【作者】 张铁峰；

【导师】 孟令军；

【作者基本信息】 山东中医药大学 ， 中医基础理论， 2008， 硕士

【摘要】 目的:运用循证医学系统评价的方法对近年来采用清热祛湿法治疗慢性乙型肝炎的临床试验文献进行定性和定量分析,为临床治疗提供最佳证据,并初步确定治疗该病的优势方药。方法:按照检索策略检索文献,进行质量评价,从中国生物医学文献光盘数据库检索出题录,在清华同方中文科技期刊全文数据库中检索全文,未检索到的文章从重庆维普咨询有限公司中文科技期刊全文数据库中检索全文,通过电子检索还未查到的文献再通过手工检索全文。文献入选标准为清热祛湿中药治疗慢性乙型肝炎的随机对照或半随机对照临床试验。评价方法采用循证医学评价方法。评价内容主要包括对所有纳入研究的资料进行一般情况定量和定性分析,对符合定量分析的资料进行Meta分析。结果:共检索到清热祛湿方药及清热祛湿方药联合其他用药治疗慢性乙型肝炎的文献题录1431条,其中236篇文献采用了随机对照试验的设计方案进行研究,全部文献发表在135种杂志上。最后纳入文献74篇,其中按照入选顺序以数目随机分组文献2篇(25-1),(25-2);以门诊病历单双序号随机分组的文献1篇(25-2);随机单盲分组文献1篇(1-4);按照入院顺序分组的文献1篇(1-59);按照随机数字表法分组的文献2篇(24-3)(26-1)。没有1篇研究报告了随机隐匿。有18篇文献报告随访,1篇研究中报告了病例脱落,没有1篇研究报告使用了意向性治疗分析。总体评价结果显示,清热祛湿法治疗慢性乙型肝炎的随机对照临床试验资料所采用的方法学质量较低,大部分研究缺乏诊疗标准或诊疗标准不统一,很少采用盲法,不良反应观察较少提及,缺少长期临床效果和生活质量的数据,数据处理的可信度差,设计方案仍不够完善和严谨。结论:目前在清热祛湿中药治疗慢性乙型肝炎的临床研究中,随机对照试验设计研究方案数量逐年增长,研究质量逐渐提高,但总体质量较低,临床科研试验设计水平有待提高。苦参碱治疗慢性乙型肝炎无论在总有效率方面还是在抗病毒效应方面,均明显优于对照组;苦参素是治疗慢性乙型肝炎的有效方药;苦参素对照干扰素治疗慢性乙型肝炎既无统计学意义又无临床意义,但其疗效接近干扰素。单方药报道中药组,研究文献缺乏,尚需临床深入研究。更多还原

【Abstract】 Objectives: Carry on qualitative and the quantitative analysis on randomized controlled trials (RCT) of clearing away heat and expelling dampness to therapies for chronic hepatitis B since 1994 to 2008 with Evidence-based medicine method,providing the best proof for the clinical reatment,and lay foundation for carrying on further study.Method:(1) With the searching terms,pick out the titlerecords of Traditional Chinese Medical (TCM) therapyies for chronichepatitis B which including the words "random".(2) Randomised or quasi randomised clinical trials of TCM therapies for chronic hepatitis B were selected for this study. (3) The evidence-based medicine’s method will be abided by for the study. The evaluation of methodological quality of clinical trials will be carried on according to the request of Cochrane manual , including allotment method of randomization,concealment of allocation sequence,blind method,withdraw or lose to visit case number and reason,intention-to-treatanalysis and so on.Main results: 501 articles were found from881pieces of title recordsconcerning this kind of literature,40.1% of which took the design of randomized trial control,and last got 236 full texts. randomized clinical trials (RCTs) and pseudo-randomized clinical trials involving 1616 chronic hepatitis B patients were identified that tested.Traditional Chinese medical therapeutic effect. The appraisal content mainly includes carrying on the circumstan-ces and the qualitative analysis on selected ordinary clinicaltrials. Carry on Meta analysis on selected randomized controlled trials(RCT) about the treatment of CHB with matrine,oxymatrine, and other Chinese herbs.Conclusion:At present,the quantity of RCT on Traditional Chinese Medicine(TCM) therapies for chronic hepatitis B has raised sharply year by year,and the quality of the studies has enhanced increasingly,however its methodological quality was poor in total. The overall trial design level of clinical studies in this aspect need enhance urgently due to the demands of clinical practice. Both the total efficient rate and theanti-virus effect of the matrine are better than the contrast obviously.Oxymatrine are effective drug for CHB.The other Chinese medicine need be ananlyized again after getting large numner of articals.更多还原