藏药相关临床随机对照试验的文献评价
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篇名: 藏药相关临床随机对照试验的文献评价
TITLE:
摘要: 目的:为提高藏药临床研究水平提供参考。方法:计算机检索PubMed、Embase、Cochrane图书馆、中国生物医学文献数据库、中国知网、维普数据库和万方数据库等,收集藏药相关的临床随机对照试验(RCT),对符合纳入标准的研究提取资料并进行分析和质量评价,综合评估藏药临床研究现状。结果:共纳入研究235篇,合计受试者29 177例。从文献数量指标来看,1989-2016年,平均每年发表藏药相关RCT文献(8.39±8.12)篇;按国际疾病分类系统-10(ICD-10)分类,研究疾病主要集中在消化系统、肌肉/骨骼系统和结缔组织、循环系统等18个系统,主要单病种包括消化道溃疡、萎缩性胃炎、类风湿性关节炎等33种;药物主要涉及独一味胶囊、奇正消痛贴、坐珠达西、仁青芒觉、珍珠七十等;其中未报告不良反应的文献共163篇,占69.36%;藏药相关文献发表单位省份覆盖广而散。从文献质量指标来看,发表期刊为美国科学引文索引收录期刊的有4篇、为《中文核心要目总览》收录期刊的有20篇、为中国科技论文统计源核心期刊的有97篇、为非核心期刊的有114篇;经Cochrane协作网偏倚风险评价工具5.1.0评价文献质量,表明研究整体质量较差。参考文献数量少(中位数为3)、参与研究人数少(中位数为1)、研究项目基金支持率低(基金文献17篇,占7.23%)、省间合作研究少(22篇,占9.36%),研究方法学整体有待进一步改进。结论:藏药临床研究目前存在数量较少、已有研究质量较低、结局指标设置不科学、对不良反应关心不足等问题,今后应加强对藏药研究人才的培养,以加快藏药研究和发展。
ABSTRACT: OBJECTIVE: To provide reference for improving clinical study of Tibetan medicine. METHODS: Retrieved from PubMed, Embase, Cochrane Library, CBM, CNKI, VIP and Wanfang database, randomized controlled trials (RCTs) about Tibetan medicine were collected. After data extraction and quality evaluation of included standard, clinical study of Tibetan medicine was evaluated comprehensively. RESULTS: A total of 235 literatures were included, involving 29 177 subjects. From aspect of literature number, the average annual publication of RCT literature related to Tibetan medicine was 8.39±8.12 during 1989-2016. According to International Classification of Disease-10 (ICD-10), the research diseases focuses on 18 systems including digestive system, muscle/skeletal system and connective tissue, and circulatory diseases,etc. The main single diseases include 33 kinds ,including peptic ulcer, atrophic ulcer and rheumatoid arthritis,etc. Involved drugs were mainly Duyiwei capsules, Qizheng xiaotong plaster, Zuozhu daxi, RPCJ, Zhenzhu qishi, etc.; the unreported ADR literature was 163, accounted for 69.36%, and the units which published Tibetan medicine-related literatures were widespread and scattered in provinces. From aspect of quality index, 4 literatures were published by journals included in SCI; 20 literatures were published by journals included in Guide to the Core Journals of China; 97 literatures were published by core journals of Chinese scientific and technological papers statistics source; 114 literatures were published by non-core journals. Literature quality of Cochrane collaboration network bias risk evaluation tool 5.1.0  showed that quality of studies was poor. There were small number of references (median number of 3), less participants (median number of 1), low support rate of the research project fund (17 fund literatures, 7.23%), small number of provincial cooperation studies (22 literatures, 9.36%). The methodology of the overall study needed to be further improved. CONCLUSIONS: There are many problems in clinical study of Tibetan medicine, such as a small quantity, low quality of existing study, unscientific setting of outcome indicators, insufficient attention to ADR. In the future, it is necessary to strengthen the training of Tibetan medicine research talents, so as to speed up the research and development of Tibetan medicine.
期刊: 2018年第29卷第16期
作者: 泽碧,索朗央宗,索朗,白玛央宗,达瓦平措
AUTHORS: ZE Bi,Suolangyangzong,SUO Lang,Baimayangzong,Dawapingcuo
关键字: 藏药;随机对照试验;文献评价
KEYWORDS: Tibetan medicine; Randomized control trial; Literature evaluation
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