【作者】 刘磊；

【导师】 李运伦；

【作者基本信息】 山东中医药大学 ， 中医内科学， 2011， 硕士

【摘要】 本研究源于山东省科技厅重点课题“清热降压胶囊的研制”(批准号:鲁科技字(2005)103号)和“教育部新世纪优秀人才支持计划”(NCET-07-0522)。目的:系统评价以“肝实肾虚”病机论治高血压病的临床疗效及安全性,为中医药治疗高血压病的临床决策提供相关循证医学证据。资料与方法:采用循证医学系统评价及Meta-分析的方法。制定高敏感检索策略,全面检索国内近20年的中医药治疗高血压病临床对照研究文献,电子检索数据库包括:①中国知网;②维普数据库;③万方数据库;④中国生物医学文献数据库。以上各库交叉检索,以免遗漏。各库尚未收录的文献,手工检索包含中医药的17种期刊。利用Rev Man 4.2软件对多个研究结果的总体效应进行Meta-分析,并进行敏感性分析、亚组分析,用漏斗图分析发表性偏倚。结果:共检索相关文献2523篇,通过检索出的引文信息筛除明显不合格文献2305篇,收集原文献共218篇。因设计方案为非随机对照试验、研究对象不符、试验措施不符、对照用药疗效不确定等原因,筛除不合格文献137篇,最终46项研究纳入本研究,有7项试验得分≧3分属高质量文献,其余属低质量文献。所有纳入研究均在国内进行,都有明确、公认的诊断标准和疗效判断标准。Meta-分析结果显示清热泻火、平肝潜阳及补肾方药治疗高血压病均安全有效,且其Meta-分析结果较稳定,但漏斗图显示可能存在发表性偏倚。结论:通过对中医药治疗高血压病的临床研究文献进行荟萃分析,表明清肝泻火、平肝潜阳及补肾法治疗原发性高血压确有疗效,在症状改善方面优于西药对照组。且不良反应和危险事件发生较少,安全性较高。按照“以法统方、以方测证”的原则分析,认为肝火上炎(肝火亢盛)证、肝阳上亢证、肾气亏虚证(含阴虚\阳虚)证可发生于高血压病,是其主要的病机变化,高血压病“肝实肾虚”的病机学说具有科学性,中医药干预原发性高血压当以“肝实肾虚”为病机分期论治。由于本系统评价纳入研究质量和数量有限,上述结论尚需更多高质量、大样本、长期随访的随机对照试验予以验证。更多还原

【Abstract】 Objective:To evaluate the efficacy and safety of essential hypertension treated in light of the pathogenesis theory of "Liver Excess and Kidney Deficiency". Methods: A high sensitive retrieval strategy was adopted for literatures of clinical controlled trial in essential hypertension treated according to"Liver Excess and Kidney Deficiency"in the 20 years. The electronic retrieval databases included:①Chinese Journal Full-text Database;②Vip Chinese Periodical Database;③Wan fang Digitized Journal Database.④Chinese Biomedical Literature Database. Seventeen TCM journals not included in databases were searched manually. By means of Rev Man 4.2 software, the overall effect of results from multiple studies was analyzed by Meta-analysis. Meanwhile, a sensitivity analysis was also done. A funnel plot was applied to analyze the publication bias. Results: 2523 clinical research literature on essential hypertension treated according to"Liver Excess and Kidney Deficiency"was retrieved . Eliminate 2305 obvious literature, according to cited literature, collect original literatures 218. 137 unqualified literatures were eliminated for not randomized controlled study, object of study is not tallying, the control group is not essential, experiment method is not tallying, and so on. There were 81 studies were included finally. Twelve trials scored greater than or equal 3 were high quality literatures, while the rest of literatures were low-quality. All the researches are completed in China, both the standard of diagnosis and the Treatment are acknowledged and explicit. The statistical analytical results display that treated in light of the pathogenesis theory of "Liver Excess and Kidney Deficiency"were safe and effective, and the results analyzed by Meta-analysis were stable and reliable. The funnel plot point out that there maybe publication bias. Conclusion: By the Meta-analysis of essential hypertension Treated by Traditional Chinese Medicine indicate that treated in light of the pathogenesis theory of "Liver Excess and Kidney Deficiency"were effective, combined with Western medicine can improve clinical symptoms and increase the total effective rate of the patients . Adverse reaction or dangerous event were less happened, the level of safety is reliable. So the mechanism of "Liver Excess and Kidney Deficiency" in essential hypertension was scientific, essential hypertension treated by Traditional Chinese Medicine should according to the pathogenesis theory of "Liver Excess and Kidney Deficiency"by stages. But further confirmation with clinical randomized controlled trials of high quality, large sample and long-term follow-up is needed.更多还原