本文選題：透析登記 + 終末期腎臟病��； 參考：《浙江大學(xué)》2015年博士論文

【摘要】：第一部分浙江省新增終末期腎病患者流行病學(xué)調(diào)查分析 目的：透析登記系統(tǒng)是終末期腎病(end stage renal disesase, ESRD)患者規(guī)范化管理的重要組成部分。浙江省透析質(zhì)量控制中心(Zhejiang Dialysis Quality and Management Center, ZDQM)建立于2007年,數(shù)據(jù)庫(kù)主要登記內(nèi)容包括透析患者的基本信息、病情發(fā)展與轉(zhuǎn)歸、藥物使用情況及化驗(yàn)室指標(biāo)等。本研究對(duì)2008～2013年ZDQM中新增ESRD患者的資料進(jìn)行分析,了解其流行病學(xué)現(xiàn)狀,以期為臨床醫(yī)師、科研人員及醫(yī)療衛(wèi)生政策的制定與修改提供參考數(shù)據(jù)。 方法：收集2008年1月至2013年12月,ZDQM數(shù)據(jù)庫(kù)中新增ESRD患者的基本信息,包括性別、年齡、透析方式、原發(fā)病構(gòu)成、轉(zhuǎn)歸情況、實(shí)驗(yàn)室數(shù)據(jù)等。對(duì)其年發(fā)病率、原發(fā)病構(gòu)成及變遷、性別年齡結(jié)構(gòu)及死亡原因等進(jìn)行統(tǒng)計(jì)分析。 結(jié)果：2008～2013年浙江省新增ESRD透析患者共26310例(其中維持性血液透析(maintenance hemodialysis, MHD)患者19143例,維持性腹膜透析(maintenance peritoneal dialysis, MPD)患者5199例),年發(fā)病率從46.3/百萬人上升至119.9/百萬人；平均年齡從53.0歲上升至58.7歲,65歲以上的患者比例從25.1%上升到37.8%；男性患者略多于女性(1.3：1)；原發(fā)病診斷前三位依次是慢性腎小球腎炎(chronicglomerulonephritis, CGN)(占全體51.3%),糖尿病腎病(diabetic nephropathy, DN)(占全體17.3%)和高血壓腎病(hypertensive nephrosclerosis, HTN)(占全體6.4%),DN呈現(xiàn)緩慢上升趨勢(shì),登記的死亡原因中,心血管事件排首位。 結(jié)論：2008～2013年浙江省ESRD年發(fā)病率持續(xù)上升,透析方式以血透治療為主,腹透治療有所增加,老年患者比例逐年上升,原發(fā)病中以慢性腎小球腎炎為主,糖尿病腎病呈現(xiàn)緩慢上升的趨勢(shì),心血管事件為ESRD透析患者的主要死因。 第二部分傾向性評(píng)分法在血液透析和腹膜透析患者生存比較中的應(yīng)用 目的：終末期腎病(end stage renal disease, ESI ID)患者采用何種透析方式生存預(yù)后更好,目前尚存爭(zhēng)議,本研究利用傾向性評(píng)分法(propensity score method, PSM)將浙江省新發(fā)ESRD透析患者的基本資料進(jìn)行匹配,比較血液透析(hemodialysis, HD)和腹膜透析(peritoneal dialysis, PD)患者的生存情況。 方法：研究對(duì)象為2008年7月1日至2013年6月30日,浙江省透析質(zhì)量控制中心(Zhejiang Dialysis Quality and Management Center, ZDQM)新接收,年齡≥18歲、透析時(shí)間90天的ESRD患者,收集患者人口統(tǒng)計(jì)學(xué)資料、診斷、血管通路等臨床基線信息,隨訪至2014年6月30日,隨訪期間發(fā)生死亡作為觀察的最終結(jié)局。將PD患者的性別、年齡、原發(fā)病及合并癥作為參照,多因素Logistic回歸計(jì)算出傾向性評(píng)分,應(yīng)用PSM,隨機(jī)地在HD組中匹配具有近似評(píng)分的患者,再通過Kaplan-Meier法、 log-rank檢驗(yàn)及Cox比例風(fēng)險(xiǎn)回歸模型對(duì)患者的生存情況進(jìn)行比較分析。 結(jié)果：共納入透析患者19846例,HD患者15610例(78.7%)、PD患者4236例(21.3%),中位隨訪時(shí)間為29個(gè)月(3-72個(gè)月)。應(yīng)用PSM匹配出4233對(duì)患者,兩組患者基線資料中,年齡、性別、原發(fā)病、合并癥(除慢性肝病),均無顯著性差異。Kaplan-Meier生存曲線顯示在PSM之前,PD患者生存率高于HD患者(log-rank檢驗(yàn),P0.001),PSM后,兩組患者總體生存率差異無統(tǒng)計(jì)學(xué)意義(log-rank檢驗(yàn),P=0.979),在開始透析后1年內(nèi)PD患者生存率優(yōu)于HD患者(P0.05)。