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Efficacy and safety of Y- 2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double- blind placebo- controlled multicentre trial

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Stroke & Vascular Neurology 2024年第1期9卷 90-95页

作者： Yu Fu Renhong Tang Rong Chen anxin wang Jinsheng Ren Shunwei Zhu Xiaofei Feng Dongsheng Fan Deparment of Neurology Peking University Third HospitalBeijingChina State Key Laboratory of Neurology and Oncology Drug Development NanjingJiangsuChina Simcere Pharmaceutical Group Limited NanjingJiangsuChina Neurodawn Pharmaceutical Co. LtdNanjingJiangsuChina Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina

Background and purpose Clinical studies have demonstrated that edaravone dexborneol can improve the functional outcomes in patients with acute ischaemic stroke(AIS).The present clinical trial aimed at testing the efficacy and safety of Y-2 sublingual tablet on 90-day functional outcome in patients with *** and design This is a randomised,double-blind,placebo-controlled,multicentre,parallel-group trial of Y-2 sublingual tablet on patients with *** estimated 914 patients at age of 18–80 years with AIS within 48 hours after symptom onset from 40 hospitals will be randomly assigned to receive Y-2 sublingual tablet or placebo for 14 *** are at score 6–20 points on National Institutes of Health Stroke Scale(NIHSS)and had a modified Rankin Scale(mRS)≤1 before this stroke,except mechanical thrombectomy and neuroprotective agents *** outcomes The primary outcome is the proportion of patients with mRS≤1 on day 90 after *** efficacy outcomes include mRS score on day 90,the proportion of patients with mRS≤2 on day 90;the change of NIHSS score from baseline to day 14 and the proportion of patients with NIHSS score≤1 at the days 14,30 and *** This trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outcomes in patients with *** registration number NCT04950920.

关键词： patients protective centre

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胃癌免疫治疗的临床研究进展

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临床外科杂志 2024年第1期32卷 99-102页

作者：黄涛汪安新付广武汉科技大学附属普仁医院胃肠外科武汉430081

晚期胃癌治疗选择有限,易发生化疗耐药。目前,包括免疫检查点抑制剂、过继细胞疗法、肿瘤疫苗、非特异免疫增强剂及细胞因子疗法在内的免疫疗法对胃癌显示出了良好的疗效。载体药物及3D打印技术也在临床前实验中取得了疗效。临床试验采... 详细信息

晚期胃癌治疗选择有限,易发生化疗耐药。目前,包括免疫检查点抑制剂、过继细胞疗法、肿瘤疫苗、非特异免疫增强剂及细胞因子疗法在内的免疫疗法对胃癌显示出了良好的疗效。载体药物及3D打印技术也在临床前实验中取得了疗效。临床试验采用免疫肿瘤学单一疗法或联合免疫化学疗法来提高胃癌病人的总体生存时间和客观反应率。根据初步证据,我们相信免疫治疗可以积极影响自然病史,改善胃癌病人的预后。

关键词：胃癌免疫治疗免疫检查点抑制剂过继细胞疗法肿瘤疫苗

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Development and validation of a nutrition-related genetic-clinical-radiological nomogram associated with behavioral and psychological symptoms in Alzheimer’s disease

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中华医学杂志(英文版) 2024年第18期137卷 2023 Nov 29页

作者： Jiang Jiwei Liu Yaou wang anxin Zhuo Zhizheng Shi Hanping Zhang Xiaoli Li Wenyi Sun Mengfan Jiang Shirui wang Yanli Zou Xinying Zhang Yuan Jia Ziyan Xu Jun Department of Neurology Beijing Tiantan Hospital Capital Medical University Beijing China National Clinical Research Center for Neurological Diseases Beijing China Department of Radiology Beijing Tiantan Hospital Capital Medical University Beijing China Department of Gastrointestinal Surgery Beijing Shijitan Hospital Capital Medical University Beijing China Department of Clinical Nutrition Beijing Shijitan Hospital Capital Medical University Beijing China Beijing International Science and Technology Cooperation Base for Cancer Metabolism and Nutrition Beijing China

