[Treatment of severe perianal cutaneous lesions in hospitalized neonates: Orabase ointment interest].
Cholestyramine ointment is an hospital preparation used as a second-intention treatment for severe perianal skin lesions. These preparations have to be declared to AFSSAPS. The aim of this study was to assess the equivalence of Orabase, a marketed paste, with intention of substitution. A clinical trial was performed to evaluate the effectiveness of cholestyramine ointment versus Orabase paste. This study was conducted in the neonatalogy unit. The principal evaluation criterion was the time to clinical recovery. Nurses also gave their subjective evaluation of each product. Although 34 children were included in the study, the time to clinical recovery delay was evaluated in 28. Time to clinical recovery was 90.5 hours for the cholestyramine ointment and 81 hours for Orabase paste. Concerning the subjective assessment, Orabase paste achieved a higher score than cholestyramine ointment (p<0.01). Orabase paste was considered to be equivalent to cholestyramine ointment.
Senon
G
G
Pharmacie à Usage Intérieur, Hôpital Robert Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris.
Hergott
C
C
Micard
S
S
Rieutord
A
A
Aujard
Y
Y
Brion
F
F
D002081:Buttocks; D002266:Carboxymethylcellulose Sodium / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002792:Cholestyramine Resin / Q000627:therapeutic use; D005260:Female; D006760:Hospitalization; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D009824:Ointments; D012720:Severity of Illness Index; D012871:Skin Diseases / Q000188:drug therapy*
D009824:Ointments; D002792:Cholestyramine Resin; C056627:Orabase; D002266:Carboxymethylcellulose Sodium