普罗布考对冠心病患者PCI术后对比剂急性肾损伤预防作用多中心临床研究
发布时间：2018-08-05 18:18
【摘要】：目的:根据多中心临床数据探讨普罗布考对冠心病患者择期行冠状动脉介入治疗(Percutaneous coronary intervention,PCI)术后对比剂急性肾损伤(Contrast induced acute kidney injury,CIAKI)的预防作用、可能的作用机制及用药的安全性,并进一步探讨各危险分层患者的预防效果。方法:入选2015年11月~2016年11月于天津市胸科医院、天津市一中心医院、天津市四中心医院、天津市泰达国际心血管病医院等四家三甲医院的心内科,拟行择期PCI术的冠心病患者641例。随机分为两组:普罗布考组(321例)及对照组(320例)。普罗布考组:PCI术前1d及术后3d,每日给予普罗布考500mg Bid po;对照组:常规药物治疗。收集两组患者的基线资料,运用本中心特有的CIAKI危险评分系统将两组分别分为低危组(178例175例)、中危组(112例116例)以及高危-极高危组(31例29例),记录各亚组患者PCI术前及术后48h、72h的血清肌酐(Scr)水平、血尿素氮(BUN)、胱抑素C(Cys-C)、肾小球滤过率估算值(eGFR)、超敏C-反应蛋白(hs-CRP)、白细胞介素-6(IL-6)、超氧化物歧化酶(SOD)、谷胱甘肽(GSH)、中性粒细胞明胶酶相关脂质运载蛋白(NGAL)、肿瘤坏死因子-α(TNF-α)水平的变化。记录两组各亚组患者CIAKI发病情况、住院及术后两周随访期间普罗布考的不良反应。结果:1.普罗布考组与对照组患者术前基线资料,差异未见统计学意义(P0.05),两组各对应低危组、中危组、高危-极高危组之间,患者术前基线资料,差异未见统计学意义(P0.05)。2.PCI术前,普罗布考组与对照组各对应亚组间,患者的Scr、BUN、Cys-C、eGFR、hs-CRP、IL-6、SOD、NGAL、GSH、TNF-α水平,差异未见统计学意义(P0.05)。3.普罗布考组CIAKI发病率低于对照组(P0.05)。4.PCI术后48h及72h,普罗布考组与对照组患者的Scr、BUN、Cys-C水平均较术前升高,eGFR水平均较术前下降(P0.05)。5.PCI术后48h及72h,普罗布考组各亚组患者BUN水平较对照组对应亚组患者各指标水平低(P0.05)。普罗布考组低危组、中危组患者Scr水平较对照组对应亚组水平低(P0.05);普罗布考组高危-极高危组患者Scr水平虽较对照组对应亚组患者减低不明显(P0.05),但两组Scr升高水平(△Scr),差异有统计学意义(P0.05)。普罗布考组各亚组患者Cys-C升高程度较对照组对应亚组低(P0.05)。普罗布考组中,低危组、中危组患者的eGFR水平高于对照组患者水平,且差异有统计学意义(P0.05);高危-极高危组患者的eGFR水平虽较对照组对应亚组患者的eGFR水平高,但差异无统计学意义(P0.05)。6.PCI术后72h,普罗布考组各亚组与对照组对应亚组患者的hs-CRP、IL-6、NGAL水平均较术前升高(P0.05);普罗布考组各亚组患者的hs-CRP、IL-6、NGAL水平均较对照组对应亚组低(P0.05)。7.PCI术后72h,普罗布考组各亚组与对照组对应亚组患者的SOD、TNF-α及GSH水平均升高(P0.05)。普罗布考组各亚组患者的SOD及GSH水平高于对照组对应亚组(P0.05);但普罗布考组各亚组患者的TNF-α水平与对照组相比,差异未见统计学意义(P0.05)。8.两组发生CIAKI的患者较未发生CIAKI的患者,PCI术后Cys-C与NGAL水平较术前比较明显升高(P0.05)。住院及术后两周随访期间,两组患者均未出现明显肝损害、肌肉毒性、胃肠道不适、Q-T间期延长等不良事件。结论:1.围手术期给予患者口服普罗布考治疗能降低CIAKI的发病率,且对低中危患者预防效果更明显。2.对比剂可能通过炎症、氧化应激反应引起急性肾损伤。3.普罗布考可能通过降低炎症及氧化应激因子水平,抑制炎症、氧化应激反应,从而发挥肾脏保护作用。4.普罗布考药物治疗的安全性良好。
[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.
【学位授予单位】：天津医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.4
本文编号：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.
【学位授予单位】：天津医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.4
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