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.