广西社区肝癌高危人群队列研究的质量控制

发布时间：2018-07-27 17:13

【摘要】：研究背景：原发性肝癌(primary liver cancer, PLC)简称肝癌,是世界及我国常见的恶性肿瘤之一,其发病率位居世界第5位,死亡率位居世界第3位,近年来发病率和死亡率有不断上升的趋势。研究表明肝癌的发生发展与多种危险因素有关,其中HBV感染是我国肝癌最主要的危险因素。流行病学队列研究多以现场调查的方式收集资料,资料数据的准确性决定着研究结论的正确性,由于一些数据的获取具有不可重复性,要求一次性获得；如果质量控制不佳,就会造成大量队列人群的不配合甚至失访,影响研究结果和资料血样的收集,对统计结果和结论产生偏差。因此,质量控制在肝癌高危人群队列研究的整个过程中至关重要。虽然国内外已有一些关于随访质量控制、标本质量控制等方面的文献报道,但国内外对高危人群队列研究整体质量控制方面的文献少见报道。目的：探讨广西社区肝癌高危人群队列研究的质量控制体系,为后续肿瘤标志物或基因的研究提供准确的数据资料及生物学标本,为此项研究的可持续发展提供更加科学合理的参考价值。方法：以检测血清乙肝两对半作为初筛手段,建立HBsAg和HBcAb均为阳性的肝癌高危人群队列；每半年进行一次追踪随访,检测血清乙肝两对半、肝功能、甲胎蛋白和肝脏B超检查,收集血样品和资料；对发现的AFP和/或肝脏B超检查异常者,进行及时的复查,同时结合其他临床检查尽早作出诊断和治疗。本文从调查开展前阶段(研究的设计、现场地点及人群的选择、制定工作手册及相关质量控制文件、质量控制制度)、准备调查阶段(调查登记表的预调查试验、研究人员的培训)、现场工作阶段(宣传动员、现场调查、现场采样、肝脏B超检查)、血样运输分离及保存、实验室检测、肝癌的临床诊断、数据管理、质量反馈等多个方面探讨肝癌高危人群对队列研究的质量控制。结果：2010年11月截至2015年12月31日,建立了肝癌高危人群队列并进行了7次随访,肝癌高危人群队列人数共2665例,收集基线调查登记表共2665份,血样本共7021例；制定了肝癌高危人员队列研究工作手册和相关质量控制文件；当前选择的社区项目点基本能够满足现场地点及人群选择条件；工作人员经过培训后,基本把握队列研究的整体流程和质量控制方法,能够很好的完成本职各项工作任务；调查登记表具有可靠性、有效性、适用性的特征,调查项目科学合理,经实践证明能够满足本队列研究调查的需求,具有较高的质量；实验室检测的质量控制方法确保了结果的准确性；血样质量良好,能够满足实验室检测和后续肿瘤标志物或基因研究的需求；采用了分类标记存储血样；建立了档案资料室,专人管理,筛查及复查资料已基本输入数据库；临床诊断肝癌8例(早期肝癌5例,晚期肝癌3例)；肝癌高危人群队列每年的随访依从性波动在51.16%-76.89%之间。结论：在广西社区肝癌高危人群队列研究中,影响数据资料及样本准确性的因素是多方面的,收集数据资料及样本虽然需要大量的人力和物力,但根据实际具体情况制定合理的操作流程和质量控制方案是保证队列研究数据资料及样本质量的关键。
[Abstract]:Background: primary liver cancer (PLC) is one of the most common malignant tumors in the world and China. Its incidence is the fifth largest in the world. The mortality rate is the third in the world. In recent years, the incidence and mortality rate are increasing. The study shows that the occurrence and development of liver cancer are related to a variety of risk factors, among them, the occurrence and development of liver cancer are related to many risk factors. HBV infection is the most important risk factor for liver cancer in China. Epidemiological cohort studies collect data mostly in the way of field investigation. The accuracy of data data determines the correctness of the research conclusions. The acquisition of some data is not repeatable and requires a one-time acquisition. If the quality control of fruit is not good, it will cause a large number of queues. It is important for the whole process of cohort study for high risk population of HCC. Although there have been some literature on the quality control of follow-up and the quality control of specimens at home and abroad, there are some domestic and foreign countries. A rare literature report on the overall quality control of high risk cohort study. Objective: To explore the quality control system for cohort study of high risk population in Guangxi community, to provide accurate data and biological specimens for the follow-up of tumor markers or genes, and to provide more scientific and rational research for the sustainable development of the research. Methods: a cohort of high risk groups of liver cancer with positive HBsAg and HBcAb was established by detecting the two half of hepatitis B as a preliminary screening method. A follow-up follow-up was conducted every half year to detect the serum hepatitis B two to half, liver function, alpha fetoprotein and liver B ultrasonography, collect blood samples and data, and detect AFP and / or liver B ultrasound examination. A timely examination of the abnormality was conducted, and the diagnosis and treatment were made as early as possible with other clinical examinations. This article from the investigation of the first stage (the design of the study, the selection of the site and the crowd, the work manual and the quality control documents, the quality control system), and the preparation of the investigation stage (the pre investigation test of the survey registration form) The quality control of the high risk population of liver cancer was discussed in many aspects, such as publicity mobilization, field survey, field sampling, liver B ultrasound examination, blood sample transport separation and preservation, laboratory testing, clinical diagnosis of liver cancer, data management, quality feedback and so on. Results: in November 2010, it was built up to December 31, 2015. A cohort of high risk people for liver cancer was set up and followed up for 7 times. A total of 2665 cases of high risk population of liver cancer were queued, 2665 were collected from the baseline survey list, and 7021 of the blood samples were collected. After training, the staff basically grasp the whole process and the quality control method of the cohort study, and can complete the work tasks well. The investigation registration form has the characteristics of reliability, validity and applicability. The survey project is scientific and reasonable, and it has proved to be able to meet the needs of the research and investigation of this queue. It has high quality; the quality control method of laboratory testing ensures the accuracy of the results; the quality of the blood samples is good enough to meet the needs of laboratory testing and subsequent tumor markers or gene studies; the use of classified markers to store blood samples; the establishment of a archival data room, special management, screening and reexamination of data has been basically lost. In the clinical diagnosis of 8 cases of liver cancer (5 cases of early liver cancer and 3 cases of advanced liver cancer), and the annual follow-up compliance of the high risk population of liver cancer is between 51.16%-76.89%. Conclusion: in the cohort study of high risk population of liver cancer in Guangxi community, the factors affecting the accuracy of data and samples are multifaceted, data and samples are collected. Although it needs a lot of manpower and material resources, it is the key to ensure the quality of the data and sample of the queue to study the reasonable operation flow and quality control scheme according to the actual situation.
【学位授予单位】：广西医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R735.7

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