中成药治疗肺纤维化的临床研究证据图分析  

Evidence map analysis of clinical research on treatment of pulmonary fibrosis with proprietary Chinese medicines

作　　者：寇梦佳 焦扬[2] 牛洁[2] KOU Meng-jia;JIAO Yang;NIU Jie(the Second Clinical Medical College,Bejing University of Chinese Medicine,Beijing 100029,China;Dongfang Hospital,Beijing University of Chinese Medicine,Bejing 100078,China)

机构地区：[1]北京中医药大学第二临床医学院,北京100029 [2]北京中医药大学东方医院,北京100078

出　　处：《中国中药杂志》2025年第5期1392-1403,共12页China Journal of Chinese Materia Medica

基　　金：北京市自然科学基金项目(7202118)。

摘　　要：该研究旨在通过构建证据图,对近30年中成药治疗肺纤维化的临床研究进行综合分析,系统评估现有证据的有效性及局限性,以期为后续临床实践、科研方向、政策制定提供科学依据。系统检索了7个中、英文数据库,检索时间从建库至2024年6月1日,对纳入文献的临床研究特征及方法学质量进行评价。最终纳入123篇文献,其中干预性研究108篇,观察性研究3篇,二次研究10篇,专家共识2篇。涉及33种中成药,其中丹红注射液使用最广泛,多数研究周期在1~3个月,样本量50~100例,常与激素或西医常规联合治疗,中成药使用普遍存在超说明书现象。主要结局指标包括肺功能、血气分析、总有效率等,存在安全性报告不足、中医特色不明显、缺乏长期结局指标以及评价主观性过强等问题。方法学质量评价方面,随机对照试验(RCT)存在随机化及结局指标测量的偏倚,并有选择性报告的风险。Meta分析则在方案注册、文献排除清单列举、利益冲突披露等方面报告不足。专家共识在制订的严谨性、科学性和应用性方面缺乏规范。目前,中成药治疗肺纤维化的临床研究证据质量亟待提高,建议未来的研究应注重研究设计的科学性与严谨性,以提高研究的标准化与可重复性。同时,应结合中医药理论,建立适合中成药治疗肺纤维化的结局指标评价体系,充分发掘中成药治疗肺纤维化的潜力。This study aimed to construct an evidence map and conduct a comprehensive analysis of clinical research literature on the treatment of pulmonary fibrosis with proprietary Chinese medicines published over the past three decades,so as to systematically evaluate the effectiveness and limitations of existing evidence and provide a scientific basis for subsequent clinical practice,research directions,and policy-making.A systematic search was conducted across 7 databases in both Chinese and English from the inception of the databases to June 1,2024.The clinical research characteristics and methodological quality of the included literature were assessed.A total of 123 pieces of literature were ultimately included,comprising 108 interventional studies,3 observational studies,10 secondary study,and 2 expert consensuses.These studies involved 33 kinds of proprietary Chinese medicines,with Danhong Injection being the most widely used.Most studies had a duration of 1-3 months and a sample size ranging from 50 to 100 cases,and they were often used in combination with steroids or conventional western medicine.There was a common phenomenon of off-label use of proprietary Chinese medicines.The main outcome indicators included pulmonary function,blood gas analysis,and total effective rate,with issues such as insufficient safety reporting,lack of distinctive traditional Chinese medicine(TCM)features,absence of long-term outcome indicators,and strong subjective evaluation.In terms of methodological quality assessment,randomized controlled trial(RCT)had biases in randomization and outcome indicator measurement and a risk of selective reporting.Meta-analysis lacked reporting on protocol registration,literature exclusion lists,and disclosure of conflicts of interest.Expert consensuses lacked standards in terms of rigor,scientific basis,and applicability.The quality of clinical research evidence on the treatment of pulmonary fibrosis with proprietary Chinese medicines urgently needs improvement.It is recommended that future research sh

关 键 词：中成药 肺纤维化 临床研究特征 方法学质量评价 证据图 

分 类 号：R259[医药卫生—中西医结合]