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Association of intraprocedural near admission-level blood pressure with functional outcome in stroke patients treated with mechanical thrombectomy. 采用机械血栓切除术治疗的脑卒中患者术中接近入院水平的血压与功能预后的关系。
Q2 Medicine Pub Date : 2024-10-01 DOI: 10.1186/s42466-024-00345-0
Min Chen, Lukas Daniel Sauer, Mika Herwig, Jessica Jesser, Meinhard Kieser, Arne Potreck, Markus Möhlenbruch, Peter Arthur Ringleb, Silvia Schönenberger

Background: Optimal blood pressure management during endovascular stroke treatment is not certain. We hypothesized that time or proportion of intraprocedural systolic blood pressure spent in a range around admission blood pressure might be associated with better clinical outcome.

Methods: We conducted a retrospective observational study at a single center at a university hospital, which included patients from August 2018 to September 2020 suffering from acute ischemic stroke with anterior circulation vessel occlusion and treated with endovascular therapy. Time and proportion of procedure time where systolic blood pressure (SBP) was near the baseline SBP on admission (bSBP) were used as exposure variables. The primary outcome was the occurrence of mRS score 0-2 three months after stroke. The primary analysis was performed by fitting a logistic regression model adjusted for baseline NIHSS, pre-stroke mRS, mTICI score, intubation, age and sex.

Results: We included 589 patients in the analysis. Mean (SD) age was 76 (12) years, 315 were women (53%) and mean (SD) NIHSS score at admission was 15 (7.5). Mean (SD) bSBP was 167 (28) mmHg and mean (SD) intraprocedural SBP was 147 (21) mmHg. The proportion of time where intraprocedural SBP was in range of bSBP ± 20% was associated with a slightly higher odds of achieving favorable outcome (adjusted OR, 1.007; 95% CI, 1.0003-1.013).

Conclusion: A higher proportion of intraprocedural time with systolic blood pressure in range of ± 20% of the admission level is associated with higher odds of favorable functional outcome.

Trial registration: Not applicable.

背景:血管内卒中治疗期间的最佳血压管理尚不确定。我们假设,术中收缩压在入院血压范围内的时间或比例可能与更好的临床预后相关:我们在一家大学医院的单个中心开展了一项回顾性观察研究,纳入了 2018 年 8 月至 2020 年 9 月期间患有前循环血管闭塞并接受血管内治疗的急性缺血性卒中患者。将收缩压(SBP)接近入院时基线SBP(bSBP)的时间和手术时间比例作为暴露变量。主要结果是中风三个月后出现 mRS 0-2 分。主要分析通过拟合逻辑回归模型进行,并对基线 NIHSS、卒中前 mRS、mTICI 评分、插管、年龄和性别进行了调整:我们将 589 名患者纳入分析。平均(标清)年龄为 76(12)岁,女性 315 人(53%),入院时 NIHSS 平均(标清)评分为 15(7.5)分。平均(标清)bSBP 为 167(28)mmHg,术中平均(标清)SBP 为 147(21)mmHg。术中 SBP 在 bSBP ± 20% 范围内的时间比例与获得良好结果的几率略高相关(调整后 OR,1.007;95% CI,1.0003-1.013):试验登记:试验注册:不适用。
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引用次数: 0
Differential diagnosis of Guillain-Barré syndrome: steroid-responsive radiculopathy in Evans syndrome. 格林-巴利综合征的鉴别诊断:埃文斯综合征的类固醇反应性根状神经病。
Q2 Medicine Pub Date : 2024-09-20 DOI: 10.1186/s42466-024-00344-1
Thomas Schulten, Ansgar Meyer, Utz Krug, Helmar C Lehmann

Guillain-Barré syndrome is the most common acute inflammatory demyelinating peripheral nerve condition. Occasionally, other autoimmune conditions can mimic Guillain-Barré syndrome but may require different diagnostic workup and treatment. We report here two patients with Evans syndrome, a rare hematological autoimmune condition who developed a subacute inflammatory radiculopathy. Similarities and distinguishing clinical and diagnostic features are discussed.

吉兰-巴雷综合征是最常见的急性炎症性脱髓鞘周围神经疾病。偶尔,其他自身免疫性疾病也会模仿吉兰-巴雷综合征,但可能需要不同的诊断和治疗。我们在此报告了两名患有埃文斯综合征(一种罕见的血液自身免疫性疾病)的患者,他们都出现了亚急性炎症性根神经病。本文讨论了这两种疾病的相似之处以及不同的临床和诊断特征。
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引用次数: 0
Prognostic models in multiple sclerosis: progress and challenges in clinical integration. 多发性硬化症的预后模型:临床整合的进展与挑战。
Q2 Medicine Pub Date : 2024-09-05 DOI: 10.1186/s42466-024-00338-z
Joachim Havla, Kelly Reeve, Begum Irmak On, Ulrich Mansmann, Ulrike Held

As a chronic inflammatory disease of the central nervous system, multiple sclerosis (MS) is of great individual health and socio-economic significance. To date, there is no prognostic model that is used in routine clinical care to predict the very heterogeneous course of the disease. Despite several research groups working on different prognostic models using traditional statistics, machine learning and/or artificial intelligence approaches, the use of published models in clinical decision making is limited because of poor model performance, lack of transferability and/or lack of validated models. To provide a systematic overview, we conducted a "Cochrane review" that assessed 75 published prediction models using relevant checklists (CHARMS, PROBAST, TRIPOD). We have summarized the relevant points from this analysis here so that the use of prognostic models for therapy decisions in clinical routine can be successful in the future.

