本文選題：腦卒中 + 癥狀性顱內(nèi)動脈粥樣硬化性狹窄　； 參考：《第三軍醫(yī)大學(xué)》2016年碩士論文

【摘要】：背景:腦卒中是我國的常見病和多發(fā)病,具有高發(fā)病率、高致殘率、高死亡率、高復(fù)發(fā)率、高經(jīng)濟負擔(dān)五大特點。顱內(nèi)動脈粥樣硬化性狹窄(Intracranial atherosclerotic stenosis,ICAS)是導(dǎo)致缺血性卒中的重要因素,尤其是在包括我國在內(nèi)的亞洲人群。對ICAS的診治對我國缺血性卒中的防治意義重大。根據(jù)ICAS是否有狹窄血管區(qū)域缺血性卒中或短暫性腦缺血發(fā)作(transient ischemic attacks,TIA)發(fā)生分為癥狀性顱內(nèi)動脈粥樣硬化性狹窄(symptomatic intracranial atherosclerotic stenosis,s ICAS)和無癥狀性顱內(nèi)動脈粥樣硬化性狹窄(asymptomatic intracranial atherosclerotic stenosis,a ICAS)。s ICAS患者再發(fā)卒中的風(fēng)險很高,且與血管的狹窄程度呈正相關(guān)。關(guān)于s ICAS治療目前尚有爭議。在WASID(the Warfarin versus Aspirin Symptomatic Intracranial Disease Study for Stroke)研究中,對重度s ICAS(狹窄率70%?99%)亞組分析發(fā)現(xiàn),即使進行了內(nèi)科治療,在1.8年的平均隨訪期內(nèi)卒中復(fù)發(fā)率仍高達19%,此后人們將s ICAS的治療寄希望于經(jīng)皮血管腔內(nèi)成形和支架植入術(shù)(percutaneous transluminal angioplasty and stenting,PTAS)[1]。而前期的一些單中心、非隨機研究和登記研究也發(fā)現(xiàn),s ICAS患者行PTAS有較好的安全性和有效性[2]。然而,2011年發(fā)表的SAMMPRIS(stenting versus aggressive medical therapy for intracranial arterial stenosis)研究[3]卻因支架組30天內(nèi)主要終點事件明顯高于內(nèi)科組(分別為14.7%、5.8%)而被提前終止。由于SAMMPRIS研究是首個多中心、前瞻性、對照、隨機研究,此后各國指南均將s ICAS的治療方法首先推薦為強化內(nèi)科治療(aggressive medical management,AMM)而非PTAS,s ICAS的PTAS自此蒙上陰影。SAMMPRIS研究發(fā)表后受到了各國學(xué)者的廣泛質(zhì)疑,質(zhì)疑的內(nèi)容包括入組標(biāo)準(zhǔn)、研究中心的選擇、術(shù)者熟練程度、強化內(nèi)科組中危險因素控制及生活方式改變在真實世界中難以達到等現(xiàn)狀,因此該項研究結(jié)果對國內(nèi)真實世界中s ICAS患者的治療并無太多指導(dǎo)意義。而且由于我國為s ICAS的大國,且目前許多中心仍將PTAS做為s ICAS治療的主要手段,在目前我國不能開展相關(guān)的隨機對照試驗研究的情況下,有必要繼續(xù)觀察國內(nèi)s ICAS患者在真實世界中PTAS與強化內(nèi)科治療對的差異本研究旨在探討在第三軍醫(yī)大學(xué)西南醫(yī)院神經(jīng)內(nèi)科就診的s ICAS患者安全有效的臨床治療方法,其結(jié)果將為重度顱內(nèi)動脈粥樣硬化性狹窄或閉塞病變患者選擇治療方案上提供參考。