Journal of Investigative Medicine最新文献

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Stenting for symptomatic intracranial arterial stenosis with different qualifying arteries: a preplanned pooled individual patient data analysis. 针对不同合格动脉的无症状颅内动脉狭窄进行支架植入术:一项预先计划的个体患者数据汇集分析。
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-26 DOI: 10.1136/svn-2024-003532
Tianhua Li, Jichang Luo, Xuesong Bai, Eyad Almallouhi, Peng Gao, Delin Liu, Ran Xu, Wenlong Xu, Guangdong Lu, Haozhi Gong, Xiao Zhang, Taoyuan Lu, Jie Wang, Renjie Yang, Zixuan Xing, Guangjie Liu, Yufu Dai, Colin P Derdeyn, Liqun Jiao, Tao Wang
{"title":"Stenting for symptomatic intracranial arterial stenosis with different qualifying arteries: a preplanned pooled individual patient data analysis.","authors":"Tianhua Li, Jichang Luo, Xuesong Bai, Eyad Almallouhi, Peng Gao, Delin Liu, Ran Xu, Wenlong Xu, Guangdong Lu, Haozhi Gong, Xiao Zhang, Taoyuan Lu, Jie Wang, Renjie Yang, Zixuan Xing, Guangjie Liu, Yufu Dai, Colin P Derdeyn, Liqun Jiao, Tao Wang","doi":"10.1136/svn-2024-003532","DOIUrl":"10.1136/svn-2024-003532","url":null,"abstract":"<p><strong>Background: </strong>The efficacy of percutaneous transluminal angioplasty and stenting (PTAS) relative to medical management in treating symptomatic intracranial arterial stenosis (ICAS) varies based on the qualifying artery. This study aims to evaluate PTAS compared with medical therapy alone in cases of ICAS involving the internal carotid artery (ICA), middle cerebral artery (MCA), vertebral artery (VA) and basilar artery (BA).</p><p><strong>Methods: </strong>This study involves a thorough pooled analysis of individual patient data from two randomised controlled trials, evaluating the efficacy of PTAS in comparison to medical management for symptomatic ICAS with different qualifying arteries. The primary outcome was stroke or death within 30 days postenrolment, or stroke in the region of the qualifying artery beyond 30 days through 1 year. A methodology based on intention-to-treat was employed, and HR accompanied by 95% CIs were used to convey risk estimates.</p><p><strong>Results: </strong>The data of 809 individuals were collected from Stenting vs Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis trial and China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis trial. Four hundred were designated for PTAS, while 409 were assigned to medical therapy alone. For the primary outcome, patients with symptomatic BA stenosis had a significantly higher risk of receiving PTAS compared with medical therapy (17.17% vs 7.77%; 9.40; HR, 2.38 (1.03 to 5.52); p=0.04). However, PTAS had no significant difference in patients with symptomatic ICA (26.67% vs 16.67%; HR, 1.68 (0.78 to 3.62); p=0.19), MCA (8.28% vs 9.79%; HR, 0.85 (0.42 to 1.74); p=0.66) and VA stenosis (9.52% vs 10.71%; HR, 0.91 (0.32 to 2.62); p=0.86) compared with medical therapy.</p><p><strong>Conclusions: </strong>PTAS significantly increases the risk of both short-term and long-term stroke in patients with symptomatic BA stenosis. Without significant technological advancements to mitigate these risks, PTAS offers limited benefits. For symptomatic ICA, MCA and VA stenosis, PTAS provided no significant advantage.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"422-430"},"PeriodicalIF":4.9,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415638/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142511021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of a deep learning method to identify acute ischaemic stroke lesions on brain CT. 开发一种深度学习方法来识别脑 CT 上的急性缺血性中风病灶。
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-26 DOI: 10.1136/svn-2024-003372
Alessandro Fontanella, Wenwen Li, Grant Mair, Antreas Antoniou, Eleanor Platt, Paul Armitage, Emanuele Trucco, Joanna M Wardlaw, Amos Storkey