多发性硬化症(MS)是中枢神经系统的一种慢性炎症性疾病,对个人健康和社会经济意义重大。迄今为止,还没有一个可用于常规临床治疗的预后模型来预测该疾病的不同病程。尽管有多个研究小组使用传统统计学、机器学习和/或人工智能方法研究不同的预后模型,但由于模型性能不佳、缺乏可移植性和/或缺乏经过验证的模型,已发表的模型在临床决策中的应用受到了限制。为了提供系统性概述,我们进行了一项 "Cochrane 回顾",使用相关核对表(CHARMS、PROBAST、TRIPOD)评估了 75 个已发表的预测模型。我们在此总结了这一分析的相关要点,以便今后在临床常规治疗决策中成功使用预后模型。
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引用次数: 0
Intrathecal IgG4 synthesis in IgG4 related spinal hypertrophic pachymeningitis: a case report. 与 IgG4 相关的脊髓肥厚性小脑膜炎的鞘内 IgG4 合成:一份病例报告。
Q2 Medicine Pub Date : 2024-08-29 DOI: 10.1186/s42466-024-00343-2
Lucia K Feldmann, Regina von Manitius, Birgit Julia Grassmann, Judith Rösler, Julia Onken, Christian Meisel, Arend Koch, Eberhard Siebert, Klemens Ruprecht, Andreas Meisel

Immunoglobulin G4 (IgG4) related hypertrophic pachymeningitis of the spinal cord is a rare condition, characterized by infiltration of the spinal meninges with IgG4-producing plasma cells and subsequent hypertrophic fibrosis. Here, we report on a 65-year-old woman with IgG4 associated hypertrophic spinal pachymeningitis, in whom cerebrospinal fluid (CSF) analysis was a decisive diagnostic tool. Not only could we demonstrate an intrathecal IgG4 production, but also IgG4 positive plasma cells in CSF. Following decompressive surgery, diagnosis of IgG4 associated hypertrophic pachymeningitis was confirmed histologically. Surgery and immunosuppressive therapy with rituximab were associated with clinical improvement. This case highlights CSF analyses as diagnostic tool for detection of IgG4 related hypertrophic pachymeningitis.

与免疫球蛋白 G4(IgG4)相关的脊髓肥厚性脊髓膜炎是一种罕见病,其特点是脊髓膜被产生 IgG4 的浆细胞浸润,随后出现肥厚性纤维化。在此,我们报告了一名患有 IgG4 相关性肥厚性脊髓髓膜炎的 65 岁女性,脑脊液(CSF)分析是诊断该病的决定性工具。我们不仅发现了鞘内 IgG4 的产生,还发现了 CSF 中 IgG4 阳性的浆细胞。减压手术后,经组织学检查确诊为 IgG4 相关性肥厚性桥脑膜炎。手术和使用利妥昔单抗进行免疫抑制治疗后,临床症状有所改善。该病例强调了 CSF 分析是检测 IgG4 相关性肥厚性桥脑的诊断工具。
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引用次数: 0
User expectations and experiences of an assistive robotic arm in amyotrophic lateral sclerosis: a multicenter observational study. 肌萎缩性脊髓侧索硬化症患者对辅助机械臂的期望和体验:一项多中心观察研究。
Q2 Medicine Pub Date : 2024-08-23 DOI: 10.1186/s42466-024-00342-3
Susanne Spittel, Thomas Meyer, Ute Weyen, Torsten Grehl, Patrick Weydt, Robert Steinbach, Susanne Petri, Petra Baum, Moritz Metelmann, Anne-Dorte Sperfeld, Dagmar Kettemann, Jenny Norden, Annekathrin Rödiger, Benjamin Ilse, Julian Grosskreutz, Barbara Hildebrandt, Bertram Walter, Christoph Münch, André Maier

Objective: Robotic arms are innovative assistive devices for ALS patients with progressive motor deficits of arms and hands. The objective was to explore the patients´ expectations towards a robotic arm system and to assess the actual experiences after the provision of the device.