亞組分析結(jié)果顯示：1)在性別、年齡、原發(fā)病、合并癥各亞組中,兩種透析方式生存率無顯著性差異(log-rank檢驗(yàn),P0.05)；2)在年齡65歲的患者亞組中,兩組患者生存率無明顯差異,其中合并糖尿病(diabetes mellitus, DM)的患者,HD組生存率高于PD組(log-rank檢驗(yàn),P0.05),非DM患者,PD組生存率高于HD組(log-rank檢驗(yàn),P0.05)；3)年齡≥65歲的患者亞組中,無論合并DM與否,兩組患者生存率無顯著性差異(log-rank檢驗(yàn),P0.05)；4)多因素Cox回歸分析結(jié)果顯示,年齡、原發(fā)病、心血管疾病、惡性腫瘤及慢性阻塞性肺部疾病(chronic obstructive pulmonary disease, COPD)為透析患者生存預(yù)后的獨(dú)立危險(xiǎn)因素,其中原發(fā)病為慢性腎小球腎炎(chronic glomerulonephritis, CGN)和高血壓腎病(hypertensive nephrosclerosis, HTN)的患者生存率明顯高于糖尿病腎病(diabetic nephropathy, DN)患者(P0.05)；5)使用動(dòng)靜脈內(nèi)瘺(arteriovenous fistula,AVF)作為血管通路的HD患者生存率高于PD患者及使用中心靜脈導(dǎo)管的HD患者(log-rank檢驗(yàn),P0.001)。 結(jié)論：在新發(fā)ESRD患者中,HD和PD患者總體生存率無顯著性差異,透析齡≤1年的PD患者生存率高于HD患者。年齡≥65歲的患者中,無論合并DM與否,HD治療與PD治療生存率無明顯差異；年齡65歲的患者中,合并DM者,HD治療生存率高于PD治療,未合并DM者,PD生存率高于HD。年齡、原發(fā)病、心血管疾病、惡性腫瘤及COPD是影響透析患者生存率的獨(dú)立危險(xiǎn)因素,原發(fā)病中DN患者的死亡風(fēng)險(xiǎn)最高,新發(fā)ESRD患者使用AVF的HD患者生存率明顯高于PD患者和使用中心靜脈導(dǎo)管的HD患者,PD治療可能會(huì)增加老年患者的死亡風(fēng)險(xiǎn)。 第三部分維持性血透患者死亡風(fēng)險(xiǎn)預(yù)測(cè)及評(píng)分模型構(gòu)建 目的：血液透析(hemodialysis, HD)患者死亡風(fēng)險(xiǎn)明顯高于普通人群,為提高臨床醫(yī)師對(duì)其死亡風(fēng)險(xiǎn)的預(yù)判能力,本研究通過臨床易于獲取的基本資料和實(shí)驗(yàn)室數(shù)據(jù),對(duì)新發(fā)維持性血透(maintenance hemodialysis, MHD)患者透析后2年內(nèi)的死亡風(fēng)險(xiǎn)進(jìn)行預(yù)測(cè),同時(shí)構(gòu)建相應(yīng)的風(fēng)險(xiǎn)評(píng)分標(biāo)準(zhǔn)。 方法：納入浙江省透析質(zhì)量控制中心(Zhejiang Dialysis Quality and Management Center, ZDQM)2008年1月1日到2012年6月30日,年齡≥18歲、透析時(shí)間90天的新增MHD患者,收集患者開始透析時(shí)的人口統(tǒng)計(jì)學(xué)資料、診斷、血管通路、實(shí)驗(yàn)室數(shù)據(jù)等信息,所有患者隨訪至2014年6月30日,隨訪期間發(fā)生死亡作為觀察的最終結(jié)局。將患者隨機(jī)分為構(gòu)建模型的訓(xùn)練組(占總體60%)和驗(yàn)證模型效度的驗(yàn)證組(占總體40%),利用訓(xùn)練組的臨床基本資料和實(shí)驗(yàn)室數(shù)據(jù),采用多因素logistic回歸統(tǒng)計(jì)方法篩選出與患者透析開始后2年內(nèi)全因死亡有關(guān)的獨(dú)立影響因素構(gòu)建模型,驗(yàn)證組通過受試者工作特征(Receiver operator characteristic,ROC)曲線下面積、敏感度及特異度,來反映預(yù)測(cè)模型的鑒別效度及符合程度；確立風(fēng)險(xiǎn)預(yù)測(cè)模型后,根據(jù)模型中各危險(xiǎn)因素的權(quán)重系數(shù)及其變量類型,共同建立評(píng)分標(biāo)準(zhǔn)。 