Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial
BackgroundEffective therapies for pulmonary fibrosis caused by coronavirus disease (COVID-19) and other etiologies are lacking. Our previous studies demonstrated that Fuzheng Huayu tablet (FZHY), a traditional Chinese medicine known for its anti-liver fibrotic properties, can improve lung function i...
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Frontiers Media S.A.
2025-03-01
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| author | Fei Jing Fei Jing Wei Wang Jia Ke Tingrong Huang Bo Jiang Qiwu Qiu Jihan Huang Songhua Zhan Wei Zhang Hui Wu Wen Su Jiawen Feng Yuan Peng Zhimin Zhao Feng Xing Chenghai Liu Chenghai Liu Chenghai Liu |
| author_facet | Fei Jing Fei Jing Wei Wang Jia Ke Tingrong Huang Bo Jiang Qiwu Qiu Jihan Huang Songhua Zhan Wei Zhang Hui Wu Wen Su Jiawen Feng Yuan Peng Zhimin Zhao Feng Xing Chenghai Liu Chenghai Liu Chenghai Liu |
| author_sort | Fei Jing |
| collection | DOAJ |
| description | BackgroundEffective therapies for pulmonary fibrosis caused by coronavirus disease (COVID-19) and other etiologies are lacking. Our previous studies demonstrated that Fuzheng Huayu tablet (FZHY), a traditional Chinese medicine known for its anti-liver fibrotic properties, can improve lung function in patients with chronic obstructive pulmonary disease and attenuate bleomycin-induced pulmonary fibrosis in rats.PurposeThis study aimed to evaluate the efficacy and safety of FZHY in post-COVID-19 pulmonary fibrosis.MethodsA multi-center, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy of a 24-week treatment with FZHY, combined with vitamin C and respiratory function rehabilitation, for treating pulmonary fibrosis in discharged convalescent COVID-19 patients. The primary outcome was the regression rate of pulmonary fibrosis assessed by the high-resolution computed tomography scores and lung function improvement (forced vital capacity [FVC], forced expiratory volume in one second [FEV1], and FEV1/FVC) after 24 weeks. Secondary outcomes included the 6-min walk distance, improvement in pulmonary inflammation, clinical symptoms, and quality of life.ResultsThis study included 142 patients, who were randomized to the FZHY (n = 72) and placebo groups (n = 70). By week 24, the regression rates of pulmonary fibrosis in the FZHY and placebo groups were 71.2% and 49.2%, respectively (p = 0.01). Limited spirometry data revealed higher FEV1/FVC in the FZHY group than in the placebo group at week 8 ([87.7 ± 7.2] % vs. [82.7 ± 6.9] %; p = 0.018). The regression rates in pulmonary inflammation in the FZHY and placebo groups were 83.8% and 68.8%, respectively (p = 0.04). At week 4, the increase in 6-min walking distance was greater in the FZHY group than in the placebo group ([41.4 ± 64.1] m vs. [21.8 ± 50.3] m; p = 0.05). However, no significant differences were observed between the groups in the improvement rate of clinical symptoms, quality of life-BREF, patient health questionnaire-9, or generalized anxiety disorder-7 scores (p > 0.05). No drug-related adverse events were reported in the FZHY group.ConclusionFZHY attenuates post-COVID-19 pulmonary fibrosis, with good safety profiles.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT04279197, identifier NCT04279197. |
| format | Article |
| id | doaj-art-a207c8f9a6c1487e858807056b0f0077 |
| institution | DOAJ |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-a207c8f9a6c1487e858807056b0f00772025-08-20T02:57:53ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-03-011610.3389/fphar.2025.15082761508276Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trialFei Jing0Fei Jing1Wei Wang2Jia Ke3Tingrong Huang4Bo Jiang5Qiwu Qiu6Jihan Huang7Songhua Zhan8Wei Zhang9Hui Wu10Wen Su11Jiawen Feng12Yuan Peng13Zhimin Zhao14Feng Xing15Chenghai Liu16Chenghai Liu17Chenghai Liu18Institute of Liver Diseases, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaShandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan, ChinaHubei University of Chinese Medicine, Wuhan, ChinaDepartment of Respiratory, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, ChinaHuangshi Hospital of Traditional Chinese Medicine, Huangshi, ChinaDepartment of Traditional Chinese Medicine, Wuhan Third Hospital, Wuhan, ChinaDepartment of Infectious Diseases, Jingmen First People’s Hospital, Jingmen, ChinaCenter for Drug Clinical Research, Institute of Interdisciplinary Integrative Medicine