Methods: A prospective observational study was conducted at 9 ALS centers in Germany. ALS-related functional deficits were assessed using the ALS-Functional Rating Scale-revised (ALSFRS-R). Motor deficit of the upper limbs was determined using a subscore of three arm-related items of the ALSFRS-R (items 4-6; range 0-12 points). User expectations before provision (expectation group, n = 85) and user experiences after provision (experience group, n = 14) with the device (JACO Assistive Robotic Device, Kinova, Boisbriand, QC, Canada) were assessed.

Results: In the total cohort, mean ALSFRS-R subscore for arm function was 1.7 (SD: 2.0, 0-9) demonstrating a severe functional deficit of the upper limbs. In the expectation group (n = 85), the following use cases of the robotic arm have been prioritized: handling objects (89%), close-body movements (88%), pressing buttons (87%), serving drinks (86%), and opening cabinets and doors (85%). In the experience group (n = 14), handling objects (79%), serving drinks (79%), near-body movements (71%), pushing buttons (71%), serving food (64%), and opening doors (64%) were the most frequent used cases. Most patients used the device daily (71.4%, n = 10), and 28.6% (n = 4) several times a week. All patients of the experience group found the device helpful, felt safe while using the device, and were satisfied with its reliability. NPS of the assistive robotic arm revealed 64% "promoters" (strong recommendation), 29% "indifferents" (uncertain recommendation) and 7% "detractors" (no recommendation). Total NPS was + 57 demonstrating strong patient satisfaction.

Conclusions: Initiation of procurement with a robotic assistive arm was confined to patients with severe functional deficit of the upper limbs. User experience underlined the wide spectrum of use cases of assistive robotic arms in ALS. The positive user experience together with high satisfaction underscore that robotic arm systems serve as a valuable treatment option in ALS patients with severe motor deficits of the arms.

目的:机械臂是一种创新型辅助设备,适用于手臂和手部进行性运动障碍的 ALS 患者。研究目的是探讨患者对机械臂系统的期望,并评估患者在使用该设备后的实际体验:在德国的 9 个 ALS 中心开展了一项前瞻性观察研究。采用 ALS 功能评定量表修订版(ALSFRS-R)评估与 ALS 相关的功能障碍。上肢的运动障碍通过 ALSFRS-R 中与手臂相关的三个项目(项目 4-6;范围 0-12 分)的子分数来确定。评估了用户在使用该装置(JACO辅助机器人装置,Kinova公司,加拿大Boisbriand市)前的期望值(期望值组,n = 85)和使用该装置后的体验(体验组,n = 14):在所有组别中,平均 ALSFRS-R 手臂功能子评分为 1.7(标准差:2.0,0-9),表明上肢功能严重不足。在期望组(n = 85)中,机器人手臂的优先使用情况如下:搬运物品(89%)、近身运动(88%)、按键(87%)、提供饮料(86%)以及打开橱柜和门(85%)。在经验组(n = 14)中,最常使用的情况是搬运物体(79%)、端饮料(79%)、近身动作(71%)、按按钮(71%)、端食物(64%)和开门(64%)。大多数患者每天使用该装置(71.4%,n = 10),28.6%(n = 4)每周使用数次。体验组的所有患者都认为该装置很有用,使用时感觉安全,并对其可靠性感到满意。辅助机械臂的 NPS 显示,64% 为 "推荐者"(强烈推荐),29% 为 "无所谓者"(不确定推荐),7% 为 "反对者"(不推荐)。总的 NPS 为 + 57,表明患者非常满意:结论:使用机器人辅助臂的患者仅限于上肢功能严重受损的患者。用户体验强调了辅助机械臂在 ALS 中的广泛用途。积极的用户体验和较高的满意度突出表明,机械臂系统对于手臂运动功能严重缺失的 ALS 患者来说是一种有价值的治疗选择。
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引用次数: 0
Perceived autonomy support in individuals with Parkinson's disease requiring emergency care: a cross-sectional pilot study. 需要紧急护理的帕金森病患者对自主支持的感知:一项横断面试点研究。
Q2 Medicine Pub Date : 2024-08-15 DOI: 10.1186/s42466-024-00340-5
Barend W Florijn, Erik W van Zwet, Ad A Kaptein, Anne A van der Plas

Background: Individuals with Parkinson's disease (PD) report a diminished perceived functional autonomy as their condition progresses. For those seeking emergency care, it is unknown whether the patient-physician relationship is instrumental in respecting patient autonomy. This study evaluated patient autonomy ideals in individuals with PD requiring emergency care and the perceived support for autonomy from emergency department physicians.

Method: Individuals with PD (n = 36, average age 78.1 years) were surveyed using the Ideal Patient Autonomy questionnaire (IPA) and the Health Care Climate Questionnaire (HCCQ). A multivariable regression analysis assessed whether patients' Hoehn and Yahr stage and IPA questionnaire results predicted HCCQ items.

