Objective: To evaluate the clinical efficacy of hydroxysafflor yellow A (HSYA) injection for traditional Chinese medicine (TCM) syndrome of acute ischemic stroke with blood stasis syndrome

and investigate its effects on levels of superoxide dismutase (SOD) and malondialdehyde (MDA). Method: A total of 71 eligible cases with acute ischemic stroke with blood stasis were randomly divided into treatment group(35 cases) and control group (36 cases). Patients in treatment group received HSYA injection

50 mg/time

and patients in control group received Erigeron breviscapus injection

30 mg/time. Both of the two kinds of medicines were dissolved into 250 mL 0.9%normal saline for intravenous drip

once per day for 14 days. Scores of blood stasis syndrome from three different time points (before drug medication

30 days after drug medication and 90 days after drug medication) were regarded as the clinical outcome indexes to evaluate their efficacy for TCM syndrome between control group and treatment group in treatment of acute ischemic stroke (blood stasis syndrome). Levels of SOD and MDA were tested before and 30 days after treatment. Result: In comparison of efficacy for TCM syndrome

the treatment group was better than control group (P<0.05). The Covariance analysis of TCM syndrome showed that 30 days after treatment

the scores decrease in treatment group (0.69±2.48) points was higher than that in control group (0.28±1.16) points

and after correcting baseline

the efficacy in treatment group was better than that in control group (P<0.05)

while 90 days after treatment

the scores decrease in treatment group (1.17±2.68) points was higher than that in control group (0.42±1.40) points

and after correcting baseline

the efficacy in treatment group was better than that in control group (P<0.01). Levels of SOD in treatment group were higher than those in control group after treatment(P<0.01)

but the levels of MDA in treatment group were lower than those in control group (P<0.01). Conclusion: Both HSYA injection and Erigeron breviscapus injection could improve the clinical symptoms to different degrees in patients with blood stasis syndrome. Both of them showed certain efficacy for blood stasis syndrome

but the efficacy in treatment group was superior to that in control group. Its mechanism may be related to relieving oxidative stress injury.