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

【摘要】：目的:觀察參元丹(SYD)對非ST段抬高急性冠脈綜合征(NSTE-ACS)患者擇期PCI圍手術期心肌損傷(PMI)的干預效果及其機制探索。方法:本課題采用隨機、雙盲、安慰劑、對照的觀察方法,研究對象均為首都醫(yī)科大學附屬北京中醫(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名符合納入標準的患者被隨機分為參元丹組(n=36)和安慰劑組(n=32),受試者在接受冠心病常規(guī)藥物治療基礎上,于術前3天至術后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。臨床觀察包括:(1)術前、術后4h、術后24h及術后7d心肌損傷標志物cTNT、CK-MB的變化;外周血EPCs計數(shù);促血管內皮生長因子VEGF、SDF-1水平變化;氧化應激指標SOD、MDA的變化;炎癥反應指標hs-CRP、IL-6的變化;(2)術前、術后24h行彩色多普勒超聲及速度向量成像技術(VVI)檢測;(3)術后30天MACE事件(4)安全性監(jiān)測。結果:(1)基線情況:參元丹組與安慰劑組納入患者各方面基線資料(一般情況、各指標術前水平等)均無統(tǒng)計學差異(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)計學差異(P0.05)。(3)CK-MB水平檢測:參元丹組術后4h、24h,安慰劑組術后4h、24h、7d比較各組術前CK-MB水平均升高(P0.05),差異均具有統(tǒng)計學意義。參元丹組術后7d較術前有升高趨勢(P0.05),差異不具有統(tǒng)計學意義。兩組術后4h、24h、7d的CK-MB水平比較,參元丹組均有低于安慰劑組趨勢,但差異不具有統(tǒng)計學意義(P0.05)。(4)EPCs動員相關:①EPCs計數(shù):參元丹組術后24h、7d比較術前外周血EPCs水平均升高(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、安慰劑組術后4h、24h、7d比較各組術前有升高趨勢(P0.05),差異不具有統(tǒng)計學意義。參元丹組術后24h、7d高于安慰劑組同時間點(P0.05),差異具有統(tǒng)計學意義。兩組術后4h比較,參元丹組有高于安慰劑組趨勢(P0.05),但差異均不具有統(tǒng)計學意義。②VEGF水平:參元丹組術后24h、7d,安慰劑組術后24h比較各組術前外周血VEGF水平均升高(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、安慰劑組術后4h、7d與各組術前比較(P0.05),差異均不具有統(tǒng)計學意義。參元丹組術后24h、7d均有高于安慰劑組同時間點趨勢(P0.05),兩組術后4h比較(P0.05),差異均不具有統(tǒng)計學意義。③SDF-1水平:參元丹組術后24h較本組術前外周血SDF-1水平升高(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、7d,安慰劑組術后4h、24h、7d與各組術前比較(P0.05),差異不具有統(tǒng)計學意義。參元丹組術后24h、7d均高于安慰劑組同時間點(P0.05),差異具有統(tǒng)計學意義。兩組術后4h比較,差異不具有統(tǒng)計學意義(P0.05)。④相關性:參元丹組PCI術前,PCI術后4h、24h、7d外周血EPCs及VEGF水平存在顯著相關關系(r=0.231,P0.05);參元丹組PCI術前,PCI術后4h、24h、7d外周血EPCs及SDF-1水平存在顯著相關關系(r=0.323,P0.05)。(5)炎癥因子相關:①hs-CRP水平:兩組術后24h較各組術前hs-CRP水平均升高(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、7d,安慰劑組術后4h、7d與各組術前比較(P0.05),差異均不具有統(tǒng)計學意義。兩組術后7d均低于各組術后24h(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、24h、7d均有低于安慰劑組同時間點的趨勢(P0.05),但差異不具有統(tǒng)計學意義。