Search

目的 分析自发性椎动脉夹层（spontaneous vertebral artery dissection，sVAD）、椎-基底动脉夹层（spontaneous vertebral-basilar artery dissection，sV-BAD）及基底动脉夹层（spontaneous basilar artery dissection，sBAD）相关脑梗死病灶分布特征及其与病变血管节段间的关系。 方法 本研究为单中心、回顾性研究，连续纳入2015年1月1日—2021年11月15日出院诊断为sVAD、sV-BAD和sBAD相关脑梗死住院患者，收集患者的一般临床资料、既往病史、脑梗死病灶特点、受累血管节段等信息。根据脑梗死病灶数量将患者分为单发脑梗死组和多发脑梗死组，比较两组上述指标的差异。 结果 本研究共入组41例患者，其中单发脑梗死组患者17例（41.5%），多发脑梗死组24例（58.5%）。单发脑梗死组与多发脑梗死组不同受累血管节段患者数量对比：V3段[右侧7（41.2%）vs. 8（33.3%），P=0.61；左侧7（41.2%）vs. 7（29.2%），P=0.42]；V4段[右侧9（52.9%）vs. 6（25.0%），P=0.07；左侧 6（35.3%）vs. 8（34.8%），P=0.97]，差异均无统计学意义。单发脑梗死组与多发脑梗死组不同脑梗死部位的患者数量对比：丘脑[0（0）vs. 9（39.1%），P=0.005]、枕叶[0（0）vs. 8（33.3%），P=0.01]、小脑[2（11.8%）vs. 20（83.3%），P＜0.001]、脑桥[1（5.9%）vs. 11（45.8%），P=0.006]、延髓 [14（82.4%）vs. 3（12.5%），P＜0.001]，单发脑梗死组延髓最多见，其余部位在多发脑梗死组更多见，差异均有统计学意义。单发脑梗死组与多发脑梗死组不同受累血管节段数量的患者例数对比：单一节段7（41.2%）vs. 9（37.5%）、两个节段7（41.2%）vs. 9（37.5%）、多节段3（17.6%）vs. 6（25.0%），差异无统计学意义（P=0.68）。 结论 本研究纳入的sVAD、sV-BAD和sBAD相关脑梗死病例中，单发脑梗死病灶多见于延髓，主要受累血管节段为V3段、V4段，脑梗死病灶数量与受累动脉节段数之间的关系尚不明确。 Objective To investigate the relationship between the distribution characteristics of cerebral infarction and vascular segments in patients with spontaneous vertebral artery dissection (sVAD), spontaneous vertebral-basilar artery dissection (sV-BAD) and spontaneous basilar artery dissection dissection (sBAD). Methods This was a single-center retrospective study. Hospitalized patients diagnosed with cerebral infarction caused by sVAD, sV-BAD and sBAD from January 1, 2015 to November 15, 2021 were continuously enrolled. General clinical data, past medical history, characteristics of cerebral infarction lesions, and involved vascular segments of patients were collected. The patients were divided into single cerebral infarction group and multiple cerebral infarction group according to the number of cerebral infarction lesions. The differences of the above indexes were compared between the two groups. Results A total of 41 patients were enrolled in this study, including 17(41.5%) in single cerebral infarction group and 24(58.5%) in multiple cerebral infarction group. Comparison of the main affected vascular segments between single cerebral infarction group and multiple cerebral infarction group: V3 segment[right side 7(41.2%) vs. 8(33.3%), P=0.61; left side 7(41.2%) vs. 7(29.2%), P=0.42]; V4 segment[right side 9(52.9%) vs. 6(25.0%), P=0.07; left side: 6(35.3%) vs. 8(34.8%), P=0.97]. The difference was not statistically significant. Comparison of the location of cerebral infarction between single cerebral infarction group and multiple cerebral infarction group: thalamus [0(0) vs. 9(39.1%), P=0.005], occipital lobe [0(0) vs. 8(33.3%), P=0.01], cerebellum [2(11.8%) vs. 20(83.3%), P

