摘要
目的：采用循证医学的方法,对梅核气的中医药临床研究现状、存在的问题和研究结果进行全面的分析,并对研究的水平进行系统评价,为优化梅核气的中医药研究方法提供参考和建议.方法：采用“万方医学数据库”和“维普中文科技期刊全文数据库”,检索1989年～2012年5月间公开发表在国内各种医学期刊上的中医药治疗梅核气的所有文献,从中筛选出所有包含有样本含量和具体治疗方法的相关文献,然后采用临床流行病学、DME方法学进行系统评价,评价内容包括研究对象的选择、随机和盲法的运用、组间均衡性比较、样本含量、统计学方法、疗效评价指标、退出和失访病例的分析、不良反应和副作用的观察等.结果：符合纳入标准的研究文献共计291篇,其中有明确纳入和排除标准的文献为3篇,有76篇文献描述了随机分组方法;采用盲法试验的只有2篇;共有47篇文献进行了组间均衡性比较;统计学方法多采用t检验、卡方检验;临床疗效指标以病人的主观感受、功能状态、生存质量及实验室指标为主;有22篇文献提到了对不良反应的观察,但只有6篇文献对不良反应进行了描述,其余16篇未发现不良反应;有63篇文献对随访情况和退出情况进行了简单的描述.结论：中医药对梅核气的研究近年来虽取得了很大的进步,但研究的水平普遍较低,且未见大样本多中心的临床研究,对研究结果的真实性与可靠性产生一定的影响.
Objective: To analyze the clinical research present situation, existing problems and the research results of globus hystericus in the methods of evidence-based medicine, and research on the level of system evaluation in order to provide reference for the study on the optimization method of globus ofTCM. Methods: Based on "Wanfang medicine database" and "VIP Chinese science and technology periodical full text database", to retrieve all the literature from 1989 to May, 2012 published in domestic medical journals of TCM treatment of Globus, selected from all contain correlative literature sample content and specific methods of treatment, and then in the system evaluation method of DME in clinical epidemiology. The evaluation content includes the selection of research object, random and blind method utilization, the balance between groups comparison, content of the sample, the statistical method, curative effect evaluation index, dropout and loss to follow-up were analyzed, adverse reactions and side effects observation. Results:There are 291 papers including 3 papers explicating inclusion and exclusion criteria document, 76 articles stating random grouping method;2 papers in blind test;a total of 47 articles compared between groups with t equilibrium,card square test;clinical indicators to the patient subjective feelings, functional status, quality of life and the main laboratory indicators;22 articles mentioned observation of adverse reactions, but only 6 articles mentioning the adverse reaction, other 16 papers not found adverse reactions;63 articles simply introduce follow-up and exiting conditions. Conclusion:Traditional Chinese Medicine treatment for globus hystericus in recent years has made great progress, but the research is still on the low level, and no large multicenter study in current clinical researches, which has a certain impact on the authenticity and reliability of the research results.
出处
《中医临床研究》
2014年第30期44-47,共4页
Clinical Journal Of Chinese Medicine
关键词
梅核气
中医药治疗
随机对照试验
系统评价
Globus hystericus
TCM treatment
Randomized controlled trial
System evaluation
