PCI術(shù)后氯吡格雷抵抗人群證候特點及血府逐瘀膠囊干預(yù)的臨床評價
發(fā)布時間:2018-06-15 17:25
本文選題:PCI術(shù)后 + 氯吡格雷抵抗; 參考:《中國中醫(yī)科學(xué)院》2016年博士論文
【摘要】:抗血小板治療在經(jīng)皮冠狀動脈介入治療(percutaneous coronary intervention,PCI)后預(yù)防支架內(nèi)血栓形成方面起著決定性的作用。但即使進(jìn)行了充分的阿司匹林加氯吡格雷雙聯(lián)抗血小板治療,還會有一定比例的支架內(nèi)血栓形成及再狹窄發(fā)生。很多PCI術(shù)后患者在客觀影像學(xué)證據(jù)顯示血管內(nèi)無明顯狹窄的情況下,仍存在著不同程度的胸悶、胸痛、焦慮等一系列不適癥狀。研究發(fā)現(xiàn)不同患者對相同劑量氯吡格雷的反應(yīng)性不同,甚至有部分患者對氯吡格雷無反應(yīng),即存在氯吡格雷抵抗。鑒于目前部分患者存在氯吡格雷抵抗現(xiàn)象,抗血小板藥物的有效性尚存不足,所以從傳統(tǒng)的活血化瘀中藥中尋找高效、低副作用的抗血小板藥物成為研究的熱點。陳可冀院士等認(rèn)為支架置入后的血管內(nèi)膜損傷實際上與傳統(tǒng)意義上的“外傷致瘀”認(rèn)識基本一致。傳統(tǒng)醫(yī)學(xué)認(rèn)為瘀血痹阻、血脈不暢,可導(dǎo)致胸悶、胸痛,以及續(xù)發(fā)的一些表現(xiàn),故活血化瘀治療會改善癥狀及預(yù)后。但是,目前對PCI術(shù)后氯吡格雷抵抗人群的中醫(yī)證型研究較少,本研究旨在廣泛收集臨床PCI術(shù)后病例資料,初步探索了解PCI術(shù)后行雙聯(lián)抗血小板治療患者的基線證型分布以及氯吡格雷抵抗人群的證候分布特點,并綜合評價應(yīng)用血府逐瘀膠囊干預(yù)氯吡格雷抵抗的臨床療效及安全性。研究目的:1.初步探索PCI術(shù)后氯吡格雷抵抗的發(fā)生率及氯吡格雷抵抗人群的中醫(yī)證型分布特點,以期尋找適當(dāng)?shù)闹嗅t(yī)藥治療方法。2.綜合評價活血化瘀藥聯(lián)合標(biāo)準(zhǔn)雙聯(lián)抗血小板藥物的臨床療效及安全性。研究方法:1.納入2013年1月1日至2014年12月31日在北京中醫(yī)藥大學(xué)東直門醫(yī)院成功進(jìn)行PCI治療,并接受標(biāo)準(zhǔn)雙聯(lián)抗血小板治療的冠心病患者308例。采集患者的一般資料,填寫中醫(yī)證候要素量表。在雙聯(lián)抗血小板治療第7天留取患者靜脈血進(jìn)行檢測,最后對采集的數(shù)據(jù)進(jìn)行統(tǒng)計分析。2.采用隨機、對照的方法,共選擇出冠心病PCI術(shù)后氯吡格雷抵抗的血瘀證患者60例,隨機分為活血化瘀組(活血組)和雙聯(lián)抗血小板組(對照組)兩組。兩組患者的西醫(yī)常規(guī)治療均按照治療冠心病的相關(guān)建議和指南進(jìn)行,并保持不同組別西醫(yī)干預(yù)的一致性。對照組繼續(xù)常規(guī)阿司匹林與氯吡格雷抗血小板治療,活血組在標(biāo)準(zhǔn)雙聯(lián)抗血小板治療的基礎(chǔ)上,加用血府逐瘀膠囊(6粒/次,每日兩次)進(jìn)行干預(yù)治療,4周為一療程(患者30天內(nèi)連續(xù)服藥28±4天)。觀察血脂、血瘀證計分、中醫(yī)癥狀計分等相關(guān)療效指標(biāo)的變化,并借助血栓彈力圖儀,在兩個時間點對患者進(jìn)行血小板活性及凝血功能的監(jiān)測,即ADP誘導(dǎo)的血小板-纖維蛋白凝塊強度(MAADP),綜合分析活血化瘀療法抗血小板治療的臨床療效及安全性,并對比血瘀證計分等的變化,探討PCI術(shù)后血瘀證計分與血小板活性之間的關(guān)系。結(jié)果:1.血瘀證是冠心病PCI術(shù)后的主要證候類型2.氣虛血瘀證是冠心病PCI術(shù)后氯吡格雷抵抗的主要證候類型3.不同證候類型冠心病PCI術(shù)后氯吡格雷抵抗患者的血小板功能(MAADP)、血糖(GLU)存在差異,具有統(tǒng)計學(xué)意義(P0.05)。4.活血組治療后血小板活性較治療前明顯降低(MAADP值明顯降低),差異有統(tǒng)計學(xué)意義(P0.05):對照組的MAADP值沒有明顯變化(P0.05)。5.活血組治療后血瘀證計分值較治療前明顯下降,有非常顯著性差異(P0.01):對照組治療前后無顯著性差異(P0.05)。兩組間治療后計分值比較有顯著性差異(P0.05)。6.活血組的心絞痛癥狀計分值治療后較治療前明顯降低(P=0.001);對照組的心絞痛癥狀計分值治療后較治療前也有改善(P=0.04);但不及活血組改善明顯,兩組間比較有顯著性差異(P0.05)。7.兩組TC、TG、LDL水平治療后均顯著降低(P0.05);但兩組之間沒有顯著性差異。8.中醫(yī)癥狀計分值,對照組治療前后比較沒有差異(P0.05);活血組治療后較治療前則有明顯下降(P0.01);兩組間治療后計分值比較有顯著性差異(P0.05)。9.兩組在觀察期間凝血四項結(jié)果沒有顯著差異,且均未有出血事件發(fā)生。結(jié)論:1.血瘀證是冠心病PCI術(shù)后的主要證候類型2.在常規(guī)雙聯(lián)抗血小板治療的基礎(chǔ)上加用活血化瘀中藥有改善氯吡格雷抵抗的作用,從而減少PCI術(shù)后近、遠(yuǎn)期支架內(nèi)血栓和再狹窄的發(fā)生率,降低PCI術(shù)后近期和遠(yuǎn)期再發(fā)缺血事件的風(fēng)險,且不增加出血風(fēng)險。
[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.
【學(xué)位授予單位】:中國中醫(yī)科學(xué)院
【學(xué)位級別】:博士
【學(xué)位授予年份】:2016
【分類號】:R541.4
【參考文獻(xiàn)】
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本文編號:2022835
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