中成药防治高脂血症的临床证据图

Evidence mapping of clinical research on prevention and treatment of hyperlipidemiawith Chinese patent medicines

目的采用证据图的方法系统检索并梳理中成药防治高脂血症的临床研究,了解该领域证据分布概况。方法计算机检索CNKI、WanFang Data、VIP、SinoMed、PubMed、Cochrane Library、Embase和Web of Science数据库,搜集中成药治疗高脂血症的相关研究,检索时限均从建库至2022年12月。采用文字结合图表的方式分析并呈现证据分布特征。结果共纳入865篇试验性研究。对纳入文献进行分析,共获得79种中成药,以血脂康片、胶囊的使用频次最高。中成药防治高脂血症的发文量从2012年后开始呈下降趋势,文献质量普遍较低;研究干预方案多为仅使用中成药,单个研究样本量多集中在60~100例,研究疗程分布在4~8周最多。临床研究未突显中医特色,仅12.7%的研究限制了研究人群的中医证型;在结局指标选择方面,对血脂水平、安全性指标关注较多,而对中医证候积分等指标关注较少。结论中成药防治高脂血症有一定的优势,但方法学和临床特征的报告存在一定不足,整体研究质量偏低。

Objective To use the evidence map system to search and sort out the clinical research on the prevention and treatment of hyperlipidemia with proprietary Chinese medicine,and to understand the distribution of evidence in this field.Methods The literature on the treatment of hyperlipidemia with proprietary Chinese medicines was retrieved from CNKI,WanFang Data,VIP,SinoMed,PubMed,Cochrane Library,Embase and Web of Science databases from inception to December 2022.The distribution characteristics of evidence were analyzed and presented by means of text and graph.Results A total of 865 articles were included and 79 kinds of proprietary Chinese medicines were obtained.The Xuezhikang tablets or capsules were the most frequently used.In recent years,the number of published articles showed a downward trend,and the literature quality was generally low.Most of the research intervention programs only used Chinese patent medicine,and the sample size of a single study was mostly 60-100 patients,and the study course was 4-8 weeks.Clinical studies did not highlight the characteristics of traditional Chinese medicine,and only 12.7%of the studies limited the syndrome type of traditional Chinese medicine in the study population.In terms of the selection of outcome indicators,more attention was paid to blood lipid levels and safety indicators,while less attention was paid to indicators such as traditional Chinese medicine syndrome scores.Conclusion The results show that Chinese patent medicine has certain advantages in the prevention and treatment of hyperlipidemia,but there are some deficiencies in the reports of methodology and clinical characteristics,and the overall quality of theresearch is low.