Department of Respiratory Medicine, Royal Devon & Exeter Hospital, Exeter, UK.
Int J Clin Pract. 2011 Jul;65(7):764-74. doi: 10.1111/j.1742-1241.2011.02685.x.
This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease.
An initial literature search revealed no suitable head-to-head trials between budesonide/formoterol and salmeterol/fluticasone and therefore a systematic review was conducted to find randomised controlled trials providing data for input into an adjusted indirect comparison of the two combination treatments using placebo as a common comparator. The Bucher adjusted indirect comparison method was used to calculate odds ratios and 95% confidence intervals.
Eight salmeterol/fluticasone trials and four budesonide/formoterol trials were identified as being relevant for the analyses. The proportion of patients experiencing a pneumonia adverse event was significantly lower with budesonide/formoterol than salmeterol/fluticasone (odds ratio, 0.47; 95% confidence interval, 0.28-0.80). The proportion of patients experiencing a pneumonia serious adverse event was also significantly lower with budesonide/formoterol than salmeterol/fluticasone (odds ratio, 0.41; 95% confidence interval, 0.19-0.86). However, there were too few events to draw any firm conclusions on pneumonia-related mortality.
The results of the indirect comparison support the hypothesis that budesonide/formoterol is associated with fewer pneumonia events than salmeterol/fluticasone in chronic obstructive pulmonary disease. The limitations of the analysis are that the results from a single study, TORCH, have a large bearing on the overall findings of the analysis, and that there is heterogeneity in the length and the dosing of the included studies, although it does not appear that heterogeneity affected the reported results. Another important limitation is the lack of predefined diagnostic standards for pneumonia in these studies.
本分析旨在比较布地奈德/福莫特罗和沙美特罗/氟替卡松治疗慢性阻塞性肺疾病患者时肺炎不良事件、肺炎严重不良事件和肺炎相关死亡率的相对发生率。
最初的文献检索未发现布地奈德/福莫特罗和沙美特罗/氟替卡松之间合适的头对头试验，因此进行了系统评价，以寻找提供数据的随机对照试验，以便将两种联合治疗方案与安慰剂作为共同对照进行调整后的间接比较。采用 Bucher 调整间接比较法计算优势比和 95%置信区间。
确定了 8 项沙美特罗/氟替卡松试验和 4 项布地奈德/福莫特罗试验与分析相关。布地奈德/福莫特罗组发生肺炎不良事件的患者比例明显低于沙美特罗/氟替卡松组（优势比，0.47；95%置信区间，0.28-0.80）。布地奈德/福莫特罗组发生肺炎严重不良事件的患者比例也明显低于沙美特罗/氟替卡松组（优势比，0.41；95%置信区间，0.19-0.86）。然而，肺炎相关死亡率的事件太少，无法得出任何确凿的结论。
间接比较的结果支持这样的假设，即在慢性阻塞性肺疾病中，布地奈德/福莫特罗与沙美特罗/氟替卡松相比，肺炎事件更少。该分析的局限性在于，来自一项研究 TORCH 的结果对分析的总体结果有很大影响，并且纳入研究的长度和剂量存在异质性，尽管异质性似乎没有影响报告的结果。另一个重要的局限性是这些研究中缺乏肺炎的预设诊断标准。
