血管内支架成形术治疗颅外颈动脉狭窄的临床研究
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摘要
目的:
     (1)探讨颅外颈动脉狭窄的相关危险因素,为颅外颈动脉狭窄的预防提供客观依据,并且有助于缺血性脑卒中的预防。
     (2)探讨CTA诊断颅外颈动脉狭窄的可行性及技术优势。
     (3)通过30例脑保护装置下颅外颈动脉狭窄血管内支架成形术的随访观察研究来探讨该手术的安全性以及有效性。
     方法:
     (1)收集2012年1月到2012年12月就诊于我院神经内、外科200颅外颈动脉狭窄的例患者,所有患者均经头颈部彩超、头颈部CTA或全脑血管造影确诊,同时选择同期在我神经内、外科住院的非颅外颈动脉狭窄的200例患者作为对照;
     (2)记录所有患者的一般情况和既往史,包括民族(汉、维)、性别、年龄、糖尿病、高血压、吸烟、饮酒史等,患者于住院第二天清晨空腹抽取静脉血,检查血糖(Glu)、低密度脂蛋白(LDL-TC)、高密度脂蛋白(HDL-TC)、甘油三酯(TG)、糖化血红蛋白(HbA1c)、同型半胱氨酸(Hcy)、c反应蛋白(hs-CRP);
     (3)组间比较,单因素计量资料采用独立样本t检验,计数资料采用χ2检验;对14个变量指标先进行单因素Logistic回归分析,为调整控制混杂因素,结合专业判断,再将所有14个变量纳入方程进行多因素Logistic回归分析,采用逐步法筛选出颅外颈动脉狭窄的独立危险因素;
     (4)收集2012年1月~2012年12月就诊于我院神经内、外科的50例颅外颈动脉狭窄的患者,所有患者均做过头颈CTA且在两周内做过脑DSA,CTA和DSA图像分别由两名放射科医师和神经外科医师阅片,判断有无颈动脉狭窄,确定狭窄的部位、程度;以DSA狭窄率的平均值为金标准,中、重度狭窄(狭窄率为30%、70%)为界,评价CTA诊断颅外颈动脉狭窄的敏感度、特异度、假阳性率、假阴性率、阳性预测值、阴性预测值、粗符合率、阳性似然比、阴性似然比、诊断指数、Kappa系数、Youden指数以及其95%的可信区间;
     (5)收集2012年1月至2012年12月就住于我院神经内、外科共30例颅外颈动脉狭窄患者,所有患者术前均行头颈CTA和脑DSA检查,确诊为中、重度颅外颈动脉狭窄,均符合血管内支架成形术的入选标准,术前均经CTA检查来明确斑块的性质且均进行神经功能评分(NIHSS),在CAS过程中联合使用了脑保护装置。术后疗效观察:①再次观察造影复查DSA片,测量判断血管扩张程度及残余血管狭窄率;②颅外颈动脉狭窄血管内支架置入术后患者临床症状改善情况以及神经功能评分(NIHSS)的变化;③观察不同类型斑块的颅外颈动脉狭窄患者支架成形术后其保护伞中组织碎片的检出率。
     结果:
     (1)病例组和对照组中一般资料通过计数资料的χ2检验可以得出,两组间民族、性别、糖尿病病史、高血压病病病史、吸烟史以及饮酒史6个观察指标中,只有高血压病病史和糖尿病病史这两个观察指标的P值<0.05具有统计学意义。
     (2)变量赋值后经单因素Logistic回归统计分析,在这14个自变量中,年龄、糖尿病、高血压病、GLU、LDL、HDL、CRP、HCY、HbA1c这9个自变量有统计学意义,其余5个自变量无统计学意义。
     (3)通过逐步logistic回归分析可以得出糖尿病病史、高血压病病史、TG、LDL、HCY、HbA1c是颅外颈动脉狭窄的独立危险因素。
     (4)50例患者100条颈动脉DSA诊断结果为无狭窄占31%(31/100)、完全闭塞占1.0%(1/100)、轻度狭窄占18.0%(18/100)、中度狭窄占25%(25/100)、重度狭窄占(25/100)。CTA检查与DSA完全符合的为86支,占86%。与金标准DSA相比较,狭窄率≥30%时,CTA的灵敏度为88.2%,其95%的可信区间为0.794-0.970;其特异度为100%,假阳性率为0,假阴性率为11.8%,阳性预测值为100.0%,阴性预测值89.1%,其95%的可信区间为0.803-0.979;符合率为94.0%,其95%的可信区间为0.894-0.987;诊断指数为188.2%,正确指数(Youden'sindex)为0.882,其95%的可信区间为0.803-1.015;且两种诊断方法的一致性Kappa值为0.880(Kappa≥0.75即表示一致性极好)。与金标准DSA相比较,狭窄率≥70%时,CTA的灵敏度为92.3%,其95%的可信区间为0.851-0.995;特异度为98.6%,其95%的可信区间为0.960-1.012;假阳性率为1.4%,假阴性率为7.7%,阳性预测为96.0%,其95%的可信区间为0.884-1.036;阴性预测值97.3%,其95%的可信区间为0.871-1.075;符合率为97.0%,其95%的可信区间为0.864-1.003;诊断指数为190.9%,正确指数(Youden'sindex)为0.909,其95%的可信区间为0.803-1.015;且两种诊断方法的一致性Kappa值为0.921(Kappa≥0.75即表示一致性极好)。
     (5)术前、术后狭窄率差值d的配对t检验,P<0.001,具有统计学意义。
     (6)通过Fisher确切概率法,P<0.05,得出硬斑、软斑以及混合斑这三种不同类型的颅外颈动脉狭窄患者其保护伞中组织碎片检出率的差异具有统计学意义,其中软斑最高达90%,其次是混合斑和硬斑。
     (7)术前神经功能NIHSS评分均值为4.47分、术后1月神经功能NIHSS评分为3.27分以及术后半年神经功能NIHSS评分为1.30分,采用Friedman M秩和检验,P<0.001,具有统计学意义,说明术前到术后1月再到术后半年患者神经功能恢复情况越来越好。
     (7)在回收的30个保护伞中,通过肉眼观察有18个伞中有组织碎片,有20例患者在球囊扩张过程中出现心率下降(<60次/min),血压下降(收缩压<90mmHg),给予阿托品、多巴胺治疗1周内均恢复。
     结论:
     (1)糖尿病病史、高血压病病史、TG、LDL、HCY、HbA1c是颅外颈动脉狭窄的独立危险因素,在颅外颈动脉狭窄的发生、发展中发挥重要作用。
     (2)CTA在诊断颈动脉狭窄程度上与DSA相比,具有很高的相关性,可常规作为颈部血管狭窄筛选和诊断的检查方法;
     (3)脑保护装置下的颈动脉支架成形术具有创伤小且围手术期并发症较少,术后缺血性卒中及死亡率的发生率较低,是治疗颅外颈动脉狭窄安全、有效的方法。
