【摘要】：背景：循證醫(yī)學(xué)是近20年來在臨床醫(yī)學(xué)實踐中發(fā)展起來的一門新興臨床方法學(xué),其研究的原則和方法日益受到人們的重視,廣泛應(yīng)用于臨床醫(yī)學(xué)研究。近年來的循證醫(yī)學(xué)實踐已改變了許多現(xiàn)代醫(yī)學(xué)治療疾病的用藥原則和方法,使治療方案更科學(xué)、更嚴(yán)謹(jǐn),對現(xiàn)代醫(yī)學(xué)的發(fā)展產(chǎn)生了巨大的影響。中醫(yī)藥學(xué)是中華民族的優(yōu)秀文明成果,在理論和實踐上有其獨特的優(yōu)勢和鮮明的特色,將循證醫(yī)學(xué)的方法用于中醫(yī)藥學(xué)的研究是近年來關(guān)心的熱點,采用循證醫(yī)學(xué)的原則和方法指導(dǎo)今后的中醫(yī)藥臨床研究,改善研究方法,提高中醫(yī)藥臨床研究質(zhì)量,必將推動中醫(yī)藥學(xué)的發(fā)展。目前,尚缺乏成熟供臨床科研廣泛應(yīng)用的專門用于中醫(yī)藥治療慢性乙型肝炎的循證醫(yī)學(xué)工作平臺,為提高中醫(yī)藥防治和研究慢性乙型肝炎的能力和水平,構(gòu)建中醫(yī)藥防治和研究慢性乙型肝炎循證醫(yī)學(xué)工作平臺顯得十分必要和迫切。 目的：為開展中醫(yī)藥防治慢性乙型肝炎的循證醫(yī)學(xué)評價(評價和尋找已有的循證醫(yī)學(xué)證據(jù))、臨床決策(指導(dǎo)臨床運用循證醫(yī)學(xué)證據(jù))和臨床研究(提供新的循證醫(yī)學(xué)證據(jù))提供中醫(yī)臨床循證醫(yī)學(xué)信息化工作平臺。 方法：在中醫(yī)基礎(chǔ)理論和循證醫(yī)學(xué)思想指導(dǎo)下,結(jié)合數(shù)理統(tǒng)計方法、計算機(jī)技術(shù)的全面應(yīng)用,通過多學(xué)科整合,構(gòu)建循證醫(yī)學(xué)工作平臺,全面收集慢性乙型肝炎臨床診療數(shù)據(jù),實現(xiàn)慢性乙型肝炎臨床診療信息的規(guī)范化采集,構(gòu)建慢性乙型肝炎病證信息數(shù)據(jù)庫,為相關(guān)臨床研究提供基礎(chǔ)數(shù)據(jù)支撐。建立中醫(yī)藥治療慢性乙型肝炎循證醫(yī)學(xué)工作平臺,為臨床診療慢性乙型肝炎提供循證醫(yī)學(xué)的證據(jù)資料和研究工具,采用循證醫(yī)學(xué)方法評價中醫(yī)藥治療慢性乙型肝炎的臨床研究,完成中醫(yī)藥治療慢性乙型肝炎臨床觀察文獻(xiàn)質(zhì)量評價。建立循證醫(yī)學(xué)工作平臺,回顧性收集慢性乙型肝炎病例資料,篩選慢性乙型肝炎發(fā)展為肝硬化、肝癌等嚴(yán)重臨床結(jié)局的危險因素,初步確立慢性乙型肝炎預(yù)后評估指標(biāo)。建立循證醫(yī)學(xué)工作平臺,對慢性乙型肝炎患者病證信息長期追蹤隨訪,對其進(jìn)行定期檢測和綜合評價,評估慢性乙型肝炎發(fā)展為肝硬化、肝癌等嚴(yán)重臨床結(jié)局的危險性大小,建立慢性乙型肝炎病程進(jìn)展監(jiān)測體系。 平臺構(gòu)建和設(shè)計首先必須準(zhǔn)確了解與分析用戶需求。需求分析是整個構(gòu)建過程的基礎(chǔ),是最困難、最耗費時間的一步。作為“地基”的需求分析是否做得充分與準(zhǔn)確,決定了在其上構(gòu)建“大廈”的速度與質(zhì)量。分析需求主要包括需求收集和需求分析兩個階段,需求收集可采用臨床跟班、專人詢問、設(shè)計調(diào)查表請臨床醫(yī)生填寫等多種方式,以滿足臨床需求和突出中醫(yī)藥診療特色為需求分析的基本原則。為了保障平臺構(gòu)建方案的可行性,采取總體設(shè)計、分步實施的構(gòu)建原則。第一步是構(gòu)建慢性乙型肝炎臨床病證信息采集系統(tǒng),系統(tǒng)試運行穩(wěn)定后,考慮納入大樣本、多中心病例；第二步是中醫(yī)肝病文獻(xiàn)管理系統(tǒng)的構(gòu)建,在收集中醫(yī)藥治療肝病文獻(xiàn)基礎(chǔ)上,分析研究全文檢索的搜索引擎開源框架庫lucene,改進(jìn)lucene結(jié)果相關(guān)性排序算法；第三步是臨床決策支持系統(tǒng)的籌建,以創(chuàng)建慢性乙型肝炎臨床診療數(shù)據(jù)倉庫為主要目標(biāo)。由于中醫(yī)臨床研究的復(fù)雜性,致使其信息系統(tǒng)和信息處理技術(shù)要求高、難度大,故采取先易后難的方法。以前期相關(guān)課題為數(shù)據(jù)源基礎(chǔ),以慢乙肝病人臨床病證數(shù)據(jù)庫的構(gòu)建為突破口,探索中醫(yī)臨床數(shù)據(jù)處理的有效方法,積累經(jīng)驗,最終滿足中醫(yī)臨床研究需求。 結(jié)果：慢性乙型肝炎病證采集系統(tǒng)的建立,為中醫(yī)臨床信息的采集和存貯提供規(guī)范和統(tǒng)一標(biāo)準(zhǔn),有利于這些信息的有效利用,為日后實現(xiàn)大樣本、多中心的臨床研究提供了一個有效的工作平臺,為構(gòu)建海量中醫(yī)臨床病證信息倉庫提供可靠的數(shù)據(jù)來源。中醫(yī)肝病文獻(xiàn)管理系統(tǒng)的建立,通過對海量文獻(xiàn)信息的篩選、過濾和分類,為臨床醫(yī)生獲取有價值的文獻(xiàn)信息提供一個高效、專業(yè)的分類文獻(xiàn)庫,結(jié)合循證醫(yī)學(xué)思想和方法實現(xiàn)對中醫(yī)藥治療慢性肝病臨床療效的系統(tǒng)評價,為中醫(yī)藥療效評價提供高級別的循證醫(yī)學(xué)證據(jù)。 