{"title":"Development of a deep learning method to identify acute ischaemic stroke lesions on brain CT.","authors":"Alessandro Fontanella, Wenwen Li, Grant Mair, Antreas Antoniou, Eleanor Platt, Paul Armitage, Emanuele Trucco, Joanna M Wardlaw, Amos Storkey","doi":"10.1136/svn-2024-003372","DOIUrl":"10.1136/svn-2024-003372","url":null,"abstract":"<p><strong>Background: </strong>CT is commonly used to image patients with ischaemic stroke but radiologist interpretation may be delayed. Machine learning techniques can provide rapid automated CT assessment but are usually developed from annotated images which necessarily limits the size and representation of development data sets. We aimed to develop a deep learning (DL) method using CT brain scans that were labelled but not annotated for the presence of ischaemic lesions.</p><p><strong>Methods: </strong>We designed a convolutional neural network-based DL algorithm to detect ischaemic lesions on CT. Our algorithm was trained using routinely acquired CT brain scans collected for a large multicentre international trial. These scans had previously been labelled by experts for acute and chronic appearances. We explored the impact of ischaemic lesion features, background brain appearances and timing of CT (baseline or 24-48 hour follow-up) on DL performance.</p><p><strong>Results: </strong>From 5772 CT scans of 2347 patients (median age 82), 54% had visible ischaemic lesions according to experts. Our DL method achieved 72% accuracy in detecting ischaemic lesions. Detection was better for larger (80% accuracy) or multiple (87% accuracy for two, 100% for three or more) lesions and with follow-up scans (76% accuracy vs 67% at baseline). Chronic brain conditions reduced accuracy, particularly non-stroke lesions and old stroke lesions (32% and 31% error rates, respectively).</p><p><strong>Conclusion: </strong>DL methods can be designed for ischaemic lesion detection on CT using the vast quantities of routinely collected brain scans without the need for lesion annotation. Ultimately, this should lead to more robust and widely applicable methods.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"499-507"},"PeriodicalIF":4.9,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415648/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tenecteplase thrombolytic therapy for acute ischaemic stroke in China: a real-world, multicentre, retrospective, controlled study. 中国急性缺血性脑卒中的特奈替普酶溶栓治疗:一项真实世界、多中心、回顾性对照研究。
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-26 DOI: 10.1136/svn-2024-003381
Ye Liu, Guozhi Lu, Dan Li, Guang Wu, Xiaoyu Zhou, Rongbo Qu, Yongren Fang, ZhiJiao He, Anqi Zhang, Lan Hong, Kun Fang, Xin Cheng, Qiang Dong
{"title":"Tenecteplase thrombolytic therapy for acute ischaemic stroke in China: a real-world, multicentre, retrospective, controlled study.","authors":"Ye Liu, Guozhi Lu, Dan Li, Guang Wu, Xiaoyu Zhou, Rongbo Qu, Yongren Fang, ZhiJiao He, Anqi Zhang, Lan Hong, Kun Fang, Xin Cheng, Qiang Dong","doi":"10.1136/svn-2024-003381","DOIUrl":"10.1136/svn-2024-003381","url":null,"abstract":"<p><strong>Background and aims: </strong>Tenecteplase (TNK) offers logistical advantages in stroke thrombolytic therapy with its single bolus administration compared with alteplase. We aim to investigate the real-world evidence regarding its safety and effectiveness in China.</p><p><strong>Methods: </strong>We conducted a retrospective study on patients receiving alteplase or TNK for acute ischaemic stroke (AIS) within 4.5 hours of onset between 1 March 2019 and 1 October 2023, from 18 stroke centres in China. Using propensity score matching (PSM), TNK-treated patients were matched 1:1 with alteplase-treated patients. The primary outcome was the rate of symptomatic intracranial haemorrhage (sICH) within 72 hours post-thrombolysis. Secondary outcomes comprised the rate of parenchymal haemorrhage type 2, any intracranial haemorrhage, any systematic bleeding and mortality at 90 days, as well as 24-hour National Institutes of Health Stroke Scale (NIHSS), early neurological improvement at 24 hours, modified Rankin Scale (mRS) shift, percentage of mRS 0-1 and mRS 0-2 at 90 days.</p><p><strong>Results: </strong>We identified 1113 patients with AIS who received TNK and 2360 patients who received alteplase. Following PSM, 1113 TNK-treated patients with AIS were matched to 1113 patients treated with alteplase. No significant differences were observed in rates of sICH (1.8% vs 1.98%, p=0.864) or other safety outcomes. Moreover, TNK-treated patients demonstrated a lower rate of any intracranial haemorrhage (OR: 0.51, 95% CI: 0.31 to 0.86, p=0.012). A higher proportion of patients achieving early neurological improvement at 24 hours (OR: 1.76, 95% CI: 1.48 to 2.09, p=0.000), better 90-day mRS (OR: 0.67, 95% CI: 0.57 to 0.79, p=0.000) as well as higher percentages of 90-day mRS 0-1 (OR: 1.27, 95% CI: 1.05 to 1.54, p=0.012) and mRS 0-2 (OR: 1.41, 95% CI: 1.14 to 1.75, p=0.001) compared with alteplase.