PCI术后氯吡格雷抵抗人群证候特点及血府逐瘀胶囊干预的临床评价

发布时间：2018-06-15 17:25

本文选题：PCI术后 + 氯吡格雷抵抗　；参考：《中国中医科学院》2016年博士论文

【摘要】：抗血小板治疗在经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)后预防支架内血栓形成方面起着决定性的作用。但即使进行了充分的阿司匹林加氯吡格雷双联抗血小板治疗,还会有一定比例的支架内血栓形成及再狭窄发生。很多PCI术后患者在客观影像学证据显示血管内无明显狭窄的情况下,仍存在着不同程度的胸闷、胸痛、焦虑等一系列不适症状。研究发现不同患者对相同剂量氯吡格雷的反应性不同,甚至有部分患者对氯吡格雷无反应,即存在氯吡格雷抵抗。鉴于目前部分患者存在氯吡格雷抵抗现象,抗血小板药物的有效性尚存不足,所以从传统的活血化瘀中药中寻找高效、低副作用的抗血小板药物成为研究的热点。陈可冀院士等认为支架置入后的血管内膜损伤实际上与传统意义上的“外伤致瘀”认识基本一致。传统医学认为瘀血痹阻、血脉不畅,可导致胸闷、胸痛,以及续发的一些表现,故活血化瘀治疗会改善症状及预后。但是,目前对PCI术后氯吡格雷抵抗人群的中医证型研究较少,本研究旨在广泛收集临床PCI术后病例资料,初步探索了解PCI术后行双联抗血小板治疗患者的基线证型分布以及氯吡格雷抵抗人群的证候分布特点,并综合评价应用血府逐瘀胶囊干预氯吡格雷抵抗的临床疗效及安全性。研究目的：1.初步探索PCI术后氯吡格雷抵抗的发生率及氯吡格雷抵抗人群的中医证型分布特点,以期寻找适当的中医药治疗方法。2.综合评价活血化瘀药联合标准双联抗血小板药物的临床疗效及安全性。研究方法：1.纳入2013年1月1日至2014年12月31日在北京中医药大学东直门医院成功进行PCI治疗,并接受标准双联抗血小板治疗的冠心病患者308例。采集患者的一般资料,填写中医证候要素量表。在双联抗血小板治疗第7天留取患者静脉血进行检测,最后对采集的数据进行统计分析。2.采用随机、对照的方法,共选择出冠心病PCI术后氯吡格雷抵抗的血瘀证患者60例,随机分为活血化瘀组(活血组)和双联抗血小板组(对照组)两组。两组患者的西医常规治疗均按照治疗冠心病的相关建议和指南进行,并保持不同组别西医干预的一致性。对照组继续常规阿司匹林与氯吡格雷抗血小板治疗,活血组在标准双联抗血小板治疗的基础上,加用血府逐瘀胶囊(6粒/次,每日两次)进行干预治疗,4周为一疗程(患者30天内连续服药28±4天)。观察血脂、血瘀证计分、中医症状计分等相关疗效指标的变化,并借助血栓弹力图仪,在两个时间点对患者进行血小板活性及凝血功能的监测,即ADP诱导的血小板-纤维蛋白凝块强度(MAADP),综合分析活血化瘀疗法抗血小板治疗的临床疗效及安全性,并对比血瘀证计分等的变化,探讨PCI术后血瘀证计分与血小板活性之间的关系。结果：1.血瘀证是冠心病PCI术后的主要证候类型2.气虚血瘀证是冠心病PCI术后氯吡格雷抵抗的主要证候类型3.不同证候类型冠心病PCI术后氯吡格雷抵抗患者的血小板功能(MAADP)、血糖(GLU)存在差异,具有统计学意义(P0.05)。4.活血组治疗后血小板活性较治疗前明显降低(MAADP值明显降低),差异有统计学意义(P0.05)：对照组的MAADP值没有明显变化(P0.05)。5.活血组治疗后血瘀证计分值较治疗前明显下降,有非常显著性差异(P0.01)：对照组治疗前后无显著性差异(P0.05)。两组间治疗后计分值比较有显著性差异(P0.05)。6.活血组的心绞痛症状计分值治疗后较治疗前明显降低(P=0.001)；对照组的心绞痛症状计分值治疗后较治疗前也有改善(P=0.04)；但不及活血组改善明显,两组间比较有显著性差异(P0.05)。7.两组TC、TG、LDL水平治疗后均显著降低(P0.05)；但两组之间没有显著性差异。8.中医症状计分值,对照组治疗前后比较没有差异(P0.05)；活血组治疗后较治疗前则有明显下降(P0.01)；两组间治疗后计分值比较有显著性差异(P0.05)。9.两组在观察期间凝血四项结果没有显著差异,且均未有出血事件发生。结论：1.血瘀证是冠心病PCI术后的主要证候类型2.在常规双联抗血小板治疗的基础上加用活血化瘀中药有改善氯吡格雷抵抗的作用,从而减少PCI术后近、远期支架内血栓和再狭窄的发生率,降低PCI术后近期和远期再发缺血事件的风险,且不增加出血风险。
[Abstract]:Antiplatelet therapy plays a decisive role in preventing stent thrombosis after percutaneous coronary intervention (percutaneous coronary intervention, PCI). But even with the full aspirin and clopidogrel double antiplatelet therapy, there will be a certain proportion of stent thrombosis and restenosis. A series of discomfort symptoms, such as chest pain, chest pain and anxiety, were still present in the patients with multiple PCI after the objective imaging evidence showed no obvious stenosis in the blood vessels. The study found that the reactivity of different patients to the same dose of clopidogrel was different, and some patients had no response to clopidogrel, that is, clopidogrel was present. In view of the current resistance of some patients with clopidogrel resistance and the shortage of antiplatelet drugs, the search for high efficiency and low side effects of antiplatelet drugs from traditional Chinese medicine for activating blood and removing blood stasis has become a hot spot of research. Academician Chen Keji believes that the vascular intima damage after stent implantation is actually in the traditional sense. The understanding of "trauma causing stasis" is basically consistent. Traditional medicine considers stagnation of blood stasis and poor blood circulation, which can lead to chest tightness, chest pain, and some manifestations of continued hair. Therefore, the treatment of blood circulation and stasis can improve the symptoms and prognosis. However, there are few studies on the TCM syndrome type of clopidogrel resistance population after PCI. This study aims to collect extensive clinical PCI after surgery. The case data, preliminarily explore the baseline distribution of the patients with double antiplatelet therapy after PCI and the characteristics of the syndrome distribution in the clopidogrel resistance population, and evaluate the clinical efficacy and safety of the use of Xuefu Zhuyu Capsule to interfere with clopidogrel resistance. Objective: 1. to explore the preliminary exploration of the hair clopidogrel resistance after PCI. Birth rate and the characteristics of TCM syndrome type distribution in clopidogrel resistance population, in order to find the appropriate traditional Chinese medicine treatment method.2. comprehensive evaluation of the clinical efficacy and safety of the combined standard double anti platelet antiplatelet drugs for activating blood and removing stasis drugs. 1. the research methods were included in the Dongzhimen Hospital of Beijing University of Chinese Medicine from January 1, 2013 to December 31, 2014. 