[Evaluation of the efficacy of ceftriaxone in acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media. A comparative study with cefotiam as the control].
In order to objectively evaluate the efficacy and the safety of ceftriaxone (CTRX) using once daily administration of 1 g to cases of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media, a group comparison study by the envelope method was conducted using cefotiam (CTM) as the control drug (2 g twice daily). The results obtained are summarized as follows. 1. Clinical efficacies evaluated by the committee were 71% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 63% and 60%, respectively, for chronic suppurative otitis media. When all cases were considered both groups evidenced a clinical efficacy of 64%, and no significant difference was observed between the 2 groups. 2. Clinical efficacies evaluated by the physician in charge were 65% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 72% and 60%, respectively, for chronic suppurative otitis media. When all cases were considered efficacies were, respectively, 70% and 64%, showing no significant difference between the 2 groups. 3. Bacteriological efficacies were 88% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 74% and 62%, respectively, for chronic suppurative otitis media. With all cases bacterial eradication rates were, respectively, 76% and 67%. Bacterial eradication rates were always higher for the CTRX group than for the CTM group, but the difference was not significant between the 2 groups. 4. Against infections caused by Staphylococcus aureus alone, CTRX showed equal clinical and bacteriological efficacies to CTM. 5. As side effects, dermatitis, vomiting, and malaise were observed in 5 cases (4%) of the CTRX group and 3 cases (3%) of the CTM group. As clinical testing abnormalities, elevations of GOT, GPT, and Al-P, and thrombocytopenia were noted only in 3 cases (5%) of the CTRX group. Furthermore, all of these abnormalities were temporary and of moderate degree or mild, thus the safety of either drug was considered high. 6. Clinical utilities were 71% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 72% and 62%, respectively, for chronic suppurative otitis media. When all cases were included, they were 72% and 66%, respectively, and there was no significant difference between the 2 groups. It is concluded from the above results that CTRX is a highly useful drug with once daily administration of 1 g in the treatment of suppurative otitis media.
Baba
S
S
Department of Otorhinolaryngology, School of Medicine, Nagoya City University.
Mori
Y
Y
Suzuki
K
K
Unno
T
T
Kawabori
S
S
Yanai
T
T
Nonaka
S
S
Takasaka
T
T
Awataguchi
T
T
Furuuchi
I
I
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001424:Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D015310:Cefotiam / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003875:Drug Eruptions / Q000209:etiology; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010033:Otitis Media / Q000188:drug therapy*; D010035:Otitis Media, Suppurative / Q000188:drug therapy* / Q000382:microbiology; D013921:Thrombocytopenia / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced
D002443:Ceftriaxone; D015310:Cefotiam