An Observational Study On Comparison Of Efficacy And Safety Between Intravenous Thrombolysis With Alteplase And Urokinase In Chinese Acute Ischemic Stroke People

OBJECTIVE:The safety and efficacy of recombinant tissue plasminogen activator(rt-PA)for intravenous thrombolysis in acute ischemic stroke within 4.5 hours has been widely recognized and has been consistently recommended by domestic and foreign guidelines.In 2001,cooperating group for national 95's project"intravenous thrombolysis with urokinase for acute cerebral infarction"confirmed that,UK is effective and relatively safe in treatment of acute cerebral infarction within 6 hours from the onset."China Guideline for Diagnosis and Treatment Acute Ischemic Stroke2014"recommended that UK can be used to treat acute ischemic stroke within 6h of onset,but at the same time it is recommended that acute ischemic stroke within 4.5hours of onset preferentially select rt-PA.Therefore,in China,the first choice is rt-PA in patients with acute ischemic stroke within 4.5h of onset,Patients with acute ischemic stroke within 4.5-6 h are more likely to choose UK.The purpose of this study was to observate and evaluat if there is any difference in the efficacy and safety of two thrombolytic drugs in Chinese acute ischemic stroke people.METHODS:A total of 846 patients with acute ischemic stroke who received intravenous thrombolytic therapy at the General Hospital of the Shenyang Military Region from July 2012 to July 2016 were continuously collected and screened by the entry and exit criteria.Eventually 809 patients were included in the study.The patients were divided into two groups according to the thrombolytic drugs.604 patients in the rt-PA group and 205patients in the UK group.Neurological deficits were assessed by the National Institutes of Health Stroke Scale(NIHSS),The short-term neurological improvement was defined as the reduction of NIHSS score?40%when hospitalized for14 days or discharged from hospital.The modified Rankin scale score(mRS)at 90 days was used as an index to evaluate the prognosis of neurological function.The mRS score0-1 was defined as a good prognosis,mRS score of 6 indicates death.The intracranial hemorrhage and gastrointestinal bleeding occurred within 7 days after thrombolysis were indicators of safety.variables were analyzed with x~2 test and t test,P<0.05indicates a statistically significant difference.RESULTS:1.Therapeutic effect evaluation(1)Primary end event:The prognosis of neurological function was good at 90 days after thrombolysis:275cases(45.5%)in rt-PA group and 88 cases(42.9%)in UK group(P=0.488).(2)90-day mortality after thrombolysis:59 cases(9.8%)in rt-PA group and 25 cases(12.2%)in UK group(P=0.202).(3)Short-term neurological function Improvement:308 patients(51.0%)in rt-PA group and 102patients(49.8%)in UK group(P=0.808).(4)In-hospital mortality:27 patients(4.5%)in rt-PA group and 12 patients(5.9%)in UK group(P=0.451).There was no significant difference in good prognosis at 90 days,90-day mortality;short-term neurological function,in-hospital mortality between the two groups.2.Safety evaluation(1)Intracranial hemorrhage within 7 days after thrombolysis:73 patients(12.1%)in rt-PA group and 24 patients(11.7%)in UK group(P=0.902).Symptomatic intracranial hemorrhage:13 patients(2.2%)in rt-PA group,5 patients(2.4%)in UK group(P=1.000).(2)Gastrointestinal bleeding within 7 days after thrombolysis:48 patients(7.9%)in rt-PA group and 18 patients(8.8%)in UK group(P=0.768).The incidence of intracranial hemorrhage and gastrointestinal bleeding was not statistically different between the two groups.CONCLUSIONS:Single-center experience suggests that in patients with acute ischemic stroke in China,intravenous thrombolysis with urokinase within 4.5-6 hours from the onset is effective and relatively safe.