| Journal: | Annals of hepatology |
| Database: | PERIÓDICA |
| System number: | 000419224 |
| ISSN: | 1665-2681 |
| Authors: | Teschke, Rolf1 Frenzel, Christian2 Wolff, Albrecht3 Herzog, Jutta1 Glass, Xaver1 Schulze, Johannes1 Eickhoff, Axel1 |
| Institutions: | 1Goethe University, Medical Faculty, Frankfurt am Main. Alemania 2University Medical Center Hamburg-Eppendorf, Department of Medicine, Hamburgo. Alemania 3Friedrich Schiller University of Jena, Division of Gastroenterology, Hepatology and Infectious Diseases, Jena, Thuringen. Alemania |
| Year: | 2012 |
| Season: | Jul-Ago |
| Volumen: | 11 |
| Number: | 4 |
| Pages: | 500-512 |
| Country: | México |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Aplicado, analítico |
| English abstract | Spontaneous reports of herb induced liver injury (HILI) represent a major regulatory issue, and it is in the interest of pharmacovigilance to identify and quantify previously unrecognized adverse reactions and to confirm or refute false positive signals of safety concerns. In a total of 13 spontaneous cases, liver disease has initially been attributed to the use of Pelargonium sidoides (PS), a plant from the South African region. Water/ethanol extracts derived from its roots are available as registered herbal drugs for the treatment of upper respiratory tract infections including acute bronchitis. Objectives. The present study examines whether and to what extent treatment by PS was associated with the risk of liver injury in these spontaneous cases. Study design: Overall, 13 spontaneous cases with primarily suspected PS hepatotoxicity were included in the study. Their data were submitted to a thorough clinical evaluation that included the use of the original and updated scale of CIOMS (Council for International Organizations of Medical Sciences) to assess causality levels. These scales are liver specific, validated for liver toxicity, structured and quantitative. Results. None of the 13 spontaneous cases of liver disease generated a positive signal of safety concern, since causality for PS could not be established on the basis of the applied CIOMS scales in any of the assessed patients. Confounding variables included comedication with synthetic drugs, major comorbidities, low data quality, lack of appropriate consideration of differential diagnoses, and multiple alternative diagnoses. Among these were liver injury due to comedication, acute pancreatitis and cholangitis, acute cholecystitis, hepatic involvement following lung contusion, hepatitis in the course of virus and bacterial infections, ANA positive autoimmune hepatitis, and other preexisting liver diseases. In the course of the case... |
| Disciplines: | Medicina |
| Keyword: | Gastroenterología, Farmacología, Diagnóstico, Hierbas, Lesiones hepáticas, Pelargonium sidoides, Hepatotoxicidad, Farmacovigilancia |
| Keyword: | Gastroenterology, Pharmacology, Diagnosis, Herbs, Hepatic lesions, Pelargonium sidoides, Hepatotoxicity, Pharmacovigilance |
| Full text: | Texto completo (Ver PDF) |