目的 本研究自发性颈动脉夹层涉及自发性颈总动脉分叉夹层（spontaneous common carotid artery bifurcation dissection，sCCABD）及自发性颈内动脉夹层（spontaneous internal carotid artery dissection，sICAD），对与此相关的缺血性卒中颅内缺血病灶分布特征与受累血管节段间的关系进行分析。 方法 本研究为单中心回顾性研究，连续入组2014年12月1日—2021年11月15日住院的sCCABD及sICAD相关缺血性卒中患者，收集患者一般临床资料、既往病史、影像学特征等信息。将患者分为颅内无梗死病灶组、单发梗死病灶组和多发梗死病灶组3组，比较不同组患者的影像学特征、受累血管部位及节段数等的差异。 结果 研究纳入sCCABD及sICAD相关缺血性卒中患者17例，其中无梗死病灶组2例，单发梗死病灶组4例，多发梗死病灶组11例。无梗死病灶组夹层发生于C1升段（2例）、C2段（1例）、C3段（1例）、C4段（1例），单发梗死病灶组夹层在C1升段（5例）最多见，多发梗死病灶组夹层多发生于C1升段（5例）和C3段（5例），C2段（4例）、C1球部（3例）和C4段（3例）次之，颈总动脉分叉（1例）和C5段（1例）最少。脑梗死灶分布模式：单发梗死病灶组表现为区域性梗死（2例）、局部梗死（1例）、深部较大梗死 （1例）；多发梗死病灶组以内分水岭梗死（4例）、区域性梗死（3例）最多见，局部梗死（2例）、深部较大梗死（2例）次之，浅表小面积梗死（1例）、深部较小梗死（1例）最少。 结论 本研究sCCABD及sICAD相关缺血性卒中患者以多发脑梗死居多，血管夹层多发生于C1升段和C3段，C1球部、C2段和C4段次之，颈总动脉分叉和C5段最少，球部可以受累或闭塞，颅内缺血病灶的多少与受累血管节段数量间的关系还不明确，还需进一步积累病例深入探讨。 Abstract: Objective The aim of the study is to investigate the relationship between the characteristics of ischemic infarction distribution and involved artery segments in patients with ischemic stroke caused by spontaneous carotid artery dissection. Spontaneous carotid artery dissection includes spontaneous common carotid artery bifurcation dissection (sCCABD) and spontaneous internal carotid artery dissection (sICAD). Methods This was a single-center retrospective study. Patients hospitalized from December 1, 2014 to November 15, 2021 were continuously recruited. They were treated for ischemic stroke caused by spontaneous carotid artery dissection (sCCABD or sICAD or both). For each patient, the clinical data, medical history, imaging characteristics, and other relevant information were collected. Then they were divided into three groups as no cerebral infarction, single infarction, and multiple infarctions and compared by radiological findings, involved vascular location, and segments of arteries. Results A total of 17 patients with ischemic stroke caused by spontaneous carotid artery dissection (sCCABD or sICAD or both) were included, including two patients with no infarction, four patients with a single infarction, and 11 patients with multiple infarctions. In the no infarction group, the arterial dissection location included C1 ascending (two cases), C2, C3, and C4 segments of the internal carotid artery (one case, respectively). Dissections were mainly found in the C1 ascending segment in the single infarction group (five cases). In the multiple infarctions group, arterial dissection occurred mostly in the C1 ascending and C3 segment (five cases, respectively), followed by the C2 (four cases), C1 bulbar (three cases), and C4 segment (three cases), and least in the common carotid artery bifurcation segment and C5 segment (one case, respectively). As for infarction location, territorial infarction (two cases), localized infarction (one case), and deep larger infarction (one case) were found in the single infarction group; internal watershed infarction (four cases), territorial infarction (three cases), localized infarction (two cases), deep larger infarction (two cases), small superficial (one case), and deep lacunar infarction (one case) were revealed in the multiple infarction group. Conclusions In this study, multiple infarctions are more common in patients with ischemic stroke caused by spontaneous carotid artery dissection (sCCABD or sICAD or both). Dissection occurs mostly in C1 ascending and C3 segments of carotid artery, followed by the C1 bulbar, C2 and C4 segments, and rarely in the bifurcation of the common carotid artery and C5 segment of the internal carotid artery. Furthermore, the spontaneous dissection could occur in the carotid bulb and cause its occlusion. The relationship between the numbers of cerebral infarction and the involved dissected artery segments is to be explored by more cases in future.

