中国西部地区肾动脉支架植入手术治疗肾动脉狭窄疾病患者的研究
发布时间：2019-06-09 15:49
【摘要】：第一部分中国西部地区肾动脉支架植入手术治疗肾动脉狭窄疾病患者的疗效分析目的:本研究比较肾动脉支架植入组和药物治疗组患者随访过程中的血压、肾功能的变化以及心脑肾不良事件发生的情况,找出可能从肾动脉支架植入手术中获得临床收益的特定类别的患者,为临床上肾动脉狭窄疾病的治疗方案的选择和制订提供指导依据。方法:中国西部地区205例在2010-1-1~2015-4-30期间经肾血管造影术诊断为肾动脉粥样硬化狭窄(ARAS)的患者纳入本研究,包括167例支架植入组患者和38例对照组患者。所有患者在手术前后的血压的变化、肾功能的改变和手术后心脑肾不良事件的发生情况被随访。评价患者疗效的终点事件包括:血压的变化,肾功能的改变和心脑肾不良事件的发生。研究者识别出支架植入组手术后血压有获益、心脑肾不良事件的发生有改善的患者,与患者的基线临床特征作相关性分析。结果:支架植入组患者随访前后的收缩压下降了21.19±22.50mmHg(P㩳0.001),舒张压下降了9.68±14.93mmHg(P㩳0.05);对照组患者随访前后收缩压下降了8.80±16.04mmHg(P㩳0.02);支架植入组随访前后收缩压的下降比对照组多12.39mmHg(P㩳0.05)。两组患者随访前后的肾功能无明显变化,支架植入组有慢性肾病组患者随访终点的血肌酐较基线时增加72.20±114.37mmol/L(P㩳0.01)。支架植入组心功能Ⅲ~Ⅳ级的患者手术后死亡和其他心脑肾不良事件的发生多于心功能Ⅰ~㩳Ⅲ级的患者。58.1%的支架植入组患者术后血压有下降,患者支架植入后血压改变的结果与患者基线时的年龄、双侧肾动脉狭窄、收缩压、外周动脉狭窄和高脂血症相关;89.6%的支架植入组患者术后心脑肾事件的发生有改善,患者支架植入术后心脑肾不良事件的发生与患者基线时双侧肾动脉狭窄、心功能分级以及糖尿病有关。结论:在有丰富介入手术经验的介入中心选择肾动脉狭窄程度"g60%且心功能Ⅰ~㩳Ⅲ级的患者尽早实施手术,患者的血压、肾功能以及心脑肾不良事件的发生可能比单纯药物治疗的临床获益大。第二部分肾动脉支架植入术和单纯药物治疗肾动脉粥样硬化狭窄疾病患者的临床试验研究目的:完成肾动脉支架植入术和单纯药物治疗肾动脉粥样硬化狭窄疾病患者的临床试验设计,在重庆医科大学附属第二医院实施临床试验,比较肾动脉支架植入术与单纯药物治疗肾动脉狭窄疾病的效果,为临床上肾动脉支架植入手术的患者选择等提供依据。方法:根据第一部分研究的结果,参考欧洲心脏病协会(ESC)外周血管疾病的诊断和治疗指南的建议,结合本中心的医疗资源、病人来源和介入技术条件,设计临床试验。在重庆医科大学附属第二医院纳入9例经肾血管造影术诊断为肾动脉狭窄疾病的患者,6例植入肾动脉支架的患者列为试验组,3例未植入肾动脉支架手术的患者列为对照组。研究者收集两组患者手术前的基线资料、肾血管造影和肾动脉支架植入手术的结果、手术前后肾素系统的检测、手术前肾血管超声的检查结果以及手术后随访6个月时的血压、服用降压药物的种类和肾功能的资料,评价肾动脉支架植入手术治疗患者高血压的疗效,分析肾素系统检测与手术前肾血管超声的检查对于肾动脉狭窄疾病的诊断意义。结果:在这一部分中肾动脉狭窄疾病(RAS)患者的纳入、排除标准和分组方法均有明确的界定,受试患者的手术方案、药物治疗和定期随访的时间、内容均有清楚说明,而研究所需要观察的终点事件及其统计分析方法等也有详细阐述。6例支架植入组患者手术后随访半年时的收缩压与舒张压较手术前分别下降了40.33±30.43mm Hg和17.17±19.53mm Hg,3例对照组患者收缩压与舒张压分别下降了22.67±16.26mm Hg和4±6mm Hg,支架植入组患者中有4例顽固性高血压患者,手术后患者血压控制良好;支架植入组患者手术前和随访6个月时服用降压药物的种类分别是3±0.63和2.67±0.82;9例患者基线时和随访6个月时的肾功能均无异常,血肌酐分别是90.01±24.70mmol/L和92.27±23.14mmol/L。9例患者手术前肾素系统检测2例患者肾素(基础)和肾素(激发)高于正常水平,其余患者未发现异常;9例患者中有4例患者手术前作肾血管超声检查显示肾动脉阻力指数增加或肾动脉主干流速增高提示肾动脉狭窄。结论:本试验设计对于临床试验具有指导作用。肾动脉支架植入手术治疗肾动脉狭窄疾病可能取得比单纯的药物治疗更好的降压效果;未发现肾素系统的检测对于肾动脉狭窄疾病患者有特别意义,患者手术前肾血管超声的检查取代肾血管造影术的测压检查取得肾动脉狭窄远端与近端的压力比的值没有实现。本临床试验受限于时间范围以及病例数少,未能获得较多的关于肾动脉支架植入手术患者的选择和诊断方法确定的具有实用价值的资料,但是研究方向是正确可取的,需要在后续的试验中收集更多的病例进行分析和评价,以期达到本试验的研究目的。
[Abstract]:Objective: To study the effect of renal artery stent implantation in the first part in the treatment of renal artery stenosis: the changes of blood pressure, renal function and the occurrence of the adverse events of the heart and brain in the follow-up of the renal artery stent implantation group and the drug treatment group were compared. Identify a particular type of patient that may obtain clinical benefit from a renal artery stent implantation procedure, provide a guide for the selection and development of a treatment plan for a clinically superior renal artery stenosis disease. Methods:205 patients with renal artery atherosclerosis (ARAS) were included in 205 patients with renal artery atherosclerosis (ARAS) during the period 2010-1-1 to 2015-4-30, including 167 patients with stent implantation and 38 control groups. The change of blood pressure before and after operation, the change of renal function and the occurrence of adverse events of heart and brain after operation were followed up. The endpoint events for evaluating the efficacy of the patient included changes in blood pressure, changes in renal function, and the occurrence of a heart-and-brain-renal adverse event. The investigator identified the benefit of the blood