[Efficacy and tolerability of morniflumate in acute otitis in infants: results of a randomized study versus placebos].
In a randomized double-blind placebo-controlled, parallel group study, 79 infants with acute otitis media received treatment with suppositories containing either Nifluril (400 mg daily, morniflumate) or placebo for five days. Both groups of patients also received amoxicilline (50 mg/kg daily) for eight days. The combination of Nifluril with antibiotic therapy gave significantly greater relief from abnormalities of the tympanic membrane (after two days treatment), inflammation of the throat and nasal congestion than did antibiotic therapy alone. Overall clinical assessment confirmed a significantly greater recover rate in the Nifluril group compared with the placebo group. Very few side effects were recorded, limited to diarrhoea, without any drug interruption. Nifluril may be recommended as an effective safe adjuvant to the antibiotic treatment of acute otitis media in infants.
Portmann
M
M
C.H.U. Pellegrin Tripode, Clinique Universitaire O R L, Bordeaux, France.
Portmann
D
D
Rohou
S
S
Pollet
M
M
Colson
J
J
Cuvelier
A
A
Fournier
J L
JL
Jeannerot
F
F
Marx
J
J
Menet
V
V
D000208:Acute Disease; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D009544:Niflumic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010033:Otitis Media / Q000188:drug therapy*; D010919:Placebos
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D009544:Niflumic Acid; C027859:morniflumate
Efficacité et tolérance du morniflumate dans les otites aiguës du nourrisson: résultats d'une étude randomisée contre placebo.