舒肝凉血方对三苯氧胺代谢产物影响的研究

目的:研究临床有效中药复方舒肝凉血汤对三苯氧胺(Tamoxifen,TAM)及其活性代谢产物4-羟基三苯氧胺(4OHtam)体内代谢的影响。方法:标本样品取自参加临床随机双盲试验的患者血标本。采用两组用药前后自身对照和组间对照的方法。TAM及4OHtam血清浓度采用高效液相-质谱联用(HPLC-MS)方法检测。使用SPSS13.0分析软件,进行统计学分析。结果:中药组服中药前血中TAM,4OHtam浓度分别为(215.63±95.36)ng·mL^-1,(4.49±1.49)ng·mL^-1。服中药后分别为(233.17±126.48)ng·mL^-1,(5.34±2.78)ng·mL^-1。安慰剂组服药前血中TAM,4OHtam浓度分别为(209.80±75.05)ng·mL^-1,(5.15±1.67)ng·mL^-1;服药后分别为(216.86±98.89)ng·mL^-1,(4.21±1.41)ng·mL^-1。两组间检验结果和用药前后各组自身比较差异均无统计学意义。结论:实验提示中药舒肝凉血汤对三苯氧胺及4-羟基三苯氧胺的体内代谢无明显影响,为该方与三苯氧胺合用的安全性提供了依据。

The Shuganliangxue Decoction's Effects on the Metabolism of Tamoxifen

Objective:To study the influence of Traditional Chinese Medicine(TCM) Shuganliangxue decoction to TAM and 4OHtam metabolism in patients.Method:All the blood samples were collected from a randomized double blind clinical trial.The serum concentration of TAM,4Ohtam between two groups,and that in one group before and after taking the decoction were compared.TAM and 4OHtam concentration in serum were determined by using HPLC-MS method.The data was analized with t-test and SPSS 13.0 statistics method.Results:Before taking TCM decoction,TAM and 4OHtam concentration were(215.63±95.36) ng·mL^-1,(4.49±1.49) ng·mL^-1 separately,and after taking TCM decoction,were(233.17±126.48) ng·mL^-1,(5.34±2.78) ng·mL^-1.In placebo group before taking"decoction" TAM and 4OHtam concentration were(209.80±75.05) ng·mL^-1,(5.15±1.67) ng·mL^-1,after taking"decoction",were(216.86±98.89) ng·mL^-1,(4.21±1.41) ng·mL^-1.There were no significant differences between the two groups and for the self control(P>0.05).Conclusions: TCM Shuganliangxue decoction did not influence the TAM and 4OHtam metabolism in serum of patients.It provides the evidence of safety for using Shuganliangxue decoction combining with TAM in clinical.