pressure after the operation of the stent implantation group, the improvement in the occurrence of adverse events in the heart and brain, and the correlation analysis with the baseline clinical characteristics of the patient. Results: The systolic blood pressure decreased by 21.19 to 22.50 mmHg (P? 0.001) and the diastolic blood pressure decreased by 9.68 to 14.93 mmHg (P? 0.05) before and after the follow-up, and the systolic pressure in the control group decreased by 8.80 to 16.04 mmHg (P? 0.02), and the decrease of systolic blood pressure before and after the follow-up of the stent implantation group was 12.39 mmHg (P? 0.05) than that in the control group. There was no significant change in renal function before and after the follow-up of the two groups, and 72.20-114.37 mmol/ L (P? 0.01) was increased in the patients with chronic kidney disease at the end of follow-up. The incidence of death and other cardiac and renal adverse events after operation of patients with cardiac function 鈪，
本文编号：2495674
[Abstract]:Objective: To study the effect of renal artery stent implantation in the first part in the treatment of renal artery stenosis: the changes of blood pressure, renal function and the occurrence of the adverse events of the heart and brain in the follow-up of the renal artery stent implantation group and the drug treatment group were compared. Identify a particular type of patient that may obtain clinical benefit from a renal artery stent implantation procedure, provide a guide for the selection and development of a treatment plan for a clinically superior renal artery stenosis disease. Methods:205 patients with renal artery atherosclerosis (ARAS) were included in 205 patients with renal artery atherosclerosis (ARAS) during the period 2010-1-1 to 2015-4-30, including 167 patients with stent implantation and 38 control groups. The change of blood pressure before and after operation, the change of renal function and the occurrence of adverse events of heart and brain after operation were followed up. The endpoint events for evaluating the efficacy of the patient included changes in blood pressure, changes in renal function, and the occurrence of a heart-and-brain-renal adverse event. The investigator identified the benefit of the blood pressure after the operation of the stent implantation group, the improvement in the occurrence of adverse events in the heart and brain, and the correlation analysis with the baseline clinical characteristics of the patient. Results: The systolic blood pressure decreased by 21.19 to 22.50 mmHg (P? 0.001) and the diastolic blood pressure decreased by 9.68 to 14.93 mmHg (P? 0.05) before and after the follow-up, and the systolic pressure in the control group decreased by 8.80 to 16.04 mmHg (P? 0.02), and the decrease of systolic blood pressure before and after the follow-up of the stent implantation group was 12.39 mmHg (P? 0.05) than that in the control group. There was no significant change in renal function before and after the follow-up of the two groups, and 72.20-114.37 mmol/ L (P? 0.01) was increased in the patients with chronic kidney disease at the end of follow-up. The incidence of death and other cardiac and renal adverse events after operation of patients with cardiac function 鈪，
本文编号：2495674
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