     (4)术前通过头颈CTA的检查来确定斑块的性质,这对选择术中具体的治疗方案,以及预防脑梗塞的发生具有重要的意义。
Objective:
     (1) To discuss the characteristics distribution of extracranial carotid stenosis and itsrisk factors, provide extracranial carotid stenosis with objective basis for the prevention, atthe same time help the secondary prevention of ischemic stroke.
     (2) To study the feasibility and technology advantage of CTA in the diagnosis ofcarotid stenosis.
     (3) The follow-up studies of the extracranial carotid stenosis intravascular stentangioplasty explore the safety and efficacy of the procedure through30cases of cerebralprotection device.
     Methods:
     (1) Collecting200cases of patients who are considered extracranial carotid stenosisin the department of neurosurgery and neurology of our hospital from June2011toDecember2012. All patients must be confirmed with PATE (head and neck) color Dopplerultrasound and PATE (head and neck) CTA or cerebral angiogram. In the same period,select200cases of patients as controls who are not considered extracranial carotid stenosisin this field.
     (2) Record all the patient's general condition and past medical history, including thenationality (han, uygur), gender, age, history of diabetes, hypertension, smoking, drinking,etc, Patients in the hospital the next morning fasting venous blood was drawn, check bloodglucose (Glu), low density lipoprotein cholesterol (LDL-TC), high-density lipoproteincholesterol (HDL-TC), triglyceride (TG), glycosylated hemoglobin (HbA1c),homocysteine (Hcy), c-reactive protein (hs CRP).
     (3) Single factor measurement data is compared between groups using independent sample test, counting data by chi-square test, single factor Logistic regression analysis isapplied for14variables indicators, screen out meaningful indexes, Control theconfounding factors, combine with professional judgment and the single factor analysis ofmeaningful variables will be done by multiple factors Logistic regression analysis,stepwise method is put into use to choose extracranial carotid stenosis related indicators.
     (4) From June2011to December2012in our hospital,50cases of ischemiccerebrovascular disease in this field, all have done CTA and done DSA within two weeks;CTA and DSA images reviewed by two radiologists and neurosurgeons respectively,determine presence of artery stenosis, the narrow parts and degree; use DSA stenosis rateof average value as the gold standard, with medium and severe stenosis (stenosis rate was30%,70%) for the value, measuring the sensitivity of the CTA, specific degree, falsepositive rate and false negative rate, crude coincidence rate, positive predictive value,negative predictive value, positive likelihood ratio and negative likelihood ratio, diagnosis,Kappa coefficient, Youden index and its95%confidence interval.
