益气活血中药干预椎动脉起始部支架置入术后再狭窄的临床研究

发布时间：2018-06-29 04:28

本文选题：脑血管 + 椎动脉　；参考：《中国中医科学院》2017年博士论文

【摘要】：随着神经介入技术和材料的发展,缺血性脑血管病的介入治疗取得了快速发展,成为治疗缺血性脑血管病的重要手段之一。然而,同冠状动脉一样,脑动脉介入术后同样面临血管再狭窄的难题,其中椎动脉起始部支架术后再狭窄率是所有颅内、外血管支架成形术中最高的。与中药干预冠状动脉介入术后再狭窄研究取得的丰硕成果相比,中药干预脑血管支架术后再狭窄的研究还仅仅处于起步阶段,研究报道少,缺乏高质量临床试验,对现有研究也缺少客观评价,因而中药干预脑血管支架术后再狭窄的疗效尚缺乏循证医学证据。本研究通过Meta分析的方法,系统评价中药干预脑血管支架术后再狭窄的疗效,并对现有文献的研究质量进行科学评估;同时通过随机对照试验,观察益气活血中药对椎动脉起始部支架置入术后再狭窄疗效的影响,并观察血瘀证、气虚证计分的变化。本研究分为两部分:第一部分:中药干预脑血管支架术后再狭窄的系统评价目的:评价中药干预脑血管支架术后再狭窄的有效性及安全性。方法:检索Pubmed、Cochrane Library、中国生物医学文献数据库(CBMDisk)、中国知网(CNKI)、万方数据库、维普资讯网、中国临床试验注册中心以及其他相关文献,按照预先设定的纳入标准和排除标准筛选资料,采用Revman5.3软件进行Meta分析,并应用风险评估工具进行研究质量的评价,应用GRADE评分进行证据级别的推荐。结果:共收集到中药干预脑血管支架术后再狭窄的文献13篇,符合纳入标准并最终进入Meta分析的研究共4项,纳入患者304例。Meta分析结果显示在常规西药治疗基础上加用中药治疗,有可能减少脑血管支架术后再狭窄的发生[OR=0.41,95%CI(0.21,0.79)],且无不良反应;在预防脑缺血事件复发方面,治疗组和对照组间差异无统计学意义。结论:系统评价的结果显示出中药联合西医常规治疗与单纯西药治疗相比,再狭窄发生可能有所减少,但纳入的研究都存在明显的方法学漏洞,结果的准确性和可靠性不高,需要更多高质量的随机对照试验。第二部分:益气活血中药干预椎动脉起始部支架置入术后再狭窄的随机、双盲、安慰剂对照研究目的:观察益气活血中药干预椎动脉起始部支架置入术后再狭窄的有效性和安全性。方法:采用随机、双盲、安慰剂对照研究方法,将椎动脉起始部支架治疗成功后、并符合气虚证和血瘀证的96例患者随机分为两组,两组均在常规西药治疗的基础性上,试验干预组同时给予益气活血中药治疗,对照组则同时给予安慰剂口服,观察两组患者服药6个月后再狭窄发生情况及脑缺血事件复发情况,以及血瘀证、气虚证计分的变化。结果:随访6个月,有3例退出试验,试验干预组再狭窄发生率19.1%(9/47),对照组再狭窄发生率28.3%(13/46),试验干预组再狭窄发生少,但两组相比无统计学差异(P0.05);随访期间试验干预组的脑缺血复发事件较对照组少,6.4%(3/47)vs13%(6/46),但两组相比无统计学差异(P0.05)。试验干预组的血瘀证计分和气虚证计分均明显下降,与对照组相比,差异有统计学意义(P0.01)。相关性分析显示再狭窄的发生与支架类型和术后6个月气虚证、血瘀证计分有关,差异有统计学意义(P0.01)。结论:再狭窄可能与血瘀证、气虚证有关,益气活血中药可以降低患者气虚证、血瘀证计分,改善患者气虚、血瘀的状态,在常规西药基础上加用益气活血中药有减少椎动脉起始部支架置入术后6个月时再狭窄发生的趋势,气虚证和血瘀证可能是椎动脉起始部支架置入术后再狭窄的影响因素之一,但仍需后期进行大样本试验验证。
[Abstract]:With the development of neural interventional techniques and materials, the interventional therapy of ischemic cerebrovascular disease has developed rapidly and has become one of the most important means for the treatment of ischemic cerebrovascular disease. However, the same as the coronary artery, cerebral artery intervention is also faced with the difficult problem of vascular restenosis after the operation of the vertebral artery stenting. Compared with the fruitful results of the intervention of the coronary artery restenosis after the intervention of the coronary artery, the study on the restenosis after the intervention of the cerebral vascular stent is only in the initial stage. The research reports are few, the high quality clinical trials are lacking, and the existing research is lack of objective evaluation. The effect of drug intervention on restenosis after cerebrovascular stenting is still lack of evidence-based medical evidence. The effect of traditional Chinese medicine on restenosis after cerebral vascular stenting was evaluated by Meta analysis, and the quality of the existing literature was evaluated scientifically. At the same time, the Chinese medicine of Yiqi Huoxue Chinese medicine was observed on the vertebral artery. The effect of the curative effect of restenosis after the initial stent implantation and the changes of blood stasis syndrome and Qi deficiency syndrome were observed. The study was divided into two parts: the first part: the objective of systematic evaluation of Chinese traditional medicine intervention after cerebral vascular stent restenosis: To evaluate the effectiveness and safety of traditional Chinese medicine to intervene restenosis after cerebral vascular stenting. Methods: retrieving Pubmed, Cochrane Li Brary, China biomedical literature database (CBMDisk), Chinese knowledge network (CNKI), Wanfang database, VP information network, Chinese clinical trial registry and other related literature, use Revman5.3 software for Meta analysis according to pre set inclusion criteria and exclusion criteria, and use risk assessment tools for research quality. Results: the GRADE score was used to recommend the level of evidence. Results: a total of 13 literature on restenosis after the intervention of cerebrovascular stenting was collected. 