| Background: Stroke is the third most common cause of death worldwide after acute coronary syndromes and cancer.In recent years,stroke has become the first cause of death in China,accounting for nearly one third of all stroke deaths worldwide.According to the2017 Ness China Stroke Epidemiological Survey,the incidence of stroke in China is 345.1per 100,000 people,the mortality rate is 159.2 per 100,000 people,and the prevalence rate is 1596.0 per 100,000 people.There are 11 million stroke patients in China,about 2.4million new stroke patients occur every year,and about 1.1 million patients die from stroke every year.Stroke is the main cause of death in China,which seriously endangers the life and health of Chinese people.According to the latest Global Burden of Disease(GBD)study,the lifetime overall risk of stroke in China is 39.9%,the highest in the world.In addition,stroke is also the number one cause of life loss due to all diseases in China.Cerebrovascular diseases accounted for more than one-fifth of China’s total mortality in 2018,according to the 2019 China Health Statistics Summary.Currently combination antiplatelet aggregation is widely applied in clinical drug treatment of ischemic cerebral stroke,especially in combination with antiplatelet aggregation in the treatment of acute ischemic pawn recommend both at home and abroad,but for the medium within 48 h of stroke onset(4 points or less NIHSS score 15 points or less)in patients with ischemic stroke gathered dual antiplatelet therapy has yet to agree,it is necessary for this part of the safety and efficacy of antiplatelet therapy in patients with further study.Objective: To investigate the efficacy and safety of aspirin(ASA)combined with clopidogrel sulfate(Clo)in the treatment of acute non-cardiac cerebral infarction(4 ≤NIHSS score ≤15)within 48 hours of onset.Methods: This study was a randomized,controlled clinical trial.Ninety patients with acute ischemic stroke who were hospitalized in Department of Neurology,Affiliated Hospital of Yan ’an University from October 2019 to December 2020 were collected,including a total of 85 patients.They were randomly divided into two groups,including 43 patients in the experimental group(clopidogrel + aspirin group)and 42 patients in the control group(aspirin group).Experimental group: on day 1,aspirin enteric-coated tablet 100 mg plus clopidogrel hydrogen sulfate tablet 300mg;on days 2-14,aspirin enteric-coated tablet100 mg once a day,clopidogrel hydrogen sulfate tablet 75 mg once a day;on days 15-90,aspirin enteric-coated tablet 100mg/d once a day.Control group: Aspirin enteric-coated tablet 100 mg once a day for 90 days.Patients enrolled in the study were assessed with NIHSS score and improved m RS score before and on the 7th,14 th and 90 th day of treatment.End-point events and adverse reactions were observed within 90 days.On the14 th and 90 th day of treatment,CT examination of the brain was performed to determine whether asymptomatic intracranial hemorrhage occurred.NIHSS,m RS score,end events within 90 days: recurrent stroke,myocardial infarction,acute coronary syndrome and allcause death,and adverse reactions: stroke progression,stomach discomfort,nasal mucosa bleeding,subcutaneous bleeding,gingival bleeding,etc.were compared between the two groups.Results: There were no significant differences in age,sex,smoking,previous hypertension,diabetes mellitus,coronary heart disease and hyperlipidemia between the experimental group and the control group(P > 0.05).Before treatment: NIHSS score and m RS score of the experimental group were(7.19±2.36)and(3.30±0.83),while that of the control group was(7.86±2.49)and m RS score of the control group was(3.52±0.80).There was no statistically significant difference between the two groups before treatment(P=0.206 and P=0.55).NIHSS score(4.79±1.90 vs 6.69±2.33,P=0.000)and improved m RS score(2.76±1.04 vs 2.97±1.02,P=0.355)in both groups at day 7 of treatment;NIHSS score on day 14(2.74±1.54 vs 5.71±1.86,P=0.000),modified m RS score(1.81±0.82 vs2.31±1.02,P=0.016);NIHSS score(1.23±1.00 vs 2.10±1.53,P=0.003)and modified m RS score(1.02±0.86 vs 1.45±1.02,P=0.039)on day 90.On the 7th,14 th and 90 th day of treatment,the NIHSS of the experimental group was significantly lower than that of the control group(P < 0.05),with statistical significance.There was no significant difference in m RS between the two groups after 7 days of treatment(P > 0.05).The comparison of m RS between the two groups on the 14 th and 90 th day of treatment showed that the experimental group was significantly lower than the control group(P < 0.05),with statistical significance.After 90 days of treatment,there were 41(95.3%)patients in the experimental group and 34(81.0%)patients in the control group.The good prognosis rate in the experimental group was significantly higher than that in the control group(P=0.039),and the difference was statistically significant.Comparison of adverse reactions between the two groups: 1(2.33%)case of progressive stroke,2 cases of stomach discomfort,4cases of subcutaneous bleeding,1 case of gingival bleeding,and 1 case of nosebleed in the experimental group;In the control group,there were 6(14.28%)cases of progressive stroke,4 cases of stomach discomfort,3 cases of subcutaneous bleeding,3 cases of gingival bleeding,and 0 cases of nosebleed.The incidence of stroke progression in the experimental group was significantly lower than that in the control group,the difference was statistically significant(P < 0.05).There was no significant difference in stomach discomfort,subcutaneous bleeding,gingival bleeding and nasal bleeding between the two groups.Comparison of end events: Within 90 days,there were 1(2.33%)cases of ischemic stroke in the experimental group and 4(9.52%)cases in the control group,with no statistical significance(P > 0.05).The experimental group had 1 hemorrhagic stroke,1acute coronary syndrome,and 0 all-cause death.In the control group,there were 0 cases of hemorrhagic stroke,2 cases of acute coronary syndrome and 1 case of all-cause death,and there was no statistical significance(P > 0.05).Conclusion:1.Dual antiplatelet therapy significantly improved neurological deficits within 90 days and reduced the risk of stroke progression compared with aspirin alone.2.Dual antiplatelet therapy does not increase the risk of bleeding compared with aspirin alone. |
PDF Full Text Request