結(jié)果：共納入4295例患者,2年內(nèi)死亡691人(占總數(shù)16.1%),多因素logistic回歸分析結(jié)果顯示年齡、原發(fā)病、血管通路、惡性腫瘤、血清白蛋白及血總鈣是患者死亡的獨(dú)立影響因素,其中血清白蛋白為保護(hù)性因素；確立模型公式=0.614*年齡(=1,2,3,4,或5)+0.864*血管通路(=0,或1)+(0.784*(若糖尿病腎病(diabetic nephropathy, DN)=1),或0.217(若高血壓腎病(hypertensive nephrosclerosis, HTN)=1),或0.796(若原發(fā)病診斷為其他及未知=1))+0.709*惡性腫瘤(=0,或1)-0.554*血清白蛋白(=0,或1)+0.270*血總鈣(=0,1,或2)-4.943；訓(xùn)練組ROC曲線下面積為0.767,95%CI(0.744～0.790),H-L檢驗(yàn),χ2=3.144,P=0.925,驗(yàn)證組驗(yàn)證,ROC曲線下面積為0.732,95%CI(0.700～0.765),敏感度和特異度分別為71.5%和64.2%；評(píng)分標(biāo)準(zhǔn)：年齡30歲：3分,每增加15歲增加3分,75歲為15分；原發(fā)�。郝阅I小球腎炎(chronic glomerulonephritis, CGN):0分,DN：4分,HTN：1分,其他：4分；血管通路：動(dòng)靜脈內(nèi)瘺(arteriovenous fistula, AVF):0分,中心靜脈導(dǎo)管：4分；合并癥：惡性腫瘤：3分；實(shí)驗(yàn)室數(shù)據(jù)：血白蛋白：35g/1：0分,35g/1：-3分；血總鈣：2.1mmol/1:1分,2.1-2.6mmol/1:0分,2.6mmol/l:3分。按最終評(píng)分分為：低危組(9分),中危組(10～13分),高危組(14～17分)和極高危組(≥18分)。 結(jié)論：本研究回顧性分析ZDQM數(shù)據(jù)庫(kù)中2008～2012年新發(fā)MHD患者信息,利用臨床易于獲得的患者基本資料和實(shí)驗(yàn)室數(shù)據(jù),構(gòu)建出MHD患者透析后2年內(nèi)的死亡風(fēng)險(xiǎn)預(yù)測(cè)模型,并設(shè)立了相應(yīng)的評(píng)分標(biāo)準(zhǔn),經(jīng)驗(yàn)證具有良好的鑒別度和準(zhǔn)確性,在今后臨床科研相關(guān)人員預(yù)判患者生存預(yù)后和制定臨床決策的過程中具有一定的參考價(jià)值。
[Abstract]:Part one epidemiological analysis of newly diagnosed end-stage renal disease in Zhejiang Province
Objective: the dialysis registration system is an important part of the standardized management of patients with end stage renal disesase (ESRD). The Zhejiang dialysis quality control center (Zhejiang Dialysis Quality and Management Center, ZDQM) is established in 2007. The main contents of the database include the basic information of the dialysis patients and the development of the disease. In this study, the data of the new ESRD patients in the 2008~2013 year ZDQM were analyzed to understand the epidemiological status in order to provide reference data for the clinicians, scientific researchers and medical health policies.
Methods: the basic information of new ESRD patients in ZDQM database from January 2008 to December 2013 was collected, including sex, age, dialysis mode, primary pathogenesis, prognosis, laboratory data and so on. The annual incidence, the Constitution and changes of the primary disease, the gender age structure and the cause of death were analyzed.