     (5) A total of30cases of patients with carotid artery stenosis who will use a cerebralprotection device in the the CAS process are collected from June2012to December2012.All the patients with severe extracranial carotid stenosis are confirmed by preoperativeDSA, and meet the inclusion criteria for endovascular stent angioplasty, the property ofplaques are made clear for all patients by CTA examination preoperatively and conductpreoperative neurological function score (NIHSS) at the same time. Postoperative efficacy:①judging the degree of vasodilation and the stenosis rate of the residual vascular by theoutcome of the reviewed radiography;②improvement of clinical symptoms and nervefunction score (NIHSS) after extracranial carotid stenosis endovascular carotid stenting③Observe the detection rate of organization debris in different types of plaque ofextracranial carotid stenosis in patients after stenting..
     Result:
     (1) The general data in the case arm and control arm can be obtained by thechi-square test. Between the two groups,6observation indicators such as ethnic, gender,history of diabetes, hypertension disease history, smoking history and drinking histories,Only do the history of hypertension and diabetes have statistically significant value of P<0.05.
     (2)Single factor Logistic regression statistical analysis after Variable assignment,among the14variabilities, age, diabetes, hypertension, GLU, LDL, HDL, CRP, HCY, HbA1c, the nine variabilities have statistically significance, the five independentvariabilities are not statistically significant.
     (3) Through stepwise logistic regression analysis, it can be drawn that history ofdiabetes, hypertension medical history, TG, LDL, HCY, HbA1c are independent riskfactors of extracranial carotid artery stenosis.
     (4)50cases of100carotid artery stenosis degree of DSA diagnosis without stenosisaccounted for31%(31/100), and occlusion was1.0%(1/100), mild stenosis was18.0%(18/100), moderate stenosis was25%(25/100), severe stenosis (25/100). CTA inspectionwith DSA in full compliance with as86, accounted for86%. Compared with the goldenstandard of DSA, the stenosis rate of30%or higher, the sensitivity of the CTA was88.2%,95%confidence interal,0.794-0.970, Its Specificity Was100%, false positive rate of0, thefalse negative rate was11.8%, positive predictive value100.0%, negative predictive valueof89.1%,95%confidence interal,0.803-0.979; Coincidence rate was94.0%,94.0%ci0.8940.987; Diagnostic index is188.2%, right (Youden index 's index is0.882, the95%confidence interal,0.803-1.015; two diagnosis methods and the consistency of theKappa value ware0.880(Kappa acuity0.75it indicates that are very good consistency).Compared with the golden standard of DSA, the stenosis rate is70%or higher, thesensitivity of the CTA was92.3%,95%confidence interal,0.851-0.995;98.6%,98.6%ci0.9601.012; False positive rate was1.4%, false negative rate was7.7%, the positiveforecast of96.0%,95%confidence interal,0.884-1.036; negative predictive value of97.3%,97.3%ci0.8711.075; Coincidence rate was97.0%,97.0%ci0.8641.003;Diagnostic index is190.9%, right index (Youden 'sindex) is0.909, the95%confidenceinteral,0.803-1.015; Two diagnosis methods and the consistency of the Kappa value was0.921(Kappa acuity0.75it indicates that the very good consistency).
     (5) Preoperative, postoperative stricture rate difference of1d paired t test, P<0.001,with statistical significance.
     (6)Through the exact probability method, P <0.05, we can conclude debris detectionrate difference of three different types of extracranial carotid artery stenosis(hard, soft andmixed plaque) in patients is statistically significant, the soft plaque up to90%, followedby mixed plaque and hard plaque.
     (7) Preoperative neurologic NIHSS score averages of4.47points, one month after sixmonths after nerve function NIHSS score was3.27and neural function NIHSS score was1.30points, using Friedman M rank and inspection (P<0.001, statistically significant, thepreoperative and postoperative1month to the recovery of neural function in patients with half a year is getting better.
     (8) Recycle30umbrella by macroscopic observation18umbrella organization offragments,20patients in the course of balloon expansion a drop in heart rate (<60times/min), drop in blood pressure (systolic blood pressure (90MMHG), given atropine,dopamine treatment1weeks in all.
     Conclusion:
     (1) History of diabetes, and hypertension, TG, LDL, HCY, HbA1c are theindependent risk factors of extracranial carotid stenosis, they play an important role in theoccurrence and development of extracranial carotid stenosis.
     (2) They can be used in the screening and diagnosis of routine inspection method ofcarotid artery stenosis.
     (3) Intravascular stent angioplasty for carotid stenosis under cerebral protectiondevice is a safe and effective mean of the treatment by which the vulnus is smaller, theperioperative complications are fewer, and lower incidences of postoperative ischemicstroke and death.
     (4) It is important to select specific therapy and prevent cerebral infarction bydetermining the plaque of preoperative head and neck CTA.
引文
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