本研究共有兩部分,一部分是回顧性研究,另一部分為前瞻性研究。目的:1、觀察本醫(yī)療中心PTAS治療s ICAS的安全性和有效性,并與內(nèi)科治療進行對比;2、觀察PTAS與內(nèi)科治療對血管狹窄程度的影響;3、觀察PTAS與內(nèi)科治療對s ICAS患者神經(jīng)功能的影響。方法:1、PTAS與內(nèi)科治療對癥狀性顱內(nèi)動脈粥樣硬化性狹窄患者再發(fā)缺血性卒中/TIA的療效的回顧性研究(1)回顧性分析2009年1月至2014年12月在我科經(jīng)全腦血管造影證實狹窄率50%?99%的s ICAS患者的相關(guān)臨床病例資料。觀察患者內(nèi)科治療與PTAS的差異;(2)收集30天內(nèi)并發(fā)癥的臨床資料,電話隨訪患者出院后1年內(nèi)再發(fā)卒中/TIA的情況,以及其他不良事件(出血、心肌梗死等)發(fā)生的情況,隨訪患者m RS評分等變化;(3)統(tǒng)計學(xué)分析卒中/TIA復(fù)發(fā)、不良事件等情況。2、PTAS與內(nèi)科治療對癥狀性顱內(nèi)動脈粥樣硬化性狹窄患者再發(fā)缺血性卒中/TIA的療效的前瞻性研究(1)所有經(jīng)DSA檢查證實狹窄率70%?99%(使用WASID試驗方法計算責(zé)任血管狹窄率)的s ICAS患者。與患者及其家屬進行有效溝通,在其充分了解試驗方案后作出治療選擇,自愿選擇是否行PTAS,而給予藥物治療后若更改方案則退出入組;(2)治療方案共分兩組:內(nèi)科組:單獨強化內(nèi)科治療,包括雙聯(lián)抗血小板聚集治療3個月(阿司匹林100mg/天+氯吡格雷75mg/天)后改為阿司匹林(100mg/天)或氯吡格雷(75mg/天)單獨抗血小板聚集治療終生、強化他汀治療、全程強化管理血管病危險因素、改善生活方式;PTAS組:在強化內(nèi)科治療的基礎(chǔ)上,進行個體化PTAS;(3)受試者入組后30天、3個月、6個月及12月進行門診、住院、電話隨訪評估終點事件以及其他不良事件發(fā)生情況。主要終點事件定義為:1年所有血管事件包括死亡的發(fā)生率;次要終點事件定義為:1)30天內(nèi)所有卒中或死亡;2)1年內(nèi)血管狹窄情況或支架再狹窄發(fā)生率,12月內(nèi)對患者進行NIHSS評分、m RS評分。結(jié)果:1、PTAS組與內(nèi)科治療對癥狀性顱內(nèi)動脈粥樣硬化性狹窄患者再發(fā)缺血性卒中/TIA的療效的回顧性研究(1)共回顧性篩查456例,最終納入245例(內(nèi)科組和PTAS組分別有181、64例),經(jīng)統(tǒng)計學(xué)分析:內(nèi)科組和PTAS組1年所有血管事件包括死亡發(fā)生率,分別為20.4%、9.4%,有明顯差異(p0.05)。其中兩組同側(cè)卒中復(fù)發(fā)率分別為14.9%、3.1%,內(nèi)科組27例,PTAS組中2例,有明顯差異(p0.05);兩組非同側(cè)卒中復(fù)發(fā)率分別為0.5%、0%,無明顯差異(p0.05);兩組死亡率分別為1.1%、0%,內(nèi)科組2例,PTAS組無死亡例,無明顯差異(p0.05);(2)30天內(nèi)所有卒中或死亡發(fā)生率:內(nèi)科組和PTAS組分別為3.9%、6.3%,無明顯差異,(p0.05)。其他不良事件:兩組DSA術(shù)后發(fā)生醫(yī)源性假性動脈瘤(femoral pseudoaneurysm,FPA)內(nèi)科組和PTAS組分別為1.1%、0%,無明顯差異(p0.05);兩者所有出血發(fā)生率分別為6.1%、7.8%,無明顯差異(p0.05);(3)1年內(nèi)無明顯或輕度神經(jīng)功能殘障的患者,即m RS≤2分,內(nèi)科組和PTAS組所占的比例分別為63.0%、92.2%,兩組之間有明顯統(tǒng)計學(xué)差異(p0.05)。