</p><p><strong>Conclusions: </strong>Thrombolysis with TNK is not associated with an increased risk of sICH, and may result in better early neurological improvement and 90-day functional outcomes compared with alteplase in patients with AIS.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"452-461"},"PeriodicalIF":4.9,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dual antiplatelet versus alteplase in anterior and posterior circulation minor stroke. 双重抗血小板与阿替普酶在轻度卒中前后循环中的作用。
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-26 DOI: 10.1136/svn-2024-003705
Yu Cui, Hui-Sheng Chen
{"title":"Dual antiplatelet versus alteplase in anterior and posterior circulation minor stroke.","authors":"Yu Cui, Hui-Sheng Chen","doi":"10.1136/svn-2024-003705","DOIUrl":"10.1136/svn-2024-003705","url":null,"abstract":"<p><strong>Objective: </strong>The Antiplatelet versus R-tPA for Acute Mild Ischaemic Stroke trial has demonstrated the non-inferiority of dual antiplatelet therapy (DAPT) to alteplase in minor non-disabling stroke. This prespecified secondary analysis aimed to investigate whether the treatment effects were similar across stroke territories.</p><p><strong>Methods: </strong>Participants were divided according to stroke territory, which were subdivided into DAPT and alteplase. An excellent functional outcome at 90 days defined as modified Rankin Scale scoring 0-1 was primary outcome. National Institutes of Health Stroke Scale (NIHSS) score change and early neurological improvement measured by a 2-point decline in NIHSS score at 24 hours were secondary outcomes. Symptomatic intracerebral haemorrhage (sICH) and bleeding events were safety outcomes. Primary analyses adjusted unbalanced baseline characteristics between treatments by multivariate logistic regression.</p><p><strong>Results: </strong>A total of 719 patients were included: 566 in anterior circulation stroke (ACS) and 153 in posterior circulation stroke (PCS). Primary outcome was 94.1% in DAPT and 91.7% in alteplase among ACS patients (adjusted risk difference (RD) and 95% CI, 1.5% (-1.5% to 4.6%), p=0.32), while 91.2% in DAPT and 91.8% in alteplase among PCS patients (adjusted RD and 95% CI, -2.1% (-8.5% to 4.4%), p=0.53). Compared with alteplase, DAPT was associated with lower risk of sICH (p=0.03) and bleeding events (p<0.001) in ACS, but only lower risk of bleeding events (p=0.007) in PCS. Additionally, among ACS patients, the alteplase was superior to DAPT in terms of decrease in NIHSS score at 24 hours compared with admission (adjusted geometric mean ratio and 95% CI, -0.09 (-0.16 to -0.03), p=0.005) and early neurological improvement (adjusted RD and 95% CI, -7.2% (-11.6% to -2.7%), p=0.001).</p><p><strong>Conclusion: </strong>Among ischaemic stroke with minor non-disabling symptoms, DAPT was similar with intravenous alteplase regarding long-term functional outcome and better safety regardless of ACS or PCS. The potential benefit of intravenous alteplase regarding early neurological improvement in patients with ACS warrants further investigation.</p><p><strong>Trial registration number: </strong>NCT03661411.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"491-498"},"PeriodicalIF":4.9,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415641/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Secondary stroke evaluation in patients admitted for CRAO in a large national inpatient sample. 在一项大型全国住院患者样本中,因CRAO入院的患者的继发性卒中评估。
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-22 DOI: 10.1136/svn-2024-003971
Sahil Doshi, Jay B Bisen, Hanaina K Bains, Ariz Keshwani, Neena Cherayil, Rukhsana G Mirza