Research, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Radiology, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China0Department of Respiratory, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China1Department of Traditional Chinese Medicine, Wuhan Integrated TCM and Western Medicine Hospital, Wuhan, China2Office of Academic Research, Wuhan Integrated TCM and Western Medicine Hospital, Wuhan, ChinaInstitute of Liver Diseases, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaInstitute of Liver Diseases, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaInstitute of Liver Diseases, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaInstitute of Liver Diseases, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaInstitute of Liver Diseases, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China3Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shanghai, China4Key Laboratory of Liver and Kidney Diseases, Ministry of Education, Shanghai, ChinaBackgroundEffective therapies for pulmonary fibrosis caused by coronavirus disease (COVID-19) and other etiologies are lacking. Our previous studies demonstrated that Fuzheng Huayu tablet (FZHY), a traditional Chinese medicine known for its anti-liver fibrotic properties, can improve lung function in patients with chronic obstructive pulmonary disease and attenuate bleomycin-induced pulmonary fibrosis in rats.PurposeThis study aimed to evaluate the efficacy and safety of FZHY in post-COVID-19 pulmonary fibrosis.MethodsA multi-center, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy of a 24-week treatment with FZHY, combined with vitamin C and respiratory function rehabilitation, for treating pulmonary fibrosis in discharged convalescent COVID-19 patients. The primary outcome was the regression rate of pulmonary fibrosis assessed by the high-resolution computed tomography scores and lung function improvement (forced vital capacity [FVC], forced expiratory volume in one second [FEV1], and FEV1/FVC) after 24 weeks. Secondary outcomes included the 6-min walk distance, improvement in pulmonary inflammation, clinical symptoms, and quality of life.ResultsThis study included 142 patients, who were randomized to the FZHY (n = 72) and placebo groups (n = 70). By week 24, the regression rates of pulmonary fibrosis in the FZHY and placebo groups were 71.2% and 49.2%, respectively (p = 0.01). Limited spirometry data revealed higher FEV1/FVC in the FZHY group than in the placebo group at week 8 ([87.7 ± 7.2] % vs. [82.7 ± 6.9] %; p = 0.018). The regression rates in pulmonary inflammation in the FZHY and placebo groups were 83.8% and 68.8%, respectively (p = 0.04). At week 4, the increase in 6-min walking distance was greater in the FZHY group than in the placebo group ([41.4 ± 64.1] m vs. [21.8 ± 50.3] m; p = 0.05). However, no significant differences were observed between the groups in the improvement rate of clinical symptoms, quality of life-BREF, patient health questionnaire-9, or generalized anxiety disorder-7 scores (p > 0.05). No drug-related adverse events were reported in the FZHY group.ConclusionFZHY attenuates post-COVID-19 pulmonary fibrosis, with good safety profiles.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT04279197, identifier NCT04279197.https://www.frontiersin.org/articles/10.3389/fphar.2025.1508276/fullFuzheng Huayu tabletpulmonary fibrosispulmonary functionCOVID-19randomized controlled trial |
| spellingShingle | Fei Jing Fei Jing Wei Wang Jia Ke Tingrong Huang Bo Jiang Qiwu Qiu Jihan Huang Songhua Zhan Wei Zhang Hui Wu Wen Su Jiawen Feng Yuan Peng Zhimin Zhao Feng Xing Chenghai Liu Chenghai Liu Chenghai Liu Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial Frontiers in Pharmacology Fuzheng Huayu tablet pulmonary fibrosis pulmonary function COVID-19 randomized controlled trial |
| title | Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full | Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_fullStr | Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_short | Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial |
| title_sort | fuzheng huayu tablets for treating pulmonary fibrosis in post covid 19 patients a multicenter randomized double blind placebo controlled trial |
| topic | Fuzheng Huayu tablet pulmonary fibrosis pulmonary function COVID-19 randomized controlled trial |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1508276/full |
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