2、PTAS組與內(nèi)科治療對癥狀性顱內(nèi)動脈粥樣硬化性狹窄患者再發(fā)缺血性卒中/TIA的療效的前瞻性研究(1)基線特征:連續(xù)納入112例患者,內(nèi)科組和PTAS組分別為76、36例,經(jīng)統(tǒng)計兩組在基線水平上是一致的;(2)PTAS組的36例患者手術(shù)成功率100%,其中2名行單純球囊擴張術(shù),18名行自膨式支架植入術(shù),16名行球擴式支架植入術(shù)。內(nèi)科組和PTAS組1年所有血管事件包括死亡的發(fā)生率,分別為19.7%、5.6%,有明顯差異(p0.05)。其中兩組同側(cè)卒中復(fù)發(fā)率分別為18.4%、2.8%,有明顯差異(p0.05)。兩組非同側(cè)卒中復(fù)發(fā)率分別為3.9%、0%,無明顯差異(p0.05)。兩組TIA復(fù)發(fā)率分別為1.3%、0%,無明顯差異(p0.05)。兩組均無急性冠脈綜合征等其他血管事件發(fā)生,無死亡發(fā)生;(3)內(nèi)科組和PTAS組30天內(nèi)所有卒中或死亡的發(fā)生率分別為0%、2.8%,無明顯差異(p0.05)。兩組患者入組30天內(nèi)均未出現(xiàn)死亡病例;(4)兩組隨訪1年時血管狹窄率分別為87.3?11.2(%)、13.9?17.5(%),有統(tǒng)計學(xué)差異(p0.05)。在內(nèi)科組中治療前與治療后血管狹窄率分別為86.1?12.3(%)、87.3?11.2(%),有明顯差異(p0.05)。在PTAS組中術(shù)前狹窄率、術(shù)后殘余狹窄率分別為83.9?10.3(%)、10.1?7.6(%),有明顯差異(p0.05)。隨訪期間發(fā)現(xiàn)PTAS組狹窄率13.9?17.5(%),與治療前83.9?10.3(%)相比有明顯差異(p0.05)。支架內(nèi)再狹窄率為8.8%;(5)PTAS組對神級功能的影響:內(nèi)科組和PTAS組中NIHSS≤3分分別有69、34例,無統(tǒng)計學(xué)差異(p0.05)。兩組m RS≤2分分別為62、35例,有明顯差異(p0.05)。內(nèi)科組治療前與治療后NIHSS≤3分分別為48、69例,有明顯差異(p0.05),其治療前和治療后的m RS≤2分分別為76、62例,有明顯差異(p0.05)。PTAS組治療前與治療后NIHSS≤3分分別為26、34例,有明顯差異(p0.05),其治療前和治療后m RS≤2分分別為36、35例,兩者之間無統(tǒng)計學(xué)差異(p0.05)。結(jié)論:1、PTAS可預(yù)防s ICAS患者1年內(nèi)復(fù)發(fā)卒中/TIA,且優(yōu)于單獨強化內(nèi)科治療;2、PTAS在嚴格篩選病例以及行個體化PTAS的基礎(chǔ)上是安全可行的;3、單獨強化內(nèi)科組的狹窄病灶未見明顯改善,強化內(nèi)科治療聯(lián)合PTAS能明顯改善血管狹窄,且其神經(jīng)功能治療前后有明顯改善;4、PTAS是預(yù)防高危s ICAS患者缺血性卒中/TIA再發(fā)的安全、有效的治療方法之一。
[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.

【學(xué)位授予單位】：第三軍醫(yī)大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：R743.3

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