国内中药煎剂行口腔护理随机对照试验的质量评价

Evaluation on quality of randomized controlled trials on domestic traditional Chinese medicine decoction for oral care

[目的]评价国内中药煎剂行口腔护理随机对照试验的报告质量,了解该领域临床试验的研究结果,为临床护理决策提供科学证据。[方法]计算机检索中国学术期刊网全文数据库、万方数据资源系统、维普中文科技期刊系统及中国生物医学文献数据库公开发表的应用中药煎剂进行口腔护理的临床随机对照试验,时间限制为建库至2015年6月,语言为中文。采用2007年中医药临床随机对照试验报告规范(CONSORT FOR TCM)、补充指标及改良Jadad评分量表进行质量评价。[结果]初步获得2 094篇文献,经筛选得到39篇符合标准的文献;39篇文献均未介绍样本量依据,15篇(38.5%)介绍纳入及排除标准;10篇(25.6%)提到随机分组的方法,但均未描述分配隐藏及实施;3篇(7.7%)提及盲法,但未描述实施方法;全部研究均为阳性结果,但均未介绍效应量和精确度;6篇(15.4%)介绍了不良反应;3篇(7.7%)考虑伦理原则,3篇(7.7%)进行中医辨证;39篇文献改良Jadad评分量表得分≤2分。[结论]国内中药行口腔护理随机对照试验的研究结果尚不能为临床护理提供可靠证据,报告质量有待提高。

Objective：To evaluate the quality of reports on randomized controlled trials domestic traditional Chinese medicine decoction for oral care,and to understand study results of clinical trials in this field,and to provide scientific evidences for clinical nursing decision.Methods：Published clinical randomized controlled trials on traditional Chinese medicine decoction for oral care in China academic journal full text database,Wanfang Data Resource System,VIP Chinese science and technology periodical system and Chinese biomedical literature database were searched by computer.Time limit was up to June 2015,Language was Chinese.Quality evaluation was conducted by adopting Chinese medicine clinical randomized controlled trials reporting standard（CONSORT FOR TCM）in 2007,supplementary indicators and modified Jadad Rating Scale.Results：A total of 2 094 papers were preliminary selected,and 39 articles met the criteria were selected;sample size basis were not introduced in 39 literatures,inclusion and exclusion criteria were introduced in 15literatures（38.5%）;method of random grouping was referred in 10literatures（25.6%）,but did not describe the distribution of hidden and implementation;blind method was referred in 3papers（7.7%）,but did not describe the implementation method;all studies were positive,but no effect quantity and precision were introduced;the adverse reactions were introdeuced in 6papers（15.4%）;ethical principles were considered in 3papers（7.7%）,and 3papers（7.7%）were in TCM syndrome differentiation;score of 39 articles in modified Jadad scale≤2.Conclusion：Results of randomized controlled trials of oral care in Chinese traditional medicine could not provide reliable evidence for clinical nursing,and quality of the report needs to be improved.