中药治疗药物监测研究的系统评价

Therapeutic drug monitoring for traditional Chinese medicine:a systematic review

目的系统评价中药治疗药物监测(TDM)的研究现状。方法计算机检索PubMed、EMbase、The Cochrane Library、CNKI、WanFang Data、CBM和VIP数据库及治疗药物监测相关协会网站,搜集中药TDM相关研究,检索时限均从建库至2022年1月。由2名研究者独立筛选文献、提取资料后,对中药TDM研究现状进行定性系统评价。结果共纳入13个研究。研究对象均来自中国,且均为小样本研究。研究人群以健康志愿者为主(85%),其次为冠心病血瘀证患者(31%)、类风湿性关节炎患者(8%)和艾滋病患者(8%)。药物干预类型包括中成药(69%)和中药饮片(31%)。研究主题均为TDM的理论研究,以浓度检测方法研究最多(77%),其次分别是血药浓度影响因素研究(15%)、标本选择研究(15%)、监测对象选择研究(8%)、浓度参考范围研究(8%)。尚无中药TDM临床实践研究。结论我国中药TDM研究尚处于探索阶段,目前发表的研究以TDM理论研究为主,尚无中药TDM临床实践相关研究。

Objective To systematically review the research status of therapeutic drug monitoring(TDM)for traditional Chinese medicine.Methods PubMed,EMbase,The Cochrane Library,CNKI,WanFang Data,CBM,VIP databases,official websites of governments and societies associated with TDM were electronically searched to collect studies on TDM for traditional Chinese medicine from inception to January,2022.Two reviewers independently screened literature and extracted data.Then,a qualitative systematic review was conducted.Results A total of 13 studies were included,all of which came from China and were small sample size studies.The studied population consisted mainly of healthy volunteers(85%),followed by patients of coronary artery disease with blood stasis pattern(31%),patients of rheumatoid arthritis(8%),and patients of acquired immune deficiency syndrome(8%).There were two types of medicine,including proprietary Chinese medicine(69%)and Chinese herbal pieces(31%).The research topics were all theoretical research of TDM,mainly concentration detection methods(77%),followed by influence factors of blood drug concentration(15%),the selection of specimen(15%),the selection of monitoring object(8%)and the concentration reference range(8%).There was no clinical practice study on TDM of traditional Chinese medicine.Conclusion TDM of traditional Chinese medicine is still in the exploratory stage in China.Published studies are mainly on the theoretical research of TDM,and no relevant studies is on clinical practice of TDM of traditional Chinese medicine.