PTAS及内科治疗对症状性颅内动脉粥样硬化性狭窄疗效的对比研究

发布时间：2018-04-20 10:59

本文选题：脑卒中 + 症状性颅内动脉粥样硬化性狭窄　；参考：《第三军医大学》2016年硕士论文

【摘要】：背景:脑卒中是我国的常见病和多发病,具有高发病率、高致残率、高死亡率、高复发率、高经济负担五大特点。颅内动脉粥样硬化性狭窄(Intracranial atherosclerotic stenosis,ICAS)是导致缺血性卒中的重要因素,尤其是在包括我国在内的亚洲人群。对ICAS的诊治对我国缺血性卒中的防治意义重大。根据ICAS是否有狭窄血管区域缺血性卒中或短暂性脑缺血发作(transient ischemic attacks,TIA)发生分为症状性颅内动脉粥样硬化性狭窄(symptomatic intracranial atherosclerotic stenosis,s ICAS)和无症状性颅内动脉粥样硬化性狭窄(asymptomatic intracranial atherosclerotic stenosis,a ICAS)。s ICAS患者再发卒中的风险很高,且与血管的狭窄程度呈正相关。关于s ICAS治疗目前尚有争议。在WASID(the Warfarin versus Aspirin Symptomatic Intracranial Disease Study for Stroke)研究中,对重度s ICAS(狭窄率70%?99%)亚组分析发现,即使进行了内科治疗,在1.8年的平均随访期内卒中复发率仍高达19%,此后人们将s ICAS的治疗寄希望于经皮血管腔内成形和支架植入术(percutaneous transluminal angioplasty and stenting,PTAS)[1]。而前期的一些单中心、非随机研究和登记研究也发现,s ICAS患者行PTAS有较好的安全性和有效性[2]。然而,2011年发表的SAMMPRIS(stenting versus aggressive medical therapy for intracranial arterial stenosis)研究[3]却因支架组30天内主要终点事件明显高于内科组(分别为14.7%、5.8%)而被提前终止。由于SAMMPRIS研究是首个多中心、前瞻性、对照、随机研究,此后各国指南均将s ICAS的治疗方法首先推荐为强化内科治疗(aggressive medical management,AMM)而非PTAS,s ICAS的PTAS自此蒙上阴影。SAMMPRIS研究发表后受到了各国学者的广泛质疑,质疑的内容包括入组标准、研究中心的选择、术者熟练程度、强化内科组中危险因素控制及生活方式改变在真实世界中难以达到等现状,因此该项研究结果对国内真实世界中s ICAS患者的治疗并无太多指导意义。而且由于我国为s ICAS的大国,且目前许多中心仍将PTAS做为s ICAS治疗的主要手段,在目前我国不能开展相关的随机对照试验研究的情况下,有必要继续观察国内s ICAS患者在真实世界中PTAS与强化内科治疗对的差异本研究旨在探讨在第三军医大学西南医院神经内科就诊的s ICAS患者安全有效的临床治疗方法,其结果将为重度颅内动脉粥样硬化性狭窄或闭塞病变患者选择治疗方案上提供参考。本研究共有两部分,一部分是回顾性研究,另一部分为前瞻性研究。目的:1、观察本医疗中心PTAS治疗s ICAS的安全性和有效性,并与内科治疗进行对比;2、观察PTAS与内科治疗对血管狭窄程度的影响;3、观察PTAS与内科治疗对s ICAS患者神经功能的影响。方法:1、PTAS与内科治疗对症状性颅内动脉粥样硬化性狭窄患者再发缺血性卒中/TIA的疗效的回顾性研究(1)回顾性分析2009年1月至2014年12月在我科经全脑血管造影证实狭窄率50%?99%的s ICAS患者的相关临床病例资料。观察患者内科治疗与PTAS的差异;(2)收集30天内并发症的临床资料,电话随访患者出院后1年内再发卒中/TIA的情况,以及其他不良事件(出血、心肌梗死等)发生的情况,随访患者m RS评分等变化;(3)统计学分析卒中/TIA复发、不良事件等情况。2、PTAS与内科治疗对症状性颅内动脉粥样硬化性狭窄患者再发缺血性卒中/TIA的疗效的前瞻性研究(1)所有经DSA检查证实狭窄率70%?99%(使用WASID试验方法计算责任血管狭窄率)的s ICAS患者。与患者及其家属进行有效沟通,在其充分了解试验方案后作出治疗选择,自愿选择是否行PTAS,而给予药物治疗后若更改方案则退出入组;(2)治疗方案共分两组:内科组:单独强化内科治疗,包括双联抗血小板聚集治疗3个月(阿司匹林100mg/天+氯吡格雷75mg/天)后改为阿司匹林(100mg/天)或氯吡格雷(75mg/天)单独抗血小板聚集治疗终生、强化他汀治疗、全程强化管理血管病危险因素、改善生活方式;PTAS组:在强化内科治疗的基础上,进行个体化PTAS;(3)受试者入组后30天、3个月、6个月及12月进行门诊、住院、电话随访评估终点事件以及其他不良事件发生情况。主要终点事件定义为:1年所有血管事件包括死亡的发生率;次要终点事件定义为:1)30天内所有卒中或死亡;2)1年内血管狭窄情况或支架再狭窄发生率,12月内对患者进行NIHSS评分、m RS评分。结果:1、PTAS组与内科治疗对症状性颅内动脉粥样硬化性狭窄患者再发缺血性卒中/TIA的疗效的回顾性研究(1)共回顾性筛查456例,最终纳入245例(内科组和PTAS组分别有181、64例),经统计学分析:内科组和PTAS组1年所有血管事件包括死亡发生率,分别为20.4%、9.4%,有明显差异(p0.05)。其中两组同侧卒中复发率分别为14.9%、3.1%,内科组27例,PTAS组中2例,有明显差异(p0.05);两组非同侧卒中复发率分别为0.5%、0%,无明显差异(p0.05);两组死亡率分别为1.1%、0%,内科组2例,PTAS组无死亡例,无明显差异(p0.05);(2)30天内所有卒中或死亡发生率:内科组和PTAS组分别为3.9%、6.3%,无明显差异,(p0.05)。其他不良事件:两组DSA术后发生医源性假性动脉瘤(femoral pseudoaneurysm,FPA)内科组和PTAS组分别为1.1%、0%,无明显差异(p0.05);两者所有出血发生率分别为6.1%、7.8%,无明显差异(p0.05);(3)1年内无明显或轻度神经功能残障的患者,即m RS≤2分,内科组和PTAS组所占的比例分别为63.0%、92.2%,两组之间有明显统计学差异(p0.05)。2、PTAS组与内科治疗对症状性颅内动脉粥样硬化性狭窄患者再发缺血性卒中/TIA的疗效的前瞻性研究(1)基线特征:连续纳入112例患者,内科组和PTAS组分别为76、36例,经统计两组在基线水平上是一致的;(2)PTAS组的36例患者手术成功率100%,其中2名行单纯球囊扩张术,18名行自膨式支架植入术,16名行球扩式支架植入术。内科组和PTAS组1年所有血管事件包括死亡的发生率,分别为19.7%、5.6%,有明显差异(p0.05)。其中两组同侧卒中复发率分别为18.4%、2.8%,有明显差异(p0.05)。两组非同侧卒中复发率分别为3.9%、0%,无明显差异(p0.05)。两组TIA复发率分别为1.3%、0%,无明显差异(p0.05)。两组均无急性冠脉综合征等其他血管事件发生,无死亡发生;(3)内科组和PTAS组30天内所有卒中或死亡的发生率分别为0%、2.8%,无明显差异(p0.05)。两组患者入组30天内均未出现死亡病例;(4)两组随访1年时血管狭窄率分别为87.3?11.2(%)、13.9?17.5(%),有统计学差异(p0.05)。在内科组中治疗前与治疗后血管狭窄率分别为86.1?12.3(%)、87.3?11.2(%),有明显差异(p0.05)。在PTAS组中术前狭窄率、术后残余狭窄率分别为83.9?10.3(%)、10.1?7.6(%),有明显差异(p0.05)。随访期间发现PTAS组狭窄率13.9?17.5(%),与治疗前83.9?10.3(%)相比有明显差异(p0.05)。支架内再狭窄率为8.8%;(5)PTAS组对神级功能的影响:内科组和PTAS组中NIHSS≤3分分别有69、34例,无统计学差异(p0.05)。两组m RS≤2分分别为62、35例,有明显差异(p0.05)。内科组治疗前与治疗后NIHSS≤3分分别为48、69例,有明显差异(p0.05),其治疗前和治疗后的m RS≤2分分别为76、62例,有明显差异(p0.05)。PTAS组治疗前与治疗后NIHSS≤3分分别为26、34例,有明显差异(p0.05),其治疗前和治疗后m RS≤2分分别为36、35例,两者之间无统计学差异(p0.05)。结论:1、PTAS可预防s ICAS患者1年内复发卒中/TIA,且优于单独强化内科治疗;2、PTAS在严格筛选病例以及行个体化PTAS的基础上是安全可行的;3、单独强化内科组的狭窄病灶未见明显改善,强化内科治疗联合PTAS能明显改善血管狭窄,且其神经功能治疗前后有明显改善;4、PTAS是预防高危s ICAS患者缺血性卒中/TIA再发的安全、有效的治疗方法之一。