针对脑血管病的危险因素积极进行早期干预管理是减少脑血管病危害最有效的方法。本章节介绍脑血管病高危人群管理的推荐意见，包括对不可干预和可干预血管危险因素的控制，阿司匹林在缺血性卒中一级预防中的应用以及首次卒中风险评估等方面。 Abstract: Early intervention to manage the risk factors of cerebrovascular disease is the most effective way to reduce the harm of cerebrovascular diseases. This chapter presents recommendations for the management of populations at high risk for cerebrovascular disease, including control of non-interventionable and interventionable vascular risk factors, the use of aspirin in the primary prevention of ischaemic stroke, and the risk assessment of first-time stroke.

临床试验是评估新药或新疗法有效性和安全性最有效的方法，可以提供高质量的循证医学证据。近年来全球的临床试验数量逐渐增加，试验结果为阴性十分常见。当临床试验的主要结果为阴性时，并不一定就意味着研究的失败，研究者还需要多方考虑以便从中找到潜在益处的线索。本文阐述了临床试验主要结局为阴性时需要考虑的12个要点，并以吲哚布芬对比阿司匹林治疗急性缺血性卒中（indobufen versus aspirin in acute ischemic stroke，INSURE）研究为例进行讨论，以期为后续的临床试验设计和结果解读提供经验。 Abstract: Clinical trials are the most effective method for evaluating the efficacy and safety of new drugs or new therapies, and can provide high-quality evidence-based medical evidence. In recent years, the number of clinical trials worldwide increased gradually, negative results from clinical trials are very common. When the main result of a clinical trial is negative, it does not necessarily mean that the study is a failure, and researchers should consider multiple factors to find potential benefits. Therefore, we elaborated in detail the 12 key points to consider, when encountering the negative primary outcome, and discussed by taking indobufen versus aspirin in acute ischemic stroke (INSURE) study as an example provide reference experience for subsequent clinical research design and results interpretation.

非劣效性设计临床试验是一类检验试验组治疗手段是否不劣于对照组治疗手段的随机对照临床试验。本文简要介绍非劣效性设计临床试验的基本概念、设计要点及其与等效性和优效性设计临床试验的差异，并通过具体案例解读，帮助读者全面了解、实施和评价非劣效性设计方法。 【Abstract】 A noninferiority design clinical trial is a type of randomized controlled clinical trials that examines whether the treatment of the experimental group is not inferior to the treatment of the control group. This paper introduces the basic concept, design points,comparison with equivalence and superiority trials, and case analysis to help readers fully understand, implement and evaluate noninferiority design clinical trials.

真实世界研究起源于实用性临床试验，在真实临床实践中评估干预的有效性和安全性，对随机对照试验以外临床疗效评价进行补充。然而，此类研究缺乏随机化，因此对混杂偏倚的控制尤为重要。倾向性评分法对多个混杂因素/协变量进行校正，是真实世界研究控制混杂因素的重要分析方法。本文介绍匹配法、分层法、协变量校正法和逆概率加权法这4种倾向性评分法，并阐述各自的优缺点。随后结合脑血管病临床研究特点，通过研究案例重点介绍倾向性评分法在脑血管病真实世界研究中的应用。 Abstract: Real-world studies, originating from pragmatic clinical trials, evaluate the effectiveness and safety of interventions in real clinical practice, as a supplement for randomized controlled trials to evaluate the effectiveness of intervention measures in real clinical environment. However, the control of confounding factors is particularly important as this type of study lacks randomization. The propensity score method, which can adjust for multiple confounders/covariates, is an important analysis method for controlling confounders in real world studies. This article introduced four methods of propensity score and discussed their advantages and disadvantages; and introduced the application of propensity score method in the real-world research on cerebrovascular disease through case studies, combined with the characteristics of clinical research on cerebrovascular disease.

