中药治疗失眠随机对照试验的文献计量学分析

Metrological Analysis of Traditional Chinese Medicine in Treating Insomnia Randomized Controlled Trial

目的:从文献计量学的角度出发,分析中药治疗失眠随机对照试验的研究特征和规律,为进一步开展中医药治疗失眠的相关研究提供借鉴。方法:在中国生物医学文献数据库、中国知识资源总库、中文科技期刊数据库、万方数据资源系统、Pubmed数据资源系统等医学文献数据库中,根据检索词,按照纳入和排除标准筛选中药治疗失眠随机对照试验的临床研究文献,通过资料提取、数据录入,对相关信息进行描述性分析。结果:纳入文献总数485篇,文献数量自1995年来呈现总体增长趋势;河南、广东、北京等地为开展中药治疗失眠研究的热点地区;69.90%的文献发表于非核心期刊;46.39%的文献为单一作者独立完成;30.93%的研究未说明受试对象的中医证型;观察组应用剂型以汤药为主,研究较多的中药组方为归脾汤、酸枣仁汤、黄连温胆汤等;对照组干预措施以艾司唑仑片和无药物对照为主。结论:基于随机对照试验的中药治疗失眠研究逐年增多,为提供更多高质量的中医疗效证据,需要从提高研究设计的严谨性,规范对照组用药,完善多中心评价,提高论文发表水平等方面加以完善,助力中医发展。

Objective:From the perspective of Metrological Analysis,this paper analyzes the research characteristics and laws of traditional Chinese medicine in treating insomnia,and provides reference for the further research.Methods:In the medical literature databases such as CBM、CNKI、VIP、Wanfang、Pubmed,etc.According to the inclusion and exclusion criteria,the literature of TCM treatment of insomnia was selected,and the related information was analyzed by data extraction and data entry.Results:Including the total number of 485,the number of documents is growing since 1995.Henan、Guangdong、Beijing and other places for the development of traditional Chinese medicine treatment of Insomnia Research are the Hot Spots;69.9%of the articles were published in non-core journals;46.39%of the articles were written by a single author;30.93%of the studies did not indicate the type of TCM Syndrome of the subjects.In the experimental group,decoction was the main dosage form,Guipi decoction,Suanzaoren decoction and Huanglian Wendan decoction were the most studied.The intervention measures of the control group were mainly estazolam tablets or no medication.Conclusion:There are more and more studies on the treatment of insomnia with Chinese herbal medicine based on Randomized controlled trial.In order to provide more high quality evidence of TCM efficacy,it is necessary to improve the rigor of the research design,standardize the medication of the control group,and perfect the multi-center evaluation,improve the publication level of papers and other aspects to develop of traditional Chinese medicine.