普羅布考對冠心病患者PCI術(shù)后對比劑急性腎損傷預防作用多中心臨床研究
發(fā)布時間：2018-08-05 18:18
【摘要】：目的:根據(jù)多中心臨床數(shù)據(jù)探討普羅布考對冠心病患者擇期行冠狀動脈介入治療(Percutaneous coronary intervention,PCI)術(shù)后對比劑急性腎損傷(Contrast induced acute kidney injury,CIAKI)的預防作用、可能的作用機制及用藥的安全性,并進一步探討各危險分層患者的預防效果。方法:入選2015年11月~2016年11月于天津市胸科醫(yī)院、天津市一中心醫(yī)院、天津市四中心醫(yī)院、天津市泰達國際心血管病醫(yī)院等四家三甲醫(yī)院的心內(nèi)科,擬行擇期PCI術(shù)的冠心病患者641例。隨機分為兩組:普羅布考組(321例)及對照組(320例)。普羅布考組:PCI術(shù)前1d及術(shù)后3d,每日給予普羅布考500mg Bid po;對照組:常規(guī)藥物治療。收集兩組患者的基線資料,運用本中心特有的CIAKI危險評分系統(tǒng)將兩組分別分為低危組(178例175例)、中危組(112例116例)以及高危-極高危組(31例29例),記錄各亞組患者PCI術(shù)前及術(shù)后48h、72h的血清肌酐(Scr)水平、血尿素氮(BUN)、胱抑素C(Cys-C)、腎小球濾過率估算值(eGFR)、超敏C-反應蛋白(hs-CRP)、白細胞介素-6(IL-6)、超氧化物歧化酶(SOD)、谷胱甘肽(GSH)、中性粒細胞明膠酶相關(guān)脂質(zhì)運載蛋白(NGAL)、腫瘤壞死因子-α(TNF-α)水平的變化。記錄兩組各亞組患者CIAKI發(fā)病情況、住院及術(shù)后兩周隨訪期間普羅布考的不良反應。結(jié)果:1.普羅布考組與對照組患者術(shù)前基線資料,差異未見統(tǒng)計學意義(P0.05),兩組各對應低危組、中危組、高危-極高危組之間,患者術(shù)前基線資料,差異未見統(tǒng)計學意義(P0.05)。2.PCI術(shù)前,普羅布考組與對照組各對應亞組間,患者的Scr、BUN、Cys-C、eGFR、hs-CRP、IL-6、SOD、NGAL、GSH、TNF-α水平,差異未見統(tǒng)計學意義(P0.05)。3.普羅布考組CIAKI發(fā)病率低于對照組(P0.05)。4.PCI術(shù)后48h及72h,普羅布考組與對照組患者的Scr、BUN、Cys-C水平均較術(shù)前升高,eGFR水平均較術(shù)前下降(P0.05)。5.PCI術(shù)后48h及72h,普羅布考組各亞組患者BUN水平較對照組對應亞組患者各指標水平低(P0.05)。普羅布考組低危組、中危組患者Scr水平較對照組對應亞組水平低(P0.05);普羅布考組高危-極高危組患者Scr水平雖較對照組對應亞組患者減低不明顯(P0.05),但兩組Scr升高水平(△Scr),差異有統(tǒng)計學意義(P0.05)。普羅布考組各亞組患者Cys-C升高程度較對照組對應亞組低(P0.05)。普羅布考組中,低危組、中危組患者的eGFR水平高于對照組患者水平,且差異有統(tǒng)計學意義(P0.05);高危-極高危組患者的eGFR水平雖較對照組對應亞組患者的eGFR水平高,但差異無統(tǒng)計學意義(P0.05)。6.PCI術(shù)后72h,普羅布考組各亞組與對照組對應亞組患者的hs-CRP、IL-6、NGAL水平均較術(shù)前升高(P0.05);普羅布考組各亞組患者的hs-CRP、IL-6、NGAL水平均較對照組對應亞組低(P0.05)。7.PCI術(shù)后72h,普羅布考組各亞組與對照組對應亞組患者的SOD、TNF-α及GSH水平均升高(P0.05)。普羅布考組各亞組患者的SOD及GSH水平高于對照組對應亞組(P0.05);但普羅布考組各亞組患者的TNF-α水平與對照組相比,差異未見統(tǒng)計學意義(P0.05)。8.兩組發(fā)生CIAKI的患者較未發(fā)生CIAKI的患者,PCI術(shù)后Cys-C與NGAL水平較術(shù)前比較明顯升高(P0.05)。住院及術(shù)后兩周隨訪期間,兩組患者均未出現(xiàn)明顯肝損害、肌肉毒性、胃腸道不適、Q-T間期延長等不良事件。結(jié)論:1.圍手術(shù)期給予患者口服普羅布考治療能降低CIAKI的發(fā)病率,且對低中�；颊哳A防效果更明顯。2.對比劑可能通過炎癥、氧化應激反應引起急性腎損傷。3.普羅布考可能通過降低炎癥及氧化應激因子水平,抑制炎癥、氧化應激反應,從而發(fā)揮腎臟保護作用。4.普羅布考藥物治療的安全性良好。
[Abstract]:Objective: To investigate the preventive effect of probucol on the prevention of acute renal injury (Contrast induced acute kidney injury, CIAKI) after coronary intervention (Percutaneous coronary intervention, PCI), the possible mechanism of action and the safety of drug use, and further discuss the effects of probucol on the selection of coronary artery disease patients with coronary artery intervention (PCI). Methods: in the Department of Cardiology, Tianjin Thoracic Hospital, Tianjin City, Tianjin four Center Hospital, Tianjin four Center Hospital, Tianjin four center hospital and Tianjin city hospital, 641 cases of coronary heart disease were randomly divided into two groups: probucol group (3). 21 cases and control group (320 cases): PreOp 1D and 3D after PCI, 500mg Bid Po per day; control group: routine medication. The baseline data of two groups of patients were collected, and two groups were divided into low risk group (178 cases, 175 cases), middle risk group (112 cases 116 cases) and high risk - polar group. The high risk group (31 cases, 29 cases), the serum creatinine (Scr) level, blood urea nitrogen (BUN), Cystatin C (Cys-C), glomerular filtration rate estimation value (eGFR), hypersensitivity C- reactive protein (hs-CRP), interleukin -6 (IL-6), superoxide dismutase, glutathione, neutrophil gelatinase related lipids were recorded before and after PCI in each subgroup. The changes in the level of