[Abstract]:Background: stroke is a common and frequently occurring disease in China, with high morbidity, high mortality, high mortality, high recurrence rate and high economic burden. Intracranial atherosclerotic stenosis (Intracranial atherosclerotic stenosis, ICAS) is an important factor leading to ischemic stroke, especially in the Asian population, including China. The diagnosis and treatment of ICAS is of great significance in the prevention and treatment of ischemic stroke in China. According to whether ICAS has ischemic stroke in the narrow vascular area or transient ischemic attack (transient ischemic attacks, TIA), it is divided into symptomatic intracranial atherosclerotic stenosis (symptomatic intracranial atherosclerotic stenosis, s ICAS) and asymptomatic The risk of recurrent stroke in patients with asymptomatic intracranial atherosclerotic stenosis (a ICAS).S ICAS is very high and has a positive correlation with the degree of vascular stenosis. In the study, the subgroup analysis of severe s ICAS (70%? 99%) found that even if medical treatment was performed, the recurrence rate of stroke was still up to 19% during the average follow-up period of 1.8 years. After that, the treatment of s ICAS was expected to be performed by percutaneous transluminal angioplasty and stent implantation (percutaneous transluminal angioplasty and stenting, PTAS) [1].. The previous single center, non random study and registration study also found that s ICAS patients had better safety and effectiveness [2]., however, the SAMMPRIS (stenting versus aggressive medical therapy for intracranial) published in 2011 was significantly higher than the internal medicine in the 30 days of the stent group. The group (14.7%, 5.8%) was terminated ahead of time. Since the SAMMPRIS study was the first multicenter, prospective, controlled, randomized study, the guidelines for the s ICAS were first recommended for the intensive medical treatment (aggressive medical management, AMM) instead of PTAS, and the PTAS of s ICAS was published after the shadow.SAMMPRIS study was published. It is widely questioned by scholars from various countries. The contents of the question include the standard of entry, the choice of the research center, the proficiency of the operator, the control of the risk factors and the change of lifestyle in the internal medicine group, which are difficult to achieve in the real world. Therefore, the results of this study do not have much guiding significance for the treatment of s ICAS patients in the real world. And because our country is a big country of s ICAS, and at present many centers still use PTAS as the main means of s ICAS treatment. It is necessary to continue to observe the difference between the domestic s ICAS patients in the real world and the contrast of the intensive internal medicine treatment in the real world under the situation that our country can not carry out the related randomized controlled trial. The purpose of this study is to explore the third A safe and effective clinical treatment for patients with s ICAS in the Department of Neurology, Southwest Hospital, Military Medical University, will provide reference for patients with severe intracranial atherosclerotic stenosis or occlusion. There are two parts of this study, part of which are retrospective study, and the other part is prospective study. Objective: 1. The safety and effectiveness of the medical center PTAS for the treatment of s ICAS, and compared with the internal medicine treatment; 2, observe the effect of PTAS and internal