根據(jù)本研究制定的納入標(biāo)準(zhǔn)和排除標(biāo)準(zhǔn),共檢索出符合要求的中醫(yī)藥治療慢性乙型肝炎臨床研究文獻(xiàn)281篇,根據(jù)循證醫(yī)學(xué)評價標(biāo)準(zhǔn),中醫(yī)藥治療性的RCT文獻(xiàn)數(shù)量呈逐年增多趨勢,但總體研究質(zhì)量還有待繼續(xù)提高,應(yīng)重視臨床研究設(shè)計的方法學(xué)研究。本研究認(rèn)為難以為建立中醫(yī)藥療效評價體系提供科學(xué)、有效、真實的證據(jù),缺乏大量可納入循證醫(yī)學(xué)評價的高質(zhì)量臨床研究。本研究全面檢索中醫(yī)藥干預(yù)HBeAg陰性慢性乙型肝炎的臨床觀察文獻(xiàn),對最終符合納入標(biāo)準(zhǔn)的24篇相關(guān)文獻(xiàn)進(jìn)行meta分析,分別比較中西醫(yī)結(jié)合治療組與單純西醫(yī)、單純中醫(yī)治療的療效差異,中西醫(yī)結(jié)合治療對改善肝功能,延緩病情發(fā)展確有一定優(yōu)勢,由于納入文獻(xiàn)數(shù)目偏少,文獻(xiàn)質(zhì)量偏低,有待后續(xù)研究進(jìn)一步證實。 經(jīng)Logistic回歸分析,本研究篩選出慢性乙型肝炎發(fā)生嚴(yán)重臨床結(jié)局的獨立危險因素包括ALP, GGT,年齡,TBIL, HBV-DNA,性別等。經(jīng)Cox回歸分析,年齡、ALB、性別、TBIL、HBV-DNA為慢性乙型肝炎發(fā)生肝硬化、肝癌等嚴(yán)重臨床結(jié)局的獨立影響因素。其中年齡、性別、HBV-DNA、TBIL同時進(jìn)入兩個多因素分析模型,年齡越長,性別為男性,HBV-DNA、TBIL水平升高,發(fā)生肝硬化、肝癌等嚴(yán)重臨床結(jié)局的危險性越高。經(jīng)判別分析,據(jù)判別分析結(jié)果,并結(jié)合臨床應(yīng)用的實用性和可行性,選擇年齡、性別、總膽紅素TBIL、口-谷氨酰轉(zhuǎn)肽酶GGT、HBV-DNA等5個觀察指標(biāo),構(gòu)建分值在0-41分之間的慢性乙型肝炎臨床預(yù)后評估模型。分值越高,發(fā)生嚴(yán)重臨床結(jié)局的危險越高。根據(jù)預(yù)后評估模型研究結(jié)果,年齡在50歲以上,肝功能指標(biāo)GGT55(u/l), TBIL18(umol/l),血清病毒學(xué)標(biāo)志物HBV-DNA病毒載量105(copies/l)的慢性乙型肝炎男性患者為發(fā)生肝硬化＼肝癌等嚴(yán)重臨床結(jié)局的高危人群。 慢性乙型肝炎病證信息庫的建立,通過對病例數(shù)據(jù)分布式網(wǎng)絡(luò)化錄入,實現(xiàn)慢性乙型肝炎病例資料結(jié)構(gòu)化管理,大大提高了臨床研究效率,對于發(fā)現(xiàn)病情進(jìn)展影響因素,準(zhǔn)確認(rèn)識疾病發(fā)生發(fā)展過程也將會起到積極作用,為慢性乙型肝炎病程進(jìn)展規(guī)律的深入研究,為后期臨床監(jiān)測體系的建立提供真實、可靠的數(shù)據(jù)源。該病證信息庫收集了262例輕、中度慢性乙型肝炎患者病證資料,對年齡、性別、總膽紅素TBIL、口-谷氨酰轉(zhuǎn)肽酶GGT、HBV-DNA等5個觀察指標(biāo)重點監(jiān)測,評估其發(fā)生肝硬化、肝癌等嚴(yán)重臨床結(jié)局的危險性高低,構(gòu)建可長期追蹤隨訪的臨床監(jiān)測體系。 結(jié)論：本研究綜合集成了中醫(yī)藥學(xué)、循證醫(yī)學(xué)、數(shù)理統(tǒng)計學(xué)和計算機(jī)技術(shù)與方法,為慢性乙型肝炎中醫(yī)臨床研究工作者開展循證醫(yī)學(xué)實踐提供規(guī)范化、信息化的工作平臺,中醫(yī)藥治療慢性乙型肝炎循證醫(yī)學(xué)工作平臺的建立與應(yīng)用,為循證醫(yī)學(xué)在中醫(yī)臨床研究中的推廣應(yīng)用提供一個示范性工作平臺。
[Abstract]:BACKGROUND: Evidence-based medicine (EBM) is a new clinical methodology developed in clinical medicine practice in the past 20 years. Its research principles and methods have been paid more and more attention and widely used in clinical medicine research. The scheme is more scientific and rigorous, which has a tremendous impact on the development of modern medicine. Traditional Chinese medicine (TCM) is an excellent civilization achievement of the Chinese nation. It has its unique advantages and distinct characteristics in theory and practice. The application of evidence-based medicine (EBM) in the research