Results: in 2008~2013 years, there were 26310 new ESRD dialysis patients in Zhejiang province (including 19143 patients with maintenance hemodialysis, MHD) and 5199 cases of maintenance peritoneal dialysis (maintenance peritoneal dialysis, MPD). The annual incidence rate rose from 46.3/ million to 119.9/ million; the average age increased from 53 years. The proportion of patients aged 58.7 and above rose from 25.1% to 37.8%; male patients were slightly more than women (1.3:1); the first three were chronic glomerulonephritis (chronicglomerulonephritis, CGN) (51.3%), diabetic nephropathy (diabetic nephropathy, DN) (all 17.3%) and hypertensive nephropathy (hypertensive nephro). Sclerosis (HTN) (accounting for 6.4% of all), DN showed a slow upward trend, and cardiovascular events ranked first among registered deaths.
Conclusion: in the past 2008~2013 years, the incidence of ESRD in Zhejiang province continued to rise. Hemodialysis was the main method of dialysis, the treatment of peritoneal dialysis was increased, the proportion of elderly patients increased year by year. The primary disease was chronic glomerulonephritis, and diabetic nephropathy showed a slow rising trend. The main cause of ESRD dialysis patients was the heart blood tube event.
The second part is the application of propensity score in hemodialysis and peritoneal dialysis patients.
Objective: the survival of patients with end-stage renal disease (end stage renal disease, ESI ID) has a better survival prognosis and is still in dispute. This study uses the tendency score (propensity score method, PSM) to match the basic data of the new ESRD dialysis patients in Zhejiang Province, and compare the hemodialysis (hemodialysis, hemodialysis) and peritoneal dialysis. An analysis of the survival of patients (peritoneal dialysis, PD).
Methods: from July 1, 2008 to June 30, 2013, the Zhejiang dialysis quality control center (Zhejiang Dialysis Quality and Management Center, ZDQM) was newly received, ESRD patients aged over 18 years and dialysis time for 90 days were collected, and the patient's demographic data, diagnosis, vascular access and other clinical baseline information were collected and followed up to 3 in June 2014. 0 days, during the follow-up period, death was the final outcome of the observation. The gender, age, primary disease and complication of PD patients were taken as reference, the tendency score was calculated by multiple factor Logistic regression, and PSM was used to match the patients with approximate score in the HD group, and then the Kaplan-Meier, log-rank test and Cox proportional risk regression model were used. The survival of the patients was compared and analyzed.
Results: 19846 cases of dialysis patients were included, 15610 cases (78.7%) of HD patients, 4236 cases (21.3%) of PD patients and 29 months (3-72 months). PSM was used to match 4233 pairs of patients. In the baseline data of the two groups, age, sex, primary disease, and complication (except chronic liver disease), there was no significant difference in the.Kaplan-Meier survival curve in PSM Before, the survival rate of PD patients was higher than that of HD (log-rank test, P0.001). After PSM, there was no significant difference in the total survival rate between the two groups (log-rank test, P=0.979). The survival rate of PD patients was superior to HD within 1 years after beginning dialysis (P0.05). The subgroup analysis showed 1) two kinds of dialysis in the sex, age, primary disease, and the subgroups of the complication. There was no significant difference in the survival rate (log-rank test, P0.05); 2) there was no significant difference in survival rate between the two groups of patients aged 65 years old, and the survival rate of group HD with diabetes mellitus, DM was higher than that of the PD group (log-rank test, P0.05), non DM patients, and the PD group survival rate was higher than that of the HD group (3); In the subgroup of patients aged more than 65 years old, no matter the combination of DM or not, there was no significant difference in survival rate between the two groups (log-rank test, P0.05), and 4) multiple factor Cox regression analysis showed that age, primary disease, cardiovascular disease, malignant tumor and chronic obstructive pulmonary disease (chronic obstructive pulmonary disease, COPD) were the survival precondition of dialysis patients. The postoperative independent risk factors, of which patients with chronic glomerulonephritis, CGN, and hypertensive nephrosclerosis, HTN, were significantly higher than patients with diabetic nephropathy (diabetic nephropathy, DN) (P0.05); 5) use arteriovenous fistula (arteriovenous fistula) as a blood vessel. The survival rate of HD patients was higher than that of PD patients and HD patients using central venous catheter (log-rank test, P0.001).