{"title":"Secondary stroke evaluation in patients admitted for CRAO in a large national inpatient sample.","authors":"Sahil Doshi, Jay B Bisen, Hanaina K Bains, Ariz Keshwani, Neena Cherayil, Rukhsana G Mirza","doi":"10.1136/svn-2024-003971","DOIUrl":"https://doi.org/10.1136/svn-2024-003971","url":null,"abstract":"<p><strong>Background: </strong>Central retinal artery occlusion (CRAO) is an ophthalmic condition associated with cerebrovascular ischaemia. In patients with acute CRAO, the 2021 American Heart Association (AHA) scientific statement recommends a diagnostic evaluation for secondary stroke prevention, including cerebrovascular imaging, cardiac rhythm monitoring, echocardiogram and labs. This study aims to understand the national stroke evaluation rates for patients with CRAO before 2021.</p><p><strong>Methods: </strong>Retrospective, cross-sectional analysis of inpatient admissions from the National Inpatient Sample between 2016 and 2021. Echocardiogram, head and neck vessel imaging and temporal artery biopsy completion during hospital admissions with a principal diagnosis of CRAO were measured. Clustering analysis was performed to characterise differences in stroke evaluations.</p><p><strong>Results: </strong>9615 inpatient stays for CRAO were identified. Only 0.3% underwent carotid ultrasounds, 10% underwent echocardiograms, and 8.5% underwent cerebrovascular imaging. Echocardiograms (10%) were most frequently performed, followed by temporal artery biopsy (6.4%). Clustering analysis reveals a cluster of older females on non-Health Maintenance Organisation Medicare receiving temporal artery biopsies. Other clusters consisted of younger males, who were more likely to receive an echocardiogram or cerebrovascular imaging and be discharged home. Independent predictors increasing the odds of undergoing stroke evaluations include female sex, transfer from another facility, residence in zip codes with a median household income of >$79 000, concurrent diagnosis of cerebral stroke, carotid atherosclerosis and nicotine dependence through cigarette use.</p><p><strong>Conclusions: </strong>In this national cohort study, low percentages of patients with CRAO were evaluated for secondary stroke prevention before the 2021 AHA scientific statement on CRAO management. Notably, higher socioeconomic status patients underwent more comprehensive stroke evaluations.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Smoking status and the efficacy of remote ischaemic conditioning: a secondary analysis of the RICAMIS trial. 吸烟状况和远程缺血调节的疗效:对RICAMIS试验的二次分析
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-19 DOI: 10.1136/svn-2025-004349
Xian-Wen Zhang, Yu Cui, Hui-Sheng Chen
{"title":"Smoking status and the efficacy of remote ischaemic conditioning: a secondary analysis of the RICAMIS trial.","authors":"Xian-Wen Zhang, Yu Cui, Hui-Sheng Chen","doi":"10.1136/svn-2025-004349","DOIUrl":"10.1136/svn-2025-004349","url":null,"abstract":"<p><strong>Background: </strong>Remote ischaemic conditioning (RIC) is a potential non-invasive neuroprotective strategy, but it remains unclear whether its efficacy is influenced by smoking status. This study explored the impact of smoking status on the therapeutic effect of RIC in patients with acute moderate ischaemic stroke through a post hoc subgroup analysis.</p><p><strong>Methods: </strong>Based on the data from the Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke trial, 1717 patients with moderate stroke (National Institutes of Health Stroke Scale score 6-16) who did not undergo reperfusion therapy were included and categorised into current smokers (n=505) and non-smokers (n=1212) based on their smoking status. Patients were randomly assigned to receive either RIC (administered twice daily for 14 days) or standard treatment. The primary outcome was excellent functional prognosis at 90 days (modified Rankin Scale, mRS scores 0-1). Multivariable regression analysis was used to evaluate the interaction between smoking status and RIC.</p><p><strong>Results: </strong>Among non-smokers, RIC significantly increased the proportion of patients achieving mRS 0-1 at 90 days (69.1% vs 62.8%; adjusted OR 1.487, 95% CI 1.143 to 1.936; p=0.003). Among current smokers, there was no significant difference in the proportion of mRS 0-1 at 90 days compared with the control group (64.1% vs 62.1%; adjusted OR 1.154, 95% CI 0.791 to 1.684; p=0.46). The interaction analysis revealed no significant association between smoking status and RIC efficacy (P for interaction=0.50).