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Clinical trial on budesonide/glycopyrronium/formoterol combined with bacterial lysate in the treatment of moderate to severe COPD complicated with bronchiectasis
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Zhen WANG, Xue-yan HAO, Xiang-hua ZHANG
Chinese Journal of Clinical Pharmacology | 2026, 42(8) : 1051 - 1057
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Chinese Journal of Clinical Pharmacology | 2026, 42(8): 1051-1057
Clinical and Basic Bridging Research
Clinical trial on budesonide/glycopyrronium/formoterol combined with bacterial lysate in the treatment of moderate to severe COPD complicated with bronchiectasis
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Zhen WANG, Xue-yan HAO, Xiang-hua ZHANG
Affiliations
  • Department of Respiratory and Critical Care Medicine, Shijiazhuang People’s Hospital, Shijiazhuang 050051, Hebei Province, China
Published: 2026-04-28 doi: 10.13699/j.cnki.1001-6821.2026.08.001
Outline
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Objective

To investigate the clinical efficacy and safety of budesonide/formoterol/glycopyrronium inhalation aerosol combined with bacterial lysate capsules in the treatment of patients with moderate-to-severe stable chronic obstructive pulmonary disease (COPD) complicated with bronchiectasis.

Methods

The patients with moderate-to-severe stable COPD complicated with bronchiectasis admitted to our hospital were divided into control group and treatment group based on their treatment regimens. Patients in control group were administered budesonide/formoterol/glycopyrronium inhalation aerosol (1 inhalation per time, twice daily), while treatment group additionally received oral bacterial lysate capsules (7 mg once daily on an empty stomach, 10 consecutive days followed by a 20-day break as one cycle). Patients in both groups were treated for 6 months. Differences in clinical efficacy, acute exacerbation, airway inflammation indicators, immune function indicators and pulmonary function were compared, and safety evaluation was performed.

Results

A total of 116 participants were enrolled, with 57 cases in control group and 59 cases in treatment group. The treatment group achieved an overall effective rate of 91.53% (54 cases/59 cases), which was statistically significantly higher to 77.19% (44 cases/57 cases) observed in control group(P<0.05). After treatment, the number of acute exacerbations in treatment and control group were (1.53±0.50) and (1.74±0.48) episodes, respectively; the duration of acute exacerbations were (9.80±2.75) and (11.16±3.06) days, respectively; the soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) levels were (33.89±7.47) and (38.34±8.35) pg·mL-1, respectively; the endothelin (ET) levels were (27.75±4.68) and (30.25±6.12) pg·mL-1, respectively; the soluble urokinase-type plasminogen activator receptor (suPAR) levels were (244.01±44.13) and (264.13±52.27) pg·mL-1, respectively; the immunoglobulin (Ig) A levels were (2.97±0.51) and (2.75±0.52) g·L-1, respectively; the IgG levels were (12.05±2.55) and (10.89±2.34) g·L-1, respectively; the IgM levels were (1.95±0.40) and (1.76±0.32) g·L-1, respectively; the IgE levels were (87.67±10.26) and (93.61±13.58) IU·mL-1, respectively; the diffusing capacity for carbon monoxide (DLCO) were (67.80±8.43)% and (64.38±7.81)%, respectively; the residual volume/total lung capacity ratio (RV/TLC) were (41.57±4.25)% and (43.61±4.11)%, respectively; the maximum minute ventilation during exercise (VEmax) were (54.24±5.61) and (51.96±5.58) L·min-1, respectively. Intergroup comparisons revealed statistically significant differences in the aforementioned indicators (P<0.05, P<0.01). Adverse drug reactions in treatment group included nausea, dizziness, mild elevated transaminase, dry mouth and hoarseness; those in control group included nausea and retching, rash, pharyngeal discomfort and elevated bilirubin. The total incidence of adverse reactions in treatment group and control group were 11.86% (7 cases/59 cases) and 8.77% (5 cases/57 cases), respectively, with no statistically significant difference (P>0.05).

Conclusion

Budesonide/formoterol/glycopyrronium inhalation aerosol combined with bacterial lysate capsules can reduce the risk of acute exacerbations and effectively improve pulmonary function in patients with moderate-to-severe stable COPD complicated with bronchiectasis. The underlying mechanism may be associated with the alleviation of airway inflammation and the enhancement of immune function

budesonide/formoterol/glycopyrronium inhalation aerosol  /  bacterial lysate capsule  /  chronic obstructive pulmonary disease  /  bacterial lysate  /  acute exacerbation  /  immunomodulation
Zhen WANG, Xue-yan HAO, Xiang-hua ZHANG. Clinical trial on budesonide/glycopyrronium/formoterol combined with bacterial lysate in the treatment of moderate to severe COPD complicated with bronchiectasis[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (8) : 1051 -1057 . DOI: 10.13699/j.cnki.1001-6821.2026.08.001
Year 2026 volume 42 Issue 8
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doi: 10.13699/j.cnki.1001-6821.2026.08.001
  • Receive Date:2026-03-16
  • Online Date:2026-08-06
  • Published:2026-04-28
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  • Received:2026-03-16
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    Department of Respiratory and Critical Care Medicine, Shijiazhuang People’s Hospital, Shijiazhuang 050051, Hebei Province, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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