A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL).

A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL).
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DOI:
10.1002/cncr.24723
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发表时间:
2010-01-15
期刊:
影响因子:
6.2
通讯作者:
Kelly, Kara M.
Kelly, Kara M.
中科院分区:
医学1区
文献类型:
--
作者:
Ladas, Elena J.;Kroll, David J.;Oberlies, Nicholas H.;Cheng, Bin;Nclao, Deborah H.;Rheingold, Susan R.;Kelly, Kara M.

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Milk thistle (MT) is often used for the treatment of chemotherapy associated hepatotoxicity despite limited preclinical and clinical investigations. Limited treatment options exist for chemotherapy-related hepatoxicity. Given the wide use of MT, we investigated MT in both the laboratory and clinical setting. In a double-blind study, children with ALL with hepatic toxicity were randomized to MT or placebo orally for 28 days. Liver function tests were evaluated during the study period. To assess MT in vitro, we evaluated supratherapeutic concentrations in an ALL cell line. 50 children were enrolled. No significant differences in the frequency of side effects, incidence and severity of toxicities, or infections were observed between groups. There were no significant changes in mean AST, ALT, or TB at day 28. At day 56, the MT group had a significantly lower AST (p=0.05) and a trend towards a significantly lower ALT (p=0.07). Although not significantly different, chemotherapy doses were reduced in 61% of the MT group, compared to 72% of the placebo group. In vitro experiments revealed no antagonistic interactions between MT and vincristine or L-asparaginase in CCRF-CEM cells. A modest synergistic effect with vincristine was observed. In children with ALL with liver toxicity, MT was associated with a trend towards significant reductions in liver toxicity. MT does not antagonize the effects of chemotherapy agents used for the treatment of ALL. Future study is needed to determine the most effective dose and duration of MT and its effect on hepatotoxicity and leukemia-free survival.
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发表时间: 1991-01-01
影响因子: 1.7
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