本文選題：參元丹 + 經(jīng)皮冠狀動(dòng)脈介入治療��； 參考：《北京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：目的:觀(guān)察參元丹(SYD)對(duì)非ST段抬高急性冠脈綜合征(NSTE-ACS)患者擇期PCI圍手術(shù)期心肌損傷(PMI)的干預(yù)效果及其機(jī)制探索。方法:本課題采用隨機(jī)、雙盲、安慰劑、對(duì)照的觀(guān)察方法,研究對(duì)象均為首都醫(yī)科大學(xué)附屬北京中醫(yī)醫(yī)院心血管科2016年7月至2016年12月擬行冠狀動(dòng)脈介入(PCI)治療的,中醫(yī)證型屬氣虛血瘀證的NSTE-ACS患者。最終68名符合納入標(biāo)準(zhǔn)的患者被隨機(jī)分為參元丹組(n=36)和安慰劑組(n=32),受試者在接受冠心病常規(guī)藥物治療基礎(chǔ)上,于術(shù)前3天至術(shù)后7天根據(jù)分組情況服用參元丹或安慰劑,并根據(jù)患者具體病情擇期行PCI治療。臨床觀(guān)察包括:(1)術(shù)前、術(shù)后4h、術(shù)后24h及術(shù)后7d心肌損傷標(biāo)志物cTNT、CK-MB的變化;外周血EPCs計(jì)數(shù);促血管內(nèi)皮生長(zhǎng)因子VEGF、SDF-1水平變化;氧化應(yīng)激指標(biāo)SOD、MDA的變化;炎癥反應(yīng)指標(biāo)hs-CRP、IL-6的變化;(2)術(shù)前、術(shù)后24h行彩色多普勒超聲及速度向量成像技術(shù)(VVI)檢測(cè);(3)術(shù)后30天MACE事件(4)安全性監(jiān)測(cè)。結(jié)果:(1)基線(xiàn)情況:參元丹組與安慰劑組納入患者各方面基線(xiàn)資料(一般情況、各指標(biāo)術(shù)前水平等)均無(wú)統(tǒng)計(jì)學(xué)差異(P0.05),具有可比性。(2)PMI發(fā)生率:參元丹組PMI的發(fā)病率(2.8%)低于安慰劑組(21.9%),兩組具有統(tǒng)計(jì)學(xué)差異(P0.05)。(3)CK-MB水平檢測(cè):參元丹組術(shù)后4h、24h,安慰劑組術(shù)后4h、24h、7d比較各組術(shù)前CK-MB水平均升高(P0.05),差異均具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后7d較術(shù)前有升高趨勢(shì)(P0.05),差異不具有統(tǒng)計(jì)學(xué)意義。兩組術(shù)后4h、24h、7d的CK-MB水平比較,參元丹組均有低于安慰劑組趨勢(shì),但差異不具有統(tǒng)計(jì)學(xué)意義(P0.05)。(4)EPCs動(dòng)員相關(guān):①EPCs計(jì)數(shù):參元丹組術(shù)后24h、7d比較術(shù)前外周血EPCs水平均升高(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、安慰劑組術(shù)后4h、24h、7d比較各組術(shù)前有升高趨勢(shì)(P0.05),差異不具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后24h、7d高于安慰劑組同時(shí)間點(diǎn)(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。兩組術(shù)后4h比較,參元丹組有高于安慰劑組趨勢(shì)(P0.05),但差異均不具有統(tǒng)計(jì)學(xué)意義。②VEGF水平:參元丹組術(shù)后24h、7d,安慰劑組術(shù)后24h比較各組術(shù)前外周血VEGF水平均升高(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、安慰劑組術(shù)后4h、7d與各組術(shù)前比較(P0.05),差異均不具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后24h、7d均有高于安慰劑組同時(shí)間點(diǎn)趨勢(shì)(P0.05),兩組術(shù)后4h比較(P0.05),差異均不具有統(tǒng)計(jì)學(xué)意義。③SDF-1水平:參元丹組術(shù)后24h較本組術(shù)前外周血SDF-1水平升高(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、7d,安慰劑組術(shù)后4h、24h、7d與各組術(shù)前比較(P0.05),差異不具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后24h、7d均高于安慰劑組同時(shí)間點(diǎn)(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。兩組術(shù)后4h比較,差異不具有統(tǒng)計(jì)學(xué)意義(P0.05)。④相關(guān)性:參元丹組PCI術(shù)前,PCI術(shù)后4h、24h、7d外周血EPCs及VEGF水平存在顯著相關(guān)關(guān)系(r=0.231,P0.05);參元丹組PCI術(shù)前,PCI術(shù)后4h、24h、7d外周血EPCs及SDF-1水平存在顯著相關(guān)關(guān)系(r=0.323,P0.05)。(5)炎癥因子相關(guān):①hs-CRP水平:兩組術(shù)后24h較各組術(shù)前hs-CRP水平均升高(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、7d,安慰劑組術(shù)后4h、7d與各組術(shù)前比較(P0.05),差異均不具有統(tǒng)計(jì)學(xué)意義。兩組術(shù)后7d均低于各組術(shù)后24h(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、24h、7d均有低于安慰劑組同時(shí)間點(diǎn)的趨勢(shì)(P0.05),但差異不具有統(tǒng)計(jì)學(xué)意義。②IL-6 水平:參元丹組術(shù)后24h、安慰劑組術(shù)后4h、24h比較本組術(shù)前IL-6水平均升高(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、7d,安慰劑組術(shù)后7d與各組術(shù)前比較(P0.05),差異均不具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、24h、7d均有低于安慰劑組同時(shí)間的趨勢(shì)(P0.05),但差異均不具有統(tǒng)計(jì)學(xué)意義。(6)氧化應(yīng)激相關(guān):①SOD水平:安慰劑組術(shù)后24h低于本組術(shù)前SOD水平(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、24h、7d,安慰劑組術(shù)后4h、7d比較各組術(shù)前,均無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)。