Objective: To evaluate the safety and efficacy of Xiangdan injection for treating the syndrome of qi deficiency and blood stasis. Method: Using cohort study method

142 patients with different diseases agreed to the syndrome of qi deficiency and blood stasis

and also agreed to use Xiangdan injection were regarded as the observation group by natural queue. Other 96 patients without Xiangdan injection treatment composed the control group. Result: Xiangdan injection could reduce the scores of the syndrome of qi deficiency and blood stasis (P<0.01)

and the total effectiveness was 89.43%

better than 72.91% in control group (P<0.01). In the observation group

eight cases (5.63%)showed mild-moderate adverse reaction. Conclusion: Xiangdan injection for treating the syndrome of qi deficiency and blood stasis is effective

but needs to pay attention to the safety in clinical use.