实效性临床试验（pragmatic clinical trials，PCT）作为真实世界研究的重要构成，在临床研究设计中越来越受到关注和重视。然而，目前对PCT的理解和应用仍存在的一些误区。因此，本文首先从PCT的概念、研究策划与设计、研究目的、常见的设计类型和核心特征等方面进行阐述，使读者全面和正确地认识PCT。其次，本文详述了PCT的使用范围、基本的统计分析原则与各类型试验设计的分析要求。最后，本文明确了此类研究的报告规范。 Abstract: Pragmatic clinical trials (PCT), as a important component of real-world research, attracted more and more attention in clinical study design. However, there exists some confusions in understanding and application of PCT. Therefore, this article provided technical specifications of PCT in terms of the concept, study planning and design, purpose, design types and core features, to make readers have a comprehensive and correct understanding of PCT; in addition, the application scope, basic statistical analysis principles, analysis requirements for various types of study design, and the report standards of PCT were also elaborated.

目的 通过比较早期与晚期缺血性卒中临床路径医疗质量干预，评价2种临床路径质量干预方法对缺血性卒中医疗服务质量关键绩效指标的改进作用。 方法 前瞻性连续纳入全国202所医院2016年4月-2017年6月的缺血性卒中住院患者。入组医院按照地理位置、医院级别、是否教学医院进行匹配，分为早期临床路径医疗质量干预（早期干预）组和晚期临床路径医疗质量干预（晚期干预）组。研究根据时间顺序分为5个阶段，每3个月为1个阶段。早期干预组自第1阶段即开始进行临床路径干预，晚期干预组则在第3阶段开始进行临床路径干预。比较2组患者的基线特征及缺血性卒中医疗服务质量关键绩效指标，评估早期与晚期临床路径质量干预对医疗质量的影响。 结果 本研究中有91所医院随机进入早期干预组，111所医院随机进入晚期干预组，共纳入患者15 167例。在10个预设的缺血性卒中医疗服务质量关键绩效指标的执行率效果评价中，第1阶段，早期干预组患者出院时给予抗栓治疗的比例较晚期干预组高（95.6% vs. 92.7%，P=0.01）。第2阶段，早期干预组患者出院时给予抗栓治疗（94.9% vs. 92.4%，P=0.01）、出院时合并高血压的患者降压治疗的比例较晚期干预组高（68.3% vs. 63.7%，P=0.02）。第3阶段中，早期干预组患者较晚期干预组患者出院时给予抗栓治疗（94.2% vs. 90.8%，P=0.01）、出院时给予他汀类药物治疗的比例高（92.7% vs. 87.6%，P=0.01）。第4阶段中，早期干预组较晚期干预组入院48 h内患者不能行走进行深静脉血栓预防（54.7% vs. 41.6%，P=0.01）、出院时给予抗栓治疗（94.7% vs. 91.1%，P=0.01）、出院时给予他汀类药物治疗的比例高（93.6% vs. 88.5%，P=0.01）。第5阶段中，早期干预组患者较晚期干预组患者时间窗内rt-PA静脉溶栓率高（40.5% vs. 29.5%，P=0.04）。 结论 早期临床路径医疗质量干预有助于改善我国缺血性卒中患者的医疗服务质量关键绩效指标。 Abstract: Objective To evaluate the improvement effect of early and late clinical pathway quality interventions on key performance indicators of medical service quality for ischemic stroke. Methods This prospective randomized control register study included consecutive ischemic stroke patients from 202 national hospitals from April 2016 to June 2017. The enrolled hospitals were matched according to the principle of geographical location, hospital level, teaching hospital, and were divided into early clinical pathway medical quality intervention group (as “early intervention group”) and “late intervention group”. The study time was divided into 5 phases, with every 3 months as one phase. The early intervention group started intervention from phase 1, and the late intervention group started from phase 3. Baseline characteristics and key performance indicators of medical service quality for ischemic stroke in the two groups were compared to assess the impact of early and late clinical pathway quality intervention on medical quality. Results There were 91 hospitals in the early intervention group and 111 hospitals in the late intervention group. A total of 15 167 patients were enrolled. In the 10 key performance indicators of medical service quality for ischemic stroke, the rate of antithrombotic therapy at discharge was higher in the early intervention group than that in the late intervention group in the first stage (95.6% vs. 92.7%, P=0.01). In the second stage, the rate of antithrombotic therapy (94.9% vs. 92.4%, P=0.01) and antihypertensives therapy (68.3% vs. 63.7%, P=0.02) in patients with hypertension were higher in the early intervention group. In the third stage, the rate of antithrombotic therapy (94.2% vs. 90.8%, P=0.01) and statin therapy (92.7% vs. 87.6%, P=0.01) at discharge were higher in the early intervention group. In the fourth stage, the early intervention group had higher rates of DVT prophylaxis (54.7% vs. 41.6%, P=0.01), antithrombotic therapy (94.7% vs. 91.1%, P=0.01) and statin therapy (93.6% vs. 88.5%, P=0.01) at discharge than the late intervention group. In the fifth stage, the early intervention group had a higher rate of rt-PA intravenous thrombolysis than the late intervention group (40.5% vs. 29.5%, P=0.04). Conclusions Early clinical pathway medical quality intervention is helpful to improve the key performance indicators of medical service quality for ischemic stroke in China.