Background: Few evidence is available in the early prediction models of behavioral and psychological symptoms of dementia (BPSD) in Alzheimer’s disease (AD). This study aimed to develop and validate a novel genetic-clinical-radiological nomogram for evaluating BPSD in patients with AD and explore its underlying nutritional ***: This retrospective study included 165 patients with AD from the Chinese Imaging, Biomarkers, and Lifestyle (CIBL) cohort between June 1, 2021, and March 31, 2022. Data on demographics, neuropsychological assessments, single-nucleotide polymorphisms of AD risk genes, and regional brain volumes were collected. A multivariate logistic regression model identified BPSD-associated factors, for subsequently constructing a diagnostic nomogram. This nomogram was internally validated through 1000-bootstrap resampling and externally validated using a time-series split based on the CIBL cohort data between June 1, 2022, and February 1, 2023. Area under receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA) were used to assess the discrimination, calibration, and clinical applicability of the ***: Factors independently associated with BPSD were:CETP rs1800775 (odds ratio [OR] = 4.137, 95% confidence interval [CI]: 1.276-13.415,P = 0.018), decreased Mini Nutritional Assessment score (OR = 0.187, 95% CI: 0.086-0.405,P <0.001), increased caregiver burden inventory score (OR = 8.993, 95% CI: 3.830-21.119,P <0.001), and decreased brain stem volume (OR = 0.006, 95% CI: 0.001-0.191,P = 0.004). These variables were incorporated into the nomogram. The area under the ROC curve was 0.925 (95% CI: 0.884-0.967,P <0.001) in the internal validation and 0.791 (95% CI: 0.686-0.895,P <0.001) in the external validation. The calibration plots showed favorable consistency between the prediction of nomogram and actual observations, and the DCA showed that the model was clinically useful in both validatio

关键词： Alzheimer’s disease Behavioral and psychological symptoms Nutrition Brain stem Cholesterol ester transfer proteins Nomogram

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Night-time diastolic blood pressure variability relates to stroke recurrence in patients who had ischaemic stroke with small artery occlusion

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Stroke & Vascular Neurology 2022年第3期7卷 237-244页

作者： Tingting wang Jie Xu anxin wang Ying Liu Xingquan Zhao Yongjun wang Yilong wang Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina

Background and purpose The association between blood pressure variability(BPV)and stroke recurrence among patients who had ischaemic stroke(IS)remains *** study aimed to investigate the association between BPV and stroke recurrence in patients who had IS of large artery atherosclerosis(LAA)subtype and small artery occlusion(SAO)*** Data from the BOSS(Blood Pressure and Clinical Outcome in Transient Ischemic Attack or Ischemic Stroke)study were *** subtypes were diagnosed according to the Trial of Org 10172 in Acute Stroke Treatment *** was performed by 24-hour ambulatory blood pressure monitoring and defined through SD of blood *** primary outcome was stroke recurrence within 90 days after *** Cox regression model was used to assess the association between BPV and stroke recurrence in patients who had IS of LAA subtype and SAO *** A total of 1390 patients who had IS from the BOSS study were included in the present *** analysis suggests that 24-hour systolic BPV(SBPV)and night-time diastolic BPV(DBPV)were significantly associated with stroke recurrence among all patients who had IS(HR,2.50,95%CI 1.07 to 5.84;HR,1.85,95%CI 1.07 to 3.21,respectively).Night-time SBPV and night-time DBPV were significantly associated with stroke recurrence in patients with SAO subtype(HR,2.77,95%CI 1.07 to 7.15;HR,3.60,95%CI 1.39 to 9.29,respectively).However,in the adjusted model,only night-time DBPV remained significant in patients with SAO subtype(HR,3.87,95%CI 1.40 to 10.71).Similar results were not found in patients who had IS of LAA *** High night-time DBPV was associated with increased risk of stroke recurrence among patients who had IS of SAO *** results of this study have implications for the secondary prevention management and future research of patients who had IS of SAO *** association between BPV and stroke recurrence in patients who had IS of LAA su

关键词： patients diastolic Blood

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Association between cumulative exposure to different lipid parameters and risk of newly developed carotid plaque

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Stroke & Vascular Neurology 2021年第3期6卷 359-365页