Results: The IPA questionnaire revealed that individuals with PD in need of emergency care emphasize the significance of medical expertise (IPA 'doctor should decide' theme 0.71) in decision-making and their desire to be fully informed about all potential risks (IPA 'obligatory risk information' theme 0.71). The average HCCQ values showed a decreasing trend across Hoehn and Yahr stages 1 to 5: 6.19, 6.03, 5.83, 5.80, and 5.23, respectively. HY scale values also influenced HCCQ items related to the physician's role.

Conclusion: In our cohort, individuals with Parkinson's disease tend to rely on medical expertise for decision-making and prioritize complete risk information during emergency care. However, this autonomy support diminishes as functional disability levels increase.

背景:帕金森病(Parkinson's disease,PD)患者表示,随着病情的发展,他们的功能自主感会减弱。对于寻求急诊治疗的患者而言,医患关系是否有助于尊重患者的自主权尚不得而知。本研究评估了需要急诊护理的帕金森病患者的自主性理想以及急诊科医生对自主性的支持感知:采用理想患者自主性问卷(IPA)和医疗环境问卷(HCCQ)对帕金森病患者(36 人,平均年龄 78.1 岁)进行了调查。一项多变量回归分析评估了患者的Hoehn和Yahr分期以及IPA问卷结果是否能预测HCCQ项目:IPA问卷调查显示,需要急诊护理的帕金森病患者在决策过程中强调医学专业知识的重要性(IPA "应由医生决定 "主题为0.71),并希望充分了解所有潜在风险(IPA "强制性风险信息 "主题为0.71)。HCCQ 平均值在 Hoehn 和 Yahr 分期 1 至 5 中呈下降趋势:分别为 6.19、6.03、5.83、5.80 和 5.23。HY量表值也影响了与医生角色相关的HCCQ项目:在我们的队列中,帕金森病患者倾向于依赖医学专业知识进行决策,并在急救过程中优先考虑完整的风险信息。然而,这种自主支持会随着功能障碍程度的增加而减少。
{"title":"Perceived autonomy support in individuals with Parkinson's disease requiring emergency care: a cross-sectional pilot study.","authors":"Barend W Florijn, Erik W van Zwet, Ad A Kaptein, Anne A van der Plas","doi":"10.1186/s42466-024-00340-5","DOIUrl":"10.1186/s42466-024-00340-5","url":null,"abstract":"<p><strong>Background: </strong>Individuals with Parkinson's disease (PD) report a diminished perceived functional autonomy as their condition progresses. For those seeking emergency care, it is unknown whether the patient-physician relationship is instrumental in respecting patient autonomy. This study evaluated patient autonomy ideals in individuals with PD requiring emergency care and the perceived support for autonomy from emergency department physicians.</p><p><strong>Method: </strong>Individuals with PD (n = 36, average age 78.1 years) were surveyed using the Ideal Patient Autonomy questionnaire (IPA) and the Health Care Climate Questionnaire (HCCQ). A multivariable regression analysis assessed whether patients' Hoehn and Yahr stage and IPA questionnaire results predicted HCCQ items.</p><p><strong>Results: </strong>The IPA questionnaire revealed that individuals with PD in need of emergency care emphasize the significance of medical expertise (IPA 'doctor should decide' theme 0.71) in decision-making and their desire to be fully informed about all potential risks (IPA 'obligatory risk information' theme 0.71). The average HCCQ values showed a decreasing trend across Hoehn and Yahr stages 1 to 5: 6.19, 6.03, 5.83, 5.80, and 5.23, respectively. HY scale values also influenced HCCQ items related to the physician's role.</p><p><strong>Conclusion: </strong>In our cohort, individuals with Parkinson's disease tend to rely on medical expertise for decision-making and prioritize complete risk information during emergency care. However, this autonomy support diminishes as functional disability levels increase.</p>","PeriodicalId":94156,"journal":{"name":"Neurological research and practice","volume":"6 1","pages":"41"},"PeriodicalIF":0.0,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11325813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141984222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-world analysis of brain atrophy in multiple sclerosis patients with an artificial intelligence based software tool. 利用基于人工智能的软件工具对多发性硬化症患者的脑萎缩情况进行真实世界分析。
Q2 Medicine Pub Date : 2024-08-08 DOI: 10.1186/s42466-024-00339-y
Caroline Reinhardt, Klemens Angstwurm, David Freudenstein, De-Hyung Lee, Christina Wendl, Ralf A Linker

Background: Atrophy of white and grey matter volumes occurs early in the brains of people with multiple sclerosis (pwMS) and has great clinical relevance. In clinical trials, brain atrophy can be quantified by magnetic resonance imaging (MRI) with automated software tools.

Methods: In this study, we analyze volumes of various brain regions with the software "md brain" based on routine MRI scans of 53 pwMS in a real-world setting. We compare brain volumes of pwMS with an EDSS ≥ 3.5 and a disease duration ≥ 10 years to the brain volumes of pwMS with an EDSS < 3.5 and a disease duration < 10 years as well as with or without immunotherapy.