Conclusion: there is no significant difference in the overall survival rate of patients with HD and PD in the new ESRD patients. The survival rate of PD patients with dialysis age less than 1 years is higher than that of the HD patients. There is no significant difference in the survival rate between HD and PD in patients with age of 65 years old. The survival rate of HD is higher than that of PD, and the survival rate of HD is higher than that of PD, and the survival rate of HD is higher than that of PD treatment, and the survival rate is higher than that of PD treatment. And DM, the survival rate of PD is higher than that of HD. age. Primary disease, cardiovascular disease, malignant tumor and COPD are independent risk factors affecting the survival rate of dialysis patients. The mortality risk of DN patients in primary disease is the highest. The survival rate of HD patients using AVF in the new ESRD patients is significantly higher than those of PD patients and HD patients using central venous catheterization, PD treatment may increase. The risk of death in elderly patients.
The third part is the prediction of death risk and the construction of scoring model for maintenance hemodialysis patients.
Objective: the risk of death in hemodialysis (HD) patients was significantly higher than that of the general population, in order to improve the ability of clinicians to prejudge the risk of death. The risk of death within 2 years after dialysis in patients with new maintenance hemodialysis (MHD) was increased by clinical data and laboratory data. Make a forecast and build a corresponding risk scoring standard.
Methods: Zhejiang Dialysis Quality and Management Center, ZDQM) from January 1, 2008 to June 30, 2012, more than 18 years old and 90 days of dialysis time were added to the new MHD patients. The demographic data, diagnosis, vascular access, laboratory data, and so on were collected and all the patients were collected. The patients were followed up to June 30, 2014, and death was the final outcome of observation during follow-up. The patients were randomly divided into a training group (60%) and a validation group (40%) to verify the validity of the model. Using the clinical data of the training group and the laboratory data, the multiple factor logistic regression method was used to select the patients and the patients. The model was constructed for all the independent factors related to death within 2 years after the beginning of dialysis. The validation group reflected the identification validity and compliance of the prediction model through the area, sensitivity and specificity under the Receiver operator characteristic (ROC) curve, and the risk factors in the model were established, and the risk factors were based on the risk factors. The weight coefficient and the type of variables are used to establish the scoring standard.
Results: a total of 4295 patients were included, and 691 people died within 2 years (16.1%). Multiple factor Logistic regression analysis showed that age, primary disease, vascular access, malignant tumor, serum albumin and blood total calcium were independent factors of death, and serum albumin was a protective factor; the model formula =0.614* age (=1,2,3,4, Or 5) +0.864* vascular access (=0, or 1) + (0.784* (if diabetic nephropathy (diabetic nephropathy, DN) =1), or 0.217 (if essential hypertensive nephropathy (hypertensive nephrosclerosis, HTN) =1), or 0.796 (if the primary disease is diagnosed as other and unknown =1)) The area of the ROC curve in the training group was 0.767,95%CI (0.744 ~ 0.790), H-L test, X 2=3.144, P=0.925, and verification group proved that the area under the ROC curve was 0.732,95%CI (0.700 ~ 0.765), the sensitivity and specificity were 71.5% and 64.2%, respectively, the age 30 years old: 3, each increase 15 years old, 3 points, 75 years as 15 points; the primary disease: Chronic Renal Small Chronic glomerulonephritis (CGN): 0 points, DN:4 points, HTN:1 points, and other: 4 points; vascular access: arteriovenous fistula (arteriovenous fistula, AVF): 0 points, central venous catheter: 4; complication: malignant tumor: 3 points; laboratory data: serum albumin: 35g/1:0, 35g/1:-3 points; blood total calcium: 2.1mmol/1:1 score 2.1-2.6mmol/1:0 scores and 2.6mmol/l:3 scores were divided into low risk group (9 points), middle risk group (10~13 points), high risk group (14~17 points) and extremely high risk group (18 points).
Conclusion: This study reviewed the information of new MHD patients in the ZDQM database for 2008~2012 years, and constructed the prediction model of death risk within 2 years after dialysis by using the basic data and laboratory data that were easy to obtain, and set up a corresponding grading standard, which proved to have good identification and accuracy. It is of some reference value for future clinical research personnel to predict survival prognosis and make clinical decisions.
【學(xué)位授予單位】：浙江大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2015
【分類號(hào)】：R692.5

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1 趙新菊;王琰;甘良英;王梅;左力;;北京市新增維持性血液透析患者的人口統(tǒng)計(jì)學(xué)及病因構(gòu)成的變遷[J];中國(guó)血液凈化;2014年03期

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