目的 探讨不同胰岛素抵抗状态对无糖尿病史的非致残性缺血性脑血管病（non-disabling ischemic cerebrovascular events，NICE）患者卒中复发风险的影响。 方法 使用稳态模型胰岛素抵抗（homeostasis model assessment of insulin resistance，HOMA-I R）指数 对胰岛素抵抗进行评估。根据不同胰岛素抵抗状态，使用四分位法将无糖尿病史的NICE患者分为4 组。该研究的主要研究终点为90 d新发卒中（包括缺血性和出血性卒中）。利用多元Cox回归模型校正 潜在协变量，评估不同胰岛素抵抗状态与卒中复发风险之间的关系，同时对不同抗血小板聚集治疗、 不同胰岛素抵抗状态与卒中复发之间的交互作用进行统计分析。 结果 本研究共纳入2325例NICE患者。根据患者不同胰岛素抵抗状态分组，4组界值分别为Q1 （HOMA-IR指数﹤1.35）、Q2（1.35≤HOMA-IR指数﹤2.17）、Q3（2.17≤HOMA-IR指数﹤3.39）及Q4（HOMAIR 指数≥3.39），4组患者人数分别为585例、575例、585例及580例。90 d随访时，共出现167例卒中复 发，其中氯吡格雷联合阿司匹林组为68例，阿司匹林组为99例。与Q1组（6.3%）比较，Q2组（9.2%，校 正HR 1.56，95%CI 1.01～2.41，P =0.04）、Q3组（5.6%，校正HR 1.04，95%CI 0.64～1.69，P =0.89）和 Q4组（7.6%，校正HR 1.35，95%CI 0.85～2.15，P =0.21）患者卒中复发风险均未明显上升。 结论 本研究未在NICE患者中发现胰岛素抵抗与卒中复发风险升高相关。 Abstract: Objective To explore the effect of different insulin resistance state on the prognosis of patients with non-disabling ischemic cerebrovascular events (NICE). Methods The homeostasis model HOMA-IR index was used to evaluate insulin resistance. According to different insulin resistance status, patients were divided into four groups by quartile method. The primary endpoint was 90-day new-onset stroke (including ischemic and hemorrhagic stroke). Multivariate Cox regression model was used to assess the relationship between different insulin resistance status and recurrent stroke. The interaction between different antiplatelet therapeutic regimen and different insulin resistance status on recurrent stroke was also analyzed. Results A total of 2325 NICE patients were enrolled in this study. According to different insulin resistance status, all patients were divided into 4 groups: Q1 (HOMA-IR index

