中药治疗原发性痛经疗效评价指标的思考——基于文献计量学视角

Reflection on the Evaluation Index of Clinical Efficacy of Traditional Chinese Medicine in the Treatment of Primary Dysmenorrhea——From the Perspective of Bibliometrics

目的通过对目前中药治疗原发性痛经随机对照试验疗效评价指标的思考与讨论,为以后的原发性痛经随机对照试验结局指标的选择提供方向。方法计算机检索PubMed、Embase、Cochrane Library、CBM、CNKI、WanFang Data和VIP数据库,对符合纳、排标准的文献进行质量评价,采用定性分析的方法描述纳入研究的一般情况及结局指标情况。结果共纳入218篇文献,其中中文文献214篇,英文文献4篇,将27个疗效评价指标分为8类,分别为:有效率、中医症状/证候、体征评分、理化指标评价、疼痛评估、安全性评价、复发率、心理状态评估、其他指标。采用临床有效率评价中药治疗原发性痛经的疗效评价指标频次最高,其次是中医症状/证候、体征评分疗效评价指标;组合指标多为2个结局指标的组合,有效率+中医症状/证候、体征评分组合出现频数最高为22次。结论中药治疗原发性痛经的RCT疗效评价指标众多,但缺乏统一标准,指标名称不规范,各个指标之间的组合随意性较强,难以全面评价疗效,安全性和卫生经济学指标关注不足,忽视了对患者的生活健康、心理状态的评价,因此亟需构建符合中医疗效特色的核心指标集,探索新的中药疗效评价发展模式。

Objective To provide the direction for the selection of outcome indicators of the randomized controlled trial of primary dysmenorrhea by thinking and discussing the evaluation indexes of the current Chinese medicine treatment of primary dysmenorrhea.Methods We searched RCTs of TCM on the treatment of primary dysmenorrhea in the databases of PubMed,Embase,the Cochrane Library,CBM,CNKI,WanFang Data and VIP,and the quality of documents meeting the standard of the inclusion was evaluated.The whole process was carried out by two professionals independently.After extracting the data,the general situation and outcome index of the research were described by qualitative analysis.Results A total of 218literatures were included,including 214 Chinese literature and 4 English literature.27 efficacy evaluation indexes were divided into 8 categories:effective rate,symptom/syndrome,physical and chemical index evaluation,pain assessment,safety evaluation,recurrence rate,psychological status evaluation and other indicators.The frequency of clinical effective evaluation of primary dysmenorrhea was the highest,followed by the evaluation index of symptoms/syndromes and signs of TCM.The combination index was mostly the combination of two outcome indicators,and the frequency of effective+TCM symptoms/syndromes and signs score was 22 times.Conclusion The evaluation indexes of RCT efficacy of TCM for primary dysmenorrhea are not standardized and lack of unified standards,the names are not unified,the combination of various indicators is strong,and it is difficult to evaluate the efficacy comprehensively.The safety and health economics indicators are not enough.The evaluation of patients'living condition is ignored.Therefore,it is urgent to construct a core index set which conforms to the treatment measures and characteristics of traditional Chinese medicine.