Results: pwMS with an EDSS ≥ 3.5 and a disease duration ≥ 10 years had significantly lower volumes of the total brain, the grey matter and of the frontal, temporal, parietal and occipital lobe regions as compared to pwMS with an EDSS < 3.5 and a disease duration < 10 years. Regional brain volumes were significantly lower in pwMS without immunotherapy.

Conclusions: The study showed that higher EDSS, longer disease duration and absence of immunotherapy was associated with lower volumes in a number of brain regions. Further real-world studies may include larger patient cohorts in longitudinal analyses.

背景:多发性硬化症患者(pwMS)脑白质和灰质体积萎缩发生较早,具有重要的临床意义。在临床试验中,脑萎缩可以通过磁共振成像(MRI)的自动软件工具进行量化:在本研究中,我们使用软件 "md brain",根据真实世界中 53 名 pwMS 的常规 MRI 扫描结果,分析了不同脑区的体积。我们将 EDSS≥3.5 且病程≥10 年的重症患者的脑容量与 EDSS≥3.5 且病程≥10 年的重症患者的脑容量进行了比较 结果:与 EDSS≥3.5 且病程≥10 年的重症患者相比,EDSS≥3.5 且病程≥10 年的重症患者的全脑容量、灰质容量以及额叶、颞叶、顶叶和枕叶区域的容量均显著低于 EDSS≥10 年的重症患者 结论:研究表明,EDSS 越高、病程≥10 年的重症患者的脑容量越小:研究表明,EDSS 越高、病程越长、未接受免疫治疗的患者大脑多个区域的体积越小。进一步的真实世界研究可能会在纵向分析中纳入更大的患者群。
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引用次数: 0
Multidisciplinary lifestyle interventions for neurological disorders during the Silent phase (MINDS) study: a multi-omics randomized controlled trial protocol. 沉默期神经系统疾病多学科生活方式干预(MINDS)研究:多组学随机对照试验方案。
Q2 Medicine Pub Date : 2024-08-01 DOI: 10.1186/s42466-024-00334-3
Sara Taylor, Seerat Sachdeva, Sandra Darling, Kayela Arrotta, Lisa Gallagher, Alexis Supan, Gabrielle Shipta, Jim Perko, Judi Bar, Joe James, Iris Petschek, Anthony Lioi, Suman Kundu, Lisa Ellison, Lynn M Bekris, Belinda Willard, Naseer Sangwan, Ignacio Mata, Hubert Fernandez, Irene Katzan, Devon Conway, Jagan Pillai, James Leverenz, Robyn M Busch, Darlene Floden, Robert Saper, John Barnard, Andre Machado, Imad Najm, Vineet Punia

Introduction: Given the prevalence and staggering cost of neurological disorders, there is dire need for effective early detection and intervention tools. Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders. The objectives of this protocol are (1) to test the impact of MLI on the progression of neurological disorders and (2) to identify multi-omic biomarkers for early stages of neurological disease and the impact of MLIs on these biomarkers.

Methods and analysis: We present the Multidisciplinary lifestyle Interventions for Neurological Disorders during the Silent phase (MINDS) protocol, a randomized controlled trial of MLI in neurologically healthy older adults (≥ 50 years old) exhibiting elevated risk for common neurological disorders: stroke, epilepsy, Parkinson's Disease, or Alzheimer's disease and related dementias. Participants will be randomly assigned to intervention (n = 100) or control (n = 100) groups. The intervention group will receive 3 months of weekly 2-hour sessions on diet education, yoga, music therapy, and cognitive skills training. The participants' neurological health and engagement in relevant lifestyle practices will be assessed at regular intervals for 12 months. Neuroimaging and samples for multi-omic analyses will be collected at baseline, and at 3 months and 12 months after enrollment. Primary outcomes will be signs of progression of the neurological disorder risk that qualified them for study enrollment or a clinical diagnosis of the disorder. Secondary and exploratory outcomes will be based on self-reported health and multi-omic data. Data analysis will include between-group and longitudinal within-group analyses.

Perspectives: The MINDS protocol and trial aims to clarify the impact of MLI on the progression of neurological disorder risk or diagnosis in older adults and to identify biomarkers that can be used to confirm MLI efficacy. The ability to validate the impact of MLI on neurological disorder progression based on biomarker data allows the identification of individuals most likely to benefit from such therapies in the early stages of neurological disease.

Trial registration: The trial is registered on the National Institutes of Health (NIH) ClinicalTrials.gov (NCT05984056) site. It was registered on August 2nd, 2023. The trial has full approval of the Cleveland Clinic Internal Review Board.

