The Efficacy Of Cilostazol Versus Aspirin For Vascular Dementia After Cerebral Infarction

Objective:Cilostazol,as a selective phosphodiesterase-3(the PDE-3)inhibitor, has a strong effect of anti-platelet aggregation,and relaxing bloodvessels, inhibiting the proliferation of smooth muscle cells,,with low risk ofgastrointestinal reactions and bleeding. Cilostazol has beenwidely used inclinical as secondary prevention of cerebral infarction in Japan. Ischemicstroke and transient ischemic attack secondary preventionguide2010pointedout that the Cilostazol prevention may be safe and effective in patients withischemic stroke in China.But very little research on the efficacy of cilostazolhas been done for vascular dementia after cerebral infarction. Aspirin as thetreatment of cerebral infarction after vascular dementia classic anti-plateletdrugs are widely used.We obverse the safety and efficacy of cilotazol forvascular dementia after cerebral infarction with aspirin for comparison in thisexperiment.Methods: This study is a prospective randomized open trial withvascular dementia patients after cerebral infarction as our research objects andaspirin for comparison. The patients who are consistent with this testconditions should be randomly divided into the test group and the controlgroup, and given a mark for MMSE, MOCA, HADs, BDs, CDRs, mRs andcomputer memory interference test.Everyone in the test group should takecilostazol for oral use,100mg, qd;while others in the control group should takeaspirin enteric-coated tablet,100mg,qd. All patients would take the drug for12months,and be followed up every two months.At every follow-up visit,weobserve any overall clinicalimpression change in the patients and make sure ifthey have any cerebral infarction recurrence, bleeding events or other adversereactions, Each patient have the assessment of cognitive function scale in MMSE and MOCA after6months and12months.RESULTS: The trial enrolled68patients, including aspirin group (34cases), age64.7±6.8years,19cases of males and15females; cilostazol groupof34patients, age64.9±7.0years, male18cases,16cases of women.31patients in each group completed the thetreatment,18males and13females inaspirin group,17males and14females in cilostazol group. There are a total ofsix cases fallen off,1case for recurrence of cerebral infarction and two casesfor brain hemorrhage in the aspirin group, two cases for recurrence ofcerebral infarction and1case was lost in the cilostazol group. The t testcompared between the two groups of the patient's age balance consistent;Thechi-square test compared between the two groups of patients with sex, race,past medical history, personal history, cultural degree balance consistent.The repeated measurement data analysis of variance results of MMSEscores of the two groups showed that: time and treatment interaction was notstatistically significant, p=0.525; the time factor was statistically significant, p=0.008; between-subjects factor on the MMSE scores was not statisticallysignificant, p=0.741. The repeated measurement data analysis of variancepairwise comparisons results of MMSE scores of the three time points in theaspirin group showed that: the within-subjects factor was not statisticallysignificant, p=0.100; the before and after treatment6months compared withno statistical significance,p=0.055; the before and after treatment12monthscompared with no statistical significance,p=0.108; after treatment6monthsand12months compared with no statistical significance, p=0.939. Therepeated measurement data analysis of variance pairwise comparisons resultsof MMSE scores of the three time points in the cilotazol group showed that:the within-subjects factor was statistically significant, p=0.021; the before andafter treatment6months compared with no statistical significance,p=0.023;the before and after treatment12months compared with no statisticalsignificance,p=0.008; after treatment6months and12months compared withno statistical significance, p=0.250. The repeated measurement data analysisof variance pairwise comparisons results of MMSE scores between the two groups on the three time points showed that: There was no significantdifference in MMSE scoress before treatment between two groups, p=0.949;there was no significant difference in MMSE scoress6months after treatmentbetween two groups, p=0.825; there was no significant difference in MMSEscoress12months after treatment between two groups,p=0.525.The repeated measurement data analysis of variance results of MOCAscores of the two groups showed that: time and treatment interaction was notstatistically significant, p=0.128; the time factor was statistically significant,p=0.000; between-subjects factor on the MOCA scores was not statisticallysignificant, p=0.610. The repeated measurement data analysis of variancepairwise comparisons results of MOCA scores of the three time points in theaspirin group showed that: the within-subjects factor was statisticallysignificant, p=0.001; the before and after treatment6months compared withno statistical significance,p=0.058; the before and after treatment12monthscompared with statistical significance,p=0.002; after treatment6months and12months compared with no statistical significance, p=0.031. The repeatedmeasurement data analysis of variance pairwise comparisons results of MMSEscores of the three time points in the cilotazol group showed that: thewithin-subjects factor was statistically significant, p=0.000; the before andafter treatment6months compared with statistical significance, p=0.000;thebefore and after treatment12months compared with statistical significance,p=0.000; after treatment6months and12months compared with no statisticalsignificance, p=0.300. The repeated measurement data analysis of variancepairwise comparisons results of MMSE scores between the two groups on thethree time points showed that: There was no significant difference in MMSEscoress before treatment between two groups, p=0.782; there was nosignificant difference in MMSE scoress6months after treatment between twogroups, p=0.190; there was no significant difference in MMSE scoress12months after treatment between two groups,p=0.581.There were two cases of patients with recurrent ischemic stroke in thecilostazol group as many as one case of patient with recurrent ischemic stroke, 2cases of patients with hemorrhagic stroke in the aspirin group. The strokeincidence of two groups was not significantly different by chi-squaretest,p=1.0.The hemorrhagic stroke incidence was not significantly differentbetween the two groups by the chi-square test, p=0.49; The ischemic strokeincidence was not significantly different between the two groups by thechi-square test, p=0.61.Conclusion: Cilostazol can treat patients with mild-to-moderatevascular dementia by improving there cognitive function. Its curative effectmay be similar to aspirin with good safety. Cilostazol is equally effective toaspirin for secondary stroke prevention in patients with non-cardioembolicischemic stroke。Cilostazol and aspirin arenot significantly different for theincidence of both ischemic stroke and hemorrhagic stroke.