颅内破裂动脉瘤开颅夹闭术与介入栓塞术疗效的非随机对照临床试验

发布时间：2018-07-29 07:59

【摘要】：研究背景脑血管病是威胁人类身体健康甚至生命的常见疾病,其高发病率、高致残率和高致死率不仅严重损害人民的健康和生活质量,同时也给家庭和国家带来沉重的经济、医疗和社会负担,是一个重要的公共卫生问题。在脑血管疾病中,动脉瘤破裂的发病率次于脑血栓与高血压脑出血,其多发生于脑内大动脉的分支、分叉、转弯处及其临近区域,常见于颅底Willis动脉环区域。动脉瘤一旦破裂,如不给予及时诊治,再出血风险很高且易危及生命,故对破裂动脉瘤应及时诊治,以改善预后。目前颅内动脉瘤临床手术治疗主要有开颅夹闭与血管内介入栓塞两种方式。开颅动脉瘤夹闭术是近50年来动脉瘤的主要外科治疗方式,并且随着手术显微镜的使用、显微神经外科器械和技术的发展,手术治疗效果显著提升,并发症发生率大幅降低。介入栓塞术始于20世纪70年代,随着介入技术和栓塞材料的不断改进,已成为动脉瘤治疗的重要方法。但两种手术方式各有不同缺点,开颅手术创伤大、对脑组织有一定损伤、感染等并发症发生率较高、对较深部位动脉瘤处理困难等。介入栓塞术相对创伤小、对脑组织无刺激,但对血管刺激较大,可能导致血管痉挛甚至闭塞,弹簧圈移位等并发症,且费用高。目前国内外各大医院多数是两种手术方式并存,随着目前人们生活水平的提高及医保的不断完善,患者在考虑经济问题的同时,也更加注重治疗的效果。而开颅夹闭和介入栓塞治疗颅内动脉瘤的疗效仍存在较大争议,尚无明确论断。研究目的探讨治疗颅内破裂动脉瘤患者的开颅夹闭和介入栓塞两种主要手术治疗方式,对比分析其近期临床效果、术后主要并发症、住院时间、住院费用等,从临床疗效及经济负担方面为颅内动脉瘤破裂患者选择恰当的手术方式提供理论依据。材料与方法本文患者来源于自2011年7月至2015年7月到滨州医学院烟台附属医院神经外科接受手术治疗的颅内破裂动脉瘤患者,按照纳入及排除标准共选取102例患者,其中行开颅夹闭术治疗的患者52例,行血管内介入栓塞术治疗的患者50例。比较两组患者的年龄、性别、重要疾病史(如糖尿病、高血压、冠心病等)、医疗保险形式、术前的Hunt-Hess分级、术前的GCS评分等;对两组的术后2周GCS评分、住院时间、住院总费用、术后1月内并发症(再出血、脑积水、脑血管痉挛、脑梗死、颅内感染、肺部感染等)、术后1月MRS评分等变量进行单因素分析;应用多元线性回归和1ogistic回归分析控制可能的混杂因素,对两组患者的各项指标进行对比分析。研究结果患者术前临床资料对比显示,开颅夹闭组患者的年龄小于介入栓塞组(P=).005),城镇居民保险患者比例高于介入栓塞组(p=0.037),合并高血压病史的比例高于介入栓塞组(0.058),术前GCS评分低于介入栓塞组(0.003),术前Hunt-Hess分级高于介入栓塞组(0.014)。在本研究中,开颅夹闭组患者的住院时间为23.81±4.78天,单个患者住院总费用6.71 土 1.29万元,术后GCS评分13.33±3.07,出现术后并发症13例(25.0%),术后 1 月 MRS 评分 0 分者 22 例(42.3%),1 分者 11 例(21.2%),2分及以上者19例(36.5%);介入栓塞组的住院时间为18.58±3.69天,单个患者住院总费用12.03±3.79万元,术后GCS评分14.37± 1.38,出现术后并发症6例(12.0%),术后1月MRS评分0分者27例(54.0%),1分者17例(34.0%),2分及上者6例(12.0%)。两组患者术后临床指标单因素分析显示,开颅夹闭组的住院时间长于介入栓塞组(P0.001),单个患者住院期间总费用低于介入栓塞组(P0.001),术后GCS评分低于介入栓塞组(P=0.034),术后并发症的比例高于介入组(P=0.092),术后MRS评分高于介入栓塞组(P=0.014)。通过多元线性回归分析控制有关混杂因素后,两组患者术后各项临床指标对比显示,开颅夹闭组的住院时间比介入栓塞组长5.6天(P0.001),单个患者住院期间总费用比介入栓塞组低4.9万元(P0.001)。两组患者在术后GCS评分(P=0.838)、术后并发症发生率(P=0.540)、术后MRS评分为1(P=0.955)或大于等于2(P=0.152)方面无统计学差异。结论经开颅夹闭术治疗和介入栓塞术治疗的颅内破裂动脉瘤患者的近期预后无明显差别;开颅夹闭术治疗的患者住院时间较长,而介入栓塞术治疗的患者住院费用较高。患者可根据自身情况作出选择。
[Abstract]:Background cerebrovascular disease is a common disease which threatens the health and life of the human body. Its high incidence, high disability rate and high mortality rate not only seriously damage the health and quality of life of the people, but also bring heavy economic, medical and social burden to families and the state. It is an important public health problem. The incidence of ruptured aneurysm is inferior to cerebral thrombosis and hypertensive intracerebral hemorrhage. It occurs mostly in the branches, bifurcations, turning points and adjacent areas of the large cerebral artery. It is common in the Willis artery ring area of the skull base. Once the aneurysm is broken, the risk of bleeding is very high and it is easy to endanger the life, so the aneurysm should be timely. Diagnosis and treatment to improve the prognosis. There are two main types of surgical treatment for intracranial aneurysms: craniotomy clipping and intravascular interventional embolization. Craniotomy aneurysm clipping is the main surgical treatment for aneurysms in the last 50 years. With the use of the surgical microscope, the development of microsurgical instruments and techniques in the microscopical Department of Neurosurgery The incidence of complications is greatly reduced. Interventional embolization begins in 1970s. With the continuous improvement of interventional techniques and embolic materials, it has become an important method for the treatment of aneurysm. However, the two surgical methods have different shortcomings. Craniotomy has a large trauma, a definite injury to the brain tissue, and a higher incidence of infection and other complications. Interventional embolization is difficult to deal with. Interventional embolization is less traumatic and has no stimulation to the brain tissue, but it has great stimulation to the blood vessels. It may lead to vascular spasm even occlusion and the coil displacement and other complications, and the cost is high. At present, most of the major hospitals at home and abroad are two kinds of surgical methods and exist, with the improvement of people's living standard and medical insurance. While the patients are constantly improving, the patients are also paying more attention to the effect of the treatment while considering the economic problems. However, there are still great disputes in the treatment of intracranial aneurysms with craniotomy and interventional embolization. The purpose of this study is to explore the two main surgical methods for the treatment of craniotomy and interventional embolization