Qualität und Sicherheit von traditionell chinesischen Arzneien in Deutschland

Medientyp: E-Book; Hochschulschrift

Titel: Qualität und Sicherheit von traditionell chinesischen Arzneien in Deutschland

Beteiligte: Hempen, Nadja Maria [Verfasser]; Huber, Roman [Akademischer Betreuer]

Körperschaft: Institut für Umweltmedizin und Krankenhaushygiene ; Albert-Ludwigs-Universität Freiburg, Medizinische Fakultät ; Albert-Ludwigs-Universität Freiburg

Erschienen: Freiburg: Universität, 2014

Umfang: Online-Ressource

Sprache: Deutsch

DOI: 10.6094/UNIFR/12943

Identifikator:

Schlagwörter: Chinesische Medizin ; Schwermetall ; Nebenwirkung ; Pestizid ; Aflatoxin ; (local)doctoralThesis ; Hochschulschrift

Entstehung:

Hochschulschrift: Dissertation, Albert-Ludwigs-Universität Freiburg, 2014

Anmerkungen: cc_by_nc_nd http://creativecommons.org/licenses/by-nc-nd/4.0/deed.de cc

Beschreibung: Abstract: Background: In the past, traditional Chinese medicine (TCM) drugs (TCD) had in part severe shortcomings regarding quality and safety. The current state of knowledge in this field was evaluated. Material and Methods: Expert interviews by using standardized questionnaires, systematic literature research of studies from Germany published in 1998–2013, systematic inquiries to surveillance authorities and information centers for intoxications as well as investigation of certificates of analysis of the TCM granulate ‘Tianwang buxin dan’ from 8 available sources in Germany and analyses of its content of lead, cadmium, and mercury. Results: Current quality and safety risks comprise self-medication, TCM-unexperienced pharmacies, Internet sale and granulates. 11 studies published between 1998 and 2008 evaluated the quality and safety of TCD in Germany. Also in newer studies, the values found for heavy metals, pesticides, and microbiological contaminants of TCD in part exceeded the maximum permissible values. 28 reports of adverse events were made to the Center for Therapy Safety in Chinese Drug Therapy (CTCA) within the years 2004–2012. A definite causality was determined in 2 cases (allergic reaction, reaction of the circulatory system); 7 of the 28 reports had a likely causality. 61 of 104 (59%) certificates of ‘Tianwang buxin dan’ from 8 different sources could be obtained. 45 of 61 certificates (74%) complied with the requirements according to the pharmacy work rules. Shortcomings were, amongst others, lacking analyses (identity, aflatoxines, microbiology, pesticides). Critical values were exceeded neither in the certificates nor in the analyses arranged by us. Conclusion: Shortcomings in quality and safety risks of TCD still remain, but must be further distinguished. Reports of adverse events are very rare

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