中医证候积分在疗效评价中的应用:基于240项随机对照试验的比较研究

Application of Chinese Medical Syndrome Scores in Effectiveness Evaluation:a Critical Appraisal of 240 Randomized Controlled Trials

目的研究中医证候积分在临床研究疗效评价中的应用现状。方法检索《中医杂志》、《中国中西医结合杂志》、Chinese Journal of Integrative Medicine(CJIM)、Evidence-Based Complementary and Alternative Medicine(ECAM)American Journal of Chinese Medicine(AJCM)5种期刊,纳入其在2013年全年发表的所有中医随机对照试验(randomized controlled trials,RCTs)。提取各文献中报告的中医证候积分及其相关信息。采用描述性统计和x^2检验方法,描述纳入研究的一般特征、各期刊RCTs中中医证候积分的报告比例、制定依据、采用的评价规则及重要程度;比较证候积分在不同病种、有无中医辨证、研究实施地、不同期刊之间的应用率差异。结果共纳入240项RCTs(中文178篇,英文62篇)。27.1%(65/240)的RCTs采用证候积分评价疗效,其中以《中国中西医结合杂志》应用率最高[35.3%(18/51)],AJCM最低(0%,0/7)。各RCTs报告的证候积分制定依据共17种,《中药新药临床研究指导原则》是最常用的依据。46项RCTs报告了具体的证候积分评分标准,6项RCTs将其作为主要或次要结局指标。研究数量排前10位病种的中医证候积分应用率最低为精神和行为障碍9.5%(2/21),最高为内分泌、营养和代谢疾病39.1%(9/23)。与无中医辨证比较,有中医辨证的RCTs应用证候积分的比例较高(P<0.01)。中文核心期刊、国内SCI收录期刊、国外SCI期刊中RCTs的证候积分应用率分别是32.0%、28.6%、4.9%,差异有统计学意义(x^2=12.4593,P<0.01)。国内学者在国内、国外期刊发表的RCTs中采用证候积分的比例分别为32.0%和7.1%,差异有统计学意义(x^2=7.3615,P<0.01)。国外学者发表的RCTs无一采用证候积分。结论中医证候积分用于疗效评价,目前还缺乏统一、通用的评价标准,在国内中医临床研究中的应用尚不普遍,在国外学术界的认可程度不高。

Objective To explore the role of traditional Chinese medicine（TCM） syndrome scores in effectiveness evaluation of clinical studies.Methods Randomized controlled trials（RCTs） of TCM published in five journals in 2013 were retrieved,including Journal of Traditional Chinese Medicine（JTCM）,Chinese Journal of Integrated Traditional and Western Medicine（CJITWM）,Chinese Journal of Integrative Medicine（CJIM）,Evidence-Based Complementary and Alternative Medicine（ECAM）,and A merican Journal of Chinese Medicine（AJCM）.The details of TCM syndrome scores and other relevant factors reported in articles were extracted and analyzed.Descriptive statistics and Chi-square test were used to describe general features of inclusive studies,ratios of reports on CM syndrome scores in each journal,formulated evidence,adopted evaluation rules,important degrees.The difference in the application rate of CM syndrome scores were compared in various diseases,diseases with or without CM syndrome typing,places where clinical studies were implemented,and different journals.Results A total of 240 RCTs were included,involving 178 published in Chinese version and 62 in English version.CM syndrome scores were used for effectiveness evaluation in 27.1%（65/240） of RCTs,of which,the highest application percentage was 35.3%（18/51） in RCTs published in CJITWM,and the lowest was 0（0/7） in RCTs published in AJCM.There were 17 methods for grading TCM syndrome scores,of which Guideline for Clinical Research of New Chinese Herbal Medicine was most commonly used.Detailed grading standards for CM syndrome scores were reported in 46 RCTs,and CM syndrome scores were taken as primary or secondary outcomes in 6RCTs.When describing the percentages of RCTs adopting TCM syndrome score by diseases classification,the lowest was 9.5%（2/21） in mental and behavioral disorders,and the highest was 39.1%（9/23） in endocrine,nutritional,and metabolic diseases.RCTs with TCM syndrome differentiation had a higher percentage of adopting TCM syndrome score than those without TCM syndrome differentiation（P〈0.01）.Statistical differences were also found among RCTs published in Chinese core journals（32.0%）,domestic science citation index（SCI） journals（28.6%）,and overseas SCI journals（4.9%）（x2=12.4593,P〈0.01）.For RCTs conducted by Chinese scholars,the percentage of using TCM syndrome score was 32.0%in three journals from China,while 7.1%in two foreign language journals,showing significant difference（x2=7.3615,P〈0.01）;none of RCTs conducted by foreign scholars used TCM syndrome scores for effectiveness assessment.Conclusions There was a lack of agreeable and universal standards for TCM syndrome scores using in effectiveness evaluation.Therefore,it was not commonly used in domestic CM clinical studies.It was not so favorably agreed in overseas academic circles.