文献类型：期刊文献

英文题名：Efficacy and safety of Tan Yin Wan in preventing acute exacerbations of COPD: A multicenter, randomized, double-blind, placebo-controlled, phase IV clinical trial

作者：Yan, Shan[1];Liu, Wei[1];Li, Suyun[2];Ma, Zhanping[3];Gao, Ye[4];Gao, Rong[5];Zhang, Chunfeng[6];Ma, Xiaoan[7];Lu, Guangbing[8];Dang, Yuqi[9];Zhao, Zhiying[10];Wang, Guangen[11];Wei, Jun[12];Chang, Xiaohong[13];Liu, Xiaoping[14];Li, Guifang[15];Xia, Xiaoli[16];Zou, Zhi[17];Zhen, Hui[18];Li, Ruitao[19];Ding, Junping[20];Gao, Maohuang[21];Cui, Xiaomin[22];Zhang, Hongchun[23];Wen, Fuqiang[24,25]

第一作者：Yan, Shan

通信作者：Zhang, HC[1];Wen, FQ[2];Wen, FQ[3]

机构：[1]Sichuan Univ, Dept Internal Med, Inst Integrated Tradit Chinese & Western Med, Div Pulm Med,West China Hosp, Chengdu, Peoples R China;[2]Henan Univ Chinese Med, Affiliated Hosp 1, Zhengzhou, Peoples R China;[3]Shaanxi Prov Hosp Chinese Med, Xian, Peoples R China;[4]Mianyang Hosp Tradit Chinese Med, Mianyang, Peoples R China;[5]Neijiang Hosp Tradit Chinese Med, Neijiang, Peoples R China;[6]Baoji High Tech Hosp, Baoji, Peoples R China;[7]Shaanxi Nucl Ind, Hosp 215, Xianyang, Peoples R China;[8]Tradit Chinese Med Hosp Meishan, Meishan, Peoples R China;[9]Yinchuan Hosp Tradit Chinese Med, Yinchuan, Peoples R China;[10]2 Hosp Baoding, Baoding, Peoples R China;[11]Handan Hosp Tradit Chinese Med, Handan, Peoples R China;[12]Wuhan Univ Sci & Technol, Tianyou Hosp, Wuhan, Peoples R China;[13]Yanan Univ, Affiliated Hosp, Yanan, Peoples R China;[14]Second Peoples Hosp Gansu Prov, Lanzhou, Peoples R China;[15]Fengfeng Gen Hosp, North China Med Grp, Handan, Peoples R China;[16]Gansu Univ Chinese Med, Affiliated Hosp, Lanzhou, Peoples R China;[17]Meishan Peoples Hosp, Meishan, Peoples R China;[18]Resp Dis Res Comm China Assoc Tradit Chinese Med, Beijing, Peoples R China;[19]Beijing Yaohai Ningkang Pharmaceut Technol Co LTD, Beijing, Peoples R China;[20]Harbin Kangsaisi Med Technol Dev Co LTD, Harbin, Peoples R China;[21]Xian CP Pharmaceut Co Ltd, Xian, Peoples R China;[22]Shaanxi Acad Tradit Chinese Med, Xian, Peoples R China;[23]China Japan Friendship Hosp, Beijing, Peoples R China;[24]Sichuan Univ, West China Hosp, West China Sch Med, Dept Resp & Crit Care Med, Chengdu, Peoples R China;[25]Sichuan Univ, Div Pulm Dis, State Key Lab Biotherapy, Chengdu, Peoples R China

第一机构：Sichuan Univ, Dept Internal Med, Inst Integrated Tradit Chinese & Western Med, Div Pulm Med,West China Hosp, Chengdu, Peoples R China

通信机构：[1]corresponding author), China Japan Friendship Hosp, Beijing, Peoples R China;[2]corresponding author), Sichuan Univ, West China Hosp, West China Sch Med, Dept Resp & Crit Care Med, Chengdu, Peoples R China;[3]corresponding author), Sichuan Univ, Div Pulm Dis, State Key Lab Biotherapy, Chengdu, Peoples R China.

年份：2025

卷号：149

外文期刊名：PHYTOMEDICINE

收录：;WOS:【SCI-EXPANDED(收录号:WOS:001633472700001)】；

基金：This work was supported by Xi'an C.P. Pharmaceutical Co., Ltd., China and the 1.3.5 project for disciplines of excellence, West China Hospital, Sichuan University (ZYGD23009). The Xi'an C.P. Pharmaceutical Co., Ltd., China provided financial support and supplied the investigational product (Tan Yin Wan) and matched placebo. Both funders had no role in the study design, data collection, data analysis, data interpretation, manuscript writing, or the decision to submit the article for publication. All scientific activities, including trial conduct, statistical analysis, and conclusion drafting, were independently performed by the researchers or the third-party independent statistical organization.

语种：英文

外文关键词：Chronic obstructive pulmonary disease; Tan Yin Wan; Exacerbation; Treating winter disease in summer; Treating disease before onset

摘要：Background: Recurrent acute exacerbations of chronic obstructive pulmonary disease (AECOPD) impose disease deterioration and economic burden. Tan Yin Wan (TYW), a traditional Chinese medicine (TCM) formulation, has shown promise in COPD management, but robust clinical evidence is lacking. Objective: We aimed to evaluate the efficacy and safety of TYW in delaying AECOPD onset, with subgroup analyses exploring the TCM principle of "Treating Winter Disease in Summer" (Dongbing Xiazhi, ), which advocates reinforcing physiological resilience in low-risk seasons to mitigate exacerbation and severity of disease in high-risk seasons. Methods: In this multicenter, randomized, double-blind, placebo-controlled, phase IV clinical trial, participants with moderate-to-severe COPD and high exacerbation risk received TYW or an identical placebo, in addition to standard therapy for 52 weeks. The primary outcome was time to the first AECOPD. Secondary outcomes included the severity of the first AECOPD, annualized exacerbation rate, proportion of AECOPD cases, symptom scales (Breathlessness, Cough, and Sputum Scale (BCSS), COPD Assessment Test (CAT), and modified Medical Research Council Dyspnea Scale (mMRC)), 6-Minute Walk Distance (6MWD), pulmonary function and safety. Results: A total of 342 patients were recruited from 18 centers between July 13, 2021, and June 5, 2023, with 308 patients in the full analysis set (FAS) and 297 in the per-protocol set (PPS). TYW significantly prolonged the time to the first AECOPD vs. placebo after adjustment for baseline confounding (adjusted HR = 0.55, 95% CI = 0.35 - 0.87, p = 0.01), and the restricted mean survival time difference (Delta RMST) was 30.45 days (95% CI = 4.68 - 56.23, p = 0.02). Improvements were demonstrated in BCSS, CAT, mMRC, and 6MWD at multiple timepoints (all p < 0.05), though lung function showed no significant differences. Exploratory subgroup analysis indicated a numerical trend toward a prolonged time to first exacerbation by 40.29 days in summer-enrolled participants (June - August) compared to non-summer-enrolled participants. This observation is tentatively consistent with the TCM principle of "Treating Winter Disease in Summer" as a proactive preventive strategy, though formal statistical significance was not achieved. Safety profiles were comparable between groups. Conclusions: TYW adjunct therapy might delay AECOPD onset and improve symptom burden, representing a preventive intervention that embodies TCM's "Treating Disease Before Onset" (Zhi Wei Bing, ) philosophy, potentially through "Treating Winter Disease in Summer", as a proactive seasonal strategy in long-term COPD management.