【摘要】：第一部分中國(guó)西部地區(qū)腎動(dòng)脈支架植入手術(shù)治療腎動(dòng)脈狹窄疾病患者的療效分析目的:本研究比較腎動(dòng)脈支架植入組和藥物治療組患者隨訪過(guò)程中的血壓、腎功能的變化以及心腦腎不良事件發(fā)生的情況,找出可能從腎動(dòng)脈支架植入手術(shù)中獲得臨床收益的特定類別的患者,為臨床上腎動(dòng)脈狹窄疾病的治療方案的選擇和制訂提供指導(dǎo)依據(jù)。方法:中國(guó)西部地區(qū)205例在2010-1-1~2015-4-30期間經(jīng)腎血管造影術(shù)診斷為腎動(dòng)脈粥樣硬化狹窄(ARAS)的患者納入本研究,包括167例支架植入組患者和38例對(duì)照組患者。所有患者在手術(shù)前后的血壓的變化、腎功能的改變和手術(shù)后心腦腎不良事件的發(fā)生情況被隨訪。評(píng)價(jià)患者療效的終點(diǎn)事件包括:血壓的變化,腎功能的改變和心腦腎不良事件的發(fā)生。研究者識(shí)別出支架植入組手術(shù)后血壓有獲益、心腦腎不良事件的發(fā)生有改善的患者,與患者的基線臨床特征作相關(guān)性分析。結(jié)果:支架植入組患者隨訪前后的收縮壓下降了21.19±22.50mmHg(P㩳0.001),舒張壓下降了9.68±14.93mmHg(P㩳0.05);對(duì)照組患者隨訪前后收縮壓下降了8.80±16.04mmHg(P㩳0.02);支架植入組隨訪前后收縮壓的下降比對(duì)照組多12.39mmHg(P㩳0.05)。兩組患者隨訪前后的腎功能無(wú)明顯變化,支架植入組有慢性腎病組患者隨訪終點(diǎn)的血肌酐較基線時(shí)增加72.20±114.37mmol/L(P㩳0.01)。支架植入組心功能Ⅲ~Ⅳ級(jí)的患者手術(shù)后死亡和其他心腦腎不良事件的發(fā)生多于心功能Ⅰ~㩳Ⅲ級(jí)的患者。58.1%的支架植入組患者術(shù)后血壓有下降,患者支架植入后血壓改變的結(jié)果與患者基線時(shí)的年齡、雙側(cè)腎動(dòng)脈狹窄、收縮壓、外周動(dòng)脈狹窄和高脂血癥相關(guān);89.6%的支架植入組患者術(shù)后心腦腎事件的發(fā)生有改善,患者支架植入術(shù)后心腦腎不良事件的發(fā)生與患者基線時(shí)雙側(cè)腎動(dòng)脈狹窄、心功能分級(jí)以及糖尿病有關(guān)。結(jié)論:在有豐富介入手術(shù)經(jīng)驗(yàn)的介入中心選擇腎動(dòng)脈狹窄程度"g60%且心功能Ⅰ~㩳Ⅲ級(jí)的患者盡早實(shí)施手術(shù),患者的血壓、腎功能以及心腦腎不良事件的發(fā)生可能比單純藥物治療的臨床獲益大。第二部分腎動(dòng)脈支架植入術(shù)和單純藥物治療腎動(dòng)脈粥樣硬化狹窄疾病患者的臨床試驗(yàn)研究目的:完成腎動(dòng)脈支架植入術(shù)和單純藥物治療腎動(dòng)脈粥樣硬化狹窄疾病患者的臨床試驗(yàn)設(shè)計(jì),在重慶醫(yī)科大學(xué)附屬第二醫(yī)院實(shí)施臨床試驗(yàn),比較腎動(dòng)脈支架植入術(shù)與單純藥物治療腎動(dòng)脈狹窄疾病的效果,為臨床上腎動(dòng)脈支架植入手術(shù)的患者選擇等提供依據(jù)。方法:根據(jù)第一部分研究的結(jié)果,參考?xì)W洲心臟病協(xié)會(huì)(ESC)外周血管疾病的診斷和治療指南的建議,結(jié)合本中心的醫(yī)療資源、病人來(lái)源和介入技術(shù)條件,設(shè)計(jì)臨床試驗(yàn)。