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DOI: 10.1055/s-2004-814541
Vergleichende Bewertung der Wirkung und klinischen Wirksamkeit von terbinafinhaltigen und bifonazolhaltigen Topika bei der Behandlung der Fußmykose
Comparative Evaluation of the Activity and Clinical Effectiveness of Terbinafine and Bifonazole Preparations in the Treatment of Pedal MycosisPublication History
Publication Date:
09 July 2004 (online)
Zusammenfassung
Hintergrund und Fragestellung: Ziel dieser Übersichtsarbeit ist die Darstellung von Wirkmodus, Erregerspektrum sowie mykologischer und klinischer Wirksamkeit von Terbinafin und Bifonazol bei der lokalen Behandlung der Fußmykose. Hierzu werden die Ergebnisse von In-vitro-Untersuchungen und In-vivo-Studien miteinander verglichen und bewertet. Methodik: Die internationale Literaturrecherche erfolgte unter Einbeziehung der Suchbegriffe nach Applikationsart, Erkrankung, Erregerspektrum, Wirkmodus, Wirkstoffen sowie In-vitro-Untersuchungen und In-vivo-Studien. Bei der Analyse der klinischen Studien wurden ausschließlich randomisierte doppelblinde kontrollierte Studien des Evidenzgrades I ausgewählt. Die Diagnose musste klinisch, im Nativpräparat und kulturell gesichert sein. Ergebnisse: In den In-vitro-Untersuchungen zeichneten sich beide Wirkstoffe durch günstige pharmakologische Eigenschaften aus. Terbinafin zeigte jedoch eine deutlich höhere intrinsische Aktivität gegen Dermatophyten, sowie einen primär fungiziden Wirkmodus. Diese überlegenen In-vitro-Eigenschaften fanden auch in klinischen Untersuchungen ihre Entsprechung. Der In-vivo-Vergleich erfolgte anhand von 12 plazebokontrollierten Studien und zwei direkten Vergleichsstudien. Beide Wirkstoffe zeigten in geeigneter Zubereitung eine unzweifelhafte Überlegenheit gegenüber Plazebo. Die ermittelten Heilungsraten der Vergleichsstudien sind bezüglich Terbinafin-Präparaten zumindest gleichwertig, zeigen jedoch teilweise eine unzweifelhafte Überlegenheit. Dabei waren Terbinafin-Präparationen überlegen durch schnelleren Wirkungseintritt, hohe Wirksamkeitsraten nach nur 1-wöchiger Behandlung bei Tinea pedis vom interdigitalen Typ und geringere Rezidivraten. Folgerungen: Der primär fungizide Wirkmodus von Terbinafin und die umgehende Penetration ins Stratum corneum mit hohen Wirkstoffkonzentrationen im Gewebe, auch nach Beendigung der Anwendung, vermögen die im Vergleich zu Bifonazol schnellere mykologische und klinische Heilung, eine kürzere Therapiedauer sowie eine geringere Rezidivrate zu erklären.
Abstract
Background and Rationale: This review focuses on the in vitro activity and clinical effectiveness of terbinafine and bifonazole in the local treatment of tinea pedis. On the basis of in vitro investigations and in vivo studies a critical comparison is accomplished. Method: The international literature search was based on the search criteria of the description of application, the indication, the activity spectrum, the mode of action of the active substances based on both in vitro investigations and in vivo studies. With the analysis of the clinical trials only randomized double-blind controlled studies of the evidence level of I were selected. The diagnosis had to be confirmed both on clinical and mycological grounds. Results: In vitro investigations revealed with both active substances favourable pharmacologic properties. Terbinafine, however, offered a much higher intrinsic activity against dermatophytes, as well as primary fungicidal activity. These superior in vitro characteristics were reflected in clinical investigations. In vivo comparison took place on the basis of 12 placebo-controlled studies and two direct comparative studies. Both active agents were found superior as compared to placebo. The results of the comparative studies are at least not inferior with respect to terbinafine, while partly an unquestionable superiority of terbinafine was shown. Terbinafine proved superior in comparison to bifonazole by higher effectiveness rates, more rapid onset of clinical improvement after one week of treatment and lower relapse rates. Conclusion: The primarily fungicidal mode of action of terbinafine as well as the immediate penetration into the stratum corneum and the presence of high levels in the tissue also after completion of application might explain the shorter time to healing in comparison with bifonazole. The same applies to shorter therapy duration as well as lower relapse rates.
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Prof. Dr. Hans C. Korting
Klinikum der Universität München · Klinik und Poliklinik für Dermatologie und Allergologie
Frauenlobstraße 9 - 11 · 80337 München
Email: H.C.Korting@lrz.uni-muenchen.de