Objective: To observe the efficacy and anticoagulant effect of Yiqi Tongluo decoction in patients with Qi-deficency and blood-stasis syndrome after cardiac valve replacement. Method: Eighty eight patients with cardiac valve replacement were selected and randomly divided into control group (44 cases) and observation group (44 cases) according to number table method. Patients of control group were treated with warfarin sodium tablets from day one to day three with dose of 3-4 mg·d-1

and after day three

with a maintenance dose of 2.5 mg·d-1. According to the international normalized ratio (INR)

dose of warfarin sodium tablets was added or subtracted each time to make the INR value reach 2-3.Patients of observation group were treated with Yiqi Tongluo decoction boiled conventionally in morning and evening

bid. Patients of both groups were observed for three months continuously. Score of traditional Chinese medicine (TCM) symptoms and thrombin time (TT)

activated partial thrombin time (APTT)

prothrombin time (PT)

and plasma fibrinogen(FIB) were compared between two groups. Levels of hemorheology indexes were detected in two groups 1 d and 3 months after the operation. Complications and deaths were recorded in two groups. Result: Three months after operation

score of TCM symptoms in observation group were significantly lower than those of control group (P<0.01). Three months after operation

There was no statistically significant difference in TT

APTT

PT and FIB between two groups. During the 1 year of follow-up

postoperative complications occurred in 3 cases (6.82%) of observation group

and 12 cases (27.27%) of control group

with statistically significant differences (P<0.05). Three months after operation

there were no statistically significant differences in various levels of hemorheology indexes between two groups. During 1 year of follow-up

death occurred in 1 case (2.27%) of observation group

and 2 cases (4.55%) in control group

with no statistically significant differences. Conclusion: Yiqi Tongluo decoction showed definite anticoagulant effect and was safe in patients with Qi-deficency and blood-stasis syndrome after cardiac valve replacement. It is worthy of clinical application.