机构：[1]Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[2]Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China[3]Department of Neurology, The Affiliated Hospital of Jiangsu University, Zhenjiang, China[4]Department of Neurology, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China[5]Department of Neurology, Dandong People's Hospital, Dandong, China[6]Department of Neurology, No. 1 Hospital of Harbin, Harbin, China[7]Department of Neurology, Fujian Provincial Hospital, Fuzhou, China[8]Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China[9]Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China神经科系统神经内科首都医科大学宣武医院[10]Department of Neurology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China浙江大学医学院附属第一医院[11]Department of Neurology, Beijing Tongren Hospital, Capital Medical University, Beijing, China首都医科大学附属同仁医院[12]Department of Neurology, Peking University First Hospital, Beijing, China
Aims Human urinary kallidinogenase (HUK) has shown favorable efficacies in acute ischemic stroke (AIS) treatment. We sought confirmation of the safety and efficacy of HUK for AIS in a large population. Methods RESK study enrolled patients with AIS of anterior circulation to receive HUK infusion. The primary endpoint was the incidence of treatment-emergent adverse events (AEs). Secondary endpoints assessed neurological and functional improvements and stroke recurrent rate. Results Of 1206 eligible patients, 1202 patients received at least one dose of HUK infusion and 983 (81.5%) completed the study. The incidence of treatment-emergent AEs and serious AEs were 55.99% and 2.41%, respectively. Pre-specified AEs of special interest occurred in 21.71% of patients, but the majority were mild and unrelated to therapy. Hypertension, age, treatment time, and drug combination were identified to be associated with drug-related blood pressure reduction. Neurological and functional evaluations revealed favorable outcomes from baseline to post-treatment assessment. The cumulative recurrence rate of stroke was 2.50% during the 90-day assessment. Conclusion HUK had an acceptable safety and tolerability profile in AIS patients. Besides, HUK demonstrated the neurological and functional improvements in AIS, further confirming its clinical efficacy in a real-world large population.
基金：
Techpool BioPharma Co. Ltd. (Guangzhou,
China) funded the RESK study and
supplied the study medication (human
urinary kallidinogenase injection).
Funder had no role in in study design,
data collection, data analysis, data
interpretation, or writing
第一作者机构：[1]Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
通讯作者：
通讯机构：[1]Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[*1]Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 1 Shuaifu Garden, Dongcheng District, Beijing 100730, China.
推荐引用方式(GB/T 7714)：
Ni Jun,Yao Ming,Wang Li-Hua,et al.Human urinary kallidinogenase in acute ischemic stroke: A single-arm, multicenter, phase IV study (RESK study)[J].CNS NEUROSCIENCE & THERAPEUTICS.2021,27(12):1493-1503.doi:10.1111/cns.13724.
APA：
Ni, Jun,Yao, Ming,Wang, Li-Hua,Yu, Ming,Li, Run-Hui...&Cui, Li-Ying.(2021).Human urinary kallidinogenase in acute ischemic stroke: A single-arm, multicenter, phase IV study (RESK study).CNS NEUROSCIENCE & THERAPEUTICS,27,(12)
MLA：
Ni, Jun,et al."Human urinary kallidinogenase in acute ischemic stroke: A single-arm, multicenter, phase IV study (RESK study)".CNS NEUROSCIENCE & THERAPEUTICS 27..12(2021):1493-1503
