PDF(Pubmed)
Abstract：
BACKGROUND: Efforts have been made to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations using a variety of measures. Broncho-Vaxom (BV) is an immunomodulating agent that has shown potential benefit by balancing between immune stimulation and regulation in patients with COPD. In this study, we evaluated the clinical efficacy of BV for reducing the risk of COPD exacerbations.
METHODS: This study was based on the Korean National Health Insurance database, which contains reimbursement information for almost the entire population of South Korea. We extracted data from 2016 to 2019 for patients started on BV during 2017-2018. We collected baseline data on demographics, comorbidities, inhaler use, hospital type, and insurance type 1 year before starting BV. We also analyzed exacerbation history, starting from the year before BV initiation.
RESULTS: In total, 238 patients were enrolled in this study. Their mean age was 69.2 ± 9.14 years, 79.8% were male, and 45% experienced at least one exacerbation. BV reduced the risk of moderate (odds ratio [OR] = 0.59, 95% confidence interval [CI]: 0.38-0.91) and moderate-to-severe exacerbations compared to pre- and post-BV (OR = 0.571, 95% CI: 0.37-0.89). BV use also reduced the incidence of moderate and moderate-to-severe exacerbations (incidence rate ratio [IRR] = 0.75, p = 0.03; and IRR = 0.77, p = 0.03, respectively). The use of BV was significantly delayed moderate exacerbations (hazard ratio = 0.68, p = 0.02), but not with moderate-to-severe or severe exacerbations.
CONCLUSIONS: The use of BV was associated with fewer moderate and moderate-to-severe exacerbations. Additionally, BV was associated with a delay in moderate COPD exacerbations.
METHODS: This study was based on the Korean National Health Insurance database, which contains reimbursement information for almost the entire population of South Korea. We extracted data from 2016 to 2019 for patients started on BV during 2017-2018. We collected baseline data on demographics, comorbidities, inhaler use, hospital type, and insurance type 1 year before starting BV. We also analyzed exacerbation history, starting from the year before BV initiation.
RESULTS: In total, 238 patients were enrolled in this study. Their mean age was 69.2 ± 9.14 years, 79.8% were male, and 45% experienced at least one exacerbation. BV reduced the risk of moderate (odds ratio [OR] = 0.59, 95% confidence interval [CI]: 0.38-0.91) and moderate-to-severe exacerbations compared to pre- and post-BV (OR = 0.571, 95% CI: 0.37-0.89). BV use also reduced the incidence of moderate and moderate-to-severe exacerbations (incidence rate ratio [IRR] = 0.75, p = 0.03; and IRR = 0.77, p = 0.03, respectively). The use of BV was significantly delayed moderate exacerbations (hazard ratio = 0.68, p = 0.02), but not with moderate-to-severe or severe exacerbations.
CONCLUSIONS: The use of BV was associated with fewer moderate and moderate-to-severe exacerbations. Additionally, BV was associated with a delay in moderate COPD exacerbations.
摘要：
背景：已通过多种措施努力降低慢性阻塞性肺疾病（COPD）加重的风险。Broncho-Vaxom（BV）是一种免疫调节剂，通过平衡COPD患者的免疫刺激和调节，显示出潜在的益处。在这项研究中,我们评估了BV降低COPD加重风险的临床疗效.
方法：本研究基于韩国国民健康保险数据库，其中包含几乎整个韩国人口的报销信息。我们提取了2016年至2019年2017年至2018年开始接受BV治疗的患者的数据。我们收集了人口统计学的基线数据,合并症,吸入器使用，医院类型,和开始BV前1年的保险类型。我们还分析了病情加重史,从BV启动前一年开始。
结果：总计，238名患者参加了这项研究。他们的平均年龄为69.2±9.14岁，79.8%为男性，和45%经历了至少一次恶化。与BV前后相比，BV降低了中度（比值比[OR]=0.59，95％置信区间[CI]：0.38-0.91）和中重度加重的风险（OR=0.571，95％CI：0.37-0.89）。使用BV还降低了中度和中度至重度加重的发生率（发生率比率[IRR]=0.75，p=0.03；IRR=0.77，p=0.03）。BV的使用显著延迟了中度加重(风险比=0.68,p=0.02),但不是中度至重度或重度恶化。
结论：使用BV与减少中度和中度至重度加重相关。此外,BV与中度COPD加重延迟相关。
方法：本研究基于韩国国民健康保险数据库，其中包含几乎整个韩国人口的报销信息。我们提取了2016年至2019年2017年至2018年开始接受BV治疗的患者的数据。我们收集了人口统计学的基线数据,合并症,吸入器使用，医院类型,和开始BV前1年的保险类型。我们还分析了病情加重史,从BV启动前一年开始。
结果：总计，238名患者参加了这项研究。他们的平均年龄为69.2±9.14岁，79.8%为男性，和45%经历了至少一次恶化。与BV前后相比，BV降低了中度（比值比[OR]=0.59，95％置信区间[CI]：0.38-0.91）和中重度加重的风险（OR=0.571，95％CI：0.37-0.89）。使用BV还降低了中度和中度至重度加重的发生率（发生率比率[IRR]=0.75，p=0.03；IRR=0.77，p=0.03）。BV的使用显著延迟了中度加重(风险比=0.68,p=0.02),但不是中度至重度或重度恶化。
结论：使用BV与减少中度和中度至重度加重相关。此外,BV与中度COPD加重延迟相关。
