肝衰竭临床科研系统和慢加急性肝衰竭预后模型的建立

发布时间：2018-04-14 16:06

本文选题：电子病历 + 临床路径　；参考：《浙江大学》2014年博士论文

【摘要】：研究背景：信息化时代扑面而至,如何更好地利用信息化手段规范优化临床流程,挖掘临床科研数据已经成为当今医学发展的重要方向之一。在亚洲地区,慢加急性肝衰竭是一组发病率高,病死率高,治疗费用昂贵的临床症候群。然而,迄今为止,鲜有在不区分病因情况下,特异性基于大样本亚洲慢加急性肝衰竭人群,利用保守治疗后的预后数据,建立的慢加急性肝衰竭预后评价系统,更缺乏针对慢加急性肝衰竭倾向人群的预后评价系统。因此,本研究的目的：充分利用信息化技术,构建肝衰竭临床科研系统,更有效率的实现临床科研数据的清洗,整理和归类分析,解决数据一致性问题,进一步摸索慢加急性肝衰竭倾向患者的预后情况,并且建立一个针对保守治疗后的慢加急性肝衰竭和慢加急性肝衰竭倾向患者的预后评价模型。方法：通过对肝衰竭临床诊治流程的梳理和规划,构建了包括肝衰竭电子病历和临床路径,肝衰竭多中心临床试验电子数据采集(EDC)系统,肝衰竭随访系统,人工肝诊治和随访系统在内的肝衰竭临床科研系统。基于上述系统,本研究对2008年12月1号至2012年2月1号收治浙江大学医学院附属第一医院,予以保守治疗的857例慢加急性肝衰竭和慢加急性肝衰竭倾向患者,进行了回顾性队列研究和分析。按照病情轻重程度,有无肝硬化等情况建立亚组,采用Kaplan-Meier生存曲线进行实际生存情况分析和比较。采用双变量分析和COX比例风险回归模型进一步分析了影响慢加急性肝衰竭预后的独立危险因素,并建立预后模型。采用ROC曲线下面积对新模型和现有模型进行了比较。结果：在研究中,我们发现慢加急性肝衰竭倾向组的患者12周的病死率是30.5%,24周的病死率是33.2%,而慢加急性肝衰竭早期组的患者12周的病死率是33.9%,24周的病死率是37.1%,慢加急性肝衰竭中期组的患者12周的病死率是49.5%,24周的病死率是53.8%；慢加急性肝衰竭晚期组的患者12周的病死率是77.2%,24周的病死率是78.5%。无论是12周病死率还是24周病死率,慢加急性肝衰竭倾向组的患者病死率和慢加急性肝衰竭早期组的患者病死率均没有统计学差异(P0.05)。而慢加急性肝衰竭倾向组的患者病死率和慢加急性肝衰竭中期组的患者病死率均有明显统计学差异(P0.0001)。慢加急性肝衰竭早期组的患者病死率和慢加急性肝衰竭中期组的患者病死率比较,慢加急性肝衰竭中期组的患者病死率和慢加急性肝衰竭晚期组的患者病死率比较,也均有明显统计学差异(P0.0001)。研究根据有无肝硬化,将全部的857例患者分为肝硬化组(n=455)和非肝硬化组(n=402)。发现肝硬化组的患者12周病死率是63.1%,24周病死率是65.5%,而非肝硬化组的患者12周病死率是45.5%,24周病死率是46.5%,无论是12周病死率还是24周病死率,两组之间均有明显的统计学差异(P0.0001)。双变量分析和COX比例风险回归模型分析发现五个和慢加急性肝衰竭以及慢加急性肝衰竭倾向患者预后密切相关的独立危险因素,分别是MELD评分,年龄,肝性脑病,甘油三酯和血小板计数水平。随着MELD评分,年龄,肝性脑病,甘油三酯水平的升高和血小板计数水平的降低,病死率增加。建立了李氏慢加急性肝衰竭模型(Li-ACLF model),R=0.021×年龄(岁)+0.279×肝性脑病分度+0.513×MELD评分一0.210×loge血小板计数(109/L)一0.176×loge甘油三酯(mg/dL)结论：研究构建的肝衰竭临床科研系统规范优化了临床流程,解决了数据一致性问题,使得临床研究能够更有效率的利用分析数据。在此基础上开展的进一步研究,发现慢加急性肝衰竭倾向患者预后较差,类似早期慢加急性肝衰竭患者,因此,建议可适当放宽我国2006年颁布的慢加急性肝衰竭诊断标准,有利于慢加急性肝衰竭倾向患者尽早得到更有效的诊治。建立的李氏慢加急性肝衰竭预后评价模型可用于慢加急性肝衰竭患者在保守治疗后的预后判断,有利于早期评估患者保守治疗的生存可能,辅助判断是否需要肝移植治疗,有利于改善患者预后。
[Abstract]:Background: the information age Pumian but how to make better use of information technology means to regulate and optimize clinical process, clinical research, data mining has become one of the important direction of medical development. In Asia, acute on chronic liver failure is a group of high incidence, high mortality, high cost of treatment of clinical syndrome. However, so far so far, few in distinguishing the cause of disease cases, specific sample of Asian acute on chronic liver failure group based on the data of prognosis after conservative treatment of acute on chronic liver failure, prognosis evaluation system, lack for the evaluation of prognosis of acute on chronic liver failure tendency of population system. Therefore, the purpose of this study is: make full use of information technology, construction of liver failure in clinical research, clinical research data for cleaning more efficient, sorting and classification analysis, to solve the data consistency problem into One step to explore the prognosis of patients with chronic acute liver failure, and establish a prognosis evaluation model for patients with chronic acute liver failure and chronic acute liver failure after conservative treatment.
Methods: the clinical diagnosis and treatment of liver failure in the process of combing and planning, including the construction of electronic medical records and clinical pathway of liver failure, liver failure, multicenter clinical trial of the electronic data acquisition system (EDC), liver failure follow-up system, system of artificial liver treatment and follow-up, liver failure clinical research system. Based on the above system, the on December 1, 2008 to February 1, 2012 from the First Affiliated Hospital of Zhejiang University School of medicine, to conservative treatment of 857 cases of acute on chronic liver failure and acute on chronic liver failure tendency patients, a retrospective cohort study was conducted and analyzed. According to the severity of the disease, there is no established cirrhosis subgroup, the Kaplan-Meier survival curves and comparative analysis the actual survival situation. By using bivariate analysis and COX proportional hazards regression model to analyze the influence of chronic prognosis of acute liver failure independent risk The risk factors and the prognosis model were established. The area under the ROC curve was used to compare the new model with the existing model.
