基于CONSORT和Jadad中医药治疗慢性阻塞性肺疾病随机对照试验质量评价  

Evaluation of RCT Quality Based on CONSORT and Jadad in the Treatment of Chronic Obstructive Pulmonary Disease

作　　者：杨惠璐 臧凝子[2] 吕晓东[1,2] 庞立健[2] 王世文 李德众 YANG Huilu;ZANG Ningzi;LYU Xiaodong;PANG Lijian;WANG Shiwen;LI Dezhong(Liaoning University of Traditional Chinese Medicine,Shenyang 110847,China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032)

机构地区：[1]辽宁中医药大学,沈阳110847 [2]辽宁中医药大学附属医院,沈阳110032

出　　处：《世界科学技术-中医药现代化》2024年第12期3187-3197,共11页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：辽宁省科技计划联合计划(应用基础研究项目)项目(2023021095-JH2/1017):中药复方清络饮下调TLR9/NF-κB/IL-6通路干扰中性粒细胞胞外陷阱抑制EMT干预AE-IPF疗效机制研究,负责人:臧凝子;中国博士后科学基金项目(2022MD723797):基于HIF-1α/BNIP3L信号补肺健脾通络法抑制线粒体自噬改善COPD合并骨骼肌功能障碍机制研究,负责人:臧凝子;中医藏象理论及应用教育部重点实验室开放基金(zyzx2210):参苓补肺通络汤下调HIF-1α信号抑制线粒体自噬改善COPD合并骨骼肌功能障碍机制研究,负责人:臧凝子。

摘　　要：目的基于CONSORT声明及扩展版和Jadad量表评价中医治疗慢性阻塞性肺疾病随机对照试验的报告质量。了解中医药治疗COPD RCT的现状,为今后研究提供借鉴。方法检索2012年1月-2022年12月PubMed、Embase、Cochrane对照试验注册数据库、Web of Science、CNKI、Wanfang Data、VIP、SinoMed等数据库文献。并采用CONSORT 2010声明及扩展版和Jadad量表对纳入的RCT文献质量进行评价。结果共纳入文献291篇(中文279、英文12)。在CONSORT声明的评价中,中英文报告率<50%的条目分别占全部条目的73.47%、34.69%。中英文报告率<10%的条目分别有25个和9个。中英文文献在试验注册、结局指标等17个条目报告率差异超过50%。基于CONSORT-CHM Formulas评价中药复方,中英文在复方的中医证型、复方干预措施细节等方面报告率低(<10%)。基于STRICTA清单评价针刺,中英文在治疗场所、用针数目等5个方面报告率低(<10%)。基于CONSORT扩展版评价灸法报告率普遍良好。据SPSS 25.0统计,基于CONSORT和Jadad评价其两者评分存在中度相关性(pearson0.419,P<0.01)。结论中医药治疗COPD RCT的报告质量还需要进一步的提高,在文题、关键词、结局指标、盲法、试验注册等方面问题较为显著。在后续研究中应多学科人才共同参与,严格按照CONSORT声明和Jadad量表规范RCT研究报告。本研究为提升RCT质量提供一定参考。Objective To evaluate the reporting quality of randomized controlled trials of TCM treatment of chronic obstructive pulmonary disease based on CONSORT statement and extended version and Jadad scale.To understand the current situation of TCM treatment of COPD RCT and provide reference for future research.Methods Pub Med,Embase,Cochrane Controlled Trial Registry,Web of Science,China Journal Full Text Database(CNKI),Wanfang Data,VIP Chinese Journal Service Platform and Sino Med were searched.The retrieval time was from January 2012 to December 2022.CONSORT 2010 statement and extended version and Jadad scale were used to evaluate the quality of the included RCTS.Results A total of 291 literatures(279 Chinese,12 English)were included.In the evaluation of CONSORT declaration,73.47%and 34.69%of all items with reporting rate less than 50%in both English and Chinese respectively.In both English and Chinese,there were 25 and 9 items with reporting rates less than 10%,respectively.The difference in reporting rates of 17 items such as trial registration and outcome index was more than 50%.Evaluating TCM Formulas based on consor-Chm formulas,the reported rates of Chinese and English formulas were poor(<10%)in terms of TCM syndrome type and details of compound intervention measures.In evaluating acupuncture based on the STRICTA list,both Chinese and English reported low rates(<10%)in five aspects,including treatment site and number of needles used.The report rate of moxibustion method based on CONSORT extended version is generally good.According to SPSS25.0,there is a moderate correlation between CONSORT and Jadad(pearson0.419,P<0.01).Conclusion The report quality of TCM treatment of COPD RCTS needs to be further improved,and there are significant problems in text topic,key words,outcome index,blind method,trial registration and other aspects.In the follow-up research,multi-disciplinary talents should be involved and RCT research reports should be regulated strictly in accordance with CONSORT declaration and Jadad scale.This s

关 键 词：慢性阻塞性肺疾病 随机对照试验 报告质量评价 中医 CONSORT声明 Jadad量表 

分 类 号：R-058[医药卫生]