Xu Li-Li, Zang Dan-Yang, Yang Shu-Guang, Yu Ning-Xia, Yu Xue-Qing
National Regional Traditional Chinese Medicine (Lung Disease) Diagnosis and Treatment Center,the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China the First Clinical Medical School, Henan University of Chinese Medicine Zhengzhou 450000, China.
Zhongguo Zhong Yao Za Zhi. 2024 Dec;49(24):6803-6812. doi: 10.19540/j.cnki.cjcmm.20240821.501.
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.
本研究系统检索了中医药治疗特发性肺纤维化（IPF）的临床研究，并采用证据图谱法总结中医药治疗IPF的整体研究现状及不足。通过检索中国知网、维普、中国生物医学文献数据库、万方、PubMed、Web of Science、Cochrane图书馆和EMbase，获取从建库至2024年2月20日发表的相关研究。通过图表结合文字的方式分析并呈现证据的分布特征。共纳入323项研究，其中包括295项随机对照试验（RCT）和28项Meta分析。该领域的发文数量呈波动上升趋势，但核心论文比例较低，且缺乏国外研究者的关注。研究者之间跨地区合作较少，相关部门重视不足。纳入的RCT质量普遍较低，样本量小、疗程短，对IPF急性加重和并发症关注不够。此外，单独使用中医药的研究较少，中医证候仍有待规范。发表的文献涉及的结局指标较多，但多数未强调主要结局指标与次要结局指标的差异。结局指标中综合指标的参考标准多样，对长期预后和卫生经济指标关注不足。纳入的Meta分析得出中医药治疗IPF具有潜在临床疗效的结论。然而，结局指标的方法学可信度分级和GRADE分级结果较低。结果表明，中医药在治疗IPF方面显示出一定优势，但纳入研究的质量不高。未来应规范临床研究方案并进行注册。开展多中心、大样本、随访的临床研究。研究报告应参照相关报告标准，提高质量并产出高级别证据，为中医药治疗IPF的临床应用提供参考。