在重慶醫(yī)科大學(xué)附屬第二醫(yī)院納入9例經(jīng)腎血管造影術(shù)診斷為腎動(dòng)脈狹窄疾病的患者,6例植入腎動(dòng)脈支架的患者列為試驗(yàn)組,3例未植入腎動(dòng)脈支架手術(shù)的患者列為對(duì)照組。研究者收集兩組患者手術(shù)前的基線資料、腎血管造影和腎動(dòng)脈支架植入手術(shù)的結(jié)果、手術(shù)前后腎素系統(tǒng)的檢測(cè)、手術(shù)前腎血管超聲的檢查結(jié)果以及手術(shù)后隨訪6個(gè)月時(shí)的血壓、服用降壓藥物的種類和腎功能的資料,評(píng)價(jià)腎動(dòng)脈支架植入手術(shù)治療患者高血壓的療效,分析腎素系統(tǒng)檢測(cè)與手術(shù)前腎血管超聲的檢查對(duì)于腎動(dòng)脈狹窄疾病的診斷意義。結(jié)果:在這一部分中腎動(dòng)脈狹窄疾病(RAS)患者的納入、排除標(biāo)準(zhǔn)和分組方法均有明確的界定,受試患者的手術(shù)方案、藥物治療和定期隨訪的時(shí)間、內(nèi)容均有清楚說(shuō)明,而研究所需要觀察的終點(diǎn)事件及其統(tǒng)計(jì)分析方法等也有詳細(xì)闡述。6例支架植入組患者手術(shù)后隨訪半年時(shí)的收縮壓與舒張壓較手術(shù)前分別下降了40.33±30.43mm Hg和17.17±19.53mm Hg,3例對(duì)照組患者收縮壓與舒張壓分別下降了22.67±16.26mm Hg和4±6mm Hg,支架植入組患者中有4例頑固性高血壓患者,手術(shù)后患者血壓控制良好;支架植入組患者手術(shù)前和隨訪6個(gè)月時(shí)服用降壓藥物的種類分別是3±0.63和2.67±0.82;9例患者基線時(shí)和隨訪6個(gè)月時(shí)的腎功能均無(wú)異常,血肌酐分別是90.01±24.70mmol/L和92.27±23.14mmol/L。9例患者手術(shù)前腎素系統(tǒng)檢測(cè)2例患者腎素(基礎(chǔ))和腎素(激發(fā))高于正常水平,其余患者未發(fā)現(xiàn)異常;9例患者中有4例患者手術(shù)前作腎血管超聲檢查顯示腎動(dòng)脈阻力指數(shù)增加或腎動(dòng)脈主干流速增高提示腎動(dòng)脈狹窄。結(jié)論:本試驗(yàn)設(shè)計(jì)對(duì)于臨床試驗(yàn)具有指導(dǎo)作用。腎動(dòng)脈支架植入手術(shù)治療腎動(dòng)脈狹窄疾病可能取得比單純的藥物治療更好的降壓效果;未發(fā)現(xiàn)腎素系統(tǒng)的檢測(cè)對(duì)于腎動(dòng)脈狹窄疾病患者有特別意義,患者手術(shù)前腎血管超聲的檢查取代腎血管造影術(shù)的測(cè)壓檢查取得腎動(dòng)脈狹窄遠(yuǎn)端與近端的壓力比的值沒(méi)有實(shí)現(xiàn)。本臨床試驗(yàn)受限于時(shí)間范圍以及病例數(shù)少,未能獲得較多的關(guān)于腎動(dòng)脈支架植入手術(shù)患者的選擇和診斷方法確定的具有實(shí)用價(jià)值的資料,但是研究方向是正確可取的,需要在后續(xù)的試驗(yàn)中收集更多的病例進(jìn)行分析和評(píng)價(jià),以期達(dá)到本試驗(yàn)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，

本文編號(hào)：2495674