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黏液活性药物治疗对捷克共和国5年随访期间慢性阻塞性肺疾病急性加重的影响:一项真实世界研究

Effect of Treatment with Mucoactive Drugs on COPD Exacerbations During 5 years of Follow-up in the Czech Republic: A Real-World Study.

作者信息

Zatloukal Jaromír, Page Clive, Brat Kristián, Svoboda Michal, Voláková Eva, Plutinský Marek, Kopecký Michal, Koblížek Vladimír

机构信息

Department of Respiratory Medicine, University Hospital Olomouc, Olomouc, Czech Republic.

Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.

出版信息

Lung. 2025 May 6;203(1):61. doi: 10.1007/s00408-025-00813-7.

Abstract

INTRODUCTION

Studies indicate that chronic treatment with mucoactive drugs may reduce COPD exacerbation rates. This real-world, multicenter, prospective, observational study aimed to determine the effect of long-term mucoactive treatment on exacerbations in patients with COPD in the Czech Republic.

METHODS

452 adult patients on the Czech Multicenter Research Database of COPD with post-bronchodilator FEV ≤ 60% of predicted value received standard of care and were followed up for 5 years. For the first 24 months, 81 patients received regular thiol-based mucoactive drugs (77 erdosteine, 4 N-acetylcysteine) at the discretion of the treating physician and 371 patients had no mucoactive treatment (control group). Erdosteine was fully reimbursed, and NAC was partially reimbursed for COPD patients. The annual number/rate of COPD exacerbations over 5 years was monitored.

RESULTS

Patients receiving mucoactive treatment for 24 months had a significantly larger reduction from baseline in all exacerbations compared to the control group (- 0.61 vs - 0.18, p = 0.026; - 0.54 vs - 0.09, p = 0.007; - 0.55 vs 0.04, p = 0.005; - 0.67 vs 0.13, p = 0.002; - 0.53 vs 0.10, p = 0.019 in the first to fifth year, respectively). The reduction in moderate exacerbations was also significantly larger in those receiving mucoactive treatment versus no mucoactive treatment. The exacerbation rate was reduced to a greater extent in the subgroups with cough or with stage 3‒4 COPD who received mucoactive treatment but was independent of the use of inhaled corticosteroids (ICS).

CONCLUSION

Mucoactive treatment for two years reduced the number of COPD exacerbations (all, moderate) over five years of follow-up. The reduction in exacerbations was more pronounced in patients with cough or with stage 3‒4 COPD but was independent of the use of ICS.

摘要

引言

研究表明,使用黏液促排剂进行长期治疗可能会降低慢性阻塞性肺疾病(COPD)的急性加重率。这项真实世界、多中心、前瞻性观察性研究旨在确定在捷克共和国,长期使用黏液促排剂治疗对COPD患者急性加重的影响。

方法

452名成年患者纳入捷克COPD多中心研究数据库,其支气管扩张剂后第一秒用力呼气容积(FEV)≤预测值的60%,接受标准治疗并随访5年。在最初的24个月里,81名患者由治疗医生酌情给予常规硫醇类黏液促排剂(77名使用厄多司坦,4名使用N-乙酰半胱氨酸),371名患者未接受黏液促排剂治疗(对照组)。厄多司坦对COPD患者全额报销,NAC部分报销。监测5年期间COPD急性加重的年次数/率。

结果

与对照组相比,接受黏液促排剂治疗24个月的患者在所有急性加重情况方面从基线的下降幅度显著更大(第一年至第五年分别为-0.61对-0.18,p = 0.026;-0.54对-0.09,p = 0.007;-0.55对0.04,p = 0.005;-0.67对0.13,p = 0.002;-0.53对0.10,p = 0.019)。接受黏液促排剂治疗的患者在中度急性加重方面的下降幅度也显著大于未接受黏液促排剂治疗的患者。在咳嗽或患有3-4期COPD的亚组中,接受黏液促排剂治疗的患者急性加重率降低幅度更大,但与吸入性糖皮质激素(ICS)的使用无关。

结论

黏液促排剂治疗两年可减少随访五年期间COPD急性加重的次数(所有类型、中度)。在咳嗽或患有3-4期COPD的患者中,急性加重的减少更为明显,但与ICS的使用无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2218/12055937/d0ad09807a01/408_2025_813_Fig1_HTML.jpg

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