PILOT-STUDY OF TERBINAFINE IN CHILDREN SUFFERING FROM TINEA-CAPITIS - EVALUATION OF EFFICACY, SAFETY AND PHARMACOKINETICS

被引:70
作者
NEJJAM, F
ZAGULA, M
CABIAC, MD
GUESSOUS, N
HUMBERT, H
LAKHDAR, H
机构
[1] LABS SANDOZ,F-92506 RUEIL MALMAISON,FRANCE
[2] HOP IBNOU ROCHD,CASABLANCA,MOROCCO
关键词
D O I
10.1111/j.1365-2133.1995.tb08632.x
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
In an open pilot study, 12 children with tinea capitis were treated for 6 weeks with oral terbinafine (125 mg/day), and followed up 2 weeks later. The study was conducted to evaluate the efficacy, safety and pharmacokinetics of terbinafine. All patients were completely cured at the end of the treatment period, and there was no evidence of relapse at follow-up. Seven had a negative culture after 3 weeks of treatment. The time to obtain culture conversion from positive to negative did not appear to be related to body weight, but to clinical severity at baseline. Terbinafine is well tolerated and safe over a 56-day period. The kinetic data show a higher clearance of terbinafine in children compared with adults, with shorter alpha- and beta-phase elimination half-lives. However, a longer terminal gamma-phase (at least 6 days) is observed, as in adults, after multiple dose administration, and this is related to elimination from the tissues. The plasma concentrations are comparable between children and adults at a steady state (125 mg/day).
引用
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页码:98 / 105
页数:8
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