Article(id=1292130358267506921, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.05.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1751299200000, receivedDateStr=2025-07-01, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997484032, onlineDateStr=2026-08-06, pubDate=1773676800000, pubDateStr=2026-03-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997484032, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997484031, creator=13701087609, updateTime=1785997484031, updator=13701087609, issue=Issue{id=1292130254689165893, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='5', pageStart='601', pageEnd='750', issueExtLink='null', onlineDate='null', pubDate='1773676800000', pubDateStr='2026-03-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997459337, creator='13701087609', updateTime=1786014469153, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201599108141219, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201599108141220, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=607, endPage=611, ext={EN=ArticleExt(id=1292130358477222122, articleId=1292130358267506921, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of budesonide combined with theophylline in patients with severe COPD complicated by bronchiectasis, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To observe the clinical efficacy and safety of budesonide/glycopyrrolate bromide/formoterol fumarate inhalation aerosol combined with theophylline sustained-release tablets in patients with severe chronic obstructive pulmonary disease (COPD) complicated by bronchiectasis (BE).
Methods Patients with BE complicated with severe COPD admitted to our hospital were divided into control group and treatment group based on the treatment method. The control group received theophylline sustained-release tablets (oral, twice daily, 0.1 g per dose), while the treatment group received budesonide/glycopyrrolate/formoterol fumarate aerosol (oral inhalation, twice daily, two puffs per dose) combined with theophylline sustained-release tablets (oral, twice daily, 0.1 g per dose). Both groups were treated for 12 weeks. Inflammatory factor levels, pulmonary ventilation function indicators and clinical efficacy were compared between the two groups, and safety was evaluated.
Results A total of 133 patients were enrolled, including 71 in treatment group and 62 in control group. Propensity score matching (PSM) was performed at 1∶1 ratio, resulting in 50 patients in each group. After treatment, the total clinical effective rates in control group and treatment group were 80.00% (40 cases/50 cases) and 92.00% (46 cases /50 cases), respectively, with statistically significant difference (P<0.05). After treatment, the levels of C-reactive protein (CRP) in treatment group and control group were (13.85±2.43) and (27.54±3.71) mg·L-1, respectively; tumor necrosis factor-alpha (TNF-α) levels were (50.54±4.28) and (59.37±4.61) pg·mL-1, respectively; interleukin-6 (IL-6) levels were (42.30±4.71) and (56.42±5.24) pg·mL-1, respectively; interleukin-8 (IL-8) levels were (15.71±2.63) and (17.88±3.11) pg·mL-1, respectively; interleukin-18 (IL-18) levels were (59.42±6.25) and (78.62±7.09) pg·mL-1, respectively. Differences in the above indicators between the two groups were statistically significant (all P<0.05). After treatment, the forced expiratory volume in 1 second (FEV1) in treatment group and control group were (2.64±0.37) and (2.06±0.32) L, respectively; forced vital capacity (FVC) were (2.82±0.30) and (2.04±0.27) L, respectively; FEV1/FVC were (65.68±5.94)% and (54.83±5.55)%, respectively. Differences in the above indicators between the two groups were statistically significant (all P<0.05). The main adverse drug reactions in treatment group were nausea, headache, rash and gastrointestinal discomfort; those in control group were nausea, insomnia, gastrointestinal discomfort and rash. The total incidence of adverse drug reactions was 10.00% in treatment group and 8.00% in control group, with no statistically significant difference (P>0.05).
Conclusion For patients with BE combined with severe COPD, the regimen of budesonide/glycopyrronium bromide/formoterol fumarate inhalation aerosol combined with theophylline sustained-release tablets demonstrates favorable clinical advantages. It can effectively reduce inflammatory factors in patients and improve their ventilation function.
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目的 观察布地格福吸入气雾剂联合茶碱缓释片在重度慢阻肺(COPD)合并支气管扩张(BE)患者中的临床疗效和安全性。
方法 将我院收治的BE合并重度COPD患者根据治疗方法分为对照组和试验组。对照组用茶碱缓释片(口服,每天2次,每次0.1 g)治疗,试验组用布地格福吸入气雾剂(口腔吸入,每天2次,每次2揿)联合茶碱缓释片(口服,每天2次,每次0.1 g)治疗。2组均治疗12周。比较2组患者的炎症因子水平、肺通气功能指标和临床疗效,并进行安全性评价。
结果 共纳入133例患者,试验组71例、对照组62例,用倾向性评分匹配(PSM)法,按照1∶1的比例进行匹配,最终每组各纳入50例患者。治疗后,对照组和试验组的临床总有效率分别为80.00%(40例/50例)和92.00%(46例/50例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的C反应蛋白(CRP)分别为(13.85±2.43)和(27.54±3.71)mg·L-1,肿瘤坏死因子-α(TNF-α)分别为(50.54±4.28)和(59.37±4.61)pg·mL-1,白介素-6(IL-6)分别为(42.30±4.71)和(56.42±5.24)pg·mL-1,白介素-8(IL-8)分别为(15.71±2.63)和(17.88±3.11)pg·mL-1,白介素-18(IL-18)分别为(59.42±6.25)和(78.62±7.09)pg·mL-1,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的第1秒用力呼气容积(FEV1)分别为(2.64±0.37)和(2.06±0.32)L,用力肺活量(FVC)分别为(2.82±0.30)和(2.04±0.27),FEV1/FVC分别为(65.68±5.94)%和(54.83±5.55)%,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的主要药物不良反应有恶心、头痛、皮疹和肠胃不适;对照组有恶心、失眠、肠胃不适和皮疹。试验组和对照组患者的药物不良反应总发生率分别为10.00%和8.00%,在统计学上差异无统计学意义(P>0.05)。
结论 针对BE合并重度COPD患者,布地格福吸入气雾剂联合茶碱缓释片方案展现出良好的临床优势,可以有效降低患者炎症因子水平,改善患者通气功能。
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