medicine treatment on the degree of vascular stenosis; 3, observe the effects of PTAS and internal medicine treatment on the neurological function of patients with s ICAS. Methods: 1, PTAS and internal medicine treatment for symptomatic intracranial atherosclerotic stenosis A retrospective study of the efficacy of bloody stroke /TIA (1) retrospective analysis of the related clinical data of patients with s ICAS confirmed by total cerebral angiography from January 2009 to December 2014. The differences in internal medical treatment and PTAS were observed. (2) the clinical data of 30 days of complications were collected, and the patients were followed up for 1 years after the hospital was discharged. The situation of recurrent stroke /TIA, as well as other adverse events (bleeding, myocardial infarction, etc.), follow up patients' m RS score, and other changes; (3) statistical analysis of /TIA recurrence and adverse events of stroke,.2, PTAS and the prospective efficacy of internal medicine treatment for recurrent ischemic stroke in patients with symptomatic intracranial atherosclerotic stenosis Study (1) all s ICAS patients with DSA examination confirmed that the stenosis rate was 70%? 99% (using the WASID test method to calculate the stenosis rate of the responsible vessel). Effective communication with the patients and their families, the choice of treatment after the full understanding of the test scheme, the voluntary selection of PTAS, and the withdrawal of the group after the drug treatment; (2) treatment. The plan was divided into two groups: internal medicine group: separate intensive medical treatment, including double anti platelet aggregation therapy for 3 months (aspirin 100mg/ days + clopidogrel 75mg/ days) to aspirin (100mg/ days) or clopidogrel (75mg/ days) alone for the treatment of platelet aggregation for life, strengthening statin therapy, strengthening the risk factors for managing vascular disease, and modifying the risk factors of vascular disease Good lifestyle; group PTAS: on the basis of intensive medical treatment, individualized PTAS was carried out; (3) the subjects were enrolled in the group for 30 days, 3 months, 6 months and December, and were hospitalized, hospitalized, telephone follow-up evaluation and other adverse events. The main terminal event was defined as the incidence of all vascular events in 1 years including the incidence of death; secondary end. Point events were defined as: 1) all stroke or death within 30 days; 2) vascular stenosis or stent restenosis in 1 years, NIHSS score and m RS score in December. Results: 1, retrospective study of the curative effect of group PTAS and internal medicine treatment for recurrent ischemic stroke in patients with symptomatic intracranial atherosclerotic stenosis (1) review 456 cases were screened, and 245 cases were included in the internal medicine group and the PTAS group. All the vascular events in the internal medicine group and the PTAS group were 20.4% and 9.4%, respectively, 20.4% and 9.4%, respectively (P0.05). The recurrence rate of the same side stroke in the two groups was 14.9%, 3.1%, the internal medicine group 27, and the 2 in the PTAS group, there were significant differences (P 0.05); the recurrence rate of two groups of non identical stroke was 0.5%, 0%, and no significant difference (P0.05); the two groups were 1.1%, 0%, 2 cases in the internal medicine group, no death cases in group PTAS, no significant difference (P0.05); (2) the incidence of all stroke or death within 30 days was 3.9%, 6.3%, (P0.05), and other adverse events: two group DSA. After operation, femoral pseudoaneurysm, FPA, and PTAS group were 1.1%, 0%, with no significant difference (P0.05), the incidence