</p><p><strong>Conclusions: </strong>In this analysis, RIC significantly improved the excellent functional prognosis of non-smoking stroke patients, but had no significant benefit for current smokers, suggesting that smoking may attenuate RIC efficacy.</p><p><strong>Trial registeration number: </strong>NCT03740971.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144884135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neuronavigation-assisted stereotactic minimally invasive puncture with tenecteplase for the treatment of acute spontaneous deep intracerebral haemorrhage (NAS-TNK): rationale and design of a multicentre randomised trial. 神经导航辅助立体定向微创穿刺tenecteplase治疗急性自发性深部脑出血(NAS-TNK):一项多中心随机试验的基本原理和设计
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-17 DOI: 10.1136/svn-2025-004234
Mingze Wang, Zhiyou Wu, Jingyi Tang, Xiudan Bai, Shaozhi Zhao, Yang Ni, Pengqi Wang, Duolao Wang, Yong Cao
{"title":"Neuronavigation-assisted stereotactic minimally invasive puncture with tenecteplase for the treatment of acute spontaneous deep intracerebral haemorrhage (NAS-TNK): rationale and design of a multicentre randomised trial.","authors":"Mingze Wang, Zhiyou Wu, Jingyi Tang, Xiudan Bai, Shaozhi Zhao, Yang Ni, Pengqi Wang, Duolao Wang, Yong Cao","doi":"10.1136/svn-2025-004234","DOIUrl":"https://doi.org/10.1136/svn-2025-004234","url":null,"abstract":"<p><strong>Introduction: </strong>Minimally invasive puncture surgery followed by thrombolysis has been proven to be an effective approach for managing hypertensive intracerebral haemorrhage (ICH). Nevertheless, its impact on improving neurological outcomes remains controversial. The integration of neuronavigation-assisted stereotactic (NAS) technology will significantly help enhance the accuracy of catheter placement, while tenecteplase (TNK), a third-generation thrombolytic agent, offers stronger capabilities in breaking down platelet-rich clots and demonstrates increased fibrin selectivity, which could enhance the overall effectiveness of thrombolytic treatment. However, the efficacy and safety of combining NAS-assisted minimally invasive puncture with TNK (NAS-TNK) in reducing disability and mortality rates among patients with acute spontaneous deep ICH remain unknown.</p><p><strong>Aim: </strong>To describe the rationale and design of the NAS-TNK trial for the treatment of acute spontaneous deep ICH.</p><p><strong>Design: </strong>NAS-TNK is a randomised, open-label, outcome-blinded multicentre trial, involving 732 participants with acute basal ganglia or thalamic haemorrhage with a haematoma volume ranging from 20 to 50 mL. This study will evaluate the efficacy and safety of NAS-TNK, administered every 24 hours at a dose of 0.009 mg/mL of haematoma volume, compared with participants receiving standard medical care. Each patient will undergo follow-up evaluations for a period of 180 days.</p><p><strong>Study outcomes: </strong>The main measure of effectiveness is the percentage of participants achieving a modified Rankin Scale Score ranging from 0 to 3 at the 180-day mark. The primary safety outcome is the all-cause death at 30 days.</p><p><strong>Discussion and conclusion: </strong>The NAS-TNK study will help improve our understanding of the benefits of NAS-TNK in patients with acute spontaneous deep ICH.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treatment of acute intracerebral haemorrhage with a Chinese herbal formula (Shengdi Dahuang Decoction): a multicentre, double-blind, randomised, placebo-controlled trial. 中药升地大黄汤治疗急性脑出血:一项多中心、双盲、随机、安慰剂对照试验
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-08-02 DOI: 10.1136/svn-2024-003931
Zhihuan Sun, Xiaoyu Zhou, Jingyan Xiang, Feng Wang, Yan Han, Yongmei Guo, Zongqi Zhang, Fan Gong, Mingzhe Wang, Dezhi Liu, Weidong Pan, Haiyan Tang, Tingting Li, Jingsi Zhang, Shan Jiang, Jihan Huang, Xiaofei Yu