of TCM is a hot topic in recent years. The principles and formulas of EBM are adopted. It will promote the development of traditional Chinese medicine to guide future clinical research of traditional Chinese medicine, improve research methods and improve the quality of clinical research of traditional Chinese medicine. It is necessary and urgent to construct an evidence-based medicine platform for the prevention and treatment of chronic hepatitis B.
OBJECTIVE: To provide information platform for clinical evidence-based medicine (EBM) of TCM in prevention and treatment of chronic hepatitis B (CHB), clinical decision-making (guiding clinical application of evidence-based medicine) and clinical research (providing new evidence-based medicine).
Methods: Under the guidance of the basic theory of traditional Chinese medicine and the thought of evidence-based medicine, combined with the comprehensive application of mathematical statistics and computer technology, the work platform of evidence-based medicine was constructed through multi-disciplinary integration, and the data of clinical diagnosis and treatment of chronic hepatitis B were collected comprehensively. The standardized collection of clinical diagnosis and treatment information of chronic hepatitis B was realized and the chronic hepatitis B was constructed. Establishing an evidence-based medicine platform for the treatment of chronic hepatitis B, providing evidence-based medicine and research tools for clinical diagnosis and treatment of chronic hepatitis B. Evidence-based medicine was used to evaluate the clinical research on the treatment of chronic hepatitis B. To evaluate the literature quality of clinical observation on chronic hepatitis B treated with traditional Chinese medicine, establish evidence-based medicine platform, retrospectively collect the data of chronic hepatitis B cases, screen the risk factors for the development of chronic hepatitis B into severe clinical outcomes such as cirrhosis and hepatocellular carcinoma, establish the prognostic evaluation index of chronic hepatitis B and establish evidence-based medicine. Learning platform, long-term follow-up of chronic hepatitis B patients'disease information, regular detection and comprehensive evaluation, evaluation of chronic hepatitis B to develop into cirrhosis, liver cancer and other serious clinical outcomes of the size of the risk, the establishment of chronic hepatitis B disease progression monitoring system.