參元丹組術(shù)后24h高于安慰劑組術(shù)后24h(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、7d均有高于安慰劑組同時(shí)間的趨勢(shì)(P0.05),但差異均不具有統(tǒng)計(jì)學(xué)意義。②MDA水平:兩組術(shù)后24h較各組術(shù)前MDA水平均升高(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。參元丹組術(shù)后4h、7d,安慰劑組術(shù)后4h、7d比較各組術(shù)前,均無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)。參元丹組術(shù)后4h、24h、7d均有低于安慰劑組同時(shí)間點(diǎn)的趨勢(shì)(P0.05),但差異均不具有統(tǒng)計(jì)學(xué)意義。(7)超聲心動(dòng)及WI技術(shù)相關(guān):①參元丹組PCI術(shù)后24h的左室射血分?jǐn)?shù)、左室舒張末徑及E/A值比較術(shù)前均未發(fā)生具有統(tǒng)計(jì)學(xué)意義的變化(P0.05)。②安慰劑組PCI術(shù)后24h的前間隔心尖段、前壁心尖段、前壁基底段、下壁心尖段、下壁中間段的應(yīng)變指標(biāo)低于本組術(shù)前水平(P0.05),差異具有統(tǒng)計(jì)學(xué)意義;PCI術(shù)后24小時(shí)參元丹組與安慰劑組比較,在前間隔心尖段、前壁心尖段、下壁心尖段參元丹組應(yīng)變指標(biāo)改善情況優(yōu)于安慰劑組(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。③安慰劑組PCI術(shù)后24h的前間隔心尖段、前壁心尖段、下壁心尖段、下壁中間段應(yīng)變率指標(biāo)低于本組術(shù)前水平(P0.05),差異具有統(tǒng)計(jì)學(xué)意義;PCI術(shù)后24h參元丹組與安慰劑組比較,在前間隔心尖段、前壁心尖段、下壁心尖段,參元丹組應(yīng)變率指標(biāo)改善情況優(yōu)于安慰劑組(P0.05),差異具有統(tǒng)計(jì)學(xué)意義。(8)MACE事件及安全性監(jiān)測(cè):兩組間比較,參元丹組術(shù)后30天MACE事件發(fā)生率(5.6%)有低于安慰劑組(15.6%)趨勢(shì),但差異不具統(tǒng)計(jì)學(xué)意義(P0.05);試驗(yàn)期間無(wú)參元丹相關(guān)的不良反應(yīng)發(fā)生,安全性良好。結(jié)論:(1)SYD能降低NSTE-ACS患者PMI發(fā)生率,并具有降低PCI圍手術(shù)期血清CK-MB水平、減少PCI術(shù)后30天MACE事件發(fā)生率趨勢(shì),且安全性良好,提示SYD對(duì)NSTE-ACS患者PCI圍手術(shù)期有一定心肌保護(hù)作用。(2)SYD可增加NSTE-ACS患者擇期PCI圍手術(shù)期外周血EPCs、VEGF及SDF-1水平,提示SYD具有改善NSTE-ACS患者擇期PCI圍手術(shù)期EPCs動(dòng)員與歸巢作用,其機(jī)制可能與上調(diào)外周血中VEGF和SDF-1的表達(dá)來(lái)實(shí)現(xiàn),這也可能是改善NSTE-ACS患者PCI圍手術(shù)期心肌損傷的機(jī)制之一。(3)SYD具有降低NSTE-ACS患者擇期PCI圍手術(shù)期血清炎癥反應(yīng)因子hs-CRP與IL-6水平趨勢(shì),提示SYD對(duì)NSTE-ACS患者擇期PCI圍手術(shù)期心肌保護(hù)作用可能與其抑制炎癥反應(yīng)相關(guān)。(4)SYD干預(yù)NSTE-ACS患者擇期PCI圍手術(shù)期,可抑制PCI術(shù)后SOD水平的降低,并具有抑制PCI術(shù)后MDA水平升高趨勢(shì),提示SYD對(duì)NSTE-ACS患者擇期PCI圍手術(shù)期心肌保護(hù)作用可能與其抗氧化應(yīng)激作用相關(guān)。(5)應(yīng)用VVI技術(shù)分析節(jié)段室壁收縮功能的變化,以節(jié)段心肌應(yīng)變及應(yīng)變率為效應(yīng)指標(biāo),發(fā)現(xiàn)參元丹組節(jié)段室壁運(yùn)動(dòng)與安慰劑組比較有一定改善,也提示VVI相較于傳統(tǒng)超聲心動(dòng)更有助于PMI的早期評(píng)估。綜上所述:SYD對(duì)NSTE-ACS患者擇期PCI圍手術(shù)期具有一定心肌保護(hù)作用,其機(jī)制可能與促進(jìn)EPCs動(dòng)員與歸巢、抑制炎癥反應(yīng)及抗氧化應(yīng)激作用相關(guān)。
[Abstract]:Objective: To observe the effect and mechanism of Shen Yuan Dan (SYD) on PCI perioperative myocardial injury (PMI) in patients with non ST segment elevation acute coronary syndrome (NSTE-ACS). Methods: a randomized, double blind, placebo-controlled, controlled study was used in this study, and the study on the cardiovascular department of Beijing Chinese Medicine Hospital affiliated to Capital Medical University 2016 From July to December 2016, the TCM syndrome type was NSTE-ACS patients with Qi deficiency and blood stasis syndrome. The final 68 eligible patients were randomly divided into the Shen Yuan Dan group (n=36) and the placebo group (n=32). The subjects were treated on the basis of the conventional medicine treatment for coronary heart disease (CAD), and were divided into groups from 3 days before the operation to 7 days after the operation. Taking Shen Yuan Dan or placebo and PCI treatment according to the specific condition of the patient, clinical observation included: (1) preoperative, postoperative 4h, postoperative 