[Comparison of clinical efficacy of rokitamycin (RKM) and ofloxacin (OFLX) for the treatment of Campylobacter enteritis by a double-blind method. The Research Committee for the Effect of Rokitamycin, Research Group for Infectious Enteritis].
The clinical efficacy, safety and usefulness of Rokitamycin (RKM), a new macrolide antibiotic, were compared with those of Ofloxacin (OFLX) for the treatment of Campylobacter enteritis by a double blind method. The daily dose level of RKM or OFLX was 600 mg. They were orally administered in three divided doses for 5 days. Of 223 cases studied, 106 cases were diagnosed as Campylobacter enteritis. Ninety cases (RKM group: 50, OFLX group: 40) except for 16 excluded or drop-out cases were analysed. There was no significant difference between the two groups in any background factors. The effectiveness and usefulness was evaluated in 88 cases (RKM group: 48, OFLX group: 40). The results obtained were as follows: 1. In a total of 82 strains of Campylobacter jejuni/coli (RKM group: 42, OFLX group: 40), the bacteriological efficacy rate of RKM (95.2%) was superior to that of OFLX (70.0%) with a significant difference (p = 0.006). 2. In 76 symptomatic patients (RKM group: 42, OFLX group: 34) on the day of the beginning of drug administration, the clinical efficacy rate was 97.6% in the RKM group and 85.3% in the OFLX group with no significant difference between the two groups. 3. In 88 evaluable patients, the global clinical efficacy rate of RKM (95.8%) was superior to that of OFLX (67.5%) with a significant difference (p = 0.001). 4. Side effect was observed in 1 (1.9%) of the 54 patients in the RKM group and none of the 44 patients in the OFLX group. Slightly abnormal laboratory findings were seen in 4 (10.8%) of the 37 patients treated with RKM and 3 (9.7%) of the 31 patients treated with OFLX, but there was no significant difference between the two groups. 5. In 88 evaluable patients, the clinical usefulness of RKM (91.7%) was superior to that of OFLX (67.5%) with a significant difference (p = 0.01). From these results, RKM is considered to be a very useful agent for the treatment of Campylobacter enteritis.
Obana
M
M
Department of Internal Medicine, Kawasaki Municipal Hospital.
Tomizawa
I
I
Takizawa
Y
Y
Nitta
Y
Y
Sagara
H
H
Seo
T
T
Sato
J
J
Tsunoda
T
T
Ota
S
S
Machii
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D002169:Campylobacter Infections / Q000188:drug therapy*; D017000:Campylobacter coli; D016123:Campylobacter jejuni; D004311:Double-Blind Method; D004751:Enteritis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015644:Miocamycin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015242:Ofloxacin / Q000627:therapeutic use*
D015644:Miocamycin; D015242:Ofloxacin; C033383:rokitamycin