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|Untersuchungen zur Pharmakokinetik und Toxizitätsprofil von Bendamustin an Patienten mit eingeschränkter Leberfunktion|
|Main title||Untersuchungen zur Pharmakokinetik und Toxizitätsprofil von Bendamustin an Patienten mit eingeschränkter Leberfunktion|
|Title variations||Analysis of pharmacokinetic and toxicity of bendamustine in patients with liver dysfunction|
Place of birth: Berlin
|1. Referee||Prof. Dr. med. I. Roots|
|Further Referee(s)||Prof. Dr. Dr. W. Kirch
Prof. Dr. med. S.M. Bode-Böger
Prof. R. Somasundaram
Prof. Dr. med. Lübke
Prof. Dr. med. Schönfelder
|Keywords||bendamustine, toxicity, pharmacokinetic, liver dysfunction|
|Classification (DDC)||610 Medical sciences; Medicine|
|Summary||The aim of the present work existed in the first-time elevation of the kinetics of bendamustine and his effective metabolics in the plasma and toxicity under conditions of limited liver function.
The investigations were led to 12 patients (5 men, 7 women) with respectable tumors and normal liver function and 13 patients (11 men, 2 women) with advanced HCC and limited liver function.
Bendamustine became tins of 120 mg / m² bendamustinhydrochlorid on two successive days (patient with limited liver function of the numbers 1-5 received on the day 2 of the gift a dose diminished on 80 mg / m²) in the form of a 30-minute continuous intravenous drip given.
The elimination of bendamustine of plasma is found delayed to patient with limited liver function in comparison to patients with the norm of suitable liver function. Also the education of both phases I-metabolics γ-Hydroxy-bendamustin and N-Desmethyl-bendamustin is delayed and found to a lower magnitude.
The clinical compatibility turned out very good with the complete absence of degree to 4-toxicity and the appearance of a total of only three provable degrees 3-toxicity (oral dryness, feeling of sickness / vomiting, fever). The mildly clinical toxicity was not found differently between both patient's groups.
The behaviour of the liver function parameters as well as PTT, Quick is found not changed after gift by bendamustine to patient with normal as well as limited liver function. Bendamustine leads to a light, nevertheless secure decrease of haemoglobine, leucocytes and granulocytes with increasing study duration to patient with limited liver function.
The depression of the lymphocytes is trained early already after 8 days at most, amounts in this measuring time to patient with limited liver function to decreases on average about 80% and is stronger coined in the 4-week observation phase after bendamustine to patient with limited liver function than to patient with the liver function corresponding to the norm. Taking into account all upraised parameters it is found in half-quantitative analysis securely stronger toxicity to patient with limited liver function in comparison to patients with not affected liver function.
On the basis of the upraised data to kinetics and toxicity of bendamustine, a reduction of the dose of bendamustine is recommended to patient with limited liver function in the magnitude by bilirubine up to 3 mg / DLs (51 µ mol/l) around up to 40%.
PDF-Datei von FUDISS_thesis_000000020028
|Number of pages||118|
|FU Department||Department of Medicine - Charité - University Medicine Berlin|
|Year of publication||2011|
|Document type||Doctoral thesis|
|Date of defense||2011-02-04|
|Created at||2010-11-30 : 07:59:49|
|Last changed||2011-01-24 : 10:49:45|