中医药治疗多寐临床文献系统综述

Review of Somnolency Clinical Literature of Traditional Chinese Medicine Treatment System

[背景]中医药治疗多寐疗效确切。[目的]分析中医药治疗多寐临床研究文献质量。[检索策略]主题词与自由词结合检索CNKI、VIP、Wanfang Data、CBMdisc、The Cochrane Library等数据库,检索时间:建库至2013年9月。手工检索教材、著作、学位论文、会议文献、专利文献、报纸、科技报告、政府出版物、标准文献、产品资料和其他尚未发表的文献等。同时追溯纳入文献参考文献。[纳入标准]中文RCT及半随机对照试验(quasi-RCT)文献。以"不分昼夜,时时欲睡,呼之能醒,醒后复睡"为主要临床特征的多寐患者,国籍、种族、年龄不限。[数据收集与分析]2位研究者根据纳入标准,独立筛选文献、提取资料和评价纳入研究的偏倚风险,并交叉核对,如遇分歧,咨询第三方协助判定。采用资料提取表,提取内容:1纳入研究一般情况:作者、试验组和对照组病例数、干预措施内容、出版时间等。2研究对象基本特征。3偏倚风险评价关键要素。4干预措施的具体细节。[主要结果]数据库获得相关文献537篇,手工本检索11篇,初检文献共548篇,阅读文献题目和摘要初筛,排除428篇,剩余120篇进一步阅读全文。Jadad评分0分文献120篇,无3分以上文献;Delphi分级Ⅲ级文献1篇,Ⅳ级文献25篇,Ⅴ级文献94篇。[问题与展望]缺少多中心,大样本随机对照临床试验研究。

[Background] Chinese medicine treating narcolepsy is curative effect. [Objective] To analyse the quality of clinical literature of traditional Chinese medicine for narcolepsy. [Retrieval tactics] Subject combined with a free word searching CNKI, VIP, WanFang Data such as database. Retrieval time： build library until September 2015. Manually Retrieved the textbooks, books, academic papers, conference papers, patent documents, newspapers, science and technology reports, government publications, standards, product information and other unpublished literature, etc. At the same time, back into the literature references. [Into standard] randomized controlled trials （RCT） or quasi-randomized controlled trials （CCTS） in the literature of traditional Chinese medicine. The patients with the main clinical features as sleeping regardless of day and night, always sleepy, can wake up by called ,can sleep back fast after wake up. Nationality, race, age were not limited. [Data collection and analysis] According to the inclusion criteria, 2 investigators independently screened the literature, extracted data and evaluated the risk of bias in the study, and cross checked, in case of disagreement, the third parties to assist in the decision. Used data extraction table, content：（1）the general information of study： the author, the cases of experiment and control group, the content of intervention measures, the publishing time, etc. （2）the basic characteristics of research objects.（3）the key elements of evaluation in Risk of bias. （4）the details of intervention measures. [Main results] 537 related literature were accessed by database, 11 by manually retrieved, 548 were early detected in totally, 428 literature were excluded after reading the title and summary of the preliminary screening, the 120 remaining literature were deeply read them full text. In Jadad score, 120 literature got 0 point, none of them got more than 3 points; In Delphi classification, one of the was class Ⅲ, 25 of them was classⅣ, 94 of them was class Ⅴ. [Problems and Prospects] Clinical research literature of Chinese medicine treating narcolepsy show that related research can provide certain basis but still lack of muhicenter, large sample randomized controlled clinical trials research, hence clinical research direction in the future.