24h and postoperative 7d myocardial damage markers, cTNT, CK-MB, peripheral blood EPCs count, vascular endothelial growth factor VEGF, SDF-1 level changes, oxidative stress indicators SOD, MDA changes; inflammatory response indicators Changes in hs-CRP and IL-6; (2) preoperative and postoperative 24h color Doppler ultrasound and velocity vector imaging (VVI) detection; (3) MACE event 30 days after operation (4) safety monitoring. Results: (1) baseline situation: the baseline data (general condition, preoperative level, etc.) of the Shen Yuan Dan group and the placebo group were not statistically different (P0.05), (2) the incidence of PMI: the incidence of PMI in the Shen Yuan Dan group (2.8%) was lower than that of the placebo group (21.9%), and the two groups had statistical difference (P0.05). (3) CK-MB level test: 4h, 24h, 4h, 24h, 7d in the placebo group after operation, 4h, 24h, 7d were all increased (P0.05) in all groups before operation (P0.05), and the difference was statistically significant. After the operation of Shen Yuan Dan group, 7d was compared The difference was not statistically significant before operation (P0.05). The CK-MB level of 4h, 24h, 7d in the two groups was lower than that of the placebo group, but the difference was not statistically significant (P0.05). (4) EPCs mobilization correlation: (1) EPCs count: 24h in the group of Shen Yuan Dan group after operation, 7d compared with the EPCs level of peripheral blood before operation (P0.05), the difference Statistical significance. 4h after operation in the Shen Yuan Dan group, 4h, 24h, 7d after operation in the placebo group compared with each group before operation (P0.05), the difference was not statistically significant. The 24h in the Shen Yuan group after operation, 7d was higher than the placebo group at the same time point (P0.05), the difference was statistically significant. The two groups after the operation 4H compared to the placebo group was higher than the placebo group trend (P0.05) But the difference was not statistically significant. (2) VEGF level: after the operation of 24h, 7d, and 24h in the group of Shen Yuan Dan group, the level of VEGF in the peripheral blood increased (P0.05) before the operation of the placebo group (P0.05), the difference was statistically significant. After the operation of the Shen Yuan Dan group, 4h, 4h, 7d and the preoperative comparison of each group (P0.05) were not statistically significant. After the operation, 24h, 7d were higher than the placebo group at the same time point trend (P0.05), the two groups after the 4H comparison (P0.05), the difference was not statistically significant. (3) SDF-1 level: after the operation of the Shen Yuan Dan group, 24h was higher than the level of SDF-1 in the peripheral blood (P0.05) before the operation of the group (P0.05), the difference was statistically significant. After the operation of Shen Yuan Dan group, 4h, 7d, placebo group after operation 4H Preoperative comparison (P0.05) was not statistically significant. 