Department of Respiratory and critical care medicine, Affiliated Hospital of Binzhou Medical University, Binzhou 256603, China;
J Thorac Dis. 2013 Aug;5(4):422-9. doi: 10.3978/j.issn.2072-1439.2013.08.26.
Although several large studies showed roflumilast (Rof) has demonstrated efficacy in patients with chronic obstructive pulmonary disease (COPD), the efficacy of Rof in dyspnea remains unclear. We therefore undertook a meta-analysis to assess the efficacy of Rof in dyspnea for COPD patients.
A computerized search through electronic databases was performed to obtain randomized controlled trials (RCTs). Dyspnea was assessed by the transition dyspnea index (TDI) and the UCSD Shortness of Breath Questionnaire (SOBQ). The quality of the included studies was assessed by the Jadad score. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were calculated and heterogeneity was assessed with the I(2) test. The effect sizes were compared with the minimum clinically important difference (MCID).
Four RCTs involving 4,767 patients with forced expiratory volume in one second (FEV1) <80% predicted met the inclusion criteria. The Jadad score of each study was 5 scores. Rof statistically improved the TDI focal score (WMD =0.30 units; 95% CI: 0.14-0.46), but failed to decrease the SOBQ (WMD =-1.10 units; 95% CI: -4.24 to 2.04). The overall effect sizes were lower than the MCID of the TDI and the SOBQ, respectively.
Sufficient evidence to support Rof relieving dyspnea in COPD patients is currently lacking. Further studies are needed to investigate the effects of Rof in dyspnea, especially for COPD patients with a different phenotype.
尽管几项大型研究表明罗氟司特(Rof)在慢性阻塞性肺疾病(COPD)患者中具有疗效,但 Rof 对呼吸困难的疗效仍不清楚。因此,我们进行了一项荟萃分析,以评估 Rof 对 COPD 患者呼吸困难的疗效。
通过电子数据库进行计算机检索,以获取随机对照试验(RCT)。呼吸困难通过过渡呼吸困难指数(TDI)和 UCSD 呼吸困难问卷(SOBQ)进行评估。纳入研究的质量通过 Jadad 评分进行评估。计算加权均数差(WMD)和 95%置信区间(CI),并使用 I(2)检验评估异质性。通过与最小临床重要差异(MCID)进行比较来比较效应大小。
符合纳入标准的有四项 RCT,共纳入 4767 名第一秒用力呼气量(FEV1)<80%预计值的患者。每项研究的 Jadad 评分均为 5 分。Rof 统计学上改善了 TDI 焦点评分(WMD=0.30 单位;95%CI:0.14-0.46),但未能降低 SOBQ(WMD=-1.10 单位;95%CI:-4.24 至 2.04)。总体效应大小低于 TDI 和 SOBQ 的 MCID。
目前尚无足够证据支持 Rof 缓解 COPD 患者的呼吸困难。需要进一步研究来探讨 Rof 对呼吸困难的影响,特别是对于具有不同表型的 COPD 患者。