| Objective: To observe the clinical therapeutic effect and safety of Ba Wei Shu Mai capsule.Methods: 48 patients with ASO were randomly divided into two groups: test group, 24 cases, were treated with Ba Wei Shu Mai capsule; control group, 24 cases, were given Tian Yuan Kang Shuan capsule. The cardinal symptoms, syndromes of TCM, blood-lipid, hemorheology, ankle-brachial index(ABI), were observed and contrasted; Meanwhile, the blood routine, routine urine, feces routine, electrocardiogram(ECG), liver function, renal function, as safety indexes, were monitored too.Results: The therapeutic effectiveness were not significant different between two groups(P>0.05) , but the cure rate of test group was superior to that of control group(P<0.05); The effective rate of syndromes of TCM in test group was higher than control group (P<0.05);after treatment, the improvement of cardinal symptoms as well as most parameters about blood-lipid and hemorheology were obvious in test group than in control group(P<0.05 or P<0.01);There existed significant progress of ABI in ischemic phase in two groups(P<0.01), which test group was prominent(P<0.05). The exceptional indexes and obvious side-effect were not observed in safety surveillance.Conclusions: Ba Wei Shu Mai capsule has the functions of invigorating qi and activating blood, eliminating blood stasis and dredging meridians. It can also decrease the blood-lipid, mitigate the hepercoagulability and improve ABI in early ASO. Ba Wei Shu Mai capsule is a safe and effective drug in treating ASO of blood stasis type.
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