戒烟干预联合布地格福吸入气雾剂治疗稳定期慢性阻塞性肺疾病患者的临床研究OA
Clinical Study of Smoking Cessation Intervention Combined with Budesonide,Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol in Patients with Stable Chronic Obstructive Pulmonary Disease
目的:评价戒烟干预与布地格福吸入气雾剂对稳定期慢性阻塞性肺疾病(COPD)患者肺功能、炎症反应、免疫功能和生活质量的影响.方法:纳入昆山市第六人民医院 2023 年 2 月—2024 年 3 月收治的 82 例稳定期 COPD 患者,依据随机数字序列按 1:1 比例分配至对照组和观察组,各 41 例.对照组接受布地格福吸入气雾剂规范治疗,观察组同步开展为期 12 个月的系统化戒烟管理,随访 12 个月,比较两组患者治疗前、随访 3、6、12 个月肺功能、炎症反应、生活质量及免疫功能变化.结果:两组第一秒用力呼气容积(FEV1)、用力肺活量(FVC)、第一秒用力呼气容积占用力肺活量百分比(FEV1/FVC)、慢性阻塞性肺疾病评估测试(CAT)评分、圣乔治呼吸问卷(SGRQ)总评分、C 反应蛋白(CRP)、白细胞介素-6(IL-6)、呼出气一氧化氮(FeNO)、CD3+、CD4+、CD8+、CD4+/CD8+均存在时间效应、时间×组别交互效应;CAT 评分、SGRQ 总评分、CRP、IL-6、FeNO、CD3+、CD4+、CD8+、CD4+/CD8+存在组别效应;随访 12 个月内,联合组发生急性加重的频次低于单纯用药组,上述差异有统计学意义(P<0.05);两组咽部不适、声音嘶哑、干咳等不良反应的总体发生情况接近,差异无统计学意义(P>0.05).结论:在规范应用布地格福吸入气雾剂的基础上开展系统化戒烟管理,可进一步改善稳定期 COPD 患者的呼吸功能、炎症状态、细胞免疫水平和健康相关生活质量,并有助于减少急性加重.戒烟干预 6 个月后逐渐显现,至 12 个月时改善趋势更为稳定,提示戒烟获益具有一定的时间累积特征.联合方案未增加治疗相关不良反应,具有较好的安全性.
Objective:To assess whether adding a structured smoking-cessation program to budesonide/glycopyrronium/formoterol fumarate inhalation aerosol improves pulmonary function,systemic and airway inflammation,cellular immunity,and health-related quality of life in patients with stable chronic obstructive pulmonary disease(COPD).Method:Eighty-two patients with stable COPD treated at the Sixth People's Hospital of Kunshan between February 2023 and March 2024 were randomly assigned in a 1:1 ratio to a medication-only group or an intervention group,with 41 patients in each group.Both groups received standardized treatment with budesonide/glycopyrronium/formoterol fumarate inhalation aerosol,whereas the intervention group additionally participated in a 12-month structured smoking-cessation program.Pulmonary function,inflammatory biomarkers,immune indices,symptom burden,and quality of life were evaluated at baseline and after 3,6,and 12 months of follow-up.Result:Significant time effects and group-by-time interactions were identified for forced expiratory volume in 1 second(FEV1),forced vital capacity(FVC),FEV1/FVC,COPD Assessment Test scores,St George's Respiratory Questionnaire total scores,C-reactive protein,interleukin-6,fractional exhaled nitric oxide,CD3+,CD4+,CD8+,and the CD4+/CD8+ratio.Significant between-group effects were also observed for symptom and quality-of-life scores,inflammatory markers,and immune-cell indices.During the 12-month follow-up,acute exacerbations occurred less frequently in the intervention group than in the medication-only group.The above differences were all statistically significant(P<0.05).The overall incidences of throat discomfort,hoarseness,dry cough,and other treatment-related adverse events were comparable between groups(P>0.05).Conclusion:Incorporating structured smoking-cessation management into fixed-dose triple inhalation therapy provides additional clinical benefits for patients with stable COPD.Improvements in respiratory function,inflammatory status,cellular immunity,and health-related quality of life became more evident after 6 months and were sustained or further enhanced at 12 months,suggesting a cumulative benefit associated with prolonged smoking abstinence.This combined strategy may also reduce acute exacerbations without increasing adverse events.
姚丽娟;邓贤坤
昆山市第六人民医院 江苏 昆山 215321昆山市第六人民医院 江苏 昆山 215321
戒烟干预布地格福吸入气雾剂慢性阻塞性肺疾病
Smoking cessation interventionBudesonide/glycopyrronium/formoterol fumarate inhalation aerosolChronic obstructive pulmonary disease
《中外医学研究》 2026 (20)
59-63,5
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