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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SPSS 13.0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。
Objective: To study the effect of Shugan Liangxue Decoction, a traditional Chinese medicine compound, on the metabolism of tamoxifen (TAM) and its active metabolite 4-hydroxy tamoxifen (4OHtam) in vivo. Methods: Specimens were taken from blood samples from patients who participated in a randomized, double-blind clinical trial. Two groups of self-control and inter-group comparisons were used. Serum concentrations of TAM and 4OHtam were detected using high-performance liquid-mass spectrometry (HPLC-MS). Statistical analysis was performed using SPSS 13.0 analysis software. Results: The concentrations of TAM and 4OHtam in blood before Chinese medicine were taken as (215.63±95.36) ng.mL-1, (4.49±1.49) ng.mL-1. After taking traditional Chinese medicine, they were (233.17±126.48) ng.mL-1, (5.34±2.78) ng.mL-1, respectively. The TAM and 4OHtam concentrations in the placebo group before treatment were (209.80±75.05) ng.mL-1, (5.15±1.67) ng.mL-1, respectively; after administration, they were (216.86±98.89) ng.mL-1. (4.21±1.41) ng.mL-1. There was no significant difference between the two groups in the test results and before and after treatment in each group. Conclusion: The experiment suggests that Shugan Liangxue Decoction has no significant effect on the metabolism of tamoxifen and 4-hydroxy tamoxifen in vivo, providing a basis for the safety of the combination with tamoxifen.