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Clinical trial of tiotropium bromide combined with salmeterol fluticasone in patients with stable chronic obstructive pulmonary disease
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Li-jun LIU1, Xiang-yun LI1, Ya-juan YANG2a, Jun-hong QIN2b
Chinese Journal of Clinical Pharmacology | 2026, 42(11) : 1501 - 1505
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Chinese Journal of Clinical Pharmacology | 2026, 42(11): 1501-1505
Clinical and Basic Bridging Research
Clinical trial of tiotropium bromide combined with salmeterol fluticasone in patients with stable chronic obstructive pulmonary disease
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Li-jun LIU1, Xiang-yun LI1, Ya-juan YANG2a, Jun-hong QIN2b
Affiliations
  • 1.Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Hebei University, Baoding 071000, Hebei Province, China
  • 2a.Department of Infectious Diseases, The NO. 2 Hospital of Baoding, Baoding 071000, Hebei Province, China
  • 2b.Department of Respiratory, The NO. 2 Hospital of Baoding, Baoding 071000, Hebei Province, China
Published: 2026-06-17 doi: 10.13699/j.cnki.1001-6821.2026.11.001
Outline
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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.

tiotropium bromide power for inhalation  /  salmeterol fluticasone power for inhalation  /  forced lung capacity  /  elafin  /  stable chronic obstructive pulmonary disease
Li-jun LIU, Xiang-yun LI, Ya-juan YANG, Jun-hong QIN. Clinical trial of tiotropium bromide combined with salmeterol fluticasone in patients with stable chronic obstructive pulmonary disease[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (11) : 1501 -1505 . DOI: 10.13699/j.cnki.1001-6821.2026.11.001
Year 2026 volume 42 Issue 11
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doi: 10.13699/j.cnki.1001-6821.2026.11.001
  • Receive Date:2026-02-26
  • Online Date:2026-08-06
  • Published:2026-06-17
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History
  • Received:2026-02-26
Funding
Affiliations
    1.Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Hebei University, Baoding 071000, Hebei Province, China
    2a.Department of Infectious Diseases, The NO. 2 Hospital of Baoding, Baoding 071000, Hebei Province, China
    2b.Department of Respiratory, The NO. 2 Hospital of Baoding, Baoding 071000, 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
species
占总种数比例
Percentage of
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Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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