for patients with intracranial ruptured aneurysms. Compared with the recent clinical effects, major postoperative complications, hospitalization time, and hospitalization costs, we provided a theoretical basis for selecting appropriate surgical methods for patients with intracranial aneurysm rupture from clinical efficacy and economic burden. Materials and methods were derived from July 2011 to July 2015 at the Yantai Affiliated Hospital of Binzhou Medical University. A total of 102 patients with intracranial ruptured aneurysms treated by surgical treatment were selected according to the inclusion and exclusion criteria, including 52 patients with craniotomy and 50 patients treated with intravascular interventional embolization. The age, sex, history of important diseases (such as diabetes, hypertension, coronary heart disease, etc.) in the two groups were compared. Risk form, preoperative Hunt-Hess grading, preoperative GCS score, and two groups of 2 weeks GCS score, hospitalization time, total hospitalization expenses, postoperative complications (rebleeding, hydrocephalus, cerebral vasospasm, cerebral infarction, intracranial infection, pulmonary infection, etc.), and MRS scores in January after operation were analyzed by single factor analysis, and multiple linear regression and 1ogis were applied. Tic regression analysis was used to control the possible confounding factors and to compare the indexes of the two groups. The comparison of the clinical data of the patients before the operation showed that the age of the patients in the craniotomy group was less than that of the interventional embolization group (P=).005), the proportion of the urban residents insured was higher than that of the embolization group (p=0.037), and the proportion of the history of hypertension was higher than that of the patients. In the interventional embolization group (0.058), the preoperative GCS score was lower than that of the interventional embolization group (0.003), and the preoperative Hunt-Hess classification was higher than that of the interventional embolization group (0.014). In this study, the hospitalization time of the craniotomy group was 23.81 + 4.78 days, the total cost of hospitalization of the individual patients was 12 thousand and 900 yuan, the postoperative GCS score was 13.33 + 3.07, and the postoperative complications were 13 cases (25%). In January, the MRS score was 0 (42.3%), 1 in 11 (21.2%), and 19 (36.5%) in 2 and above. The hospitalization time of the interventional embolization group was 18.58 + 3.69 days. The total cost of hospitalization in a single patient was 12.03 + 37 thousand and 900 yuan. After the operation, the GCS score was 42.3%. Cases (34%), 2 points and 6 cases (12%). The single factor analysis of postoperative clinical indexes in two groups showed that the time of hospitalization in the craniotomy group was longer than that of interventional embolization group (P0.001), the total cost of individual patients was lower than that of interventional embolization group (P0.001), and the postoperative GCS score was lower than that of interventional embolization group (P=0.034), and the proportion of postoperative complications was higher than that in the intervention group (P= 0.092), the postoperative MRS score was higher than that of interventional embolization group (P=0.014). After multiple linear regression analysis to control the related confounding factors, the clinical indexes of the two groups after operation showed that the time of hospitalization in the craniotomy group was 5.6 days longer than that of the interventional embolization group (P0.001), and the total cost of individual patients was 49 thousand yuan lower than that of the interventional embolization group (P0.001). In the two groups, the postoperative GCS score (P=0.838), postoperative complication rate (P=0.540), postoperative MRS score of 1 (P=0.955) or greater than 2 (P=0.152) had no statistical difference. Conclusion there was no significant difference in the short-term prognosis of intracranial ruptured aneurysm patients treated with craniotomy and interventional embolization; patients treated with craniotomy were treated with craniotomy Hospitalization time is longer, and the cost of hospitalization is higher in patients undergoing interventional embolization. Patients can choose according to their own conditions.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R651.12

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