目的 评估中国急性缺血性卒中和短暂性脑缺血发作（transient i schemic a ttack，TIA）患者二级预防 药物依从性的现状。 方法 中国国家卒中登记研究Ⅱ（China National Stroke Registry，CNSRⅡ）2012年6月-2013年1月连续 入组急性缺血性卒中和TIA的住院患者25 018例，收集患者人口学信息、临床特点及用药信息等资料， 统计患者发病后3个月、6个月及12个月的药物依从性。按照随访12个月时患者二级预防药物依从性分 为依从组和非依从组，比较两组患者的各因素特点，并对影响因素进行多因素分析。 结果 16 489例急性缺血性卒中和TIA患者完成12个月的随访。缺血性卒中二级预防药物总体依从性 3个月、6个月、12个月分别为47.0%、44.5%和34.9%。出院12个月时二级预防药物依从性最好的为降 糖药（63.86%），之后分别为降压药（61.9%）、抗血小板药（57.58%）、华法林（44.92%）和他汀类药 物（24.36%）。二级预防药物依从性多因素分析结果显示：高龄、女性、既往糖尿病史、本次发病为 TIA是卒中二级预防药物依从性偏低的影响因素，而既往有卒中病史的患者药物依从性相对较好。 结论 中国急性缺血性卒中和TIA患者二级预防药物总体依从性仍偏低，且随时间的延长逐渐下降。 Abstract: Objective To investigate the status of medication compliance in secondary prevention for ischemic stroke (IS) or transient ischemic attack (TIA). Methods From June 2012 to January 2013, 25 018 patients with acute ischemic stroke (AIS) or TIA were admitted in the China National Stroke Registry II (CNSR II). The data of patients’ demographics, clinical features and medications use in secondary prevention at 3, 6 and 12 months were collected. Medication persistence at 3, 6 and 12 months was defined as continuation of prescribed medications from discharge to every follow-up point. According to the drug compliance at 12 months, these patients were divided into compliance and noncompliance groups. The factor feature of both groups were compared, and multifactor analysis was conducted to identify the influence factors of drug compliance. Results 16 489 patients who completed 1-year follow-up were analyzed. The rate of secondary prevention medications compliance at 3, 6 and 12 months were 47.0%, 44.5% and 34.9%, respectively. Drugs compliance at 12 months after discharge as follows: the best compliance was diabetes drugs (63.86%), followed by antihypertensive drugs (61.9%), antiplatelet drugs (57.58%), warfarin (44.92%), and statins (24.36%). Multi-factor analysis showed that elder age, female, history of diabetes mellitus, and TIA of cerebrovascular events were influence factors of poor compliance to secondary prevention drugs treatment, while patients with history of stroke had better compliance to secondary prevention drugs. Conclusion The compliance of secondary prevention medications within 12 months in patients with IS and TIA were relatively low, and declined gradually over time.

目的 探讨颅内外动脉粥样硬化的相关因素是否存在差异。 方法 在中国颅内动脉粥样硬化研究的数据库中，将患者分为4组：无显著颅内外动脉狭窄或闭塞组、 单纯颅内动脉病变组、单纯颅外动脉病变组及颅内合并颅外动脉病变组。以无显著颅内外动脉狭窄 或闭塞组作为参考，应用多元Logistic回归分析，评估颅内外动脉病变的相关因素。 结果 共入组2864例缺血性脑血管病患者，其中无显著颅内外动脉狭窄或闭塞组1388例（48.5%）、 单纯颅内动脉病变组1074例（37.5%）、单纯颅外动脉病变组141例（4.9%）、颅内合并颅外动脉 病变组261例（9.1%）。多因素分析显示，单纯颅内动脉病变的独立相关因素包括：白质病变[比值比 （odds ratio，OR）1.359，95%（confidence interval，CI）1.109～1.666，P =0.0031] 、白细胞计数（OR 1.045， 95%CI 1.007～1.084，P =0.0210）、空腹血糖（OR 1.054，95%CI 1.009～1.101，P =0.0182）、高密度脂 蛋白（OR 0.644，95%CI 0.480～0.864，P =0.0034）；单纯颅外动脉病变的独立相关因素包括：高龄 （OR 1.047，95%CI 1.026～1.069，P