24h, 7d in the group of Shen Yuan Dan group were higher than that in the placebo group at the same time point (P0.05), and the difference was statistically significant. The difference between the two groups was not statistically significant (P0.05). (P0.05) correlation: there was a significant phase in the 4h, 24h, 7d peripheral blood EPCs and the level of 7D peripheral blood before the operation of PCI in the group of Shen Yuan Dan group. Relationship (r=0.231, P0.05); before PCI in Shen Yuan group, there was a significant correlation between EPCs and SDF-1 levels in 4h, 24h, 7d after PCI (r=0.323, P0.05). (5) correlation of inflammatory factors: (1) hs-CRP level: the two groups were higher than each group before operation, and the difference was statistically significant. 4h, 7d and each group preoperative comparison (P0.05), the difference was not statistically significant. The two groups after the operation of 7D were lower than 24h (P0.05) after the operation, the difference was statistically significant. After the operation, 4h, 24h, 7d were lower than the placebo group at the same time point (P0.05), but the difference was not statistically significant. After the operation, 4h, 24h compared with the average increase of IL-6 water (P0.05) before operation (P0.05), the difference was statistically significant. The difference was not statistically significant between the 4h, 7d and placebo group after operation (P0.05) after operation in the group of Shen Yuan Dan group (P0.05), and there was a trend of 4h, 24h, 7d after the operation of the Shen Yuan Dan group. (6) oxidative stress correlation: (1) SOD level: 24h in placebo group was lower than before operation SOD level (P0.05), the difference was statistically significant. 4h, 24h, 7d, 4H in placebo group after operation in the group of Shen Yuan Dan group, 7d compared to each group before operation, no statistical difference (P0.05). Statistical significance. 4h, 7d after the operation of the Shen Yuan group were higher than the placebo group at the same time (P0.05), but the difference was not statistically significant. (2) MDA level: 24h after operation in the two groups increased (P0.05) compared with each group before operation (P0.05), the difference was statistically significant. After operation of the Shen Yuan Dan group, 4h, 7d, placebo group after operation, 4h, 7d compared groups before the operation, all the no group Study difference (P0.05). The trend of 4h, 24h and 7d in the group of Shen Yuan Dan group was lower than that in the placebo group at the same time point (P0.05), but the difference was not statistically significant. (7) the correlation of echocardiography and WI Technology: (1) the left ventricular ejection fraction, left ventricular diastolic diameter and E/A value of the left ventricular diastolic end diastolic diameter and E/A value of the group of Shen Yuan Dan group were not statistically significant before the operation. P0.05. (2) the anterior septal apical segment of the 24h in the placebo group, the anterior apical segment, the anterior wall base segment, the inferior wall apical segment, the inferior wall segment and the lower middle segment were lower than the preoperative level (P0.05), and the difference was statistically significant. 