Junhui Gong, Naifu Nie, Minrui Jiang, Xinyu Yang, Qinghua Wang, Jia Deng, Jun Kang, Xin Li, Li Zhang, Ying Zhang, Nuo Luo, Xiaoyi Du, Ling Wang, Wei Zhou, Hui Cao, Kunlin Li, Guoqiang Cao, Li Li
{"title":"未分离肝素、乙酰半胱氨酸、布地奈德和异丙托溴铵联合雾化治疗COVID-19肺炎住院患者的疗效和安全性：一项随机对照临床试验","authors":"Junhui Gong, Naifu Nie, Minrui Jiang, Xinyu Yang, Qinghua Wang, Jia Deng, Jun Kang, Xin Li, Li Zhang, Ying Zhang, Nuo Luo, Xiaoyi Du, Ling Wang, Wei Zhou, Hui Cao, Kunlin Li, Guoqiang Cao, Li Li","doi":"10.1186/s12890-025-03824-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Promoting the absorption of COVID-19 pneumonia is critical for reducing pulmonary sequelae and improving prognosis. This study aimed to evaluate the efficacy and safety of nebulized unfractionated heparin, acetylcysteine, budesonide, and ipratropium bromide (HABIT) in hospitalized patients with COVID-19 pneumonia.</p><p><strong>Methods: </strong>This single-center, open-label, randomized, parallel-group trial was conducted at a tertiary hospital in China. Participants were randomized 1:1 to receive either standard of care (SOC) or SOC plus nebulized HABIT. The HABIT protocol included daily quadruple nebulization for seven days, comprising 6000 units heparin sodium, 2 mg budesonide, 0.3 g acetylcysteine, and 0.5 mg ipratropium bromide. The primary outcome was the change in lung lesions assessed by chest CT scans on admission (Day 0) and post-treatment (Day 8).</p><p><strong>Results: </strong>A total of 74 patients were randomized to the HABIT group (n = 37) or the control group (n = 37). Four patients per group were excluded during follow-up, leaving 66 patients for final analysis. Baseline CT scores were comparable between groups (10.55 ± 3.11 vs. 10.76 ± 2.85, p = 0.774). Post-treatment, the HABIT group showed significantly lower mean CT scores (6.6 ± 2.98 vs. 8.69 ± 2.53, p = 0.003) and greater lesion absorption (37.5% vs. 20%, p < 0.001) compared to controls. The HABIT group also exhibited a non-significant improvement in PaO<sub>2</sub>/FiO<sub>2</sub> (75.27 vs. 51.23, p = 0.113). Safety analysis showed no significant differences in activated partial thromboplastin time or serious adverse events.</p><p><strong>Conclusion: </strong>The adjunctive HABIT regimen demonstrates favorable efficacy and safety in treating COVID-19 pneumonia.</p><p><strong>Trial registration: </strong>The clinical trial was registered with the Chinese Clinical Trial Registry (ChiCTR; www.chictr.org.cn ; ID: ChiCTR2300073871) on July 24, 2023. Ethical approval was valid from May 2023 to May 2025.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":"25 1","pages":"346"},"PeriodicalIF":2.6000,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of combined nebulization of unfractionated heparin, acetylcysteine, budesonide and ipratropium bromide in hospitalised patients with COVID-19 pneumonia: a randomized controlled clinical trial.\",\"authors\":\"Junhui Gong, Naifu Nie, Minrui Jiang, Xinyu Yang, Qinghua Wang, Jia Deng, Jun Kang, Xin Li, Li Zhang, Ying Zhang, Nuo Luo, Xiaoyi Du, Ling Wang, Wei Zhou, Hui Cao, Kunlin Li, Guoqiang Cao, Li Li\",\"doi\":\"10.1186/s12890-025-03824-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Promoting the absorption of COVID-19 pneumonia is critical for reducing pulmonary sequelae and improving prognosis. This study aimed to evaluate the efficacy and safety of nebulized unfractionated heparin, acetylcysteine, budesonide, and ipratropium bromide (HABIT) in hospitalized patients with COVID-19 pneumonia.</p><p><strong>Methods: </strong>This single-center, open-label, randomized, parallel-group trial was conducted at a tertiary hospital in China. Participants were randomized 1:1 to receive either standard of care (SOC) or SOC plus nebulized HABIT. The HABIT protocol included daily quadruple nebulization for seven days, comprising 6000 units heparin sodium, 2 mg budesonide, 0.3 g acetylcysteine, and 0.5 mg ipratropium bromide. The primary outcome was the change in lung lesions assessed by chest CT scans on admission (Day 0) and post-treatment (Day 8).