{"title":"Treatment of acute intracerebral haemorrhage with a Chinese herbal formula (Shengdi Dahuang Decoction): a multicentre, double-blind, randomised, placebo-controlled trial.","authors":"Zhihuan Sun, Xiaoyu Zhou, Jingyan Xiang, Feng Wang, Yan Han, Yongmei Guo, Zongqi Zhang, Fan Gong, Mingzhe Wang, Dezhi Liu, Weidong Pan, Haiyan Tang, Tingting Li, Jingsi Zhang, Shan Jiang, Jihan Huang, Xiaofei Yu","doi":"10.1136/svn-2024-003931","DOIUrl":"https://doi.org/10.1136/svn-2024-003931","url":null,"abstract":"<p><strong>Importance: </strong>Per preliminary studies, Shengdi Dahuang Decoction (SDD) is potentially effective for acute intracerebral haemorrhage (ICH); however, its effectiveness has not been rigorously assessed in extensive randomised clinical trials.</p><p><strong>Objective: </strong>To evaluate whether SDD can improve 90-day functional outcomes in patients with ICH.</p><p><strong>Design: </strong>Randomised, double-blind, placebo-controlled clinical trial included patients with acute ICH within 4 hours of symptom onset at five hospitals in Shanghai, China.</p><p><strong>Interventions: </strong>Patients were randomised 1:1 to receive either SDD granules (each sachet contained 15 g of raw <i>Rehmannia glutinosa</i> and 5 g of raw rhubarb) or placebo granules orally or via a nasogastric tube (as soon as possible within 12 hours of onset, two times daily for 7 days), in addition to ICH guideline-directed treatments. Per our preclinical study, SDD reduces inflammatory injury after ICH in rats.</p><p><strong>Main outcomes: </strong>The primary outcome measure was the proportion of patients with a score ranging 0-1 on the modified Rankin Scale (mRS) on the 90th day.</p><p><strong>Results: </strong>Of the total 1211 participants with cerebral haemorrhage assessed for eligibility, 483 were enrolled. Of this, 242 participants were randomly assigned to receive SDD granules and 241 to receive placebo granules (mean age, 62.7 years; 72.9% male). Among these, 112 (46.3%) and 84 (34.9%) patients in the SDD and placebo groups, respectively, had an mRS score of 0-1 on the 90th day (adjusted relative risk 1.20, 95% CI 1.00 to 1.43; p=0.046) . The proportion of patients with poor clinical outcomes (mRS score of 5 or 6 at 90 days) was higher in the placebo group (11.2%) than in the SDD group (5.4%) (p=0.021). The 90-day mortality rate (p=0.299), 7-day National Institute of Health Stroke Scale score (p=0.583), 7-day Glasgow Coma Scale score (p=0.577), 24-hour haematoma enlargement rate (p=0.675) or 7-day relative perihaematomal oedema did not significantly differ (p=0.343) between the groups. The incidence of adverse events between the two groups did not differ significantly (p>0.05).</p><p><strong>Conclusions: </strong>In patients with acute ICH, incorporating SDD as a supplementary intervention alongside guideline-directed treatments may help enhance 90-day functional outcomes; however, more clinical trials are required to further prove its efficacy.</p><p><strong>Trial registration number: </strong>NCT04200781.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144769207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Altered gut microbiota and short-chain fatty acid in acute ischaemic stroke with active cancer. 急性缺血性卒中伴活动性癌症患者肠道菌群和短链脂肪酸的改变。
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-07-30 DOI: 10.1136/svn-2025-004217
Wei Song, Xiaofei Lin, Genghong Xia, Yueran Ren, Xuxuan Gao, Linling Shen, Qiheng Wu, Jia Yin
{"title":"Altered gut microbiota and short-chain fatty acid in acute ischaemic stroke with active cancer.","authors":"Wei Song, Xiaofei Lin, Genghong Xia, Yueran Ren, Xuxuan Gao, Linling Shen, Qiheng Wu, Jia Yin","doi":"10.1136/svn-2025-004217","DOIUrl":"https://doi.org/10.1136/svn-2025-004217","url":null,"abstract":"<p><strong>Background: </strong>Acute ischaemic stroke (AIS) in patients with active cancer presents unique etiological factors and correlates with worse outcomes. Although gut microbiota dysbiosis has been separately documented in stroke pathophysiology and cancer progression, gut microbial profiles in patients with concurrent conditions remain unexplored. We investigated gut microbiota composition and short-chain fatty acid (SCFA) levels in patients with AIS and active cancer.</p><p><strong>Methods: </strong>In this prospective observational study, we analysed consecutive patients with AIS admitted between 2018 and 2023. Gut microbiota profiles were characterised using 16S rRNA sequencing. Faecal SCFAs were quantified by gas chromatography-mass spectrometry, and serum biomarkers of intestinal barrier function were measured. Functional outcomes were assessed using the modified Rankin Scale (mRS) at 180 days poststroke.