| Objective:To evaluate the efficacy and safety of combination with berberine and low dose atorvastatin for secondary prevention of patients with acute ischemic stroke, and comparing it with singly use of larger dose atorvastatin, based on the previous studies of berberine on its multiple mechanisms.Methods:The patients aged from 35 to 75 years old with a first episode of ischemic stroke within one month, who at least had a treatable risk factor of cerebrovascular disease, were randomly assigned to the combination therapy group or the standard secondary prevention control group. During the treatment, berberine therapeutic group was treated with berberine hydrochloride tablets 0.3g three times a day, atorvastatin tablet 10mg every night, aspirin enteric-coated tablet 0.1g every day and standard therapies for other risk factors lasting for 3 months. The control group were all treated with atorvastatin tablets 20mg every night, aspirin enteric-coated tablet 0.1g every day and standard therapies for other risk factors lasting for 3 months. The primary efficacy endpoint were the mRS scores of the patients, the improvemert of the NIHSS scores, the levels of lipid and HsCRP and the condition variance of carotid artery plaques at the third month. The secondary efficacy endpoint were recurrence rate and fatality caused by stroke of various reasons within 3 months and episodes cardiovascular of various reasons and episodes of peripheral vascular. The safety index were liver and kidney function, CK, blood counts, and the self-symptom of the patients in the three months.This project was carried out with the approval of the ethics committee of Shenzhen people's hospital and informed consent of the patients.Results:The proportion of completion of the total treatment of the therapeutic group and control group were [91.7%(55/60)versus95.0%(57/60)]. The NIHSS and mRS of the two group patients both improved significantly after 3 months treatment, respectively P<0.01 and P＜0.01. The comparison for NIHSS and mRS scores of the two groups after 3 month treatment manifested no statistical significance (P=0.402, P=0.341). The levels of TC and LDL-C after 3 months decreased on average compared to that of pre-therapy, and all had statistical significance(P< 0.01).The TG levels of therapeutic group showed statistical significance compared to that of pre-therapy, but there was not statistical significance to that of control group. There was statistical significance for the TG levels between the two groups after 3 month treatment (P<0.01). No statistical significance had been seen in either group in the comparison of the level of HDL-C pre and post treatment. Both the therapeutic and control group HsCRP levels decreased significantly after treatment(P<0.01). There was not statistical significance in the HsCRP level between the two groups (P=0.408). Statistical significance was seen in the carotid artery IMT of the two groups pre-and post-treatment (P<0.05).The carotid artery plaques of the two groups were more stable than that of pre-treatment. The proportion of low level echo plaques decreased were seen in both groups (P< 0.05) and the proportion of high level echo plaques increased (P<0.05). But there was not statistical significance for the differences between the two groups. The recurrence rate and fatality of the two groups during the 3 months follow-up phase showed no statistical significance. The liver and kidney function of the two groups during the 3 months follow-up showed no statistical significance.Conclusion:Comparing with singly use of atorvastatin 20mg every night, the combination of berberine 0.3 three times a day and atorvastatin 10mg every night for the secondary prevention of acute ischemic stroke lasting for 3 months has the same effect on the reduction of serum TC, LDL-C and HsCRP, neither of them has effect on serum HDL-C, but the reduction of TG in the therapeutic group is significant when compared with that of the control group. After 3 months treatment, the carotid artery plaques in the two groups are more stable than it was before. Furthermore, the significant improvement of NIHSS and mRS were seen in both groups.
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