</p><p><strong>Results: </strong>A total of 74 patients were randomized to the HABIT group (n = 37) or the control group (n = 37). Four patients per group were excluded during follow-up, leaving 66 patients for final analysis. Baseline CT scores were comparable between groups (10.55 ± 3.11 vs. 10.76 ± 2.85, p = 0.774). Post-treatment, the HABIT group showed significantly lower mean CT scores (6.6 ± 2.98 vs. 8.69 ± 2.53, p = 0.003) and greater lesion absorption (37.5% vs. 20%, p < 0.001) compared to controls. The HABIT group also exhibited a non-significant improvement in PaO<sub>2</sub>/FiO<sub>2</sub> (75.27 vs. 51.23, p = 0.113). Safety analysis showed no significant differences in activated partial thromboplastin time or serious adverse events.</p><p><strong>Conclusion: </strong>The adjunctive HABIT regimen demonstrates favorable efficacy and safety in treating COVID-19 pneumonia.</p><p><strong>Trial registration: </strong>The clinical trial was registered with the Chinese Clinical Trial Registry (ChiCTR; www.chictr.org.cn ; ID: ChiCTR2300073871) on July 24, 2023. Ethical approval was valid from May 2023 to May 2025.</p>\",\"PeriodicalId\":9148,\"journal\":{\"name\":\"BMC Pulmonary Medicine\",\"volume\":\"25 1\",\"pages\":\"346\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-07-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Pulmonary Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12890-025-03824-5\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Pulmonary Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12890-025-03824-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
Efficacy and safety of combined nebulization of unfractionated heparin, acetylcysteine, budesonide and ipratropium bromide in hospitalised patients with COVID-19 pneumonia: a randomized controlled clinical trial.
Background: Promoting the absorption of COVID-19 pneumonia is critical for reducing pulmonary sequelae and improving prognosis. This study aimed to evaluate the efficacy and safety of nebulized unfractionated heparin, acetylcysteine, budesonide, and ipratropium bromide (HABIT) in hospitalized patients with COVID-19 pneumonia.
Methods: This single-center, open-label, randomized, parallel-group trial was conducted at a tertiary hospital in China. Participants were randomized 1:1 to receive either standard of care (SOC) or SOC plus nebulized HABIT. The HABIT protocol included daily quadruple nebulization for seven days, comprising 6000 units heparin sodium, 2 mg budesonide, 0.3 g acetylcysteine, and 0.5 mg ipratropium bromide. The primary outcome was the change in lung lesions assessed by chest CT scans on admission (Day 0) and post-treatment (Day 8).
Results: A total of 74 patients were randomized to the HABIT group (n = 37) or the control group (n = 37). Four patients per group were excluded during follow-up, leaving 66 patients for final analysis. Baseline CT scores were comparable between groups (10.55 ± 3.11 vs. 10.76 ± 2.85, p = 0.774). Post-treatment, the HABIT group showed significantly lower mean CT scores (6.6 ± 2.98 vs. 8.69 ± 2.53, p = 0.003) and greater lesion absorption (37.5% vs. 20%, p < 0.001) compared to controls. The HABIT group also exhibited a non-significant improvement in PaO2/FiO2 (75.27 vs. 51.23, p = 0.113). Safety analysis showed no significant differences in activated partial thromboplastin time or serious adverse events.
Conclusion: The adjunctive HABIT regimen demonstrates favorable efficacy and safety in treating COVID-19 pneumonia.
Trial registration: The clinical trial was registered with the Chinese Clinical Trial Registry (ChiCTR; www.chictr.org.cn ; ID: ChiCTR2300073871) on July 24, 2023. Ethical approval was valid from May 2023 to May 2025.
期刊介绍：
BMC Pulmonary Medicine is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of pulmonary and associated disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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