| Background:In recent years,the incidence of stroke has increased year by year.China is already the country with the heaviest stroke burden and the youngest stroke incidence in the world.Stroke has become the leading cause of death for residents in China.Acute ischemic stroke is the most common type of stroke,accounting for about 70%,while mild stroke accounts for about 46.4% of the ischemic stroke population.Mild stroke,also called minor stroke,are traditionally considered to have mild clinical symptoms and are "non-disabling",so mild stroke are often easily overlooked by the public.However,studies have shown that patients with mild stroke are precisely the high-risk group of recurrent stroke,and recurrence of stroke often indicates a poor prognosis and even residual disability.Therefore,while actively promoting the prevention of stroke,we will give early and effective treatment to patients with mild stroke.This will improve the clinical symptoms of such patients,reduce the disability rate,improve the prognosis,and return them to social life as soon as possible.It is also of great significance to reduce the burden on individuals,families and society.The CHANCE study in China is a multi-center,randomized,double-blind,parallel-controlled study.Patients with acute noncardiogenic mild ischemic stroke within 24 hours of onset time were assigned to dual antiplatelet treatment(Clopidogrel combined with Aspirin)group and single antiplatelet treatment(Aspirin)group.The study results show that Clopidogrel combined with Aspirin treatment can significantly reduce the risk of stroke recurrence without increasing the risk of bleeding in patients,which provides strong evidence for the use of DAPT in mild stroke.Previous studies have shown that the establishment of collateral circulation is a very important factor to effectively improve clinical symptoms and prognosis of patients.Butylphthalide,as a new class I chemical drug developed in China,can improve the collateral circulation by remodeling cerebral blood flow microcirculation,increasing cerebral perfusion in ischemic areas,and promoting angiogenesis.This study prospectively included patients with acute noncardiogenic mild ischemic stroke within 24 hours of onset time.We explored whether the treatment that DAPT combined with Butylphthalide and Sodium Chloride Injection has better clinical efficacy and safety,for a view to providing more references for the treatment of mild ischemic stroke.Objective:To investigate the clinical efficacy and safety of Butylphthalide and Sodium Chloride Injection combined with dual antiplatelet therapy in treating noncardiogenic mild ischemic stroke within 24 hours of onset time.Methods:This study was a prospective randomized controlled design.Patients with acute ischemic stroke(First onset,onset time<24 hours,NIHSS?5 points)admitted to the Department of Neurology from December 2018 to December 2019 were selected as the research objects.All patients met the diagnostic criteria of the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018,and improved head MRA or head and neck CTA,neck vascular ultrasound,cardiac ultrasound,etc.Auxiliary examinations are used to identify the cause and exclude cardiogenic patients based on TOAST etiology classification.Eighty cases were to be collected and randomly divided into control group and treatment group,with 40 cases in each group.The control group was treated with Clopidogrel(300 mg for the first time,followed by 75 mg/d)and Aspirin(100 mg/d)for 21 days,and then Clopidogrel(75 mg/d)was used for 90 days alone;the treatment group was treated with Butylphthalide and Sodium Chloride Injection for 14 days(25 mg/time,2 times/day)on the basis of the control group.The National Institutes of Health Stroke Scale Score(NIHSS score)and Barthel Index(BI)were counted before and after 14 days of treatment in the two groups to evaluate the short-term efficacy.All patients were followed up to 90 days,and adverse reactions occurred during the period were recorded in detail to evaluate safety.The modified Rankin scale score(m RS score)of 90 days were recorded to assess prognosis.Rseults:1.Comparison of general clinical data between two groups of patientsA total of 80 study subjects were included and randomly divided into two groups,each with 40 cases.No cases fell off during the entire study.There was no significant difference in gender,age,past history,personal history,admission NIHSS score,and admission BI index between the two groups of patients(P>0.05).2.Evaluation and comparison of short-term efficacy between the two groupsThere was no significant difference in the NIHSS score and the BI between the two groups before treatment(P>0.05).After 14 days of treatment,the NIHSS score of the two groups decreased,and the BI increased.The difference between the same group before and after treatment was statistically significant(P <0.05);and the treatment group had a lower NIHSS score and a higher BI than the control group.The difference was statistically significant(P<0.05);32 patients in the control group were effective,and 39 patients in the treatment group were effective.The difference between the two groups was statistically significant(P<0.05).3.Evaluation and comparison of prognosis between the two groupsNineteen patients in the control group had a good prognosis at 90 days(m RS score 0-1),and 29 patients in the treatment group had a good prognosis.The difference between the two groups was statistically significant(P<0.05).4.Safety assessment and comparison between the two groupsThere were no serious adverse events such as gastrointestinal bleeding and intracranial hemorrhage in both groups.There was 1 case of nausea in the control group and 1 case of mild dizziness in the treatment group.There was no significant difference between the two groups(P>0.05).Conclusion:For patients with noncardiogenic mild ischemic stroke within 24 hours of onset time,Butylphthalide and Sodium Chloride Injection combined with dual antiplatelet therapy can improve short-term clinical efficacy,improve prognosis,and have good safety. |
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