4 studies were conformed to the inclusion criteria and finally entered the Meta analysis. The results of 304 cases of.Meta analysis in the patients showed that the use of traditional Chinese medicine on the basis of conventional western medicine treatment could reduce the brain. The recurrence of restenosis after stent was [OR=0.41,95%CI (0.21,0.79)], and no adverse reaction was found. There was no significant difference between the treatment group and the control group in preventing the recurrence of cerebral ischemia. Conclusion: the results of the systematic evaluation showed that the restenosis may be reduced compared with the traditional Chinese medicine combined with the western medicine. However, there are obvious methodological loopholes in the study, the accuracy and reliability of the results are not high, and more high quality randomized controlled trials are needed. The second part: the intervention of Yiqi Huoxue traditional Chinese medicine to intervene the restenosis after the stenting of the vertebral artery stenting, double blind, placebo pairs of research purposes: To observe the intervention of qi invigorating and activating blood Chinese medicine to intervene the vertebral artery Methods: a randomized, double blind, placebo-controlled study was conducted with a randomized, double-blind, placebo controlled study. 96 patients with Qi deficiency syndrome and blood stasis syndrome were randomly divided into two groups. The two groups were all on the basis of conventional western medicine. The control group was treated with traditional Chinese medicine, and the control group was given the placebo oral administration at the same time. The occurrence of restenosis and the recurrence of cerebral ischemic events in the two groups after 6 months of taking medicine, and the changes of the blood stasis syndrome and Qi deficiency syndrome were observed. The results were followed up for 6 months, 3 cases were withdrawn, the incidence of restenosis was 19.1% (9/47), and the restenosis occurred in the control group. Rate 28.3% (13/46), the experimental intervention group had less restenosis, but there was no statistical difference between the two groups (P0.05). The cerebral ischemia recurrence events in the experimental intervention group were less than the control group, 6.4% (3/47) vs13% (6/46), but there was no statistical difference (P0.05). The scores of blood stasis syndrome and Qi deficiency syndrome in the intervention group were significantly lower than those in the control group, and the control group were significantly lower than those in the control group. The difference was statistically significant (P0.01). The correlation analysis showed that the occurrence of restenosis was related to the type of stent and the 6 months of qi deficiency syndrome and blood stasis syndrome, and the difference was statistically significant (P0.01). Conclusion: restenosis may be related to blood stasis syndrome and Qi deficiency syndrome, and the TCM can reduce Qi deficiency syndrome, blood stasis syndrome, and improve the patient's suffering. The state of qi deficiency and blood stasis, supplementing qi and activating blood with traditional Chinese medicine on the basis of conventional western medicine can reduce the tendency of restenosis at 6 months after the stenting of the vertebral artery. Qi deficiency syndrome and blood stasis syndrome may be one of the factors affecting the restenosis after the stenting of the vertebral artery, but a large sample test still needs to be carried out later.
【学位授予单位】：中国中医科学院
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R743

【参考文献】