Hintergrund und Fragestellung: Die lokale antimykotische Behandlung interdigitaler Tinea pedis ist eine anerkannte
und effektive Methode. In Deutschland sind - neben dem Hydroxypyridon Ciclopyroxolamin
- Azole und Allylamine die therapiebestimmenden pharmakologischen Gruppen. Ziel dieser
Untersuchung war die Darstellung der Wirksamkeit topischer Therapieoptionen im Sinne
von mykologischer und klinischer Heilung bei interdigitaler Tinea pedis in Deutschland.
Methodik: Ausschließlich randomisierte, doppelblinde kontrollierte klinische Studien zur Therapie
der Tinea pedis wurden in die Analyse einbezogen. Die Diagnose musste klinisch, im
Nativpräparat und kulturell gesichert sein.
Ergebnisse: 40 Studien zu Azolen und Allylaminen wurden analysiert. Der Vergleich von Azolen
mit Placebo ergab mykologische Heilungsraten von 60-91 % (Placebo 10-67 %) und klinische
Heilungsraten von 64-95 % (Placebo 10-63 %). Placebokontrollierte Studien zu Allylaminen
(Naftifin und Terbinafin) zeigten mykologische Heilungsraten von 62-100 % (Placebo
10-45 %) und klinische Heilungsraten von 66-86 % (Placebo 4-44 %). Wirkstoff war
Placebo in allen Studien signifikant überlegen. In Vergleichsstudien waren Allylamine
(insbesondere Terbinafin) Azolen zum Teil signifikant überlegen. Terbinafin zeigte
schon nach einer Woche hohe Wirksamkeitsraten. Azole erreichten erst nach 4 Wochen
effektive Heilungsraten.
Folgerungen: Topische Allylamine sind in der Wirksamkeit den Azolen gleichwertig bis überlegen,
insbesondere Terbinafin. Dies lässt sich auf die günstigen pharmokokinetischen Eigenschaften
von Terbinafin und den fungiziden Wirkmodus der Allylamine im Gegensatz zum fungistatischen
Wirkungsmechanismus der Azole zurückführen.
Background and objective: Local antimycotic therapy of interdigital tinea pedis is widely accepted and efficacious.
In Germany at present, the azoles and allylamines - apart from the hydroxypyridone
derivative ciclopiroxolamine - are the pharmacological agents applied most often.
This study focuses on the efficacy of topical therapeutic options in Germany, by
regarding the mycological and clinical cure rates of interdigital tinea pedis.
Methods: Only randomised, double-blind and controlled clinical trials of tinea pedis therapy
were selected for the evaluation. Microbiological culture and microscopic information
were indispensable criteria for the clinical diagnoses.
Results: The data from 40 randomised clinical trials of azoles and allylamines were included
in the analysis. The comparison of azoles with the placebo revealed mycological cure
rates between 60 - 91 % (placebo 10 - 67 %) and clinical cure rates between 64
- 95 % (placebo 10 - 63 %). Placebo-controlled trials of allylamines (naftifine
and terbinafine) indicated mycological cure rates between 62 - 100 % (placebo 10
- 45 %) and clinical cure rates between 66 - 86 % (placebo 4 - 44 %). Both the azoles
and the allylamines were significantly superior to the placebo. Comparative studies
between azoles and allylamines occasionally indicated the significantly superior
cure rates of allylamines (especially terbinafine). The high cure rates of terbinafine
could be detected after therapy duration of merely one week, whereas the azoles have
to be applied for four weeks before good efficacy was reached.
Conclusion: In several trials the allylamines - especially terbinafine - proved superior to
the azoles. This may be explained by the fungicidal mode of action of the allylamines
and the favourable pharmacokinetic characteristics of terbinafine, in contrast to
the fungistatic mechanism of the azoles.
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