</p><p><strong>Results: </strong>Among 942 consecutive AIS patients, 156 met inclusion criteria: 42 with active cancer and 114 matched controls. Patients with concurrent AIS and cancer demonstrated significant taxonomic alterations, characterised by elevated <i>Firmicutes</i>-to-<i>Bacteroidetes</i> ratio (F/B: 1.2 vs 0.6; p=0.010) and <i>Clostridiales</i>-to-<i>Bacteroidales</i> ratio (C/B: 1.1 vs 0.6; p=0.008) compared with controls. These patients exhibited enrichment of inflammation-associated bacteria, depletion of SCFA-producing microbes, reduced faecal SCFA levels and elevated markers of intestinal barrier dysfunction (all p<0.05). The abundance of inflammation-associated genera <i>Erysipelotrichaceae</i> and <i>Dorea</i> correlated with elevated D-dimer levels and worse 180-day mRS scores. Multivariate analysis identified <i>Clostridiales</i> abundance, F/B and C/B ratios as independent predictors of poor functional outcomes (mRS≥3) at 180 days.</p><p><strong>Conclusions: </strong>Patients with concurrent AIS and active cancer demonstrate distinct gut microbiota profiles and reduced SCFA production, associated with compromised intestinal barrier function and poor outcomes. These observations suggest perturbed gut-brain axis function and motivate exploratory research into microbiota-targeted approaches for this high-risk population.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144754858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of fluid balance with 3-month outcomes in severe acute ischaemic stroke. 严重急性缺血性脑卒中患者体液平衡与3个月预后的关系
IF 4.9 1区 医学
Journal of Investigative Medicine Pub Date : 2025-07-30 DOI: 10.1136/svn-2024-004001
Meng Liu, Yanan Wang, Xing Hua, Linrui Huang, Ming Liu, Simiao Wu
{"title":"Association of fluid balance with 3-month outcomes in severe acute ischaemic stroke.","authors":"Meng Liu, Yanan Wang, Xing Hua, Linrui Huang, Ming Liu, Simiao Wu","doi":"10.1136/svn-2024-004001","DOIUrl":"https://doi.org/10.1136/svn-2024-004001","url":null,"abstract":"<p><strong>Background: </strong>Fluid therapy is commonly used for patients with severe stroke, for whom fluid balance is a safety endpoint for evaluating the therapy. We aimed to investigate the association of fluid balance with 3-month outcomes in patients with severe ischaemic stroke.</p><p><strong>Methods: </strong>We enrolled patients with severe ischaemic stroke (National Institutes of Health Stroke Scale score ≥15) admitted to the department of neurology within 24 hours after the onset of stroke symptoms. Daily fluid balance volume in millilitres was defined as 24-hour fluid input minus fluid output. We calculated the mean value of daily fluid balance for the first 3 days after admission, and categorised patients as having positive fluid balance (daily fluid balance>+500 mL), even fluid balance (between -500 and +500 mL) and negative fluid balance (<-500 mL). The primary outcome was all-cause death at 3 months. We conducted multivariable logistic regression to investigate the association of fluid balance with 3-month death, with even fluid balance as the reference group.</p><p><strong>Results: </strong>Of the 354 patients (mean age 73.1±12.9 years, 48.6% males) with severe ischaemic stroke, 94 patients (26.6%) had positive fluid balance, 194 patients (54.8%) had even fluid balance and 66 patients (18.6%) had negative fluid balance. Patients with positive fluid balance had a higher risk of 3-month death (adjusted OR 2.18, 95% CI 1.24 to 3.85, p=0.007), while patients with negative fluid balance did not show a significant difference (adjusted OR 1.68, 95% CI 0.88 to 3.20, p=0.115). The restricted cubic spline analysis illustrated a U-shaped trend of dose response relationship for mean daily fluid balance in relation to the adjusted OR of 3-month death (p for non-linearity=0.02).</p><p><strong>Conclusion: </strong>In patients with severe ischaemic stroke, the positive fluid balance in the first 3 days was associated with a higher risk of death at 3 months.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144754859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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