| Objective: With the rapid development of economy, the significant changes of living condition and lifestyle and acceleration of the process of population aging, cerebrovascular disease has become the leading cause of death in our country. Its"three highs"(high morbidity, high mortality and high disability rate) do serious harm to people's health, reduce quality of life; moreover, it brings the heavy medical, economic and social problems. Atherosclerosis is the primary pathological basis of cerebral infarction. At present, PAS therapy is commended for the second-grade prevention aimed to atherithrombotic cerebral infarction patients, which has obtained good curative effect. However, because of individual differences, it can not benefit each patient. Therefore, how to choose the appropriate drug for second-grade prevention to individualized treatment? This is still a major issue which troubles clinicians.This study was a prospective, randomized, controlled, open labeled phase IV clinical trial which as"aspirin"control to evaluate the effects and safety of cilostazol, probucol and the combination of both drugs on the biomarkers related to atherithrombotic cerebral infarction patients, which aims to discuss the curative effects and safety of cilostazol, probucol and the combination of both drugs on the treatment of anti-atherosclerosis and tries to find a new anti-atherosclerosis therapy which could provide some inspirations for clinical individualized medication.Methods: 40 atherithrombotic cerebral infarction patients, 40 to 80 years old, were chosen, of which the indicators of atherosclerosis had to meet one of the following conditions: previously diagnosed typeⅡdiabetes; previously diagnosed as primary hypertension; atherosclerosis stenosis in any two or more sites of cerebral artery, carotid artery, limb artery and coronary artery by the results of contrast examination and ultrasonic examination. In this study as aspirin control, the patients were randomly divided into 4 groups, with 10 patients in each group, namely group A (aspirin group), group B (cilostazol group), group C (probucol group) and group D (cilostazol + probucol group). Study drug and method: cilostazol 100mg, twice a day, oral administration after breakfast and supper; probucol 250mg, twice a day, oral administration after breakfast and supper; the patient in each group took 100mg aspirin enteric-coated tablets regularly, and the standard treatment was carried out according to medical conditions of patients (abstain from tobacco and alcohol, control of hypertension and hyperglycemia and other treatments). 12 weeks was in total. The biomarkers related to atherosclerosis were measured respectively before and after taking the drug. The occurrences of ischemic events and adverse events were recorded and clinical data were collected. Statistical analysis were performed for all data by SPSS 17.0 software (p-value = 0.05).Results:①The ratio of LDL-C/HDL-C in group B after treatment was significantly less than before, with a significant difference (p<0.05), compared with group A and group D respectively, with a significant difference (p<0.05); the levels of hs-CRP, ox-LDL, sVCAM-1, sICAM-1, TC, LDL-C and TG had a decreasing tendency and the level of HDL-C had a ascending tendency,however, without statistical difference.②The level of HDL-C in group C after treatment was significantly lower than before, with a significant difference(p<0.05); the levels of hs-CRP, ox-LDL, sVCAM-1, TC and TG had a decreasing tendency, however, without statistical difference.③The level of sICAM-1 in group D after treatment was significantly lower than before, with a significant difference(p<0.05); the levels of hs-CRP, IL-6, ox-LDL, sVCAM-1, TC and TG had a decreasing tendency, however, without statistical difference.④There was no significant difference on each index in group A after treatment.⑤There was no recurrence of cerebral infarction, transient ischemic attack, the occurrences of bleeding adverse events and serious adverse events for 35 subjects in follow-up period.Conclusion:①Cilostazol can lower the ratio of LDL-C/HDL-C, which plays a role in regulating blood lipids.②Combination therapy of cilostazol and probucol can lower the level of sICAM-1.③In the secondary prevention of cerebral infarction, the curative effect of each treatment group of this study in early stage (3 months) was significant, and with the safety.
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