导言:鉴于神经系统疾病的发病率和惊人的费用,我们迫切需要有效的早期检测和干预工具。新出现的证据表明,多学科生活方式干预(MLI)可降低神经系统疾病的风险和病情发展。本方案的目标是:(1) 检验多学科生活方式干预对神经系统疾病进展的影响;(2) 确定神经系统疾病早期阶段的多组学生物标志物以及多学科生活方式干预对这些生物标志物的影响:我们提出了针对静默期神经系统疾病的多学科生活方式干预(MINDS)方案,这是一项针对神经系统健康的老年人(≥ 50 岁)的多学科生活方式干预随机对照试验,这些老年人患常见神经系统疾病(中风、癫痫、帕金森病或阿尔茨海默病及相关痴呆症)的风险较高。参与者将被随机分配到干预组(100 人)或对照组(100 人)。干预组将接受为期 3 个月每周 2 小时的饮食教育、瑜伽、音乐疗法和认知技能培训。在为期 12 个月的时间里,将定期对参与者的神经系统健康状况和参与相关生活方式的情况进行评估。将在基线期、入组后 3 个月和 12 个月收集神经影像和多组学分析样本。主要结果将是使他们有资格参加研究的神经系统疾病风险的进展迹象或疾病的临床诊断。次要和探索性结果将基于自我健康报告和多组数据。数据分析将包括组间分析和组内纵向分析:MINDS方案和试验旨在阐明MLI对老年人神经系统疾病风险或诊断进展的影响,并确定可用于确认MLI疗效的生物标志物。根据生物标志物数据验证MLI对神经系统疾病进展的影响,可以在神经系统疾病的早期阶段识别出最有可能从这种疗法中获益的个体:该试验已在美国国立卫生研究院(NIH)ClinicalTrials.gov(NCT05984056)网站注册。注册日期为 2023 年 8 月 2 日。该试验已获得克利夫兰诊所内部审查委员会的全面批准。
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引用次数: 0
Endovascular thrombectomy in patients with anterior circulation stroke: an emulated real-world comparison. 前循环中风患者的血管内血栓切除术:模拟真实世界的比较。
Q2 Medicine Pub Date : 2024-07-25 DOI: 10.1186/s42466-024-00331-6
Jochen A Sembill, Maximilian I Sprügel, David Haupenthal, Svenja Kremer, Michael Knott, Iris Mühlen, Bernd Kallmünzer, Joji B Kuramatsu

Background: Endovascular thrombectomy (EVT) has been proven effective in anterior circulation stroke due to large vessel occlusion (LVO). However, translation from randomized clinical trials (RCTs) with highly selected patients to real-world requires confirmation, particularly to identify associations outside of strict selection criteria.

Aims: This study aims to compare functional outcomes after EVT in real-world with those reported in RCTs, and to identify associations with functional outcome after EVT outside RCT-criteria.

Methods: This study analyzed longitudinal German real-world data from the Stroke Research Consortium in Northern Bavaria (STAMINA) cohort from January, 2015 to June, 2019. We conducted a trial emulation, comparing patients with anterior circulation stroke and LVO meeting selection criteria for RCTs investigating EVT (1) predominantly within 6 hours with those from HERMES meta-analysis, and (2) within 6-24 hours with those from AURORA meta-analysis. We (3) analyzed treatment effects of EVT and association with functional outcome in patients treated outside RCT criteria.

Results: Of 598 patients, 281 (47.0%) met RCT-criteria for treatment within 6 hours (hereinafter STAMINA-HERMES), 74 (12.4%) met RCT-criteria for treatment within 6-24 hours (STAMINA-AURORA), and 277 (46.3%) patients received EVT outside RCT-criteria. We observed no difference in rates of functional independence or mortality, comparing STAMINA-HERMES with HERMES meta-analysis (mRS 0-1: n=120/281 [43%] vs. 291/633 [46%], p=0.36; mortality: n=34/281 [12%] vs. 97/633 [15%], p=0.20), and STAMINA-AURORA with AURORA meta-analysis (mRS 0-1: n=26/74 [35%] vs. 122/266 [46%], p=0.10, mortality: n=10/74 [14%] vs. 45/266 [17%], p=0.48). Patients treated outside RCT-criteria had worse outcome (mRS 0-1: n=38/277 [14%], mortality: n=90/277 [32%], both p<0.001); possibly driven by pre-existing functional dependence (n=172/277 [62%]). Compared to matched controls, EVT outside of RCT-criteria was associated with lower mortality (absolute treatment effect: -14%, 95% Confidence Interval [CI] -23 to -5, p<0.01), but not with recovery to functional independence or premorbid functional status (treatment effect: 4%, CI -4 to 11, p=0.34), which was associated with lower NIHSS (Odds ratio [OR] 0.86, CI 0.80-0.92, p<0.001) and age (OR 0.95, CI 0.93-0.98, p=0.002).

Conclusions: Translation of EVT outcomes reported in RCTs into real-world is possible, however, almost half of patients did not meet trial criteria. Identification of patients who functionally benefit from frequently performed EVT outside RCT-criteria requires further investigation.

Trial registration: Clinicaltrials.gov, NCT04357899.