24 hours after PCI, the Shen Yuan Dan group was compared with the comfort group, at the apical apical segment, the anterior apical segment and the inferior wall apex in the anterior septal section. The improvement of the strain index of the Duan Shen Yuan group was better than that of the placebo group (P0.05), and the difference was statistically significant. (3) the pre apical apical segment of the 24h in the placebo group, the apical segment of the anterior wall, the lower wall apical segment, the middle segment of the lower wall of the placebo group were lower than the preoperative level of the group (P0.05), and the difference was statistically significant. The 24h Shen Yuan Dan group after PCI and the consolation of the consolation of the group 24h. The improvement of the strain rate index in the apical apical segment, the anterior apical segment, the lower wall apical segment and the Shen Yuan Dan group was better than the placebo group (P0.05). (8) the MACE event and safety monitoring: the incidence of MACE events at the 30 day after the two groups (5.6%) was lower than the placebo group (15.6%), but the difference was less than that of the placebo group (15.6%), but the difference was less than that of the placebo group. The difference was not statistically significant (P0.05); the adverse reactions associated with no Shen Yuan Dan occurred during the test. Conclusion: (1) SYD could reduce the incidence of PMI in NSTE-ACS patients, reduce the level of serum CK-MB in the perioperative period of PCI, reduce the incidence of MACE events at the 30 day after PCI, and have good safety, suggesting SYD to NSTE-ACS PCI. (2) SYD can increase the level of EPCs, VEGF and SDF-1 in peripheral blood of patients with NSTE-ACS, suggesting that SYD has the effect of improving EPCs mobilization and homing in PCI perioperative period of NSTE-ACS patients. The mechanism may be achieved by up regulation of VEGF and SDF-1 in peripheral blood. One of the mechanisms of myocardial injury during the perioperative period of PCI. (3) SYD has a tendency to reduce the level of serum inflammatory response factors hs-CRP and IL-6 in PCI perioperative period of NSTE-ACS patients, suggesting that the myocardial protective effect of SYD on NSTE-ACS patients may be related to its inhibition of inflammation. (4) SYD intervention NSTE-ACS patients should be selected for PCI perioperative period, It can inhibit the decrease of SOD level after PCI and inhibit the increase of MDA level after PCI operation, suggesting that the myocardial protective effect of SYD on PCI perioperative period may be related to its antioxidant stress. (5) the changes of segmental ventricular wall contraction function are analyzed with VVI technique, and the effect of segmental strain and strain rate is the effect index. The ventricular wall movement in the segment of the Shen Yuan Dan group is better than that of the placebo group. It also suggests that the VVI phase is more helpful to the early evaluation of PMI than the traditional echocardiography. To sum up, SYD has a certain myocardial protective effect on the perioperative PCI perioperative period of NSTE-ACS patients. The mechanism may be related to the promotion of EPCs mobilization and homing, inhibition of inflammatory response and antioxidant activity. Stress related.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R541.4

