中国临床药理学杂志2026，Vol.42Issue(8)：1051-1057,7.DOI:10.13699/j.cnki.1001-6821.2026.08.001
布地格福联合细菌溶解产物治疗中重度COPD合并支气管扩张的临床研究
Clinical trial on budesonide/glycopyrronium/formoterol combined with bacterial lysate in the treatment of moderate to severe COPD complicated with bronchiectasis
摘要
Abstract
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.关键词
布地格福气雾剂/细菌溶解产物胶囊/慢性阻塞性肺疾病/支气管扩张/急性加重/免疫调节Key words
budesonide/formoterol/glycopyrronium inhalation aerosol/bacterial lysate capsule/chronic obstructive pulmonary disease/bacterial lysate/acute exacerbation/immunomodulation分类
医药卫生引用本文复制引用
王震,郝雪燕,张湘华..布地格福联合细菌溶解产物治疗中重度COPD合并支气管扩张的临床研究[J].中国临床药理学杂志,2026,42(8):1051-1057,7.基金项目
河北省2025年度医学科学研究课题计划基金资助项目(20251154) （20251154）
