Article(id=1292135405126701701, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.11.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1772035200000, receivedDateStr=2026-02-26, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998687297, onlineDateStr=2026-08-06, pubDate=1781625600000, pubDateStr=2026-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998687297, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998687297, creator=13701087609, updateTime=1785998687297, updator=13701087609, issue=Issue{id=1292135402790482407, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1781625600000', pubDateStr='2026-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1785998686739, creator='13701087609', updateTime=1786014315540, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292200954833686587, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292200954833686588, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1501, endPage=1505, ext={EN=ArticleExt(id=1292135405323833990, articleId=1292135405126701701, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of tiotropium bromide combined with salmeterol fluticasone in patients with stable chronic obstructive pulmonary disease, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To explore the clinical efficacy and safety of tiotropium bromide powder for inhalation combined with salmeterol xinafoate powder for inhalation in patients with stable chronic obstructive pulmonary disease (COPD).
Methods Patients with stable COPD in our hospital were divided into control group and experimental group by random number table method. The control group was given salmeterol fluticasone inhalation powder, 1 inhalations per time, twice a day; the treatment group was additionally treated with tiotropium bromide powder for inhalation, 1 tablet per time, once a day. Both groups were treated continuously for 8 weeks. The clinical efficacy, forced vital capacity, respiratory condition, serum elafin level, and adverse drug reactions were compared between the two groups.
Results A total of 102 patients were enrolled. There were 51 cases in each group. Throughout the treatment period, 2 participants in the control group were lost to follow-up, and 1 case in the treatment group withdrew due to withdrawal of informed consent. Ultimately, control group had 49 cases and treatment group had 50 cases. After treatment, the treatment group (92.00%, 46 cases/50 cases) exhibited a superior total clinical effective rate (75.51%, 37 cases/49 cases), respectively; and the difference was statistically significant (P<0.05). After treatment, the percentage of predicted value (FEV1%) in the treatment group and the control group was (57.64±5.88)% and (54.78±5.61)%, respectively; FVC was (2.58±0.40) and (2.14±0.32) L, respectively; peak expiratory flow rate (PEF) was (1.43±0.31) and (1.31±0.21) L·s-1, respectively; the treatment group showed significantly higher levels of the above indicators compared with the control group (all P<0.05). After treatment, the modified British Medical Research Council respiratory questionnaire (mMRC) scores of the treatment group and the control group were (1.05±0.11) and (1.15±0.18) points, respectively; The serum elafin levels of the treatment group and the control group were (10.28±1.95) and (9.34±1.20) pg·mL-1, respectively; the secretory leukocyte protease inhibitor (SLPI) levels were (56.39±6.54) and (52.15±6.04) ng·mL-1, respectively; the levels of growth differentiation factor-15 (GDF-15) were (867.44±108.50) and (930.16±121.39) ng·mL-1, respectively; there were statistically significant differences in the above indicators between the two groups(all P<0.05). In the treatment group, adverse drug reactions such as arrhythmia, gastrointestinal reactions, and joint pain, while those in the control group included arrhythmia, gastrointestinal reactions, joint pain, and dry mouth. The total incidence rates of adverse drug reactions in the treatment group and the control group were 22.00% (11 cases/50 cases) and 26.53% (13 cases/49 cases), respectively; there was no statistically significant difference between the two groups (P>0.05).
Conclusion Tiotropium bromide power for inhalation combined with salmeterol fluticasone power for inhalation has outstanding efficacy in the treatment of stable COPD, which can improve forced vital capacity, respiratory status and elafin level, and has a good safety profile.
, authors=Li-jun LIU
1, Xiang-yun LI
1, Ya-juan YANG
2a, Jun-hong QIN
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目的 探究噻托溴铵吸入粉雾剂联合沙美特罗替卡松吸入粉雾剂对稳定期慢阻肺（COPD）患者的临床疗效和安全性。
方法 将本院稳定期COPD患者按照随机数表法分为对照组和试验组。对照组给予沙美特罗替卡松吸入粉雾剂，1次1吸，每日2次；试验组在对照组基础上加用噻托溴铵吸入粉雾剂，1次1粒，每日1次，2组均连续治疗8周。比较2组患者的临床疗效、用力肺活量、呼吸状况、血清elafin水平，并进行安全性评价。
结果 共入组102例患者，试验组与对照组各51例。治疗期间，对照组因失访脱落2例，试验组因撤回知情同意脱落1例，最终对照组纳入49例、试验组纳入50例。治疗后，试验组和对照组的临床总有效率分别为92.00%（46例/50例）和75.51%（37例/49例），在统计学上差异有统计学意义（P<0.05）。治疗后，试验组和对照组的第1秒用力呼气容积占预计值百分比（FEV1％）分别为（57.64±5.88）%和（54.78±5.61）%，FVC分别为（2.58±0.40）和（2.14±0.32）L，呼气峰值流速（PEF）分别为（1.43±0.31）和（1.31±0.21）L·s-1，试验组上述指标均显著高于对照组（均P<0.05）。治疗后，试验组和对照组的改良版英国医学研究委员会呼吸问卷（mMRC）评分分别为（1.05±0.11）和（1.15±0.18）分；elafin水平分别为（10.28±1.95）和（9.34±1.20）pg·m-1，分泌型白细胞蛋白酶抑制因子（SLPI）水平分别为（56.39±6.54）和（52.15±6.04）ng·mL-1；生长分化因子-15（GDF-15）水平分别为（867.44±108.50）和（930.16±121.39）ng·mL-1，2组上述指标比较，在统计学上差异有统计学意义（均P<0.05）。试验组的药物不良反应有心律失常、胃肠道反应、关节疼痛，对照组有心律失常、胃肠道反应、关节疼痛、口干。试验组和对照组的药物不良反应总发生率分别为22.00%（11例/50例）和26.53%（13例/49例），在统计学上差异无统计学意义（P>0.05）。
结论 噻托溴铵吸入粉雾剂联合沙美特罗替卡松吸入粉雾剂治疗稳定期COPD的疗效突出，可改善用力肺活量、呼吸状况及elafin水平，安全性良好。
, authors=刘丽君
1, 李翔云
1, 杨娅娟
2a, 秦俊红
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刘丽君（1985-），女，主治医师，主要从事呼吸内科方面的工作和研究
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