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Effect of Green Tea Supplements on Liver Enzyme Elevation: Results from a Randomized Intervention Study in the United States

机译：绿茶补充剂对肝酶升高的影响：美国随机干预研究的结果

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摘要

Liver injury effects of green tea-based products have been reported in sporadic case reports. However, no study has examined systematically such adverse effects in an unbiased manner. We examined the potential effects of a high, sustained oral dose of green tea extract (GTE) on liver injury measures in a randomized, placebo-controlled, double-blinded phase II clinical trial, which enrolled 1,075 women with the original aim to assess the effect of daily GTE consumption for 12 months on biomarkers of breast cancer risk. The current analysis examined the effect of GTE consumption on liver injury in 1,021 participants (513 in GTE and 508 in placebo arm) with normal baseline levels of liver enzymes. Among women in the GTE arm, alanine aminotransferase (ALT) increased by 5.4 U/L [95% confidence interval (CI), 3.6-7.1] and aspartate aminotransferase increased by 3.8 U/L (95% CI, 2.5-5.1), which were significantly higher than those among women in the placebo arm (both P < 0.001). Overall, 26 (5.1%) women in GTE developed moderate or more severe abnormalities in any liver function measure during the intervention period, yielding an OR of 7.0 (95% CI, 2.4-20.3) for developing liver function abnormalities as compared with those in the placebo arm. ALT returned to normal after dechallenge and increased again after one or more rechallenges with GTE. The risefall pattern of liver enzyme values following the challenge-dechallenge cycles of GTE consumption strongly implicates the effect of high-dose GTE on liver enzyme elevations. (C) 2017 AACR.
机译：零星案例报告报告了绿茶产品的肝损伤影响。然而，没有以无偏见的方式系统地检测到这种不良影响的研究。我们研究了高持续的口服剂量绿茶提取物（GTE）对肝损伤措施对随机，安慰剂的双盲期II临床试验中的潜在影响，该临床试验登记了1,075名妇女，以评估每日GTE消耗对乳腺癌风险的生物标志物进行12个月的影响。目前的分析检测了GTE消耗对1,021名参与者（GTE和508中的513中的肝损伤的影响，具有正常的肝酶基线水平。在GTE臂的女性中，丙氨酸氨基转移酶（ALT）增加了5.4 U / L [95％置信区间（CI），3.6-7.1]和天冬氨酸氨基转移酶增加3.8 U / L（95％CI，2.5-5.1），这显着高于安慰剂臂中女性（均为P <0.001）。总体而言，GTE中的26例（5.1％）妇女在干预期间在任何肝功能测量中发育了中度或更严重的异常，与那些相比，产生肝功能异常的7.0（95％CI，2.4-20.3）。安慰剂手臂。 Alt在翻译后恢复正常，并在使用GTE的一个或多个重新接受后再次增加。 GTE消耗攻击 - 癸符​​循环后肝酶值的起重率模式强烈暗示高剂量GTE对肝酶升高的影响。 （c）2017年AACR。

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  • 来源
    《Cancer prevention research.》 |2017年第10期|共9页
  • 作者

    Yu Zheming; Samavat Hamed; Dostal Allison M.; Wang Renwei; Torkelson Carolyn J.; Yang Chung S.; Butler Lesley M.; Kensler Thomas W.; Wu Anna H.; Kurzer Mindy S.; Yuan Jian-Min;

  • 作者单位

    Univ Pittsburgh Inst Canc UPMC Canc Pavil Suite 4C 5150 Ctr Ave Pittsburgh PA 15232 USA;

    Univ Minnesota Dept Food Sci &

    Nutr St Paul MN 55108 USA;

    Univ Minnesota Dept Med Div Gastroenterol Hepatol &

    Nutr Box 736 UMHC Minneapolis MN 55455 USA;

    Univ Pittsburgh Inst Canc UPMC Canc Pavil Suite 4C 5150 Ctr Ave Pittsburgh PA 15232 USA;

    Univ Minnesota Sch Med Dept Family Med &

    Community Hlth Minneapolis MN 55455 USA;

    Rutgers State Univ Ernest Mario Sch Pharm Dept Biol Chem Piscataway NJ USA;

    Univ Pittsburgh Inst Canc UPMC Canc Pavil Suite 4C 5150 Ctr Ave Pittsburgh PA 15232 USA;

    Univ Pittsburgh Inst Canc UPMC Canc Pavil Suite 4C 5150 Ctr Ave Pittsburgh PA 15232 USA;

    Univ Southern Calif Keck Sch Med Dept Prevent Med Los Angeles CA USA;

    Univ Minnesota Dept Food Sci &

    Nutr St Paul MN 55108 USA;

    Univ Pittsburgh Inst Canc UPMC Canc Pavil Suite 4C 5150 Ctr Ave Pittsburgh PA 15232 USA;

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  • 正文语种 eng
  • 中图分类 肿瘤学;
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