| Objectives:The prevalence of minor ischemic stroke is increasing year by year,but its prognosis is poor,and there is no effective treatment strategy.This study aims to illustrate the reliability of the Stroke-Patient reported outcome for patients with minor ischemic stroke.Besides,the clinical efficacy of sequential treatment of butylphthalide in patients with minor ischemic stroke and its effect to improve the prognosis were proved,and the risk factors affecting the prognosis of these patients were analyzed.Methods:In this prospective randomized controlled study,from September 2020 to June2022,patients with acute minor ischemic stroke admitted to the Department of Neurology in Shanxi cardiovascular hospital were selected as subjects.All patients met the diagnostic criteria for acute ischemic stroke in China Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018.Conditions were added on this basis: first onset,within 48 hours,NIHSS score ≤3,and cardiogenic patients were excluded according to TOAST etiology classification.The subjects were randomly divided into the NBP group and the Non-NBP group according to 1:1,and the sample size of each group is estimated to be 100 cases,with total of 200 cases,and collecting patients’ basic information,past history,personal history,and relevant examination and laboratory indicators after admission.The Non-NBP group was given general treatment recommended by the guidelines.The NBP group was given intravenous infusion of butylphthalide sodium chloride injection for 14d(25mg/ time,twice/day)on the basis of the Non-NBP group,and then continued to take butylphthalide soft capsules orally for 90d(200mg/ time,three times/day).The scores of Stroke-Pro,NIHSS and m RS were recorded in both groups before treatment and at 14,30 and 90 days of treatment.The results were used to evaluate the short-term efficacy and prognosis.Adverse outcomes and adverse reactions during this period were also recorded.The risk factors affecting prognosis of patients with minor ischemic stroke were analyzed by univariate and multivariate regression analysis.Results:1.Comparison of general clinical data between the two groupsForty-eight subjects were eligible for the study and they were randomly divided into two groups(1:1 ratio).Case shedding did not appear in this study.The two groups were compared in gender,age,past history,personal history,NIHSS,m RS and Stroke-PRO scores on admission and related laboratory indicators,and there was no statistical significance(P>0.05),indicating comparability.2.Comprehensive assessments between the two groupsBefore treatment,there were no significant differences in the physiological,psychological and social scores of Stroke-PRO between two groups(P>0.05).At the end of 14-day of threapy,the scores in the physical,psychological and social field of two groups were decreased,the differences were statistically significant(P<0.05),but the opposite result appeared in the comparison between the 2 groups(P>0.05).At 30 d and 90 d of treatment,the scores in the physiological,psychological,social and therapeutic fields of the two groups were decreased,and the differences were statistically significant(P<0.05),while in the physiological field between groups the differences were not statistically significant(P>0.05).And there were significant differences in psychological,social and therapeutic scores(P<0.05).3.Evaluation and comparison of short-term efficacy between the two groupsNo obvious and significant differences in scores of NIHSS and m RS between 2groups before treatment(P>0.05).NIHSS and m RS of patients in the two groups decreased to varying degrees,and patients in the same group were compared to himself,and the change shows significant differences after 14 days of treatment(P<0.05).The scores of NIHSS and m RS in the NBP group were lower than those in the Non-NBP group,and the difference between groups was statistically significant(P<0.05).In addition,after 14 days of treatment,79 cases in Non-NBP group were effective,and the effective rate was 79%.In the NBP group,87 cases were effective,the effective rate was 87%,the difference between groups was statistically significant(P<0.05).4.Prognosis assessment and comparison between the two groupsThe changes of scores of NIHSS and m RS at 30 and 90 days of follow-up between 2 groups were similar with its at 14 days.At 90 days of follow-up,NIHSS scores(0.56±0.88,P<0.05)and m RS scores of the NBP group(0.20±0.32,P<0.01)were significantly lower than NIHSS scores(1.50±0.90,P<0.01)and m RS Scores(0.78±0.60,P<0.01)of the Non-NBP group.NIHSS and m RS scores in the NBP group were decreased by 70.8% and 76.7%,and NIHSS and m RS scores in the NonNBP group were decreased by 47.3% and 9.3%,and the difference between groups was statistical criteria(P<0.05).In addition,at 90 days of follow-up,the recurrence rate of stroke was 2% in the NBP group and 5% in the Non-NBP group,and the difference was meaningful(P<0.05).5.Security assessment and comparison between the two groupsNo serious adverse reactions such as abnormal transaminase,elevated fibrinogen,respiratory tract infection,digestive tract hemorrhage,or intracerebral hemorrhage occurred in the two groups during the study period.6.Analysis of prognostic risk factorsDiabetes mellitus,high homocysteine,high total cholesterol and low density lipoprotein were independent predictors of outcome after treatment for minor ischemic stroke.Conclusions:1.The Stroke-PRO scale has a similar effect to NIHSS and m RS,which can evaluate the degree of clinical neurological impairment of patients with MIS.In addition,it can integrate the evaluation of treatment effects by both doctors and patients,and can evaluate patients’ physical and life functions in various aspects,which is helpful to establish a harmonious relationship between patients and doctors.2.Sequential treatment of butylphthalide is effective for minor ischemic stroke,which can effectively promote the recovery of neurological deficits,reduce the recurrence rate of stroke,and has good safety.Thus,it can be applied in clinical treatment work of minor ischemic stroke.3.Diabetes mellitus,hyperhomocysteinemia,hypercholesterolemia and high density lipoproteinemia may affect the efficacy of butylphthalide sequential therapy for acute minor ischemic stroke. |
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