Gong Junhui, Nie Naifu, Jiang Minrui, Yang Xinyu, Wang Qinghua, Deng Jia, Kang Jun, Li Xin, Zhang Li, Zhang Ying, Luo Nuo, Du Xiaoyi, Wang Ling, Zhou Wei, Cao Hui, Li Kunlin, Cao Guoqiang, Li Li
Department of Respiratory Medicine, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, 400042, China.
Department of Radiology, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, China.
BMC Pulm Med. 2025 Jul 22;25(1):346. doi: 10.1186/s12890-025-03824-5.
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.
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).
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/FiO (75.27 vs. 51.23, p = 0.113). Safety analysis showed no significant differences in activated partial thromboplastin time or serious adverse events.
The adjunctive HABIT regimen demonstrates favorable efficacy and safety in treating COVID-19 pneumonia.
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.
促进新型冠状病毒肺炎（COVID-19肺炎）的吸收对于减少肺部后遗症和改善预后至关重要。本研究旨在评估雾化普通肝素、乙酰半胱氨酸、布地奈德和异丙托溴铵（HABIT）对COVID-19肺炎住院患者的疗效和安全性。
本单中心、开放标签、随机、平行组试验在中国一家三级医院进行。参与者按1:1随机分组，分别接受标准治疗（SOC）或SOC加雾化HABIT。HABIT方案包括每日进行四次雾化，持续七天，其中包含6000单位肝素钠、2毫克布地奈德、0.3克乙酰半胱氨酸和0.5毫克异丙托溴铵。主要结局是通过入院时（第0天）和治疗后（第8天）的胸部CT扫描评估的肺部病变变化。
共有74例患者被随机分为HABIT组（n = 37）或对照组（n = 37）。随访期间每组排除4例患者，最终纳入66例患者进行分析。两组的基线CT评分相当（10.55±3.11 vs. 10.76±2.85，p = 0.774）。治疗后，与对照组相比，HABIT组的平均CT评分显著更低（6.6±2.98 vs. 8.69±2.53，p = 0.003），病变吸收情况更好（37.5% vs. 20%，p < 0.001）。HABIT组的动脉血氧分压/吸入氧浓度（PaO/FiO）也有非显著性改善（75.27 vs. 51.23，p = 0.113）。安全性分析显示活化部分凝血活酶时间或严重不良事件无显著差异。
辅助使用HABIT方案在治疗COVID-19肺炎方面显示出良好的疗效和安全性。
该临床试验于2023年7月24日在中国临床试验注册中心（ChiCTR；www.chictr.org.cn；ID：ChiCTR2300073871）注册。伦理批准有效期为2023年5月至2025年5月。