Results: in this study, we found that acute on chronic liver failure tendency group patients with 12 week mortality rate was 30.5%, the mortality rate is 33.2% to 24 weeks, and acute on chronic liver failure patients with early 12 week mortality rate was 33.9%, the mortality rate is 37.1% to 24 weeks, acute on chronic liver failure in the group of patients 12 week period mortality rate was 49.5%, the mortality rate is 53.8% to 24 weeks; chronic late acute liver failure patients 12 week mortality rate was 77.2%, the mortality rate of 78.5%. is 24 weeks whether the mortality for 12 weeks or 24 weeks, the fatality rate of acute on chronic liver failure tendency group the mortality rate in patients with acute on chronic liver failure and mortality rate in patients with early group had no significant difference (P0.05). The difference and acute on chronic liver failure tendency group mortality rate in patients with acute on chronic liver failure and mortality rate in patients with intermediate groups there were statistically significant (P0.0001). Acute on chronic liver failure early group The mortality of patients in the mid stage group was significantly lower than that in the patients with acute or chronic liver failure, and there was a significant difference in mortality between the mid and chronic acute liver failure group and the late acute liver failure group (P0.0001).
According to the study of hepatic cirrhosis, 857 cases of all patients were divided into cirrhosis group (n=455) and non cirrhosis group (n=402). It is found that the patients with liver cirrhosis group 12 week mortality rate is 63.1%, the 24 week mortality rate is 65.5%, while the non cirrhosis patients with 12 week mortality rate was 45.5%, the mortality rate is 24 weeks 46.5%, whether the mortality for 12 weeks or 24 weeks mortality rate between the two groups had statistically significant difference (P0.0001).
Independent risk factors for bivariate analysis and COX regression analysis found five and acute on chronic liver failure and acute on chronic liver failure tendency closely related to the prognosis of patients, respectively, MELD score, age, hepatic encephalopathy, triglyceride level and platelet count. With the MELD score, age, hepatic encephalopathy, lower triglyceride levels and the increase of the level of platelet count, the mortality rate increased. Lee established acute on chronic liver failure model (Li-ACLF model), R=0.021 * +0.279 * age (years) hepatic encephalopathy +0.513 * MELD score index of 0.210 * loge platelet count (109/L) of a 0.176 x loge triglyceride (mg/dL) conclusion: the construction of the liver failure of clinical research system specification to optimize the clinical procedure, solve the problem of data consistency, makes clinical research more effectively using data analysis. On the basis of the further development Study found that acute on chronic liver failure tendency of patients with poor prognosis, similar to the early chronic patients with acute liver failure, therefore, suggestions may be appropriate to relax the acute on chronic liver failure diagnosis standard of our country promulgated in 2006, for patients with acute on chronic liver failure diagnosis and treatment as early as possible to get more effective tendency. To evaluate the prognosis of chronic Lee acute liver failure model can be used for patients with acute on chronic liver failure, in the judgment of the prognosis after conservative treatment, is conducive to the early assessment of patients with conservative treatment survival may determine the need, auxiliary liver transplantation and improve the prognosis of patients.

【学位授予单位】：浙江大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：R575.3;R-332

【参考文献】