作者： Jianwei Wu Yu wang Kaijiang Kang anxin wang Jie Xu Xingquan Zhao Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Center of Stroke Beijing Institute for Brain DisordersBeijingChina Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease BeijingChina Department of Epidemiology and Health Statistics School of Public HealthCapital Medical UniversityBeijingChina Beijing Municipal Key Laboratory of Clinical Epidemiology BeijingChina

Background and purpose Both the magnitude and cumulative exposure of atherogenic lipoproteins have an impact on the atherosclerosis risk,and the exploration focus has shifted from one single lipoprotein assessment to the cumulative exposure of *** aim to investigate the relationship between cumulative exposure to different lipid parameters and the risk of newly developed carotid plaque in this *** In the Asymptomatic Polyvascular Abnormalities Community study,2947 participants were included with follow-up every 2 years from 2006 to *** parameters including total cholesterol(TC),triglycerides(TGs),low-density lipoprotein cholesterol(LDLC),high-density lipoprotein cholesterol(HDLC)and non-HDLC were *** exposure was calculated by adding the weighted sum of the difference between the measured value and the cut-off value of each *** developed carotid plaques were identified by carotid ultrasound performed at the third and fourth *** In the univariate analysis,non-HDLC burden had the highest ORs among the five lipid parameters for newly developed carotid plaque in each quartile,as 1.0(reference),1.35(1.09-1.67),1.68(1.36-2.08)and 2.74(2.22-3.38)from the lowest to the highest *** the multivariate analysis and sensitivity analysis,we obtained similar *** TC burden,TG burden,LDLC burden and non-HDLC burden are all independent risk factors for newly developed carotid plaque,especially for the vulnerable *** lipid parameters,non-HDLC burden is an optimal ***,the predictive value remained significant for participants under the age of 65 years old or free of hypertension,diabetes mellitus and hyperlipidaemia.

关键词： carotid Lipid cholesterol

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In- hospital complications affect short- term and long- term mortality in ICH: a prospective cohort study

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Stroke & Vascular Neurology 2021年第2期6卷 201-206页

作者： Yaqing Zhang Yongjun wang Ruijun Ji anxin wang Yilong wang Zhonghua Yang Liping Liu Penglian wang Xingquan Zhao Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease BeijingChina Center of Stroke Beijing Institute for Brain DisordersBeijingChina

Background Medical complications strongly affected the mortality of patients with ***,only limited research has studied the effect of in-hospital medical complications on the mortality of patients with spontaneous intracerebral haemorrhage(ICH)*** the China National Stroke Registry,the effect was prospectively and systematically investigated in patients with spontaneous ICH during their hospitalisation,at 3,6 and 12 months after disease *** This study collected data on patients over 18 years old with spontaneous ICH from 132 Chinese clinical centres across 32 provinces and four municipalities(Hong Kong included),from September 2007 to August *** on patient complications,death and other information were acquired through paper-based registry *** multivariable logistic regression,the association of medical complications with stroke outcomes was *** Of 3255 patients with spontaneous ICH,878(26.97%)had in-hospital medical ***-hospital medical complications were independent risk factors for death during the hospitalisation(adjusted OR 4.41,95% CI 3.18 to 6.12),at 3 months(adjusted OR 2.18,95% CI 1.70 to 2.80),6 months(adjusted OR 1.84,95% CI 1.45 to 2.34)and 12 months(adjusted OR 1.59,95% CI 1.26 to 2.01)after spontaneous *** The results revealed that the short-term and long-term mortality of patients with spontaneous ICH in China was significantly associated with their in-hospital medical complications.

关键词： complications prospective mortality

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Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase Ⅱ, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial

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Stroke & Vascular Neurology 2019年第3期4卷 109-114页

作者： Jie Xu Yilong wang anxin wang Zhiqiang Gao Xiaoping Gao Huisheng Chen Junshan Zhou Xingquan Zhao Yongjun wang Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Department of Neurology The Second Affiliated Hospital of Nanjing Medical UniversityNanjingChina Department of Neurology The First Affiliated Hospital of Hunan Normal UniversityChangshaChina Department of Neurology General HospitalPLA Shenyang Military RegionShenyangChina Department of Neurology Nanjing First HospitalNanjing Medical UniversityNanjingChina

