系统检索中医药治疗特发性肺纤维化(IPF)的临床研究，运用证据图梳理，总结中医药治疗IPF的研究现状与不足。检索中国知网(CNKI)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、万方(Wanfang)、PubMed、Web of Science、Cochrane Library、EMbase数据库中医药治疗IPF的相关文献，检索时间为建库至2024年2月20日。采用图、表与文字描述相结合的方式呈现证据分布。最终纳入323篇文献，包括295篇随机对照试验(RCTs)、28篇Meta分析。该领域发文量呈波动性上升趋势，纳入文献核心论文占比较低，缺少国外研究者的关注，研究者间跨地区合作较少，相关部门重视不足。纳入RCT质量不高，样本量偏小，治疗疗程不足，对IPF急性加重期及合并症的关注不足，单纯中医药干预较少，中医证型缺乏标准化，结局指标繁多，未重视主要、次要结局指标的区分，复合指标参考标准不一，远期预后、卫生经济学指标关注不足。纳入Meta分析显示，中医药治疗IPF有潜在的临床疗效，但方法学可信度分级均为极低级，结局指标的GRADE分级也较低。结果表明，中医药治疗IPF有一定优势，但纳入文献质量不高。未来应进一步规范临床研究方案并进行注册，开展多中心、大样本、足疗程的临床研究，文献报告应参照相关报告规范，以提高文献质量，形成高级别循证证据，为中医药治疗IPF的临床应用提供参考。
Evidence mapping of clinical research on traditional Chinese medicine in treatment of idiopathic pulmonary fibrosis
This study systematically retrieved the clinical studies in the treatment of idiopathic pulmonary fibrosis (IPF) with traditional Chinese medicine (TCM) and employed evidence mapping to summarize the overall research status and deficiencies of TCM in treating IPF.CNKI,VIP,SinoMed,Wanfang,PubMed,Web of Science,Cochrane Library,and EMbase were searched for the relevant studies published from inception to February 20,2024.The distribution characteristics of the evidence were analyzed and presented through charts combined with words.A total of 323 studies were included,including 295 randomized controlled trials (RCTs) and 28 Meta-analysis.The number of publications in this field rose with fluctuations,yet the proportion of core papers was low,and the research lacked the attention of foreign researchers.There were scant cross-regional collaboration between researchers and insufficient attention from relevant departments.The included RCT generally had low quality,with small sample sizes,short treatment courses,and insufficient attention to acute exacerbation and complications of IPF.In addition,few studies employed TCM alone,and the TCM syndromes remained to be standardized.A considerable number of outcome indicators were involved in the publications,while the majority of them failed to emphasize the disparity between primary and secondary outcome indicators.There were diverse reference standards for the comprehensive indicators among the outcome indicators,and insufficient attention was paid to long-term prognosis and health economic indicators.The included Meta-analysis concluded that TCM had potential clinical efficacy in treating IPF.However,the methodological credibility grading and the GRADE grading results of outcome indicators were low.The results suggested that TCM demonstrated certain advantages in the treatment of IPF,while the quality of the included studies was not high.In the future,clinical research protocols should be standardized and registered.Multicenter,large-sample,and follow-up clinical studies should be conducted.The research reports should refer to relevant reporting standards to improve the quality and generate high-level evidence,thus providing a reference for the clinical application of TCM in the treatment of IPF.
idiopathic pulmonary fibrosistraditional Chinese medicineevidence mapmethodology
NETL
NSTL
万方数据