carrier protein (NGAL) and tumor necrosis factor - alpha (TNF- alpha). Record the incidence of CIAKI in the two groups of subgroups and the adverse reaction of probucol during the two week follow-up. Results: there was no significant difference in baseline data between the 1. probucol group and the control group (P0.05), and the two groups corresponded to the low risk group and middle risk. Group, high risk - high risk group, the preoperative baseline data of the patients were not statistically significant (P0.05) before.2.PCI, the probucol group and the control group were in the corresponding subgroups, and the patients' Scr, BUN, Cys-C, eGFR, hs-CRP, IL-6, SOD, NGAL, GSH, TNF- alpha level, the difference was lower than the control group. 05) 48h and 72h after.4.PCI, the levels of Scr, BUN and Cys-C in the probucol group and the control group were higher than those before the operation, and the eGFR level was lower than that of the preoperative decrease (P0.05).5.PCI operation, and the BUN level in the group of probucol group was lower than that of the control group. Compared with the control group, the level of the subgroup was lower than the control group (P0.05), while the Scr level in the high-risk group of the probucol group was not significantly lower than that of the control group (P0.05), but the level of Scr increased (delta Scr) in the two groups was statistically significant (P0.05). The level of Cys-C in the subgroups of the probucol group was lower than that of the control group (P0.05). In the rob test group, the eGFR level of the patients in the low risk group and the middle risk group was higher than the control group, and the difference was statistically significant (P0.05). The eGFR level of the high-risk group was higher than that of the control group, but the difference was not statistically significant (P0.05).6.PCI after 72h, and the subgroups of the probucol group corresponded with the control group. The levels of hs-CRP, IL-6 and NGAL in the subgroup were all higher than those before the operation (P0.05), and the levels of hs-CRP, IL-6 and NGAL in the subgroups of the probucol group were all lower than those of the control group (P0.05), 72h, the SOD, the TNF- alpha and the level of the sub group of the probucol group and the control group were all elevated. The level of SOD and GSH was higher than that of the control group (P0.05), but the TNF- alpha level of the patients in the group of probucol group was not statistically significant compared with the control group (P0.05) the patients with CIAKI in the.8. two group were compared with those who did not have CIAKI, and the Cys-C and NGAL levels after PCI were significantly higher than those before the operation (P0.05). The hospitalization and two weeks follow-up after the operation were followed up. During the two groups, there were no obvious liver damage, muscular toxicity, gastrointestinal discomfort, and Q-T interval prolongation. Conclusion: oral probucol treatment in the 1. perioperative period can reduce the incidence of CIAKI, and the prevention effect of the low medium risk patients is more obvious that the.2. contrast agent may pass the inflammation and the oxidative stress causes acute kidney. .3. probucol injury may be safe by reducing the levels of inflammatory and oxidative stress factors, inhibiting inflammation, and oxidative stress response, and thus playing the protective role of kidney.4. in the drug treatment of probucol.
