Kapur Nitin, Petsky Helen L, Bell Scott, Kolbe John, Chang Anne B
Department of Respiratory and Sleep Medicine, Children's Health Queensland, Lady Cilento Children's Hospital, Brisbane, Queensland, Australia.
Cochrane Database Syst Rev. 2018 May 16;5(5):CD000996. doi: 10.1002/14651858.CD000996.pub3.
Bronchiectasis is being increasingly diagnosed and recognised as an important contributor to chronic lung disease in both adults and children in high- and low-income countries. It is characterised by irreversible dilatation of airways and is generally associated with airway inflammation and chronic bacterial infection. Medical management largely aims to reduce morbidity by controlling the symptoms, reduce exacerbation frequency, improve quality of life and prevent the progression of bronchiectasis. This is an update of a review first published in 2000.
To evaluate the efficacy and safety of inhaled corticosteroids (ICS) in children and adults with stable state bronchiectasis, specifically to assess whether the use of ICS: (1) reduces the severity and frequency of acute respiratory exacerbations; or (2) affects long-term pulmonary function decline.
We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Register of trials, MEDLINE and Embase databases. We ran the latest literature search in June 2017.
All randomised controlled trials (RCTs) comparing ICS with a placebo or no medication. We included children and adults with clinical or radiographic evidence of bronchiectasis, but excluded people with cystic fibrosis.
We reviewed search results against predetermined criteria for inclusion. In this update, two independent review authors assessed methodological quality and risk of bias in trials using established criteria and extracted data using standard pro forma. We analysed treatment as 'treatment received' and performed sensitivity analyses.
The review included seven studies, involving 380 adults. Of the 380 randomised participants, 348 completed the studies.Due to differences in outcomes reported among the seven studies, we could only perform limited meta-analysis for both the short-term ICS use (6 months or less) and the longer-term ICS use (> 6 months).During stable state in the short-term group (ICS for 6 months or less), based on the two studies from which data could be included, there were no significant differences from baseline values in the forced expiratory volume in the first second (FEV) at the end of the study (mean difference (MD) -0.09, 95% confidence interval (CI) -0.26 to 0.09) and forced vital capacity (FVC) (MD 0.01 L, 95% CI -0.16 to 0.17) in adults on ICS (compared to no ICS). Similarly, we did not find any significant difference in the average exacerbation frequency (MD 0.09, 95% CI -0.61 to 0.79) or health-related quality of life (HRQoL) total scores in adults on ICS when compared with no ICS, though data available were limited. Based on a single non-placebo controlled study from which we could not extract clinical data, there was marginal, though statistically significant improvement in sputum volume and dyspnoea scores on ICS.The single study on long-term outcomes (over 6 months) that examined lung function and other clinical outcomes, showed no significant effect of ICS on any of the outcomes. We could not draw any conclusion on adverse effects due to limited available data.Despite the authors of all seven studies stating they were double-blind, we judged one study (in the short duration ICS) as having a high risk of bias based on blinding, attrition and reporting of outcomes. The GRADE quality of evidence was low for all outcomes (due to non-placebo controlled trial, indirectness and imprecision with small numbers of participants and studies).
AUTHORS' CONCLUSIONS: This updated review indicates that there is insufficient evidence to support the routine use of ICS in adults with stable state bronchiectasis. Further, we cannot draw any conclusion for the use of ICS in adults during an acute exacerbation or in children (for any state), as there were no studies.
在高收入和低收入国家,支气管扩张症的诊断越来越多,并且被认为是成人和儿童慢性肺病的一个重要病因。其特征为气道不可逆扩张,通常与气道炎症和慢性细菌感染相关。药物治疗主要旨在通过控制症状来降低发病率,减少急性加重频率,改善生活质量并防止支气管扩张症进展。这是一篇首次发表于2000年的综述的更新版。
评估吸入性糖皮质激素(ICS)用于稳定期支气管扩张症成人和儿童的疗效和安全性,具体评估使用ICS是否:(1)降低急性呼吸道加重的严重程度和频率;或(2)影响长期肺功能下降。
我们检索了Cochrane对照试验注册库(CENTRAL)、Cochrane气道组试验注册库、MEDLINE和Embase数据库。我们于2017年6月进行了最新的文献检索。
所有比较ICS与安慰剂或不使用药物的随机对照试验(RCT)。我们纳入了有支气管扩张症临床或影像学证据的儿童和成人,但排除了囊性纤维化患者。
我们根据预定的纳入标准审查检索结果。在本次更新中,两名独立的综述作者使用既定标准评估试验的方法学质量和偏倚风险,并使用标准表格提取数据。我们将治疗分析为“接受的治疗”并进行敏感性分析。
该综述纳入了7项研究,涉及380名成人。在380名随机参与者中,348名完成了研究。由于7项研究报告的结果存在差异,我们只能对短期使用ICS(6个月或更短时间)和长期使用ICS(>6个月)进行有限的荟萃分析。在短期组的稳定期(使用ICS 6个月或更短时间),基于两项可纳入数据的研究,使用ICS的成人在研究结束时第一秒用力呼气量(FEV)(平均差(MD)-0.09,95%置信区间(CI)-0.26至0.09)和用力肺活量(FVC)(MD 0.01 L,95%CI -0.16至0.17)与基线值相比无显著差异(与未使用ICS相比)。同样,与未使用ICS相比,我们在使用ICS的成人中未发现平均急性加重频率(MD 0.09,95%CI -0.61至0.79)或健康相关生活质量(HRQoL)总分有任何显著差异,尽管可用数据有限。基于一项我们无法提取临床数据的非安慰剂对照研究,使用ICS时痰量和呼吸困难评分有轻微但具有统计学意义的改善。一项关于长期结果(超过6个月)的研究,该研究检查了肺功能和其他临床结果,显示ICS对任何结果均无显著影响。由于可用数据有限,我们无法就不良反应得出任何结论。尽管所有7项研究的作者均称其为双盲研究,但基于盲法、失访和结果报告,我们将一项研究(短期使用ICS)判定为具有高偏倚风险。所有结果的GRADE证据质量均低(由于非安慰剂对照试验、间接性以及参与者和研究数量少导致的不精确性)。
本次更新的综述表明,没有足够的证据支持在稳定期支气管扩张症成人中常规使用ICS。此外,由于没有研究,我们无法就ICS在急性加重期成人或儿童(任何状态)中的使用得出任何结论。