety of TMS-19-Q.GC tablet (TMS), a new macrolide antibiotic preparation, were compared with those of josamycin (JM) in the treatment of acute odontogenic infection under multicentered double-blind controlled study at the daily dosage of 600 mg of TMS or 1,200 mg of JM. The results obtained were as follows: The patients entered into the study were 265 cases and 112 in TMS group and 111 in JM group were adopted to evaluate for the efficacy. The evaluation was made by 2 ways i.e. changes in total clinical scores of the symptom and the doctors assessment. Efficacy rating of TMS and JM were 81.3 and 82.0% judged by the score and 73.2 and 77.5% judged by doctors in charge respectively. In the cases with 15 to 20 of total scores at the initial visit, considered to be suitable for the evaluation of antibiotics, the efficacy rating of both drugs were 86.7% in TMS and 84.6% in JM. Organisms were isolated from 34 cases in TMS and 40 in JM and the clinical effectiveness in those cases were almost the same. Slight adverse reactions were observed in 6 cases (4.6%) of TMS group and 1 (0.8%) of JM. In 3 cases (4 incidences) of TMS group and 1 of JM slightly abnormal laboratory findings were found. On the statistical analysis of the data regarding efficacy, safety and usefulness, both drugs had no significant difference. From these results, TMS was considered as effective as JM in the treatment of acute odontogenic infection at a daily half doses of JM.

Topics: Acute Disease; Adolescent; Adult; Aged; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Leucomycins; Male; Middle Aged; Miocamycin; Periodontal Diseases; Tablets

In order to compare the clinical efficacy and safety of TMS-19-Q.GC tablet (TMS) with josamycin tablet (JM) in acute tonsillitis, the double blind trial was carried out with the daily dosage of 200 mg X 3 in TMS and 400 mg X 3 in JM. Number of cases evaluated for clinical efficacy were 154 cases (73 treated with TMS and 81 treated with JM). The effective rating of TMS and JM were 89.0% and 88.9% judged by doctors in charge, and 82.2% and 85.2% judged by committee respectively. Bacteriological effects were satisfactory to yield the eradication rates of 93.8% in TMS and 94.7% in JM. Number of cases evaluated for safety were 199 cases (101 treated with TMS and 98 treated with JM). The incidence of side effect was 4.0% (4/101) in TMS and 5.1% (5/98) in JM and most of them were mild gastro-intestinal disorders. Number of cases evaluated for utility were 156 cases (74 treated with TMS and 82 treated with JM). The usefulness rates were 85.1% in TMS and 86.6% in JM. There was no significant difference between TMS and JM, in clinical effect, bacteriological effect, safety and utility. From these results, daily 600 mg dosage of TMS was as useful as daily 1,200 mg dosage of JM in the treatment for acute tonsillitis.

Topics: Acute Disease; Adolescent; Adult; Aged; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Leucomycins; Male; Middle Aged; Miocamycin; Tablets; Tonsillitis

Pharmacokinetic, bacteriological and clinical studies on a new macrolide antibiotic, rokitamycin (RKM) dry syrup for pediatric use, were done, and results as summarized below were observed: 1. Five children with ages between 6 and 10 years were administered orally with RKM at a dose level of 10 mg/kg either at 30 minutes before or 30 minutes after meal on a crossover design, and plasma concentrations and urinary excretion rates of the drug were measured. Plasma concentrations of RKM following the administration before meal were 0.50 microgram/ml at 1/2 hour, 0.43 microgram/ml at 1 hour, 0.15 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. Plasma concentrations following the administration after meal were 0.11 microgram/ml at 1/2 hour, 0.15 microgram/ml at 1 hour, 0.09 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. The 0-6 hour urinary recovery rates were 1.41% following the administration before meal, and 0.93% following the administration after meal. These results suggested that the drug might be absorbed more rapidly, giving a higher plasma concentration, when administered before meal than when administered after meal. Changes in plasma concentrations of RKM following the administration of 10 mg/kg before meal were similar to those of two 100 mg RKM tablets (TMS-19-Q.GC tablets) to adult patients. Therefore, it seemed optimal to administer 10 mg/kg 3 times daily at fasting to children as a rule.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Administration, Oral; Blood Chemical Analysis; Bronchitis; Child; Child, Preschool; Drug Evaluation; Enteritis; Female; Humans; Leucomycins; Male; Miocamycin; Pharyngitis; Pneumonia; Respiratory Tract Infections

Clinical efficacies of a new macrolide antibiotic, rokitamycin (RKM, TMS-19-Q), were studied in acute pediatric infections. Responses to the RKM administration were evaluable in 62 out of 68 patients consisted of 7 patients with pharyngitis (efficacy rate of 85.7%, 6/7 patients), 4 with bronchitis (25.0%, 1/4), 9 with tonsillitis (100%, 9/9), 13 with mycoplasmal pneumonia (100%, 13/13), 13 with hemolytic streptococcal infections (92.3%, 12/13), 14 with pneumonia (57.1%, 8/14), one with pertussis (100%, 1/1) and another with Chlamydia pneumonia (100%, 1/1) thus an overall efficacy rate of 82.3% was achieved. Urticaria was observed in one of the patients as an adverse reaction to the drug, while abnormal laboratory test results were noted in 3 patients, but none of such changes were severe. The drug, even when administered in combination with a theophylline preparation, exerted no effects on the serum concentration of the latter.

Topics: Acute Disease; Administration, Oral; Bacterial Infections; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Infant, Newborn; Leucomycins; Male; Miocamycin; Theophylline; Urticaria