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补肺活血胶囊治疗“长新冠”患者疗效的亚组再分析

A Subgroup Reanalysis of the Efficacy of Bufei Huoxue Capsules in Patients With "Long-Covid-19".

作者信息

Hou Chi, Xing Yue, Chen Yuqin, Wang Tingping, Qi Jingjing, Jia Xiaoqing, Zeng Xiansheng, Bai Jianling, Lu Wenju, Deng Yu, Zhong Bihua, Lei Yongxia, Chen Yilin, Lian Zhan, Zhou Haohao, Yan Junping, Yang Xuejiao, Yu Hao, Zhou Jiawei, Qiu Lixia, Zhai Yunliang, Geng Wanli, Zhong Nanshan, Liu Chunli, Wang Jian

机构信息

State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health The First Affiliated Hospital of Guangzhou Medical University Guangzhou China.

Department of Organ Transplantation, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Southern Medical University Guangzhou China.

出版信息

Pulm Circ. 2025 Apr 27;15(2):e70084. doi: 10.1002/pul2.70084. eCollection 2025 Apr.

Abstract

Bufei huoxue capsules (BFHX), manufactured products of traditional Chinese medicine, have demonstrated anti-inflammatory properties and efficacy against chronic pulmonary diseases and COVID-19. This study was designed to further determine the clinical efficacy of BFHX in diverse patient subgroups during the convalescent phase of COVID-19, extending upon previously reported findings from a multicenter randomized controlled trial. Patients who had clinically recovered from COVID-19 were blindly assigned to BFHX or placebo groups. All enrolled patients underwent chest computed tomography (CT) imaging, 6-min walking distance (6MWD) test, and fatigue assessment inventory (FAI) at monthly follow-up for 3 months. A post hoc subgroup reanalysis was performed on subgroups of sex, age, severity of acute illness, and positive/negative IgG antibody against S antigen variants. A total of 129 patients were enrolled in BFHX ( = 64) and placebo groups ( = 65). The 6MWD and FAI scores were more significantly improved in females and mild patients than in males and severe patients after BFHX treatment. Lung CT image evaluated by the change in whole lung volume and mean CT value showed that the patients below 60 years gained more therapeutic effects after 3 months of BFHX treatment ( = 0.0008;  = 0.017;  = 0.0313, respectively). The subgroup reanalysis implies that the therapeutic effectiveness of BFHX in managing COVID-19 convalescence could potentially be influenced by factors including gender, age, and disease severity. This study was registered with the China Clinical Trial Registration Center (registration number: ChiCTR2000032573).

摘要

补肺活血胶囊(BFHX)是中药制成品,已显示出抗炎特性以及对慢性肺部疾病和新冠肺炎的疗效。本研究旨在进一步确定BFHX在新冠肺炎康复期不同患者亚组中的临床疗效,这是基于之前一项多中心随机对照试验报告的结果进行的拓展研究。从新冠肺炎临床康复的患者被随机分配至BFHX组或安慰剂组。所有入组患者在3个月的每月随访中均接受胸部计算机断层扫描(CT)成像、6分钟步行距离(6MWD)测试和疲劳评估量表(FAI)评估。对性别、年龄、急性疾病严重程度以及针对S抗原变体的IgG抗体阳性/阴性亚组进行事后亚组再分析。BFHX组(n = 64)和安慰剂组(n = 65)共纳入129例患者。BFHX治疗后,女性和轻症患者的6MWD和FAI评分改善比男性和重症患者更显著。通过全肺体积变化和平均CT值评估的肺部CT图像显示,60岁以下患者在接受BFHX治疗3个月后获得了更多治疗效果(分别为P = 0.0008;P = 0.017;P = 0.0313)。亚组再分析表明,BFHX在管理新冠肺炎康复方面的治疗效果可能会受到性别、年龄和疾病严重程度等因素的影响。本研究已在中国临床试验注册中心注册(注册号:ChiCTR2000032573)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8e0/12034259/28c32c084526/PUL2-15-e70084-g003.jpg

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