②IL-6 水平:參元丹組術后24h、安慰劑組術后4h、24h比較本組術前IL-6水平均升高(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、7d,安慰劑組術后7d與各組術前比較(P0.05),差異均不具有統(tǒng)計學意義。參元丹組術后4h、24h、7d均有低于安慰劑組同時間的趨勢(P0.05),但差異均不具有統(tǒng)計學意義。(6)氧化應激相關:①SOD水平:安慰劑組術后24h低于本組術前SOD水平(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、24h、7d,安慰劑組術后4h、7d比較各組術前,均無統(tǒng)計學差異(P0.05)。參元丹組術后24h高于安慰劑組術后24h(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、7d均有高于安慰劑組同時間的趨勢(P0.05),但差異均不具有統(tǒng)計學意義。②MDA水平:兩組術后24h較各組術前MDA水平均升高(P0.05),差異具有統(tǒng)計學意義。參元丹組術后4h、7d,安慰劑組術后4h、7d比較各組術前,均無統(tǒng)計學差異(P0.05)。參元丹組術后4h、24h、7d均有低于安慰劑組同時間點的趨勢(P0.05),但差異均不具有統(tǒng)計學意義。(7)超聲心動及WI技術相關:①參元丹組PCI術后24h的左室射血分數(shù)、左室舒張末徑及E/A值比較術前均未發(fā)生具有統(tǒng)計學意義的變化(P0.05)。②安慰劑組PCI術后24h的前間隔心尖段、前壁心尖段、前壁基底段、下壁心尖段、下壁中間段的應變指標低于本組術前水平(P0.05),差異具有統(tǒng)計學意義;PCI術后24小時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變指標改善情況優(yōu)于安慰劑組(P0.05),差異具有統(tǒng)計學意義。③安慰劑組PCI術后24h的前間隔心尖段、前壁心尖段、下壁心尖段、下壁中間段應變率指標低于本組術前水平(P0.05),差異具有統(tǒng)計學意義;PCI術后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,參元丹組應變率指標改善情況優(yōu)于安慰劑組(P0.05),差異具有統(tǒng)計學意義。(8)MACE事件及安全性監(jiān)測:兩組間比較,參元丹組術后30天MACE事件發(fā)生率(5.6%)有低于安慰劑組(15.6%)趨勢,但差異不具統(tǒng)計學意義(P0.05);試驗期間無參元丹相關的不良反應發(fā)生,安全性良好。結論:(1)SYD能降低NSTE-ACS患者PMI發(fā)生率,并具有降低PCI圍手術期血清CK-MB水平、減少PCI術后30天MACE事件發(fā)生率趨勢,且安全性良好,提示SYD對NSTE-ACS患者PCI圍手術期有一定心肌保護作用。(2)SYD可增加NSTE-ACS患者擇期PCI圍手術期外周血EPCs、VEGF及SDF-1水平,提示SYD具有改善NSTE-ACS患者擇期PCI圍手術期EPCs動員與歸巢作用,其機制可能與上調外周血中VEGF和SDF-1的表達來實現(xiàn),這也可能是改善NSTE-ACS患者PCI圍手術期心肌損傷的機制之一。(3)SYD具有降低NSTE-ACS患者擇期PCI圍手術期血清炎癥反應因子hs-CRP與IL-6水平趨勢,提示SYD對NSTE-ACS患者擇期PCI圍手術期心肌保護作用可能與其抑制炎癥反應相關。(4)SYD干預NSTE-ACS患者擇期PCI圍手術期,可抑制PCI術后SOD水平的降低,并具有抑制PCI術后MDA水平升高趨勢,提示SYD對NSTE-ACS患者擇期PCI圍手術期心肌保護作用可能與其抗氧化應激作用相關。(5)應用VVI技術分析節(jié)段室壁收縮功能的變化,以節(jié)段心肌應變及應變率為效應指標,發(fā)現(xiàn)參元丹組節(jié)段室壁運動與安慰劑組比較有一定改善,也提示VVI相較于傳統(tǒng)超聲心動更有助于PMI的早期評估。綜上所述:SYD對NSTE-ACS患者擇期PCI圍手術期具有一定心肌保護作用,其機制可能與促進EPCs動員與歸巢、抑制炎癥反應及抗氧化應激作用相關。
[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.
【學位授予單位】：北京中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R541.4

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