| Objective:Through large-scale clinical research, observing the therapy effects of Chinese medicine which can nourify Qi, activate Blood and nourish Yin, represented by Dengzhanshengmai capsule, in secondary prevention of ischemic stroke, so evidence based medicine can be provided for the application of Traditional Chinese Medicine in secondary prevention interventions of ischemic stroke.Method:The research system summaried and evaluated the researches on the secondary prevention of ischemic stroke at home and abroad, and established the intervention program of Traditional Chinese Medicine in secondary prevention of ischemic stroke. Prspective, Multi-centered, Double Blinded,large-scaled RCT ways are used.using the same inclusion and exclusion criteria, in 30 hospitals, chaired by the Affiliated Hospital of Chengdu University of TCM, stroke patients who met the standards of ischemic stroke were randomly divided into Dengzhanshengmai capsule treatment group and placebo group. On the basis of western medicine treatment, the two groups were separatively given Dengzhanshengmai capsule and placebo capsule(2pills per day).observation period was 1 year, monthly follow-up, filling out medical forms and the original CRF table. the incidence of Patients fatal and nonfatal stroke recurrence, fatal and non fatal cardiovascular events, peripheral arterial disease of the two groups Improvement in functional disability before and after treatment (mRS score), risk factors closely related to the stroke such as lipids, glucose and other indicators such as blood, urine, stool, liver and kidney function during the treatment, and before and after treatment were observed after 12 months.Result:Eventually 1240 cases which met the standards were included (620 cases in treatment group and control group 620 cases). The baseline material in two groups were comparable (P> 0.05). The stroke patients with recurrent in treatment group were 18 cases, the total 2.90%,32 cases of recurrent stroke patients in matched group, the total 5.16%; the recurrence of stroke patients of two sets were examined, P< 0.05, which have statistically significant, explain in reducing recurrence rate in treatment group was better than matched group, and can reduce the recurrence rate of 2.2 percent above. The type of recurrent stroke can also see, and then send the type of stroke in IS primarily. The stroke mortality and the whole cause of death mortality has no obvious difference between two groups (P> 0.05). Two groups before treatment, treatment 180 days, treatment 360 days of mRS score, blood fat levels (TG, TC, HDL, LDL) is compared between both not significant (P> 0.05), the mRS score before and after the treatment are compared within a significant differences. By Essen stroke risk score, low-risk layered between the two groups, high-risk layered between the two groups, statistics results and comparison are similar with above. The treatment group appear adverse events/reaction in 12 cases(1.9%),18 cases (2.9%) of adverse events/reaction in the matched group, the laboratory safety index showed no obvious unusual.Conclusion:Compared with the matched group, Chinese medicine which can nourify Qi, activate Blood and nourish Yin (Dengzhanshengmai capsule) can obviously reduce the recurrence rate of stroke, especially reduce the recurrence of IS; To reduce mortality and all-cause mortality in two groups do not have apparent differences; To improve the patients disabled function (mRS score) have better trend than pure western medicine therapy; To The lipid levels between two groups are with similar. The method of nourifying Qi, activating Blood and nourishing Yin is effective therapies to the secondary prevention of ischemic stroke, Dengzhanshengmai capsule is a definite effective traditional Chinese medicine to prevent the recurrence of stroke, which is worth to promote wider dissemination and application on clinical treatment.
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