中医药干预非酒精性脂肪性肝病随机对照临床研究结局指标的现状分析

Situation Analysis of the clinical outcomes of randomized controlled trials of traditional Chinese medicine intervention in non-alcoholic fatty liver disease

目的:总结并评价中医药干预非酒精性脂肪性肝病(NAFLD)随机对照临床试验(RCTs)中的结局指标使用现状,为该领域临床研究的结局指标选择提供参考。方法:系统检索英文数据库Medline、EMbase、Cochrane Library,中文数据库中国知网(CNKI)、维普(VIP)和万方(Wanfang),时间为2018年1月1日至2022年12月31日发表的中医药治疗NAFLD的RCTs相关文献,采用定性分析方法,描述纳入研究的结局指标情况。结果:初步检索出相关文献2537篇,最终纳入78篇。78项临床研究的结局指标主要分为6类、15种,包括临床疗效评价类指标、肝脏无创检查指标、生化相关指标、人体测量学及生活质量相关指标、安全性指标和其他类。结论:中医药治疗NAFLD的RCTs结局指标的选择存在较多问题,针对复杂疾病的多维度评价应该借鉴国际核心指标集的创建方法,构建符合中医药治疗措施、疗效特色的核心结局指标集。

Objective:To synthesize and appraise the prevailing employment of outcome measures within randomized controlled trials(RCTs)concerning traditional Chinese medicine(TCM)interventions targeting non-alcoholic fatty liver disease(NAFLD),and to furnish guidance pertinent to the selection of such outcome measures for future clinical investigations.Methods:RCTs about TCM on the treatment of NAFLD in the common databases were screened from Medline,EMbase,Cochrane Library,CNKI,VIP and Wanfang databases.A qualitative analysis described all the outcomes in the included studies.Results:A total of 2537 related literature were preliminarily screened,and 78 trials were finally included.A total of 78 RCTs and their outcomes were categorized into 6 categories and 15 kinds,including effect evaluation,non-invasive liver examination,biochemical parameters,anthropometric and life quality-related parameters,safety outcome,and other outcomes.Conclusion:There exist numerous challenges in the selection of outcome indicators for RCTs focusing on TCM treatment of NAFLD.To comprehensively assess the multidimensional nature of complex illnesses,it is imperative to draw insights from the methodology employed in creating internationally recognized sets of core outcome indicators.Therefore,it is recommended to develop a core outcome indicator set that aligns with the treatment modalities and efficacy characteristics specific to TCM.