Diagnostisches Vorgehen bei Lebererkrankungen durch pflanzliche Mittel

Zusammenfassung

Hintergrund: Lebererkrankungen durch pflanzliche Mittel sind selten und werden ärztlicherseits und regulatorisch meist nicht sorgfältig genug evaluiert, mit der Konsequenz, dass wichtige alternative Erkrankungen mit spezifischen Therapiemöglichkeiten verpasst werden. Zudem lässt die Datenqualität oft Defizite erkennen und erschwert zusätzlich eine adäquate Evaluierung.

Methode: Basierend auf eigenen Erfahrungen und einer selektiven Literaturrecherche wurden Empfehlungen erarbeitet, die Datenerhebung und die Kausalitätsbewertung wesentlich zu verbessern.

Ergebnisse: Die für die Diagnose einer hepatischen UAW wichtigen Kriterien umfassen klinische Manifestation, Abklingphase, Typ der Leberschädigung, (ungewollte) Reexposition, Komedikation, Risikofaktoren, Einbeziehung der Grunderkrankung und sicherer Ausschluss alternativer Ursachen. Dabei kann die Datenqualität der Fälle von Lebererkrankungen durch primär vermutete pflanzliche Mittel allein durch ein striktes Vorgehen bei der Datenerhebung unter Verwendung eines leberspezifischen Meldeformulars wesentlich verbessert werden. Zur Kausalitätssicherung steht zudem eine leberspezifische Skala zur Verfügung, die sich sowohl bei den behandelnden Ärzten als auch den regulatorischen Bewertungen im Rahmen der notwendigen Pharmakovigilanz bewährt hat und weiter ausgebaut werden sollte. Durch verschiedene diagnostische Schritte ist darüber hinaus sicherzustellen, dass alternative Ursachen der Symptomatik rechtzeitig erkannt und diesbezügliche adäquate Therapien eingeleitet werden.

Schlussfolgerung: In der Klinik und Praxis stellen primär vermutete hepatische Nebenwirkungen von pflanzlichen Mitteln eine besondere ärztliche und regulatorische Herausforderung dar, die einer deutlich verbesserten Datenqualität und Kausalitätsevaluierung bedarf.

Abstract

Background: Herb-induced liver injuries are rare and often lack careful evaluation by physicians and regulatory agencies, with the consequence that alternative diseases with specific therapeutic modalities are missed. Other shortcomings are low data quality that additionally complicates adequate evaluation.

Methods: Based on our own experience and a selective literature search, recommendations are presented that will substantially improve data acquisition and causality evaluation.

Results: Important diagnostic criteria include clinical manifestation, dechallenge, type of liver injury, (unintentional) reexposure, comedication, risk factors, primary disease, and definitive exclusion of alternative causes. Concomitantly, the data quality in cases of primarily assumed herbal hepatotoxicity may be substantially improved merely by strict data acquisition using a liver specific form. To establish the diagnosis of hepatic adverse drug reaction, a liver specific causality assessment method is available, which has been proven valuable for physicians and regulatory agencies for pharmacovigilance issues, and should be used more often. Using additional diagnostic steps, care should be taken that alternative diseases are recognized in time and treated adequately.

Conclusion: In hospital and outpatient settings, primarily assumed herb-induced liver injury is a particular challenge for physicians and regulatory agencies that requires substantially improved case data quality and causality evaluation.

Schlüsselwörter

Leber - toxische Lebererkrankung - pflanzliche Mittel

Key words

liver - toxic liver diseases - herbal drugs

• Literatur

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