Article(id=1292130223294795851, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.08.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1773590400000, receivedDateStr=2026-03-16, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997451851, onlineDateStr=2026-08-06, pubDate=1777305600000, pubDateStr=2026-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997451851, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997451851, creator=13701087609, updateTime=1785997451851, updator=13701087609, issue=Issue{id=1292130221843571059, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1777305600000', pubDateStr='2026-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997451505, creator='13701087609', updateTime=1786014411018, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201355276480844, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201355276480845, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1051, endPage=1057, ext={EN=ArticleExt(id=1292130223479345228, articleId=1292130223294795851, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial on budesonide/glycopyrronium/formoterol combined with bacterial lysate in the treatment of moderate to severe COPD complicated with bronchiectasis, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
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

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目的

观察布地格福吸入气雾剂联合细菌溶解产物胶囊治疗中重度稳定期慢性阻塞性肺疾病(COPD)合并支气管扩张患者的临床疗效与安全性。

方法

将我院收治的中重度稳定期COPD合并支气管扩张患者按照治疗方案的不同分为对照组和试验组。对照组予以布地格福吸入气雾剂治疗(每次1揿,每日2次),试验组在对照组基础上联合细菌溶解产物胶囊口服(每日空腹服用7 mg,连续10 d,停20 d为1个周期)。2组均治疗6个月。比较2组患者的临床疗效、急性加重情况、气道炎症指标、免疫功能指标和肺功能,并进行安全性评价。

结果

共纳入116例患者,对照组57例,试验组59例。治疗后,试验组患者的临床总有效率为91.53%(54例/59例),显著高于对照组的77.19%(44例/57例)(P<0.05)。治疗后,试验组与对照组的急性加重次数分别为(1.53±0.50)和(1.74±0.48)次,急性加重持续时间分别为(9.80±2.75)和(11.16±3.06)d,可溶性髓系细胞触发受体-1(sTREM-1)分别为(33.89±7.47)和(38.34±8.35)pg·mL-1,内皮素(ET)分别为(27.75±4.68)和(30.25±6.12)pg·mL-1,可溶性尿激酶型纤溶酶原激活物受体(suPAR)分别为(244.01±44.13)和(264.13±52.27)pg·mL-1,免疫球蛋白(Ig)A分别为(2.97±0.51)和(2.75±0.52)g·L-1,IgG分别为(12.05±2.55)和(10.89±2.34)g·L-1,IgM分别为(1.95±0.40)和(1.76±0.32)g·L-1,IgE分别为(87.67±10.26)和(93.61±13.58)IU·mL-1,一氧化碳弥散量(DLCO)分别为(67.80±8.43)%和(64.38±7.81)%,残气量/肺总量比值(RV/TLC)分别为(41.57±4.25)%和(43.61±4.11)%,最大运动时分钟通气量(VEmax)分别为(54.24±5.61)和(51.96±5.58)L·min-1,上述指标在2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。试验组的药物不良反应包括恶心、头晕、转氨酶轻度升高、口干和声音嘶哑,对照组包括恶心干呕,皮疹、咽部不适与胆红素升高。试验组和对照组的药物不良反应总发生率分别为11.86%(7例/59例)和8.77%(5例/57例),在统计学上差异无统计学意义(P>0.05)。

结论

在布地格福吸入气雾剂基础上联合细菌溶解产物胶囊能够降低中重度稳定期COPD合并支气管扩张患者急性加重风险,有效改善肺功能,其机制与联合用药可以有效减轻气道炎症和增强机体免疫功能有关。

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王震(1981-),男,副主任医师,主要从事呼吸危重症诊疗相关方面的临床工作和研究

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王震 MP: 18233171116 E-mail:
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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
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王震 , 郝雪燕 , 张湘华
中国临床药理学杂志 | 临床与基础桥接研究 2026,42(8): 1051-1057
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中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (8) : 1051 -1057
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
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王震 , 郝雪燕, 张湘华
作者信息
  • 石家庄市人民医院 呼吸与危重症医学科,河北 石家庄 050051
通讯作者:
王震 MP: 18233171116 E-mail:
作者简介:

