Department of Respiratory Medicine, Jiangxi Provincial People's Hospital Affiliated to Nanchang University, No. 92 Aiguo Road, Nanchang, 330006, Jiangxi, China,
Department of Anesthesiology, The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Nanchang, 330006, Jiangxi, China,
Int J Chron Obstruct Pulmon Dis. 2019 Apr 1;14:757-766. doi: 10.2147/COPD.S192166. eCollection 2019.
The aim of this study was to investigate the comparative risks of budesonide/formoterol, versus placebo or monotherapies, for the treatment of patients with stable COPD.
We undertook a systematic search of the literature in PubMed, Embase, and the Cochrane Central Register of Controlled Trials, for randomized controlled trials (RCTs) comparing budesonide/formoterol with control regimens for the treatment of patients with stable COPD and at least 12 weeks of follow-up, meeting the inclusion criteria. Studies were reviewed, and OR with corresponding 95% CI was used to pool the results.
A total of eight studies involving 9,254 patients met the inclusion criteria of this meta-analysis. Compared with placebo, combination therapy with budesonide/formoterol was associated with a significantly higher risk of adverse effects including oral candidiasis (OR: 3.09, 95% CI: 1.95-4.91) and dysphonia (OR: 2.76, 95% CI: 1.40-5.44), but not pneumonia (OR: 0.94, 95% CI: 0.64-1.37) or bronchitis (OR: 1.36, 95% CI: 0.95-1.95). A similar pattern was also evident for the comparison of formoterol with budesonide/formoterol, with increased occurrence of oral candidiasis (OR: 2.72, 95% CI: 1.33-5.58) and dysphonia (OR: 4.13, 95% CI: 1.95-8.76); however, there were no significant differences in pneumonia (OR: 1.31, 95% CI: 0.98-1.74) or bronchitis (OR: 1.05, 95% CI: 0.83-1.31). In contrast, compared with budesonide, combined budesonide/formoterol was associated with similar risks of adverse effects, including pneumonia (OR: 1.20, 95% CI: 0.60-2.39), bronchitis (OR: 0.95, 95% CI: 0.41-2.20), oral candidiasis (OR: 0.79, 95% CI: 0.41-1.53), and dysphonia (OR: 1.00, 95% CI: 0.40-2.47).
Combination therapy does not cause more adverse events, including pneumonia and bronchitis, than control (placebo, formoterol, or budesonide) treatment in patients with stable COPD, while there were higher risks of oral candidiasis and dysphonia compared with the non-inhaled corticosteroid group (placebo, formoterol).
本研究旨在探讨布地奈德/福莫特罗与安慰剂或单药治疗稳定期 COPD 患者的比较风险。
我们对 PubMed、Embase 和 Cochrane 对照试验中心注册数据库进行了系统文献检索，以寻找符合纳入标准的比较布地奈德/福莫特罗与对照方案治疗稳定期 COPD 患者且随访时间至少 12 周的随机对照试验（RCT）。对研究进行了综述，并使用 OR 及其相应的 95%CI 来汇总结果。
共有 8 项涉及 9254 名患者的研究符合本荟萃分析的纳入标准。与安慰剂相比，布地奈德/福莫特罗联合治疗与不良反应风险显著增加相关，包括口腔念珠菌病（OR：3.09，95%CI：1.95-4.91）和发音困难（OR：2.76，95%CI：1.40-5.44），但不包括肺炎（OR：0.94，95%CI：0.64-1.37）或支气管炎（OR：1.36，95%CI：0.95-1.95）。对于福莫特罗与布地奈德/福莫特罗的比较，也出现了类似的模式，口腔念珠菌病（OR：2.72，95%CI：1.33-5.58）和发音困难（OR：4.13，95%CI：1.95-8.76）的发生率增加；然而，肺炎（OR：1.31，95%CI：0.98-1.74）或支气管炎（OR：1.05，95%CI：0.83-1.31）的发生率无显著差异。相比之下，与布地奈德相比，联合使用布地奈德/福莫特罗与不良反应风险相似，包括肺炎（OR：1.20，95%CI：0.60-2.39）、支气管炎（OR：0.95，95%CI：0.41-2.20）、口腔念珠菌病（OR：0.79，95%CI：0.41-1.53）和发音困难（OR：1.00，95%CI：0.40-2.47）。
在稳定期 COPD 患者中，与对照（安慰剂、福莫特罗或布地奈德）治疗相比，联合治疗并不会导致更多的不良反应，包括肺炎和支气管炎，但与非吸入性皮质激素组（安慰剂、福莫特罗）相比，口腔念珠菌病和发音困难的风险更高。
