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Blogger's Note: it would be unusual for a study to be completed only in Stage 11 (due to small numbers); possible typo?; full paper and/or revision may clarify
Abstract
Magnesium isoglycyrrhizinate (MI) has been complementarily used for restoring the
hepatic impairments caused by taxol plus platinum based chemotherapies
in China. Due to the hepatic dependence of paclitaxel elimination, this
pilot clinical study aimed to investigate the influence of MI on the
pharmacokinetics of paclitaxel in epithelial ovarian cancer patients.
During the standard chemotherapy of intravenous paclitaxel (125 mg/m2 infused over a 3-h period) and intraperitoneal cisplatin (60 mg/m2)
for patients with FIGO stage II epithelial ovarian cancer, 9 each of
total 18 patients were respectively treated with intravenous MI (100 mg)
or vehicle control for 4 days. Plasma paclitaxel was analyzed by HPLC
and the pharmacokinetic parameters were calculated with
non-compartmental analysis. The hematological, hepatic and renal status
was monitored before and 3 days after paclitaxel administration. It was
observed the terminal t 1/2 and MRT of paclitaxel were
significantly (p = 0.002 and 0.001) reduced by MI, respectively, from
11.0 ± 2.2 and 5.6 ± 1.0 h to 7.7 ± 1.7 and 4.0 ± 0.3 h. Hematological
toxicity indicated by platelet count and hepatic events marked with ALT,
AST and γ-GT were significant in both groups. In spite of the
insignificance of decreased system exposure of paclitaxel and recovered
hepatic function by MI, they did correlate with each other. It was
therefore deduced that the liver toxicities of paclitaxel plus cisplatin
chemotherapy potentially decrease hepatic elimination and increase
system exposure of paclitaxel, and the recovery of liver function by MI
helps to restore hepatic clearance of paclitaxel. The clinical
significance of this pharmacokinetic interaction requires further
studies with larger population size.
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