【學位授予單位】：天津醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R541.4
本文編號：2166601
[Abstract]:Objective: To investigate the preventive effect of probucol on the prevention of acute renal injury (Contrast induced acute kidney injury, CIAKI) after coronary intervention (Percutaneous coronary intervention, PCI), the possible mechanism of action and the safety of drug use, and further discuss the effects of probucol on the selection of coronary artery disease patients with coronary artery intervention (PCI). Methods: in the Department of Cardiology, Tianjin Thoracic Hospital, Tianjin City, Tianjin four Center Hospital, Tianjin four Center Hospital, Tianjin four center hospital and Tianjin city hospital, 641 cases of coronary heart disease were randomly divided into two groups: probucol group (3). 21 cases and control group (320 cases): PreOp 1D and 3D after PCI, 500mg Bid Po per day; control group: routine medication. The baseline data of two groups of patients were collected, and two groups were divided into low risk group (178 cases, 175 cases), middle risk group (112 cases 116 cases) and high risk - polar group. The high risk group (31 cases, 29 cases), the serum creatinine (Scr) level, blood urea nitrogen (BUN), Cystatin C (Cys-C), glomerular filtration rate estimation value (eGFR), hypersensitivity C- reactive protein (hs-CRP), interleukin -6 (IL-6), superoxide dismutase, glutathione, neutrophil gelatinase related lipids were recorded before and after PCI in each subgroup. The changes in the level of carrier protein (NGAL) and tumor necrosis factor - alpha (TNF- alpha). Record the incidence of CIAKI in the two groups of subgroups and the adverse reaction of probucol during the two week follow-up. Results: there was no significant difference in baseline data between the 1. probucol group and the control group (P0.05), and the two groups corresponded to the low risk group and middle risk. Group, high risk - high risk group, the preoperative baseline data of the patients were not statistically significant (P0.05) before.2.PCI, the probucol group and the control group were in the corresponding subgroups, and the patients' Scr, BUN, Cys-C, eGFR, hs-CRP, IL-6, SOD, NGAL, GSH, TNF- alpha level, the difference was lower than the control group. 05) 48h and 72h after.4.PCI, the levels of Scr, BUN and Cys-C in the probucol group and the control group were higher than those before the operation, and the eGFR level was lower than that of the preoperative decrease (P0.05).5.PCI operation, and the BUN level in the group of probucol group was lower than that of the control group. Compared with the control group, the level of the subgroup was lower than the control group (P0.05), while the Scr level in the high-risk group of the probucol group was not significantly lower than that of the control group (P0.05), but the level of Scr increased (delta Scr) in the two groups was statistically significant (P0.05). The level of Cys-C in the subgroups of the probucol group was lower than that of the control group (P0.05). In the rob test group, the eGFR level of the patients in the low risk group and the middle risk group was higher than the control group, and the difference was statistically significant (P0.05). The eGFR level of the high-risk group was higher than that of the control group, but the difference was not statistically significant (P0.05).6.PCI after 72h, and the subgroups of the probucol group corresponded with the control group. The levels of hs-CRP, IL-6 and NGAL in the subgroup were all higher than those before the operation (P0.05), and the levels of hs-CRP, IL-6 and NGAL in the subgroups of the probucol group were all lower than those of the control group (P0.05), 72h, the SOD, the TNF- alpha and the level of the sub group of the probucol group and the control group were all elevated. The level of SOD and GSH was higher than that of the control group (P0.05), but the TNF- alpha level of the patients in the group of probucol group was not statistically significant compared with the control group (P0.05) the patients with CIAKI in the.8. two group were compared with those who did not have CIAKI, and the Cys-C and NGAL levels after PCI were significantly higher than those before the operation (P0.05). The hospitalization and two weeks follow-up after the operation were followed up. During the two groups, there were no obvious liver damage, muscular toxicity, gastrointestinal discomfort, and Q-T interval prolongation. Conclusion: oral probucol treatment in the 1. perioperative period can reduce the incidence of CIAKI, and the prevention effect of the low medium risk patients is more obvious that the.2. contrast agent may pass the inflammation and the oxidative stress causes acute kidney. .3. probucol injury may be safe by reducing the levels of inflammatory and oxidative stress factors, inhibiting inflammation, and oxidative stress response, and thus playing the protective role of kidney.4. in the drug treatment of probucol.
【學位授予單位】：天津醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R541.4
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