Objective Gastrointestinal(GI)bleeding in patients who had a stroke is strongly associated with a higher risk of death and loss of independence.However,it is unknown whether GI bleeding increases risk for recurrence o...Objective Gastrointestinal(GI)bleeding in patients who had a stroke is strongly associated with a higher risk of death and loss of independence.However,it is unknown whether GI bleeding increases risk for recurrence of stroke.In this study,we assess the potential relationship between GI bleeding and stroke recurrence in patients within 12 months of an acute ischaemic stroke(AIS),using the China National Stroke Registry(CNSR).Methods This study included 22216 patients who had an ischaemic stroke included in the CNSR from 2007 to 2008.We analysed baseline patient characteristics,GI bleeding and outcomes of patients who had an AIS,specifically stroke recurrence at 3,6 and 12 months.We used multivariable logistic regression to evaluate a possible association between GI bleeding and stroke recurrence.results Of the 12415 patients included in our study,12.3%,15.5%and 17.7%had a stroke recurrence at 3,6 and 12 months,respectively.GI bleeding was an independent stroke recurrence risk factor in patients after ischaemic stroke at 3 months(adjusted OR 1.481,95%CI 1.118 to 1.962),6 months(adjusted OR 1.448,95%CI 1.106 to 1.896)and 12 months(adjusted OR 1.350;95%CI 1.034 to 1.763).Conclusion GI bleeding was associated with the increased risk of stroke recurrence after an AIS.展开更多
Background Tenecteplase(TNK)possesses several pharmacological characteristics superior to conventional alteplase(rt-PA),with well-established safety and efficacy profile in Caucasians.There exists controversy over the...Background Tenecteplase(TNK)possesses several pharmacological characteristics superior to conventional alteplase(rt-PA),with well-established safety and efficacy profile in Caucasians.There exists controversy over the optimal dose of intravenous rt-PA for East Asians with acute ischaemic stroke(AIS).Current study aimed to determine the safety dose range of recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)for patients with AIS in China.Methods This multicentre,prospective,randomised,open-label,blinded end-point,phase II study compared three tiers of 0.1,0.25,0.32 mg/kg rhTNK-tPA(to a maximum of 40 mg)with standard 0.9 mg/kg rt-PA(to a maximum of 90 mg)in patients who were eligible for intravenous thrombolysis.The safety outcome were symptomatic intracranial haemorrhage(sICH)within 36 hours.Results Between May 2018 and February 2020,240 patients were randomly assigned to four group,4 of whom did not receive study treatment.The intention-to-treat analysis included 236 patients.There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group(63.3%,77.2%,66.7%vs 62.7%).The number of sICH was 3 of 60(5.0%)in the 0.1 mg/kg group,none in the 0.25 mg/kg group,2 of 60(3.3%)in the 0.32 mg/kg group and 1(1.7%)of 59 in the rt-PA group.There were no significant between-group differences in severe adverse events.Conclusions Similar to the Caucasians,rhTNK-tPA was well tolerated in Chinese patients with AIS at all doses administered within 3 hours of symptom onset.The dose-efficacy profile of rhTNK-tPA needs to be established with future investigations.展开更多
基金supported by grants from the National Key Research and Development Program from the Ministry of Science and Technology of China(2018YFC1312400)the Ministry of Science and Technology of the People’s Republic of China(2016YFC0901002,2016YFC0901001,2017YFC1310901,2017YFC1307905 and 2018YFC1312903)+3 种基金grants from Beijing Municipal Administration of Hospitals’Mission Plan(SML20150502)grants from National Natural Science Foundation of China(81600999)grants from Beijing Municipal Science&Technology Commission(D171100003017002 and D151100002015003)grants from National Science and Technology Major Project(2017ZX09304018).
文摘Objective Gastrointestinal(GI)bleeding in patients who had a stroke is strongly associated with a higher risk of death and loss of independence.However,it is unknown whether GI bleeding increases risk for recurrence of stroke.In this study,we assess the potential relationship between GI bleeding and stroke recurrence in patients within 12 months of an acute ischaemic stroke(AIS),using the China National Stroke Registry(CNSR).Methods This study included 22216 patients who had an ischaemic stroke included in the CNSR from 2007 to 2008.We analysed baseline patient characteristics,GI bleeding and outcomes of patients who had an AIS,specifically stroke recurrence at 3,6 and 12 months.We used multivariable logistic regression to evaluate a possible association between GI bleeding and stroke recurrence.results Of the 12415 patients included in our study,12.3%,15.5%and 17.7%had a stroke recurrence at 3,6 and 12 months,respectively.GI bleeding was an independent stroke recurrence risk factor in patients after ischaemic stroke at 3 months(adjusted OR 1.481,95%CI 1.118 to 1.962),6 months(adjusted OR 1.448,95%CI 1.106 to 1.896)and 12 months(adjusted OR 1.350;95%CI 1.034 to 1.763).Conclusion GI bleeding was associated with the increased risk of stroke recurrence after an AIS.
基金supported by the National Natural Science Foundation of China(81870905)the National Key R&D Program of China(2017YFC1308204)+2 种基金the National Science and Technology Major Project(2017ZX09304018)the Beijing Municipal Administration of Hospitals Incubating Program(PX2018022)sponsored and funded by Guangzhou Recomgen Biotech Co.,Ltd.
文摘Background Tenecteplase(TNK)possesses several pharmacological characteristics superior to conventional alteplase(rt-PA),with well-established safety and efficacy profile in Caucasians.There exists controversy over the optimal dose of intravenous rt-PA for East Asians with acute ischaemic stroke(AIS).Current study aimed to determine the safety dose range of recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)for patients with AIS in China.Methods This multicentre,prospective,randomised,open-label,blinded end-point,phase II study compared three tiers of 0.1,0.25,0.32 mg/kg rhTNK-tPA(to a maximum of 40 mg)with standard 0.9 mg/kg rt-PA(to a maximum of 90 mg)in patients who were eligible for intravenous thrombolysis.The safety outcome were symptomatic intracranial haemorrhage(sICH)within 36 hours.Results Between May 2018 and February 2020,240 patients were randomly assigned to four group,4 of whom did not receive study treatment.The intention-to-treat analysis included 236 patients.There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group(63.3%,77.2%,66.7%vs 62.7%).The number of sICH was 3 of 60(5.0%)in the 0.1 mg/kg group,none in the 0.25 mg/kg group,2 of 60(3.3%)in the 0.32 mg/kg group and 1(1.7%)of 59 in the rt-PA group.There were no significant between-group differences in severe adverse events.Conclusions Similar to the Caucasians,rhTNK-tPA was well tolerated in Chinese patients with AIS at all doses administered within 3 hours of symptom onset.The dose-efficacy profile of rhTNK-tPA needs to be established with future investigations.