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症状性和无症状性颈动脉狭窄的内膜切除术预防卒中。临床试验综述及手术治疗建议。

Endarterectomy for preventing stroke in symptomatic and asymptomatic carotid stenosis. Review of clinical trials and recommendations for surgical therapy.

作者信息

Levinson M M, Rodriguez D I

机构信息

Division of Cardiovascular and Thoracic Surgery, Hutchinson Hospital, Hutchinson, Kansas, USA.

出版信息

Heart Surg Forum. 1999;2(2):147-68.

Abstract

BACKGROUND

Multicenter, randomized trials have demonstrated advantages for surgery over medical therapy in both symptomatic and asymptomatic carotid stenosis of greater than 70%. Controversial interpretations of these trials are debated between medical and surgical camps. The goal of this review is to summarize the current state of knowledge in carotid stenosis and the role of surgery and several advances in operative management.

METHODS

Summaries of seven major controlled trials of carotid endarterectomy versus medical therapy are presented along with supportive data from over 90 related publications. Criticisms, deficiencies as well as strengths are offered.

RESULTS

All studies in which trial design, clinical variables, case selection, complication definition, and patient follow-up were well conceived and performed showed statistically significant advantages for surgical therapy within a remarkable short interval of follow-up (less than 3 years). Carotid endarterectomy demonstrated a two to four fold reduction in the late incidence of stroke when compared to optimum medical management (risk factor reduction and initiation of antiplatelet therapy). Reduction in stroke risk over time remains stable in surgically treated patients whereas medically treated patients clearly show progression of stenosis and evolution of new neurologic events with time. Several studies indicate that diabetes is a risk factor for stroke with medical therapy that is eliminated by surgical therapy. Advantages were more clearly demonstrated when symptomatic patients (TIAs, stroke, or amaurosis) were studied, but asymptomatic patients received significant benefit as well. The degree of benefit measured was in direct balance to the perioperative risk. Perioperative stroke and death rates must be low (less than 3% combined for asymptomatic patients) in order for statistically significant differences to be detected. However, most centers now can perform carotid endarterectomy within these outcome parameters.

CONCLUSIONS

Randomized trials support the safety and efficacy of carotid endarterectomy for stenosis greater than 70% (with or without symptoms). Advantages of surgery over medical therapy were found in less than three years and there is ample evidence to suggest that the differences between these groups would have been even more pronounced had longer follow-up been obtained. Thus for patients who face many years of risk after diagnosis of a carotid lesion, early surgery is the most important and effective intervention for preventing stroke. The results of these trials raised initial concern over increasing health care expenditures from rising surgical case volumes. However, studies of cost effectiveness confirmed that surgery saves health care dollars when compared to the long term care of stroke victims.

摘要

背景

多中心随机试验已证明,对于症状性和无症状性颈动脉狭窄超过70%的患者,手术治疗优于药物治疗。医学阵营和外科阵营对这些试验存在争议性解读。本综述的目的是总结颈动脉狭窄的当前知识状态、手术的作用以及手术管理方面的一些进展。

方法

介绍了七项颈动脉内膜切除术与药物治疗的主要对照试验的总结,以及来自90多篇相关出版物的支持数据。同时给出了批评意见、不足之处及优势。

结果

所有试验设计、临床变量、病例选择、并发症定义和患者随访均构思完善且执行良好的研究显示,在较短的随访期(不到3年)内,手术治疗具有统计学上的显著优势。与最佳药物治疗(降低危险因素和启动抗血小板治疗)相比,颈动脉内膜切除术使中风的晚期发生率降低了两到四倍。随着时间的推移,手术治疗患者的中风风险降低保持稳定,而药物治疗患者则明显显示出狭窄进展和新的神经事件随时间演变。多项研究表明,糖尿病是药物治疗导致中风的一个危险因素,而手术治疗可消除这一因素。对有症状患者(短暂性脑缺血发作、中风或黑矇)进行研究时,优势更明显,但无症状患者也有显著获益。所衡量的获益程度与围手术期风险直接平衡。围手术期中风和死亡率必须较低(无症状患者合并发生率低于3%),才能检测到统计学上的显著差异。然而,现在大多数中心都能在这些结果参数范围内进行颈动脉内膜切除术。结论:随机试验支持颈动脉内膜切除术治疗狭窄超过70%(无论有无症状)的安全性和有效性。手术治疗优于药物治疗的优势在不到三年的时间里就已显现,且有充分证据表明,如果进行更长时间的随访,这些组之间的差异会更加明显。因此,对于诊断为颈动脉病变后面临多年风险的患者,早期手术是预防中风最重要且有效的干预措施。这些试验结果最初引发了对手术病例数量增加导致医疗保健支出增加的担忧。然而,成本效益研究证实,与中风患者的长期护理相比,手术节省了医疗保健费用。

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