of all bleeding was 6.1%, 7.8%, and no significant difference (P0.05); (3) there was no obvious or mild deity disability in 1 years, that is, m RS < 2, and the proportion of the internal medicine group and the PTAS group. The 63%, 92.2%, and two groups had significant statistical differences (P0.05).2, group PTAS and the prospective study on the efficacy of internal medicine treatment for recurrent ischemic stroke in patients with symptomatic intracranial atherosclerotic stenosis (1) baseline characteristics: 112 patients were consecutively included, and the internal and PTAS groups were 76,36 cases respectively, and the two groups were in the baseline water. (2) 36 patients in group PTAS had a success rate of 100%, of which 2 had balloon dilatation, 18 self expanding stents, 16 balloon dilatation. All vascular events in the internal medicine group and the PTAS group included the incidence of death, 19.7%, 5.6%, respectively (P0.05). Two groups of ipsilateral apoplexy were found. Recurrence rates were 18.4% and 2.8%, respectively (P0.05). The recurrence rate of non identical stroke in two groups was 3.9% and 0%, respectively (P0.05). The recurrence rate of TIA in the two group was 1.3%, 0%, no significant difference (P0.05). There were no other vascular events such as acute coronary syndrome and no death in the two groups; (3) all stroke within the internal medicine and PTAS group within 30 days. The incidence of or death was 0%, 2.8%, no significant difference (P0.05). There were no deaths in two groups of patients within 30 days; (4) the two groups were followed up for 1 years, 87.3? 11.2 (%), 13.9? 17.5 (%), with statistical differences (P0.05). The rate of vascular stenosis in the internal medicine group was respectively 86.1? 12.3 (%), 87.3?% (%), respectively before and after treatment in the internal medicine group. Significant difference (P0.05). In group PTAS, the preoperative stenosis rate was 83.9? 10.3 (%), 10.1? 7.6 (%), and there were significant differences (P0.05). The stenosis rate of group PTAS was 13.9? 17.5 (%) during the follow-up period, compared with 83.9? 10.3 (%) before treatment (P0.05). The rate of restenosis in stent was 8.8%; (5) the effect of group PTAS on the mental function: Internal Medicine There were 69,34 cases in group PTAS and group PTAS, and there were no statistical differences (P0.05). There were significant differences (P0.05) in the two groups of M RS < 2 as 62,35 cases, respectively (P0.05). There were significant differences (P0.05) before and after treatment in the internal medicine group, respectively (P0.05). There were significant differences between the two groups before and after the treatment. Before and after treatment NIHSS less than 3 scores were 26,34 cases, respectively, there were significant differences (P0.05), before and after the treatment of M RS < 2 as 36,35 cases, respectively, there was no statistical difference between the two (P0.05). Conclusion: 1, PTAS can prevent s ICAS patients in 1 years of relapse stroke /TIA, and better than single intensive internal medicine treatment; 2, PTAS in strict screening of cases and line of individuals. On the basis of PTAS, it is safe and feasible. 3, the narrow focus of the internal medicine group is not obviously improved. The intensive internal medicine treatment combined with PTAS can obviously improve the vascular stenosis, and its nerve function is obviously improved before and after the treatment. 4, PTAS is one of the safe and effective methods to prevent the /TIA redevelopment in the ischemic stroke of the high-risk s ICAS patients.

【学位授予单位】：第三军医大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R743.3

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