中医药治疗非酒精性脂肪性肝病的临床研究证据图

Evidence map of clinical research on the treatment of non-alcoholic fatty liver Disease with traditional Chinese medicine

目的:采用证据图的方法,对近10年中医药治疗非酒精性脂肪性肝病的临床随机对照试验(RCTs)和系统评价/Meta分析进行系统检索和梳理,展现该领域的证据分布情况。方法:计算机检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、CBM、Wanfang和VIP数据库,检索时限从2012年11月至2022年11月,纳入符合纳排标准的中医药治疗非酒精性脂肪性肝病的RCTs和系统评价/Meta分析,采用图表与文字结合的形式对证据分布特点进行分析。结果:共纳入RCTs文献636篇,系统评价/Meta分析文献27篇。RCTs文献发文量趋势总体较为平稳,研究疾病以非酒精性脂肪性肝病和非酒精性脂肪性肝炎为主。多数RCTs研究的样本量集中于60~100例。干预措施类别包括中药复方口服、中成药口服,针灸、穴位埋线、穴位贴敷、中药离子导入、推拿等中医外治法和保肝药、降脂药、降糖药等常规西医治疗方案。采用较多的疗效评价指标包括临床疗效、肝功能指标、血脂指标、中医证候积分、超声指标和CT指标。绝大多数RCTs文献未描述随机化的分配隐藏方案和未采用盲法。系统评价/Meta分析文献研究结果均为治疗存在潜在疗效,研究可信度分级均为极低。结论:中医药治疗NAFLD疗效肯定,但存在RCTs设计不合理、偏倚风险较高、样本量较小、缺少中医药主导的干预方案体系、疗效评价指标选择不统一和系统评价质量较低的不足。今后应重视RCT和系统评价的方法学质量和报告质量,探索中医药主导的干预体系,形成统一的中医疗效评价标准,开展大规模、多中心的RCT研究,为中医药治疗NAFLD领域提供更高质量的证据。

Objective:To systematically search and sort out clinical randomized controlled trials(RCTs)and systematic evaluations/meta-analyses of traditional Chinese medicine(TCM)in the treatment of non-alcoholic fatty liver disease(NAFLD)in the past 10 years using the method of evidence map,and display the distribution of evidence in this field.Methods:PubMed,Embase,Web of Science,Cochrane Library,CNKI,CBM、Wanfang and VIP were searched by computer,with a search time frame of November 2012 to November 2022.RCTs and systematic review/Meta analysis in the treatment of non-alcoholic fatty liver disease with TCM which met the inclusion criteria were included.The distribution characteristics of evidence were analyzed using a combination of charts and text.Results:A total of 636 RCTs and 27 systematic review/meta analysis articles were included.The overall trend in the number of RCTs published is relatively stable,with the main diseases studied being non-alcoholic fatty liver disease and non-alcoholic steatohepatitis.The sample size of most of the RCTs studies focuses on 60 to 100 cases.The types of intervention measures include oral TCM compound,traditional Chinese patent medicines,acupuncture point threadsacupuncture,acupressure point application,TCM iontophoresis,massage and other external treatments of TCM,and conventional western medicine treatment schemes such as liver protection drugs,lipid-lowering drugs,and hypoglycemic drugs.More commonly used efficacy evaluation indicators include clinical efficacy,liver function indicators,blood lipid indicators,TCM syndrome scores,ultrasound indicators,and CT indicators.The vast majority of RCTs literature does not describe randomized allocation concealment schemes and does not use blind methods.Systematic evaluation/Meta analysis of articles shows the TCM treatment has potential efficacy,but the research reliability rating is extremely low.Conclusion:The efficacy of TCM in the treatment of NAFLD is positive,but there are shortcomings such as unreasonable design of RCTs,high risk of bias,small sample size,lack of intervention plan system led by TCM,inconsistent selection of efficacy evaluation indicators and low quality of systematic evaluation.In the future,attention should be paid to the methodological quality and reporting quality of RCTs and systematic review.Intervention system led by TCM should be explored and unified TCM efficacy evaluation standard should be formed.More large-scale,multicenter RCTs research should be carried out to provide higher quality evidence for the treatment of NAFLD by TCM.