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 ;冠心病合理用藥指南[J];中國(guó)醫(yī)學(xué)前沿雜志(電子版);2016年06期

2 陳偉偉;高潤(rùn)霖;劉力生;朱曼璐;王文;王擁軍;吳兆蘇;李惠君;鄭哲;蔣立新;胡盛壽;;《中國(guó)心血管病報(bào)告2014》概要[J];中國(guó)循環(huán)雜志;2015年07期

3 郭浩;李磊;侯金才;劉建勛;;中藥促治療性血管新生防治缺血性心腦血管疾病的研究進(jìn)展[J];中國(guó)中藥雜志;2015年01期

4 劉毅;李志j;江騰春;傅強(qiáng);;黃芪多糖對(duì)2型糖尿病患者外周血內(nèi)皮祖細(xì)胞數(shù)量和功能的影響[J];中國(guó)醫(yī)藥導(dǎo)報(bào);2014年34期

5 張彤;劉元峰;宋憲波;蘇文革;吳波;戴國(guó)華;;補(bǔ)腎活血中藥動(dòng)員大鼠骨髓EPC修復(fù)內(nèi)皮功能的實(shí)驗(yàn)研究[J];中西醫(yī)結(jié)合心腦血管病雜志;2014年01期

6 戴國(guó)華;張彤;吳波;焦華琛;劉元峰;宋憲波;;補(bǔ)腎活血中藥激活MMP-9信號(hào)通路動(dòng)員大鼠骨髓EPCs的分子機(jī)制研究[J];中國(guó)中西醫(yī)結(jié)合雜志;2013年06期

7 蔣宇;;丹參酚酸B對(duì)外周血內(nèi)皮祖細(xì)胞增殖、粘附和遷移功能的影響[J];中國(guó)民族民間醫(yī)藥;2013年01期

8 韓雅玲;;中國(guó)經(jīng)皮冠狀動(dòng)脈介入治療指南2012(簡(jiǎn)本)[J];中國(guó)醫(yī)學(xué)前沿雜志(電子版);2012年12期

9 張偉;賀冰;李平;李亮;鄧常清;;中醫(yī)藥調(diào)控內(nèi)皮祖細(xì)胞的現(xiàn)狀與思路[J];湖南中醫(yī)藥大學(xué)學(xué)報(bào);2012年03期

10 焦鵬;常起;陳彬;楊娜娜;唐瑜菁;夏作理;;泰山白花丹參提取物對(duì)人臍血內(nèi)皮祖細(xì)胞增殖、黏附及分泌NO的影響[J];中華中醫(yī)藥雜志;2011年11期

相關(guān)博士學(xué)位論文 前1條

1 褚福永;不穩(wěn)定型心絞痛冠脈介入期間證候動(dòng)態(tài)演變及方證相應(yīng)研究[D];中國(guó)中醫(yī)科學(xué)院;2010年

，

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