背景:血管内血栓切除术(EVT)已被证实对大血管闭塞(LVO)引起的前循环卒中有效。目的:本研究旨在比较真实世界中 EVT 后的功能预后与 RCT 中报告的功能预后,并识别 RCT 标准之外 EVT 后功能预后的相关性:本研究分析了德国北部巴伐利亚州卒中研究联合会(STAMINA)队列从2015年1月至2019年6月的纵向真实世界数据。我们进行了试验仿真,比较了符合研究 EVT 的 RCT 选择标准的前循环卒中和 LVO 患者:(1)主要在 6 小时内与 HERMES 荟萃分析中的患者进行比较;(2)在 6-24 小时内与 AURORA 荟萃分析中的患者进行比较。我们(3)分析了EVT的治疗效果以及在RCT标准之外接受治疗的患者的功能预后:在 598 名患者中,有 281 人(47.0%)符合 6 小时内治疗的 RCT 标准(以下简称 STAMINA-HERMES),74 人(12.4%)符合 6-24 小时内治疗的 RCT 标准(STAMINA-AURORA),277 人(46.3%)在 RCT 标准之外接受了 EVT 治疗。我们观察到,STAMINA-HERMES 和 HERMES meta 分析在功能独立率或死亡率方面没有差异(mRS 0-1:n=120/281 [43%] vs. 291/633 [46%],p=0.36;死亡率:n=34/281 [12%] vs. 97/633 [15%],p=0.20),以及 STAMINA-AURORA 与 AURORA 的荟萃分析(mRS 0-1:n=26/74 [35%] vs. 122/266 [46%],p=0.10;死亡率:n=10/74 [14%] vs. 45/266 [17%],p=0.48)。在RCT标准之外接受治疗的患者预后较差(mRS 0-1: n=38/277 [14%],死亡率:n=90/277 [32%],均为p结论:将 RCT 报告的 EVT 结果转化为现实世界是可能的,但是,几乎一半的患者不符合试验标准。在RCT标准之外,识别从频繁进行的EVT中获益的患者还需要进一步研究:试验注册:Clinicaltrials.gov,NCT04357899。
{"title":"Endovascular thrombectomy in patients with anterior circulation stroke: an emulated real-world comparison.","authors":"Jochen A Sembill, Maximilian I Sprügel, David Haupenthal, Svenja Kremer, Michael Knott, Iris Mühlen, Bernd Kallmünzer, Joji B Kuramatsu","doi":"10.1186/s42466-024-00331-6","DOIUrl":"10.1186/s42466-024-00331-6","url":null,"abstract":"<p><strong>Background: </strong>Endovascular thrombectomy (EVT) has been proven effective in anterior circulation stroke due to large vessel occlusion (LVO). However, translation from randomized clinical trials (RCTs) with highly selected patients to real-world requires confirmation, particularly to identify associations outside of strict selection criteria.</p><p><strong>Aims: </strong>This study aims to compare functional outcomes after EVT in real-world with those reported in RCTs, and to identify associations with functional outcome after EVT outside RCT-criteria.</p><p><strong>Methods: </strong>This study analyzed longitudinal German real-world data from the Stroke Research Consortium in Northern Bavaria (STAMINA) cohort from January, 2015 to June, 2019. We conducted a trial emulation, comparing patients with anterior circulation stroke and LVO meeting selection criteria for RCTs investigating EVT (1) predominantly within 6 hours with those from HERMES meta-analysis, and (2) within 6-24 hours with those from AURORA meta-analysis. We (3) analyzed treatment effects of EVT and association with functional outcome in patients treated outside RCT criteria.</p><p><strong>Results: </strong>Of 598 patients, 281 (47.0%) met RCT-criteria for treatment within 6 hours (hereinafter STAMINA-HERMES), 74 (12.4%) met RCT-criteria for treatment within 6-24 hours (STAMINA-AURORA), and 277 (46.3%) patients received EVT outside RCT-criteria. We observed no difference in rates of functional independence or mortality, comparing STAMINA-HERMES with HERMES meta-analysis (mRS 0-1: n=120/281 [43%] vs. 291/633 [46%], p=0.36; mortality: n=34/281 [12%] vs. 97/633 [15%], p=0.20), and STAMINA-AURORA with AURORA meta-analysis (mRS 0-1: n=26/74 [35%] vs. 122/266 [46%], p=0.10, mortality: n=10/74 [14%] vs. 45/266 [17%], p=0.48). Patients treated outside RCT-criteria had worse outcome (mRS 0-1: n=38/277 [14%], mortality: n=90/277 [32%], both p<0.001); possibly driven by pre-existing functional dependence (n=172/277 [62%]). Compared to matched controls, EVT outside of RCT-criteria was associated with lower mortality (absolute treatment effect: -14%, 95% Confidence Interval [CI] -23 to -5, p<0.01), but not with recovery to functional independence or premorbid functional status (treatment effect: 4%, CI -4 to 11, p=0.34), which was associated with lower NIHSS (Odds ratio [OR] 0.86, CI 0.80-0.92, p<0.001) and age (OR 0.95, CI 0.93-0.98, p=0.002).</p><p><strong>Conclusions: </strong>Translation of EVT outcomes reported in RCTs into real-world is possible, however, almost half of patients did not meet trial criteria. Identification of patients who functionally benefit from frequently performed EVT outside RCT-criteria requires further investigation.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT04357899.</p>","PeriodicalId":94156,"journal":{"name":"Neurological research and practice","volume":"6 1","pages":"37"},"PeriodicalIF":0.0,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11270839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141763597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Endovascular treatment of primary M3 occlusion stroke in clinical practice: analysis of the German Stroke Registry. 原发性 M3 闭塞中风的血管内治疗临床实践:德国中风登记分析。
Q2 Medicine Pub Date : 2024-07-18 DOI: 10.1186/s42466-024-00330-7
Niklas M Beckonert, Johannes M Weller, Anna C Alegiani, Tobias Boeckh-Behrens, Milani Deb-Chatterji, Gerhard F Hamann, Lars U Krause, Nils C Lehnen, Louisa Nitsch, Sven Poli, Christian Riedel, Steffen Tiedt, Sarah Zweynert, Gabor C Petzold, Franziska Dorn, Felix J Bode