Background Edaravone Dexborneol is a novel neuroprotective agent that comprised edaravone and(+)-borneol,a food additive with an anti-inflammatory effect in animal ischaemic stroke *** study aims to assess the safety and efficacy of Edaravone Dexborneol compared with edaravone in treating patients with acute ischaemic stroke(AIS).Methods In this multicentre,randomised,double-blind,multiple-dose,active-controlled,phaseⅡclinical trial,patients with AIS within 48 hours after stroke onset were randomly assigned(1:1:1:1)to low-dose(12.5 mg),medium-dose(37.5 mg)or high-dose(62.5 mg)Edaravone Dexborneol groups,and an active control group with edaravone(30 mg)by 30 min intravenous infusion every 12 hours,for 14 consecutive *** primary efficacy outcome was the proportion of modified Rankin Scale(mRS)score≤1 at 90 days and National Institutes of Health Stroke Scale(NIHSS)score change from baseline to 14 days after *** safety outcome included any adverse event during 90 days after *** Of 385 patients included in the efficacy analysis,94 were randomised to low-dose group,97 to medium-dose group,98 to high-dose group and 96 to the control *** significant difference was observed among the four groups on mRS score(mRS≤1,p=0.4054)at 90 days or NIHSS score change at 14 days(p=0.6799).However,a numerically higher percentage of patients with mRSscore≤1 at 90 days in the medium-dose(69.39%)and high-dose(65.63%)groups was observed than in the control group(60.64%).No significant difference in severe adverse events was found among the four groups(p=0.3815).Conclusions Compared with edaravone alone,Edaravone Dexborneol was safe and well tolerated at all doses,although no significant improvement in functional outcomes was observed at 90days.

关键词： patients doses protective

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CO_(2) combining power and outcomes in patients with acute ischaemic stroke or transient ischaemic attack

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Stroke & Vascular Neurology 2021年第2期6卷 252-259页

作者： anxin wang Xue Tian Hongqiu Gu Yingting Zuo Xia Meng Wei Lv Hao Li Yongjun wang China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Epidemiology and Health Statistics School of Public HealthCapital Medical UniversityBeijingChina Beijing Municipal Key Laboratory of Clinical Epidemiology BeijingChina

Background and purpose The clinical significance of carbon dioxide combining power(CO_(2) CP)in ischaemic cerebrovascular disease is not well established,and the role of CO_(2) CP in the prognosis of acute ischaemic stroke(AIS)or transient ischaemic attack(TIA)has not been *** objective of the study was to investigate the associations between CO2CP and clinical outcomes in patients with AIS or *** Data were derived from the China National Stroke Registry *** were classified into five groups by quintiles of CO_(2) CP levels and three groups according to the normal range of CO_(2)CP(23-29 mmol/L).Multivariable Cox and logistic regressions were adopted to explore the associations of CO_(2) CP levels with all-cause death and poor functional outcomes(modified Rankin Scale(mRS)3-6/2-6)at 3 months and 1 *** Among 9531 patients included in the study,the median(IQR)CO_(2) CP was 24.9(23.0-27.0)mmol/*** adjustment for potential confounders,patients in the first CO_(2) CP quintile(21.1-23.3 mmol/L)had higher risk of all-cause death and poor functional outcomes(mRS score of 3-6/2-6)(HR or OR with 95% CI 2.37(1.32 to 4.25),1.49(1.20 to 1.83)and 1.21(1.03 to 1.42),respectively)compared with those in the fourth *** results were found for outcomes at 1 ***,all associations were also significant when CO_(2) CP was<23 mmol/L compared with CO_(2) CP of 23-29 mmol/*** Decreased CO_(2) CP was associated with high risk of all-cause death and poor functional outcomes in patients with AIS or TIA.

