Effectiveness of intravenous r- tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study  

作　　者：Xinhong Wang Xiaoqiu Li Yuming Xu Runhui Li Qingcheng Yang Yong Zhao Fengyun Wang Baoying Sheng Runqing Wang Shaoyuan Chen Lihua Wang Liying Shen Xiaowen Hou Yu Cui Duolao Wang Bin Peng Craig S Anderson Huisheng Chen On behalf of INTRECIS Investigators 

机构地区：[1]Neurology,General Hospital of Northern Theatre Command,Shenyang,Liaoning,China [2]Neurology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou,China [3]Neurology,Central Hospital Affiliated to Shenyang Medical College,Shenyang,China [4]Neurology,The People’s Hospital of Anyang City,Anyang,China [5]Neurology,Haicheng Hospital of Traditional Chinese Medicine,Haicheng,China [6]Neurology,Liaocheng People's Hospital,Liaocheng,Shandong,China [7]Neurology,The First Affiliated Hospital of Jiamusi University,Jiamusi,China [8]Neurology,Zhengzhou Central Hospital,Zhengzhou,China [9]Neurology,The 32183 Military Hospital of PLA,Baicheng,China [10]Neurology,The Second Affiliated Hospital of Harbin Medical University,Harbin,China [11]Neurology,Tieling County Central Hospital,Tieling,China [12]Clinical Sciences,Liverpool School of Tropical Medicine,Liverpool,UK [13]Neurology,Peking Union Medical College Hospital,Beijing,China [14]The George Institute for Global Health,Sydney,New South Wales,Australia [15]不详

出　　处：《Stroke & Vascular Neurology》2021年第4期603-609,I0060-I0066,共14页卒中与血管神经病学（英文）

基　　金：This study was funded by National Key R&D Program of China(2017YFC1308200);Stroke Prevention and Treatment Project of the National Health Commission-Research and Popularization of Appropriate Intervention Technology for the Stroke High Risk Group in China(GN-2016R0008).

摘　　要：Background Intravenous recombinant tissue plasminogen activator(r-tPA)and urokinase(UK)are both recommended for the treatment of acute ischaemic stroke(AIS)in China,but with few comparative outcome data being available.We aimed to compare the outcomes of these two thrombolytic agents for the treatment of patients within 4.5 hours of onset of AIS in routine clinical practice in China.Methods A pre-planned,prospective,nationwide,multicentre,real-world registry of consecutive patients with AIS(age≥18 years)who received r-tPA or UK within 4.5 hours of symptom onset according to local decision-making and guideline recommendations during 2017-2019.The primary effectiveness outcome was the proportion of patients with an excellent functional outcome(defined by modified Rankin scale scores 0 to 1)at 90 days.The key safety endpoint was symptomatic intracranial haemorrhage according to standard definitions.Multivariable logistic regression was used for comparative analysis,with adjustment according to propensity scores to ensure balance in baseline characteristics.Results Overall,4130 patients with AIS were registered but 320 had incomplete or missing data,leaving 3810 with available data for analysis of whom 2666 received r-tPA(median dose 0.88(IQR 0.78-0.90)mg/kg)and 1144 received UK(1.71(1.43-2.00)×104 international unit per kilogram).There were several significant intergroup differences in patient characteristics:r-tPA patients were more educated,had less history of stroke,lower systolic blood pressure,greater neurological impairment and shorter treatment times from symptom onset than UK patients.However,in adjusted analysis,the frequency of excellent outcome(OR 1.18,95%CI 1.00 to 1.40,p=0.052)and symptomatic intracranial haemorrhage(OR 0.70,95%CI 0.33 to 1.47,p=0.344)were similar between groups.Conclusions UK may be as effective and carry a similar safety profile as r-tPA in treating mild to moderate AIS within guidelines in China.Registration http://www.clinicaltrials.gov.unique identifier:NCT02854592.

关 键 词：PROSPECTIVE ROUTINE NATIONWIDE 

分 类 号：R743[医药卫生—神经病学与精神病学]