Background: Endovascular treatment (ET) options for acute stroke due to distal middle cerebral artery occlusions are rapidly evolving, but data on outcome and safety are sparse. We therefore performed an analysis of patients undergoing ET for primary M3 occlusions in routine clinical practice in a nationwide registry.

Methods: Patients enrolled between 01/20 and 12/21 in the prospective, multicenter German Stroke Registry-Endovascular Treatment (GSR-ET) were screened for mechanical thrombectomy performed for primary M3 occlusion. We analyzed neurological deficit as measured by the National Institute of Health Stroke Scale (NIHSS), symptomatic intracranial hemorrhage (sICH), thrombectomy technique, successful reperfusion (modified Thrombolysis in Cerebral Infarction [mTICI] score of 2b-3) and functional outcome as measured by the modified Rankin Scale (mRS) at discharge and 90 days.

Results: Out of 5574 patients, 11 patients (0.2%, median age 80 years, 54.5% female) underwent ET for primary M3 occlusion. All patients had pre-admission mRS ≤ 1, median NIHSS on admission was 8, and successful reperfusion was achieved in 6/11 patients (54.5%). While no vasospasm, dissection or perforation was reported, symptomatic intracranial hemorrhage occurred in 2 patients (18.2%). Favorable outcome (mRS ≤ 2) was achieved in 6/11 patients (54.5%) at 90-day follow-up.

Conclusions: ET for primary M3 occlusions is rarely performed. While technically feasible, the procedure's potential benefits must be carefully weighed against its associated risks, including clinically relevant complications. Caution and further research is needed to optimize patient selection for this intervention.

Trial registration: GSR-ET; ClinicalTrials.gov Identifier: NCT03356392; Trial Registration Date: 11/29/2017.

背景:针对大脑中动脉远端闭塞导致的急性卒中的血管内治疗(ET)方案发展迅速,但有关疗效和安全性的数据却很少。因此,我们在一个全国范围的登记处对常规临床实践中接受 ET 治疗原发性 M3 闭塞的患者进行了分析:方法:我们筛选了在 20 年 1 月至 21 年 12 月期间入选前瞻性多中心德国卒中登记-血管内治疗(GSR-ET)的患者,对其进行机械血栓切除术治疗原发性 M3 闭塞。我们分析了美国国立卫生研究院卒中量表(NIHSS)测量的神经功能缺损、症状性颅内出血(sICH)、血栓切除技术、再灌注成功率(改良脑梗塞溶栓治疗[mTICI]评分为2b-3)以及出院时和90天后改良Rankin量表(mRS)测量的功能预后:在5574名患者中,有11名患者(0.2%,中位年龄80岁,54.5%为女性)因M3原发性闭塞而接受了ET治疗。所有患者入院前 mRS 均小于 1,入院时 NIHSS 中位数为 8,6/11 患者(54.5%)成功实现了再灌注。虽然没有血管痉挛、夹层或穿孔的报道,但有2名患者(18.2%)出现了无症状的颅内出血。在90天的随访中,6/11名患者(54.5%)获得了良好的治疗效果(mRS≤2):结论:M3原发性闭塞的ET手术很少实施。尽管技术上可行,但必须仔细权衡该手术的潜在益处和相关风险,包括临床相关并发症。需要谨慎行事并开展进一步的研究,以优化对患者的选择:试验注册:GSR-ET;ClinicalTrials.gov Identifier:试验注册:GSR-ET;ClinicalTrials.gov Identifier:NCT03356392;试验注册日期:2017年11月29日。
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Neurological research and practice
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