关键词： patients ischaemic acute

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Safety and efficacy of oral antiplatelet for patients who had acute ischaemic stroke undergoing endovascular therapy

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Stroke & Vascular Neurology 2021年第2期6卷 230-237页

作者： Xiaochuan Huo Raynald Jing Jing anxin wang Dapeng Mo Feng Gao Ning Ma Yilong wang Yongjun wang Zhongrong Miao Neurointervention center Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Center of Stroke Beijing Institute for Brain DisordersBeijingChina Beijing Tiantan Hospital BeijingChina Neurointervention center Beijing Tiantan HospitalBeijingChina

Background and purpose To investigate the safety and efficacy of oral antiplatelet therapy(APT)for patients who had acute ischaemic stroke(AIS),receiving endovascular therapy(EVT).Methods Patients were divided into non-APT group and APT(single APT or dual APT(DAPT)*** safety and efficacy endpoints at 3-month follow-up were symptomatic intracranial haemorrhage(sICH),recanalisation rate,clinical outcome and *** Among 915 patients who had AIS,those in APT group(n=199)showed shorter puncture-to recanalisation time,lower frequency of intravenous thrombolysis and more use of tirofiban compared with those in non-antiplatelet group(n=716)(p<0.05 for all).Oral APT was found to be associated with superior clinical outcome compared with non-APT(APT(44.2%)versus non-APT(41.1%)),adjusted OR=2.605,95% CI 1.244 to 5.455,p=0.011).DAPT showed superior clinical outcome compared with non-APT(DAPT(56.5%)versus non-APT(41.1%),adjusted OR=5.405,95% CI 1.614 to 18.102,p=0.006)and lower risk of mortality at 3-month follow-up(DAPT(4.8%)versus non-DAPT(17.7%),adjusted OR=0.008,95%CI 0.000 to 0.441,p=0.019).There was no significant difference in sICH between the two *** Oral APT prior to undergoing EVT is safe and may accompany with superior clinical *** may associate with superior clinical outcomes and lower risk of mortality.

关键词： mortality patients acute

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上肢动作研究测试量表评定亚急性期缺血性卒中患者偏瘫侧上肢及手功能的信效度和敏感性研究

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中国卒中杂志 2024年第8期19卷 915-923页

作者：吴娱倩张玉梅臧大维范小伟王安心张晓丽孟霞首都医科大学附属北京天坛医院康复医学科北京100070 国家神经系统疾病临床医学研究中心首都医科大学附属北京天坛医院神经病学中心首都医科大学附属北京天坛医院神经精神与临床心理科

目的探讨上肢动作研究测试(action research arm test,ARAT)量表应用于亚急性期缺血性卒中患者上肢及手功能障碍评定的效度、信度和敏感性。方法本研究招募2020年1月—2022年5月于首都医科大学附属北京天坛医院等17家医院住院的300例缺... 详细信息

目的探讨上肢动作研究测试(action research arm test,ARAT)量表应用于亚急性期缺血性卒中患者上肢及手功能障碍评定的效度、信度和敏感性。方法本研究招募2020年1月—2022年5月于首都医科大学附属北京天坛医院等17家医院住院的300例缺血性卒中患者,并由两名评定者分别对受试者进行ARAT量表评估。同时以Fugl-Meyer运动功能评定量表上肢部分(Fugl-Meyer assessment-upper extremity,FMA-UE)作为效标。分别采用Spearman相关分析及验证性因子分析评价ARAT量表的效标效度及结构效度;采用Cronbach’sα系数及组内相关系数评价ARAT量表的内部信度、敏感性及外部信度。结果以FMA-UE为效标,ARAT量表总分与其总分呈正相关(r=0.946,P<0.001)。结构效度检验中,验证性因子分析结果表明:因子间相关系数范围为0.79~0.92,模型整体拟合指标为χ^(2)/df=7.011,P=0.001,比较拟合指数=0.906,增值拟合指数=0.907,规范拟合指数=0.895,近似误差均方根=0.055。各因子的组合信度值在0.964~0.983,各因子的平均变异抽取量在0.940~0.952。内部一致性检验中,评分等级的Cronbach’sα系数为0.987,敏感性分析中,Cronbach’sα系数在0.986~0.987。外部一致性检验中,两名评定者间的组内相关系数最高为0.999,95%CI集中于0.961~0.999。结论ARAT量表具有良好的效标效度、结构效度、信度和敏感性,适用于亚急性期缺血性卒中患者偏瘫侧上肢及手功能的评估。

关键词：缺血性卒中上肢功能手功能效标效度结构效度信度敏感性上肢动作研究测试量表

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