| Background:Stroke is internationally recognized as the second most common cause of death and the third most common cause of disability.Among all stroke types,ischemic stroke occupies the first place,causing death and residual disability in approximately 3.4 million patients worldwide.The early treatment of ischemic stroke is related to the neurological prognosis of the patient,and the most effective treatment is early recombinant tissue plasminogen activator(r-tPA)intravenous thrombolysis and mechanical thrombectomy(MT).).Mechanical thrombectomy can achieve revascularization,but its use in primary care is limited by the need for expensive equipment and specialized technicians,so the use of pharmacological intravenous thrombolysis is relatively widespread.Early Neurological Deterioration(END)occurs in approximately 10 %of patients with ischemic stroke within 24 h after intravenous thrombolysis,and is often indicative of poor neurological prognosis.The current clinical guidelines do not recommend the use of augatroban for noncardiac embolism.However,current clinical guidelines do not recommend the use of antithrombotic drugs within 24 hours of thrombolysis,making the management of such patients a current challenge,and further exploration of treatment options for neurological deterioration within 24 hours of intravenous thrombolysis in patients with acute ischemic stroke is needed.Objective:To investigate the efficacy and safety of applying argatroban for the treatment of neurological deterioration occurring within 24 hours after r-tPA intravenous thrombolysis in patients with acute cerebral infarction,and to analyze the efficacy of applying argatroban for different etiologies,different severity of disease and different infarct sites.Methods:Patients with acute cerebral infarction attending the stroke unit of Nanshi Hospital of Henan University from October 2020 to August 2022 were collected retrospectively.All patients received standard-dose intravenous thrombolytic therapy with alteplase and were closely observed by a neurologist for at least 24 hours.Patients who met the inclusion and exclusion criteria were divided into a trial group(augatroban combined with conventional treatment)and a control group(conventional treatment only)according to the treatment regimen they received after admission to the hospital,after computer tomography(CT)scan of the head was repeated to exclude bleeding.Patients in the trial group were subgrouped into light,medium,and heavy stroke groups according to the National Institute of Health stroke scale(NIHSS)at the time of admission,and after excluding cardiogenic embolism and cerebral infarction of unknown etiology,the patients were classified into large-artery After excluding cardiogenic embolism and cerebral infarction of unknown cause,patients were divided into large-artery atherosclerosis(LAA)and small-artery occlusion(SAO)groups according to the etiology.Posterior circulation stroke(PCS)group.The general clinical data,NIHSS score,90-d Modified Rankin Scale(m RS)and adverse events were collected from each group at each time point(at admission,at the end of thrombolysis,at END,at 24 h,7 d and 14 d of admission),and END was defined as the worsening of neurological deficits within 24 h after intravenous thrombolysis treatment.END was defined as a worsening of neurological deficits that occurred within 24 h after intravenous thrombolysis and was accompanied by a corresponding increase of ≥2 points in NIHSS score.The recent efficacy,long-term prognosis,total clinical efficiency and incidence of adverse events of different subgroups were analyzed to evaluate the efficacy and safety of argatroban in patients with END after intravenous thrombolysis.Results:1.194 patients were included,including 108 cases in the trial group and 86 cases in the control group.The differences in gender,age,history of hypertension,diabetes,coronary artery disease,cerebral infarction,atrial fibrillation,alcohol and smoking,pre-treatment LDL and homocysteine were not statistically significant(p>0.05)and comparable between the two groups.2.Overall comparison between the two treatment groups:(1)Recent prognosis: the differences between NIHSS scores of the test group and the control group at admission and before treatment were not statistically significant(both p>0.05),and after treatment: 7d and 14 d after admission(both p<0.05),the NIHSS scores of the test group were lower than those of the control group,and the differences were statistically significant.The test group △NIHSS score 4(3,5.5)was significantly higher than the control group 2(1,3),and the improvement of NIHSS score and m RS score in the test group before and after treatment was better than that in the control group(P < 0.05).(2)Long-term prognosis: 80 patients(66.7 %)in the test group had a good long-term neurological prognosis,which was significantly better than 51patients(60.5 %)in the control group,with no statistically significant difference(P > 0.05).(3)Comparison of treatment effect: the total effective rate of the test group was 89.8%,and the total effective rate of the control group was 80.2%,and the effective rate of the test group was significantly better than that of the control group(p<0.05).3.Subgroup analysis:(1)According to the baseline NIHSS score,the patients were divided into three subgroups of mild,moderate and severe stroke according to the initial stroke severity.The difference in NIHSS scores between the three groups was not statistically significant(p>0.05).The difference in efficacy between groups was statistically significant(P < 0.05): light stroke group: △NIHSS score 4(3,5)before and after treatment,total effective rate of treatment was 88.9%;medium stroke group: △NIHSS score 4.5(3,6)before and after treatment,total effective rate of treatment was 91.2%;heavy stroke group: △NIHSS score 4.5(3,7)before and after treatment,total effective rate of treatment was 85.0%.The total effective rate was 85.0%.Further two-by-two comparison showed that the differences between the heavy and medium groups were statistically significant,and the clinical treatment efficiency of light and medium stroke was better than that of heavy stroke according to the specific distribution.(P < 0.05).There was no statistically significant difference in the 90-d long-term prognosis of the three groups.(2)There was no statistically significant difference in the baseline data between the two groups(P > 0.05)when noncardiogenic stroke was divided into two subgroups,LAA and SAO,according to TOAST typing.After treatment,the NIHSS scores of both groups decreased compared with those before treatment,and the comparison between groups showed that the differences of △NIHSS scores and △m RS scores were statistically significant(P < 0.05),and according to the specific median size,it was higher in the LAA group than in the SAO group.However,there was no statistically significant difference in the comparison of total treatment efficiency between the two groups of patients(P > 0.05).(3)According to the infarct site shown by cranial MRA,the patients in the ACS group and PCS group were divided into ACS group and PCS group.14-d △NIHSS score and △m RS score of patients in the ACS group and PCS group were significantly improved compared with those before treatment,but the difference was not statistically significant(P > 0.05),and there was no statistically significant difference in the comparison of total treatment efficiency between patients in the two groups(P>0.05).4.Safety analysis: There was no statistically significant difference in the incidence of adverse drug events between the test group and the control group(P>0.05),and there was no statistically significant difference in the incidence of adverse drug events between different subgroups(P>0.05).Conclusion:1.For AIS patients with early neurological deterioration after r-tPA intravenous thrombolysis,timely initiation of argatroban treatment can prevent further neurological deterioration and significantly improve the prognosis of patients without increasing the risk of adverse events.2.Argatroban treatment in patients with END after intravenous thrombolysis of acute cerebral infarction of LAA type and SAO type can improve the symptoms of neurological deficits,and the efficacy may be better in LAA patients than in SAO patients.3.Both PCS and ACS patients with END after intravenous thrombolysis of acute cerebral infarction could improve the symptoms of neurological deficits when treated with argatroban,and the application of this drug in PCS patients is reasonable. |
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