Abstract: Background Traditional Chinese medicine (TCM) is widely applied in the clinical treatment of chronic obstructive pulmonary disease (COPD) and has shown notable therapeutic effects. However, the lack of standardized outcome measures in relevant clinical trials has limited the full demonstration of TCM efficacy and restricted its further development. Objective To establish a standardized evaluation indicator system for assessing the clinical efficacy of TCM in treating COPD and to highlight its characteristics and advantages. Methods A set of candidate evaluation indicators was developed through a literature review (January 1 2020 to April 20 2023) and patient questionnaires. A total of 37 experts in respiratory TCM, integrated Chinese and Western clinical practice, nursing, and evidence-based methodology participated in three rounds of Delphi surveys to determine the indicators. The analytic hierarchy process was used to calculate indicator weights.Results The response rates for the three rounds of expert consultation were 100.0%, 97.2%, and 94.3%, respectively. In the third round, Kendall's W coefficients for the stable stage and acute exacerbation stage were 0.550 and 0.475, respectively (both P<0.001), indicating good expert agreement. The final evaluation indicator system consisted of 6 primary and 21 secondary indicators for the stable stage, and6 primary and 28 secondary indicators for the acute exacerbation stage. For the stable stage, the weights of the primary indicators were: TCM syndrome differentiation (0.065), symptoms and signs (0.113), laboratory and imaging examination (0.113), quality of life (0.113), long-term prognosis (0.554), and safety (0.042). For the acute exacerbation stage, the weights were: TCM syndrome differentiation (0.044), symptoms and signs (0.301), laboratory and imaging examination (0.124), quality of life (0.085), long-term prognosis (0.315), and safety (0.131). Conclusion A comprehensive evaluation indicator system for assessing the clinical efficacy of TCM in COPD was established. The system highlights TCM's advantage in both prevention and treatment, with long-term prognosis receiving the highest weight. It may provide a reference for the standardization of efficacy evaluation in TCM treatment of COPD.

Key words: Pulmonary disease, chronic obstructive, Traditional Chinese medicine therapy, Delphi method, Analytic hierarchy process, Efficacy evaluation, Evaluation indicator system

摘要： 背景 中医药在慢性阻塞性肺疾病(以下简称慢阻肺)临床治疗中广泛运用，疗效显著，但相关临床试验的结局指标尚未得到统一和规范，中医药的疗效未充分展现，在一定程度上限制了中医药的学科发展。目的 为充分展现中医药临床疗效，构建中医药治疗慢阻肺临床疗效评价指标体系，规范中医药疗效指标，彰显中医药特色与优势。方法 通过文献检索时间为2020-01-01—2023-04-20及患者问卷构建条目池，遴选全国呼吸方向中医、中西医临床，护理，循证方法学专家37名，进行3轮德尔菲专家咨询构建中医药治疗慢阻肺临床疗效评价指标体系，运用层次分析法计算各指标权重。结果 三轮专家咨询积极系数分别为和100.0%、97.2%、94.3%；第三轮稳定期、急性加重期肯德尔协调系数（Kendall's W 系数）分别为0.550和0.475（P<0.001）；最终构建出稳定期包括6个一级指标，21个二级指标；急性加重期6个一级指标，28个二级指标的中医药治疗慢阻肺临床疗效评价指标体系。其中稳定期一级指标权重：中医病证（0.065）、症状体征（0.113）、理化检查（0.113）、生活质量（0.113）、远期预后（0.554）、安全性（0.042）。急性加重期一级指标权重：中医病证（0.044）、症状体征（0.301）、理化检查（0.124）、生活质量（0.085）、远期预后（0.315）、安全性（0.131）。结论 构建了一套综合性的中医药临床疗效评价指标体系，同时突出了中医药辨治优势在于防治，疗效长远，远期预后权重最高，可为中医药治疗慢阻肺临床疗效评价指标规范化提供参考。

关键词: 肺疾病, 慢性阻塞性；中医药疗法；德尔菲法；层次分析法；疗效评价；指标体系