Requirement analysis is the foundation of the whole construction process, the most difficult and time-consuming step. The adequacy and accuracy of requirement analysis as a "foundation" determines the speed and quality of building a "building" on it. Set and demand analysis are two stages. Needs can be collected by clinical attendants, special inquiries, questionnaires designed for clinicians to fill in and other ways to meet clinical needs and highlight the characteristics of traditional Chinese medicine diagnosis and treatment as the basic principles of demand analysis. The first step is to build a chronic hepatitis B clinical syndrome information acquisition system, the system trial run stable, consider into large samples, multi-center cases; the second step is the construction of traditional Chinese medicine liver disease literature management system, based on the collection of traditional Chinese medicine treatment of liver disease literature, research and analysis of full-text search engine open source framework library lucene, change The third step is the preparation of the clinical decision support system to create a clinical diagnosis and treatment data warehouse of chronic hepatitis B as the main goal. The subject is based on the data source, taking the construction of the clinical syndrome database of patients with chronic hepatitis B as a breakthrough point, to explore the effective methods of clinical data processing of traditional Chinese medicine, accumulate experience, and ultimately meet the needs of clinical research of traditional Chinese medicine.
Results: The establishment of the collection system of chronic hepatitis B syndromes provides a standard and unified standard for the collection and storage of clinical information of TCM, which is conducive to the effective utilization of this information, provides an effective working platform for the future large sample and multi-center clinical research, and provides a platform for the construction of a large amount of information warehouse of TCM clinical syndromes. The establishment of a literature management system for liver diseases of traditional Chinese medicine provides an efficient and professional classification literature base for clinicians to obtain valuable literature information by screening, filtering and classifying massive literature information. It provides high-level evidence-based medical evidence for the evaluation of TCM efficacy.
According to the inclusion criteria and exclusion criteria formulated by this study, 281 clinical research literatures on chronic hepatitis B treated by traditional Chinese medicine were retrieved. According to the evaluation criteria of evidence-based medicine, the number of therapeutic RCT literatures of traditional Chinese medicine increased year by year, but the overall research quality still needs to be improved. The clinical research design should be emphasized. Methodological research. This study considers that it is difficult to provide scientific, effective and real evidence for the establishment of a therapeutic evaluation system of traditional Chinese medicine, and lacks a large number of high-quality clinical studies that can be included in the evaluation of evidence-based medicine. The meta-analysis of the relevant literature, respectively, compares the curative effect difference between the treatment group of integrated Chinese and Western medicine and the treatment group of Western medicine alone. The treatment of integrated Chinese and Western medicine has certain advantages in improving liver function and delaying the development of the disease.
Logistic regression analysis showed that the independent risk factors for severe clinical outcomes of chronic hepatitis B were ALP, GGT, age, TBIL, HBV-DNA, sex, etc. Cox regression analysis showed that age, ALB, sex, TBIL, HBV-DNA were independent risk factors for severe clinical outcomes of chronic hepatitis B, such as cirrhosis and liver cancer. Gender, HBV-DNA and TBIL entered two multivariate analysis models at the same time. The older the age, the male, the higher the level of HBV-DNA and TBIL, the higher the risk of severe clinical outcomes such as cirrhosis and liver cancer. The higher the score, the higher the risk of serious clinical outcomes. According to the results of the prognostic evaluation model, the age above 50 years old, liver function indicators GGT55 (u/l), TBIL18 (umol/l), serum virological markers. Male chronic hepatitis B patients with HBV-DNA viral load 105 (copies/l) were at high risk for severe clinical outcomes such as cirrhosis and liver cancer.
The establishment of chronic hepatitis B syndrome information database can realize the structured management of chronic hepatitis B case data through distributed and network input of case data. It can greatly improve the efficiency of clinical research. It will also play a positive role in finding out the influencing factors of disease progress and accurately understanding the process of disease occurrence and development. The data of 262 patients with mild to moderate chronic hepatitis B were collected from the disease information bank. The five indexes, including age, sex, total bilirubin TBIL, oral-glutamyl transpeptidase GGT, HBV-DNA, were monitored to evaluate the occurrence of liver disease. The risk of severe clinical outcomes such as cirrhosis and hepatocellular carcinoma is high or low.
Conclusion: This study integrates the traditional Chinese medicine, evidence-based medicine, mathematical statistics and computer technology and methods to provide a standardized and informationized platform for the clinical research workers of chronic hepatitis B to carry out evidence-based medicine practice. The establishment and application of evidence-based medicine platform of traditional Chinese medicine for the treatment of chronic hepatitis B are also discussed. The application of syndrome medicine in clinical research of traditional Chinese medicine provides an exemplary work platform.
【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2012
【分類號】：R259

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