王震(1981-),男,副主任医师,主要从事呼吸危重症诊疗相关方面的临床工作和研究

Clinical trial on budesonide/glycopyrronium/formoterol combined with bacterial lysate in the treatment of moderate to severe COPD complicated with bronchiectasis
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
出版时间: 2026-04-28 doi: 10.13699/j.cnki.1001-6821.2026.08.001
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目的

观察布地格福吸入气雾剂联合细菌溶解产物胶囊治疗中重度稳定期慢性阻塞性肺疾病(COPD)合并支气管扩张患者的临床疗效与安全性。

方法

将我院收治的中重度稳定期COPD合并支气管扩张患者按照治疗方案的不同分为对照组和试验组。对照组予以布地格福吸入气雾剂治疗(每次1揿,每日2次),试验组在对照组基础上联合细菌溶解产物胶囊口服(每日空腹服用7 mg,连续10 d,停20 d为1个周期)。2组均治疗6个月。比较2组患者的临床疗效、急性加重情况、气道炎症指标、免疫功能指标和肺功能,并进行安全性评价。

结果

共纳入116例患者,对照组57例,试验组59例。治疗后,试验组患者的临床总有效率为91.53%(54例/59例),显著高于对照组的77.19%(44例/57例)(P<0.05)。治疗后,试验组与对照组的急性加重次数分别为(1.53±0.50)和(1.74±0.48)次,急性加重持续时间分别为(9.80±2.75)和(11.16±3.06)d,可溶性髓系细胞触发受体-1(sTREM-1)分别为(33.89±7.47)和(38.34±8.35)pg·mL-1,内皮素(ET)分别为(27.75±4.68)和(30.25±6.12)pg·mL-1,可溶性尿激酶型纤溶酶原激活物受体(suPAR)分别为(244.01±44.13)和(264.13±52.27)pg·mL-1,免疫球蛋白(Ig)A分别为(2.97±0.51)和(2.75±0.52)g·L-1,IgG分别为(12.05±2.55)和(10.89±2.34)g·L-1,IgM分别为(1.95±0.40)和(1.76±0.32)g·L-1,IgE分别为(87.67±10.26)和(93.61±13.58)IU·mL-1,一氧化碳弥散量(DLCO)分别为(67.80±8.43)%和(64.38±7.81)%,残气量/肺总量比值(RV/TLC)分别为(41.57±4.25)%和(43.61±4.11)%,最大运动时分钟通气量(VEmax)分别为(54.24±5.61)和(51.96±5.58)L·min-1,上述指标在2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。试验组的药物不良反应包括恶心、头晕、转氨酶轻度升高、口干和声音嘶哑,对照组包括恶心干呕,皮疹、咽部不适与胆红素升高。试验组和对照组的药物不良反应总发生率分别为11.86%(7例/59例)和8.77%(5例/57例),在统计学上差异无统计学意义(P>0.05)。

结论

在布地格福吸入气雾剂基础上联合细菌溶解产物胶囊能够降低中重度稳定期COPD合并支气管扩张患者急性加重风险,有效改善肺功能,其机制与联合用药可以有效减轻气道炎症和增强机体免疫功能有关。

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
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
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. 中国临床药理学杂志, 2026 , 42 (8) : 1051 -1057 . DOI: 10.13699/j.cnki.1001-6821.2026.08.001
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
  • 河北省2025年度医学科学研究课题计划基金资助项目(20251154)
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doi: 10.13699/j.cnki.1001-6821.2026.08.001
  • 接收时间:2026-03-16
  • 首发时间:2026-08-06
  • 出版时间:2026-04-28
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  • 收稿日期:2026-03-16
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河北省2025年度医学科学研究课题计划基金资助项目(20251154)
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    石家庄市人民医院 呼吸与危重症医学科,河北 石家庄 050051

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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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