308 cases of coronary heart disease with standard double anti platelet therapy were performed with PCI treatment. The general data of the patients were collected and the TCM syndrome factor scale was filled in. The venous blood was checked for seventh days by double anti platelet therapy. Finally, the data collected were statistically analyzed by.2., a random and control method was used to select the crown. 60 patients with clopidogrel resistance to blood stasis after PCI were randomly divided into two groups: the Huoxue Huayu group (Huoxue group) and the double anti platelet group (control group). The two groups of patients were performed according to the relevant recommendations and guidelines for the treatment of coronary heart disease, and the consistency of different groups of Western medicine intervention was maintained. The control group continued the routine asin. Aspirin and clopidogrel were treated with antiplatelet therapy. On the basis of standard double anti platelet therapy, the group was treated with Xuefu Zhuyu Capsule (6 grains per day, two times a day), and 4 weeks was a course of treatment (28 + 4 days of continuous medication in 30 days). The changes of blood lipid, blood stasis syndrome, TCM symptom score, and other related curative effect indexes were observed and borrowed. The blood platelet activity and coagulation function of patients were monitored at two time points, that is, platelet fibrin clot intensity (MAADP) induced by ADP, and the clinical efficacy and safety of blood stasis removing therapy were comprehensively analyzed and compared with blood stasis syndrome. The score of blood stasis syndrome after PCI was discussed and the score of blood stasis syndrome was discussed. Relationship between platelet activity. Results: 1. blood stasis syndrome is the main syndrome type 2. Qi deficiency and blood stasis after PCI for coronary heart disease (CAD PCI), the main syndrome type of clopidogrel resistance after coronary heart disease 3., 3. different syndrome types of coronary heart disease after coronary heart disease (MAADP) and blood glucose (GLU), there is a difference in blood sugar (GLU), with statistics Significance (P0.05).4. Huoxue group after treatment significantly lower platelet activity than before treatment (MAADP value significantly decreased), the difference was statistically significant (P0.05): the MAADP value of the control group did not change significantly (P0.05).5. activating blood group after treatment, the score of blood stasis syndrome was significantly lower than before the treatment (P0.01): the control group before and after treatment no treatment (P0.01) Significant difference (P0.05). There was significant difference in the score of two groups after treatment (P0.05) the score value of angina pectoris in.6. Huoxue group was significantly lower than before treatment (P=0.001); the score value of angina pectoris in the control group was improved after treatment (P=0.04), but the improvement of the blood group was obvious, and there was a significant difference between the two groups. P0.05.7. two groups TC, TG, LDL level after treatment significantly decreased (P0.05), but there was no significant difference between the two groups of.8. TCM symptom score values, no difference before and after treatment (P0.05) in the control group (P0.05); the blood group after treatment was significantly lower than before treatment (P0.01); two groups after treatment, there was a significant difference (P0). .05) there was no significant difference in the four blood coagulation results during the observation period and no bleeding event occurred during the observation period. Conclusion: the 1. blood stasis syndrome is the main syndrome type after PCI operation of coronary heart disease (2.). The use of traditional Chinese medicine with activating blood and removing stasis on the basis of conventional double anti platelet therapy can improve the effect of clopidogrel resistance, thus reducing the near and long term after the PCI operation. The incidence of thrombosis and restenosis in stent can reduce the risk of ischemic events in the short and long term after PCI, and do not increase the risk of bleeding.
【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】：2016
【分类号】：R541.4

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