| Objective:Cerebral watershed infarction is Very easy to progress because of its special etiology and pathogenesis.Due to the limitation of time window,only 1% of patients can receive thrombolysis.Because of its pharmacokinetic characteristics and high platelet reactivity,oral antiplatelet drugs can not act quickly and can not effectively prevent the progress of cerebral watershed infarction.In the Japanese guidelines for the treatment of ischemic stroke,argatroban is recommended for the treatment of acute atherosclerotic stroke.In addition,recent studies have shown that the efficacy of argatroban beyond the thrombolytic time window is definite and does not increase the risk of bleeding.The purpose of this study was to evaluate the efficacy and safety of argatroban in the treatment of cerebral watershed infarction beyond the time window of thrombolysis.Method:This study adopts a prospective observational study.From September 2017 to June 2019,collect the inpatients in neurology department of the Second Affiliated Hospital of Nanchang University.Clinical diagnosis of ischemic stroke(In line with the criteria set out in China's guidelines for the diagnosis and treatment of acute ischemic stroke 2014).First onset,Within 6h-72 h from the time of initial onset,Age from 18 to 80,Gender is not restricted,All patients were examined by MRI sequence(including T1 WI,T2WI,DWI,T2-FLAIR,3D-TOF-MRA),and met the criteria of cerebral watershed infarction.After admission,we prospectively collected the general clinical data and related biochemical indicators of patients,and assessed the degree of neurological deficit with NIHSS score.The treatment strategy of the patient after admission is decided by the attending physician(not involved in any process of this study).Then according to the treatment strategy,the patients who met the inclusion criteria and exclusion criteria were divided into two groups: argatroban group and aspirin plus clopidogrel group.We continued to collect patients' NIHSS scores on the 3rd,7th and 14 th day after treatment,as well as relevant biochemical and imaging indicators.The initial stroke severity was divided into three subgroups according to the baseline NIHSS score: Mild neurological injury group(0-6 score),Moderate neurological injury group(7-15 score),Severe neurological injury group(? 16 score),The difference of NIHSS score and the effect of clinical treatment in the two treatment groups and each subgroups before and after treatment were compared.(a good result is defined as: The NIHSS score at discharge is reduced by ? 4 points compared with that at admission,or the NIHSS score at discharge is equal to 0 or 1;Progress is defined as: NIHSS score at discharge is higher than that at admission).Observe the occurrence of adverse reactions in each group.All data were analyzed by spss22.0 software.Result:1.From September 2017 to June 2019,65 patients were included,Among them,30 cases of Argatroban group,35 cases of aspirin plus clopidogrel group(3 cases uncompleted),32 cases in the actual group,and 62 patients in the total group.Two groups of sex,age,hypertension,diabetes,Heart disease,Stroke,smoking and drinking history,before treatment,blood lipid,Homocysteine,D-2 polymer,Fibrinogen,Hct,the proportion of Ipsilateral intracranial artery stenosis and Infarct types and each subgroups were not statistically significant(p>0.05),and the difference was comparable.2.Compared with before treatment,the NIHSS score of argatroban group decreased significantly on the 3rd day(p=0.032),7th day(p < 0.001)and the 14 th day after treatment(p < 0.001);However,compared with before treatment,there was no significant difference in NIHSS scores on the 3rd day,7th day and 14 th day after treatment in the aspirin plus clopidogrel group.Before treatment,the NIHSS score of argatroban group was significantly higher than that of aspirin plus clopidogrel group(P=0.007).There was no significant difference in NIHSS score between the two groups on the 3rd day,7th day and 14 th day after treatment.A total of 22 cases in the argatroban group achieved good results after treatment,and 10 cases in the aspirin plus clopidogrel group.The probability of achieving good results in the argatroban group was73.3%,which was significantly higher than that in the aspirin plus clopidogrel group 31.3%%(p=0.001).There was 1 case of progression after treatment in the argatroban group and 9 cases in the aspirin plus clopidogrel group.The progression rate of the argatroban group was 3.3%,which was significantly lower than that of the aspirin plus clopidogrel group(28.1%,P= 0.008).3.Mild neurological injury group(0-6 score): Before treatment,there was no significant difference in NIHSS score between argatroban group and aspirin plus clopidogrel group(p > 0.05).After treatment,the NIHSS scores of argatroban group and aspirin plus clopidogrel group were lower than those before treatment,although there was no significant difference between the two groups,on the 14 th day after treatment,the NIHSS score of argatroban group was significantly lower than that before treatment(P=0.001),while the NIHSS score of aspirin plus clopidogrel group had no significant difference compared with that before treatment.And there was no progress in the argatroban group,while there were 3 cases in the aspirin plus clopidogrel group.Moderate neurological injury group(7-15 score): Before treatment,there was no significant difference in NIHSS score between argatroban group and aspirin plus clopidogrel group(p > 0.05).Compared with the aspirin plus clopidogrel group,argatroban group could significantly improve the neurological deficit on the 7th and 14 th day after treatment(P < 0.05),and had better prognosis and lower deterioration.Severe neurological injury group(? 16 score): Before treatment,there was no significant difference in NIHSS score between argatroban group and aspirin plus clopidogrel group(p > 0.05).On the 3rd day,7th day and 14 th day after treatment,the neurological deficit was significantly improved in argatroban group(P < 0.05),and good results were achieved in 5 cases(5/5),while in aspirin plus clopidogrel group were achieved in 0 cases(0/2).4.Security Analysis: During the treatment of aspirin plus clopidogrel group,there was a patient who failed to complete the experiment due to gastrointestinal bleeding,and there was no bleeding in argatroban group,and there was no obvious liver and kidney function damage and other complications in both groups.Conclusion: For patients with subcortical cerebral watershed infarction who have exceeded the thrombolysis time window and complicated with intracranial vascular stenosis,aspirin plus clopidogrel therapy may be safe but has no obvious effect,and has higher progression rate in acute phase.Argatroban can significantly improve the neurological deficit of subcortical cerebral watershed infarction patients with moderate and severe neurological impairment,and reduce the rate of early progression,in addition there are no obvious bleeding,liver and kidney function damage and other complications. |
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