天津中医药2026，Vol.43Issue(5)：586-594,9.DOI:10.11656/j.issn.1672-1519.2026.05.07
中医药治疗肺动脉高压随机对照试验结局指标的选择及评价
Selection and evaluation of outcome measures in randomized controlled trials of traditional Chinese medicine for the treatment of pulmonary hypertension
摘要
Abstract
[Objective]To evaluate the selection and reporting of outcome measures used in randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)for pulmonary hypertension(PH).[Methods]Seven databases(China National Knowledge Infrastructure,Wanfang Data,VIP Database,SinoMed,PubMed,Cochrane Library,and Web of Science)were systematically searched from inception to December 31,2024.RCTs investigating TCM interventions for PH were included.Two reviewers independently screened studies and extracted data.The risk of bias and the characteristics of outcome measures were analyzed and evaluated.[Results]A total of 107 RCTs involving 9 454 participants were included.Overall,730 reporting instances of outcome measures were extracted and categorized into five domains:endpoint events(3 times,0.41%),symptoms/signs(clinical symptom efficacy 90 times,TCM symptoms/syndromes 69 times,total 21.78%),exercise capacity and quality of life(exercise capacity 50 times,quality of life 26 times,total 10.41%),laboratory/instrumental assessments(440 times,60.28%),and safety outcomes(52 times,7.12%).Only one trial explicitly distinguished primary and secondary outcomes.The three most frequently reported outcomes were clinical symptom effective rate,echocardiography-estimated pulmonary artery systolic pressure,and TCM syndrome score.Most trials assessed outcomes at 4 weeks after treatment initiation.The evaluation of TCM symptoms/syndromes was mainly based on the Guiding Principles for Clinical Research of New Chinese Herbal Medicine(Trial Implementation).[Conclusion]In recent years,the number of RCTs on TCM for PH has increased;however,the selection and application of outcome measures remain heterogeneous and insufficiently standardized.Developing a core outcome set(COS)that reflects the characteristics and advantages of TCM is warranted to improve the quality and standardization of future clinical research.关键词
肺动脉高压/中医药/随机对照试验/结局指标Key words
pulmonary hypertension/traditional Chinese medicine/randomized controlled trial/outcome measures分类
医药卫生引用本文复制引用
李明伟,王帅,王琳,周宙,周梦雪,王贤良,毛静远..中医药治疗肺动脉高压随机对照试验结局指标的选择及评价[J].天津中医药,2026,43(5):586-594,9.基金项目
国家中医药传承创新团队项目(ZYYCXTD-C-202203) （ZYYCXTD-C-202203）
天津市南开区中医药传承创新发展示范试点项目(20240204012) （20240204012）
天津中医药大学第一附属医院创新团队培育计划项目. （）
