Summary
In an open, prospective, randomized study, the efficacy of fluconazole was compared with that of the combination amphotericin B/flucytosine. Forty surgical patients with deep-seated mycoses were included in the study. Absolute inclusion criteria were histological finding of fungi in a tissue sample taken during surgery from e. g. peritoneum, pancreas, lungs or trachea, a positive blood culture or candida lesion of the eye. According to the random list 20 patients received up to 0.5 mg amphotericin B per kg body weight in combination with 3×2.5 g flucytosine (5-FC) daily and 20 patients received fluconazole, 400 mg on the first day and then 300 mg daily. The two therapy groups were comparable in terms of age, sex and underlying diseases. Gastrointestinal perforations (27 times) were the most frequent underlying diseases.Candida albicans was the fungus most frequently detected microbiologically (34 times). The pathogens were eliminated from 12 patients in the fluconazole group and 14 patients in the combination group. The median elimination time was 8.5 days in the fluconazole group and 5.5 days in the amphotericin B/5-FC group. Six patients died in the fluconazole group, whereas five patients died in the comparison group. Side effects which necessitated switching of therapy occurred twice in the combination group. In deep-seated candida mycoses, surgical patients receiving the combination therapy with amphotericin B/5-FC showed an earlier elimination than patients on monotherapy with fluconazole. With respect to cure rates there was no difference between these two regimens.
Zusammenfassung
In einer offenen, prospektiven Vergleichsstudie sollte die Wirksamkeit von Fluconazol gegenüber der Kombination Amphotericin B/Flucytosin geprüft werden. In die Studie wurden 40 chirurgische Patienten mit tiefen Mykosen aufgenommen. Absolute Einschlußkriterien waren der histologische Nachweis von Pilzen in Gewebsproben, die intraoperativ beispielsweise aus dem Peritoneum, Pankreas, Lunge oder Trachea entnommen wurden, eine positive Blutkultur und eine Candidaläsion des Auges. Entsprechend einem Randomplan erhielten 20 Patienten Amphotericin B bis 0,5 mg/kgKG in Kombination mit Flucytosin (5-FC) 3×2,5 g. 20 Patienten erhielten Fluconazol initial 400 mg und jeden weiteren Tag 300 mg. Beide Therapiegruppen waren nach Alter, Geschlecht und Grunderkrankungen vergleichbar. Gastrointestinale Perforationen (27×) standen bei den Grunderkrankungen im Vordergrund. Am häufigsten konnteCandida albicans (34×) mikrobiologisch nachgewiesen werden. In der Fluconazolgruppe konnten die Erreger 12 mal und in der Kombinationsgruppe (Amphotericin B/5-FC) 14 × eliminiert werden. Die Eliminationszeit betrug im Median in der Fluconazlogruppe 8,5 und in der Amphotericin B/5-FC-Gruppe 5,5 Tage. Sechs Patienten starben in der Fluconazolgruppe, während in der Vergleichsgruppe fünf Patienten verstarben. In der Kombinationsgruppe traten zweimal Nebenwirkungen auf, die ein Umsetzen erforderten. Bei tiefen Candidamykosen chirurgischer Patienten zeigt sich unter der Kombination Amphotericin B/5-FC eine frühere Elimination gegenüber der Monotherapie mit Fluconazol. In bezug auf die Heilungsrate fanden sich keine Unterschiede in den beiden Therapiegruppen.
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Kujath, P., Boos, C., Lerch, K. et al. Comparative study of the efficacy of fluconazole versus amphotericin B/flucytosine in surgical patients with systemic mycoses. Infection 21, 376–382 (1993). https://doi.org/10.1007/BF01728917
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DOI: https://doi.org/10.1007/BF01728917