[Efficacy and safety of one dose ceftriaxone vs. ten-day oral amoxicillin for treatment of acute otitis media in children].
OBJECTIVE
To compare the efficacy and safety of a single ceftriaxone injection with 10-day oral amoxicillin in the treatment for children's acute otitis media.


METHODS
This study was a prospective, comparative, open randomized, multicenter trial. In the ceftriaxone group, a single dose sodium ceftriaxone (50 mg/kg, total dose < 1 g) was injected. In the amoxicillin group, the oral amoxicillin [40 mg/(kg.d), tid] was used for 10 days. Totally 236 cases aged from 0.5 to 12 years were enrolled and 212 cases completed the study. These patients were followed up twice and clinical signs and symptoms were recorded, otoscopy, peripheral blood WBC count, hearing test (pure tone test) and tympanography were performed.


RESULTS
In the ceftriaxone group, 103/106 cases were cured or improved (97.17%), while in the amoxicillin group 96/106 cases were cured or improved (90.57%) (P < 0.05). Ceftriaxone was significantly better than amoxicillin in the treatment. Totally 4 cases had side effects such as papular skin rash, urticaria around mouth, skin pigmentation, two cases in the ceftriaxone group and other two cases in the amoxicillin group. There was no significant difference between the 2 groups in side effects.


CONCLUSIONS
Ceftriaxone injection was significantly better than ten-day oral amoxicillin for treatment of acute otitis media in children. The single dose regimen with ceftriaxone seems to be a good choice for children, particularly for.
Zhang
Ya-mei
YM
Department of Otorhinolaryngology, Beijing Children's Hospital, Capital University of Medical Sciences, Beijing 100045, China.
Dong
Pin
P
Lu
Pei
P
D000208:Acute Disease; D000284:Administration, Oral; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D002443:Ceftriaxone; D000658:Amoxicillin