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基于牛津证据等级评价中药治疗脑卒中的证据质量研究

发布时间:2018-05-05 10:19

  本文选题:牛津证据等级 + 脑卒中 ; 参考:《新疆医科大学》2017年硕士论文


【摘要】:目的:应用2001牛津循证医学中心临床证据分级评价2011-2015年中医类双核心期刊杂志文章中药治疗脑卒中的证据等级分布情况,并应用循证医学核心内容简化成的PICOFSn七大要素主要对纳入研究文献的结局、随访进行评价,对临床应用中药治疗脑卒中临床研究证据进行详细评价,以期为临床治疗脑卒中循证用药指南的制定提供依据。方法:选择2014年最新北大图书馆中国中文核心期刊目录和最新2015-2016年CSCD目录共有的双核心中医类期刊共计19种为目标期刊,以电子检索和手工检索的形式检索,包括中国知网数据库、相关期刊论文、中国生物医学文献数据库网络版、重庆维普中文科技期刊数据库、万方数据库和中国中医药期刊文献数据库在内的国内各大中文数据库,交叉检索以防漏检或误检。全部数据库检索时间从2011年1月1日至2015年12月31日。由2位研究员依照纳入与排除标准筛选文献,提取资料和采用PICOFSn七要素(患者、干预措施、对照组、结局指标、随访时间、研究类型、样本例数)进行论文分解,并按2001牛津循证医学中心临床证据水平分级进行证据分级。结果:按照纳入及排除标准,共纳入33篇文献,其中随机对照试验文献占36.4%,半随机对照试验占48.6%,系统综述/Meta分析占6%,同期非随机对照试验研究占3%,回顾性分析占6%;其中8篇文献报告了主要结局指标,占24.2%;所有纳入33篇文献均报告了次要结局指标,报告率为100.0%;纳入文献中9篇文章对安全性指标进行了报告,报告率为27.3%;所纳入文献中只有1篇文章做了随访,其余32篇文章均未提及随访内容;研究所纳入的目前中药治疗脑卒中临床研究证据主要集中在Ⅱb类、Ⅲb类,分别占36.4%和51.6%,而证据等级级别最高的Ⅰ类证据仅占9%,包括Ⅰa类6%,Ⅰb类3%,此外还包括少量Ⅳ类证据,占3%。结论:研究发现纳入文献所报告的主要结局指标报告率偏低。研究纳入文献中只有1篇文章做了随访。基于2001牛津证据等级分级分析可以发现目前中药治疗脑卒中临床研究证据等级级别仍然有待于进一步提高。活血化瘀仍然是治疗脑卒中不可忽视的方法。
[Abstract]:Objective: to evaluate the distribution of evidence levels in the treatment of stroke with traditional Chinese medicine (TCM) in 2001 Oxford Center for Evidence-Based Medicine (Oxford Center for Evidence-Based Medicine) from 2011 to 2015. The seven elements of PICOFSn, which were simplified as the core content of evidence-based medicine, were mainly used to evaluate the outcome of the study and follow-up, and to evaluate the clinical evidence of clinical treatment of stroke with traditional Chinese medicine in detail. In order to provide evidence-based medication guidelines for the clinical treatment of stroke. Methods: a total of 19 double-core TCM periodicals were selected from the Chinese core journals catalogue of the latest Peking University Library in 2014 and the latest CSCD catalogue from 2015 to 2016, which were retrieved by electronic and manual retrieval. Including the China knowledge Network Database, the full text Database of Chinese Journals, the online Edition of China Biomedical Literature Database, the Chongqing Weipu Chinese Science and Technology Journal Database, The Chinese databases of Wanfang database and Chinese traditional Chinese medicine periodical literature database are cross-searched to prevent missed or false detection. All databases are retrieved from January 1, 2011 to December 31, 2015. Two researchers sifted the literature according to the inclusion and exclusion criteria, extracted the data and used the seven elements of PICOFSn (patient, intervention, control group, outcome index, follow-up time, type of study, sample number) to decompose the paper. The evidence was classified according to the level of clinical evidence of Oxford Evidence-based Medical Center (Oxford) 2001. Results: according to the criteria of inclusion and exclusion, 33 articles were included. Among them, the literature on randomized controlled trials accounted for 36.4%, semi-randomized controlled trials accounted for 48.6%, systematic review / meta-analysis accounted for 6%, non-randomized controlled trials accounted for 3%, retrospective analysis accounted for 6%, eight of them reported the main outcome indicators. 24.2%; all 33 articles included reported secondary outcome indicators with a reporting rate of 100.0; 9 articles included reported safety indicators with a reporting rate of 27.3x; only 1 article was followed up. The other 32 articles did not mention the contents of follow-up, and the clinical evidence of traditional Chinese medicine for stroke was mainly in category 鈪,

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