Pan Lei, Jiang Xue-Ge, Guo Jun, Tian Yuan, Liu Chang-Ting
Nanlou Respiratory Diseases Department, Chinese PLA General Hospital, Beijing, China.
Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Binzhou Medical University, Binzhou, China.
J Clin Pharmacol. 2015 Oct;55(10):1086-92. doi: 10.1002/jcph.518. Epub 2015 May 25.
This study aimed to identify the effects of OM-85 BV in patients with chronic obstructive pulmonary disease (COPD). PubMed, Embase, CINAHL, and ClinicalTrials.gov were searched for eligible randomized controlled trials (RCTs). The major end point was exacerbation rate, and the minor end points included duration of hospitalization, severity of acute exacerbation, incidence rate of patients using antibiotics, and adverse events. All data were derived with relative risks (RRs) and weighted mean differences. Five RCTs with 1190 patients were enrolled in the meta-analysis. OM-85 BV was associated with 20% and 39% reductions in exacerbation rate (RR, 0.80; 95% confidence interval [CIs], 0.65-0.97; P = .03) and incidence rate of patients using antibiotics (RR, 0.61; 95%CI, 0.48-0.77; P < .0001) compared with the placebo. However, OM-85 BV was not significantly associated with duration of hospitalization, severity of acute exacerbation, and total adverse events. Current evidence supporting the benefits of OM-85 BV to COPD patients is inadequate. Further larger-scale trials must be conducted to validate our findings and the efficacy of OM-85 BV in COPD patients.
本研究旨在确定OM-85 BV对慢性阻塞性肺疾病(COPD)患者的影响。检索了PubMed、Embase、CINAHL和ClinicalTrials.gov以查找符合条件的随机对照试验(RCT)。主要终点是急性加重率,次要终点包括住院时间、急性加重的严重程度、使用抗生素患者的发生率以及不良事件。所有数据均采用相对风险(RR)和加权平均差得出。五项包含1190名患者的RCT纳入了荟萃分析。与安慰剂相比,OM-85 BV使急性加重率(RR,0.80;95%置信区间[CI],0.65-0.97;P = 0.03)和使用抗生素患者的发生率(RR,0.61;95%CI,0.48-0.77;P < 0.0001)分别降低了20%和39%。然而,OM-85 BV与住院时间、急性加重的严重程度以及总不良事件并无显著关联。目前支持OM-85 BV对COPD患者有益的证据不足。必须进行进一步的大规模试验以验证我们的研究结果以及OM-85 BV对COPD患者的疗效。