| Background: Cerebrovascular disease is a serious disease affecting human health,among which the most common type is ischemic stroke,accounting for about 70% of cerebrovascular diseases.Acute ischemic stroke is characterized by high morbidity,mortality,disability and recurrence rates,which bring heavy burden to society and families.Its treatment is divided into two aspects: vascular recanalization and neuroprotection.4.5 hours to accept the onset of restructuring the original organization fibrinolytic enzyme activators(r-t PA)intravenous thrombolysis treatment,is considered to be the recanalization of acute ischemic stroke is the most effective drug treatment,and only be clear guidelines recommended method at home and abroad,but currently intravenous thrombolysis rate of only 30%,and also face the narrow time window limit.And risk of bleeding and reperfusion injury.Edaravone dexborneol is a new national Class I innovative drug,which was newly listed in July 2020.It is a new neuroprotective drug with 4:1 compatibility of edaravone and dexborneol as two active ingredients.Animal experiments and subsequent clinical trials showed that edaravone dexborneol has significant neuroprotective effect,effectively promoting the recovery of patients with cerebral infarction and improving the prognosis of patients with cerebral infarction.However,the short-term efficacy and long-term prognosis of edaravone dexborneol after intravenous thrombolysis in patients with acute ischemic stroke have not been studied in detail.Objective: To evaluate the overall clinical efficacy and safety of intravenous thrombolysis combined with edaravone dexborneol in the treatment of acute ischemic stroke,and to provide theoretical basis for finding new and more effective treatment schemes for patients with acute ischemic stroke after thrombolysis.Methods: In this study,a prospective,open and randomized controlled design was adopted,and 100 patients with acute ischemic stroke who were hospitalized in the Department of Neurology,the First Affiliated Hospital of Shaoxing University of Arts and Sciences from January 2021 to December 2021 and met the admission criteria were randomly divided into two groups: edaravone after thrombolysis and edaravone dexborneol after thrombolysis.Collect the clinical and laboratory data of patients,including gender,age,complications,NIHSS score,m RS score,blood routine,liver and kidney function,adverse reactions,etc.The changes of NIHSS score,m RS score,effective rate and significant rate before and after treatment were calculated to evaluate the curative effect,and the adverse events such as bleeding transformation and liver and kidney function were observed to evaluate the safety of the two groups.Results:1.Comparison of general baseline data between two groups of patientsA total of 100 subjects were included in this study,all of which completed the whole test process,and there were no shedding cases.All patients were randomly divided into two groups,50 cases in each group,of which 28 cases were male and 22 cases were female in the control group.There were 27 males and 23 females in the group of dalavone dexborneol.The control group was 40-77 years old,with an average of(63.30±8.92)years old.The age of the dalavone dexborneol group was 25-78 years old,with an average of(61.64±11.89)years old.There was no significant difference in gender,age,personal history,past history,NIHSS score and m RS score between the two groups(P>0.05,comparable).2.Comparison of neurological function between the two groups2.1 In terms of National Institutes of Health Stroke Scale(NIHSS),there was no significant difference between the pre-treatment control group(6.20±4.34)and the edaravone group(6.70±5.16)(P>0.05).In-group comparison,compared with before treatment,the NIHSS scores of patients in the control group decreased after 7 days(4.22±3.79),14 days(3.68±3.77)and 90 days(2.88±3.72),showing a downward trend,and the difference was statistically significant(P < 0.05).The NIHSS scores of the patients in the group of Dalafenone and Dextromethol decreased after 7 days(2.36±3.37),14 days(3.20±3.19)and 90 days(1.06±2.81),showing a downward trend,and the difference was statistically significant(P<0.05).Comparison between the two groups showed that the NIHSS scores of edaravone dexborneol group were lower than those of the control group on 7th,14 th and 90 th days after treatment,and the difference between the two groups was statistically significant(P<0.05).2.2 In terms of modified Rankin scale score(mRS),there was no significant difference between the control group before treatment(3.78±1.36)and edaravone dexborneol group(3.38±1.09)(P>0.05).In-group comparison,it was found that compared with before treatment,the m RS scores of patients in control group decreased after 7 days(2.80±1.63),14 days(2.50±1.67)and 90 days(1.96±1.31),showing a downward trend,and the difference was statistically significant(P < 0.05).The m RS scores of the patients in the group of delavone dexborneol decreased after 7 days(2.00±1.21),14 days(1.60±1.21)and 90 days(0.90±0.96),and the difference was statistically significant(P<0.05).The comparison between the two groups showed that the m RS scores of edaravone dexborneol group were lower than those of the control group on 7th,14 th and 90 th days after treatment,and the difference between the two groups was statistically significant(P<0.05).2.3 The total effective rate of improving neurological function Compared with before treatment,90 days after treatment,both the control group and edaravone dexborneol group can effectively improve the clinical manifestations and promote the recovery of neurological function.In the control group,3 cases were cured(6.0%),31 cases were markedly effective(32.0%),10 cases were improved(20.0%),0 cases were ineffective(0.0%)and 1 case was deteriorated(2.0%).32 cases(64.0%)were cured,15 cases(30.0%)were markedly improved,2 cases(4.0%)were ineffective,1 case(2.0%)was deteriorated,and 0 case(0.0%)was deteriorated.The total effective rates of the control group and the edaravone dexborneol group were 98.0%,and there was no significant difference between the two groups(P>0.05).3.Safety evaluation of two groups of patients During the whole study,one patient in the control group got worse,which led to prolonged hospital stay.No serious adverse reactions related to therapeutic drugs were found in other patients,such as hemorrhage conversion,gastrointestinal bleeding,anaphylactic shock,respiratory failure,cardiac insufficiency and other adverse reactions.In terms of blood examination,one patient in the control group developed hepatic insufficiency(2%)after treatment,which improved after symptomatic treatment such as liver protection,while the other patients did not find hepatic and renal insufficiency,thrombocytopenia and high-sensitivity C-reactive protein.Conclusion: 1.Edaravone dexborneol injection combined with intravenous thrombolytic therapy can significantly improve the clinical symptoms of patients with acute ischemic stroke,reduce the neurological deficit score,reduce the short-term disability rate and improve the prognosis.2.Edaravone dexborneol injection has low incidence of adverse reactions,mild severity and good safety in clinical application. |
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