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支气管热成形术与奥马珠单抗治疗未控制的重度哮喘的间接比较。

Indirect comparison of bronchial thermoplasty versus omalizumab for uncontrolled severe asthma.

作者信息

Niven Robert M, Simmonds Michael R, Cangelosi Michael J, Tilden Dominic P, Cottrell Suzanne, Shargill Narinder S

机构信息

a MAHSC, University of Manchester and University Hospital of South Manchester , Manchester , UK.

b Boston Scientific , Sydney , NSW , Australia.

出版信息

J Asthma. 2018 Apr;55(4):443-451. doi: 10.1080/02770903.2017.1337789. Epub 2017 Jul 14.

Abstract

OBJECTIVE

Bronchial thermoplasty (BT) as an add-on therapy for uncontrolled severe asthma is an alternative to biologic therapies like omalizumab (OM). We conducted an indirect treatment comparison (ITC) to appraise comparative effectiveness of BT and OM.

METHODS

A systematic literature review identified relevant randomized controlled trials. The ITC followed accepted methodology.

RESULTS

The ITC comprised a sham-controlled trial of BT (AIR2) and two placebo-controlled trials of OM (INNOVATE; EXTRA). Comparing the BT post-treatment period to ongoing treatment with OM, showed no significant differences in the rate ratios (RRs) for severe exacerbations (RR of BT versus OM = 0.91 [95% CI: 0.64, 1.30]; p = 0.62) or hospitalizations (RR = 0.57 [95% CI: 0.17, 1.86]; p = 0.53); emergency department visits were significantly reduced by 75% with BT (RR = 0.25 [95% CI: 0.07, 0.91]; p = 0.04); the proportions of patients with clinically meaningful response on the asthma quality-of-life questionnaire were comparable (RR = 1.06 [95% CI: 0.86, 1.34]; p = 0.59). The RR for exacerbations statistically favours OM over the total study period in AIR2 (RR = 1.50 [95% CI: 1.11, 2.02]; p = 0.009) likely reflecting a transient increase in events during the BT peri-treatment period.

CONCLUSIONS

The ITC should be interpreted cautiously considering the differences between patient populations in the included trials. However, based on the analysis, BT compares well with a potentially more costly pharmacotherapy for asthma. Clinicians evaluating the relative merits of using these treatments should consider the totality of evidence and patient preferences to make an informed decision.

摘要

目的

支气管热成形术(BT)作为治疗控制不佳的重度哮喘的附加疗法,是奥马珠单抗(OM)等生物疗法的替代方案。我们进行了一项间接治疗比较(ITC),以评估BT和OM的相对疗效。

方法

通过系统的文献综述确定相关的随机对照试验。ITC遵循公认的方法。

结果

ITC包括一项BT的假手术对照试验(AIR2)和两项OM的安慰剂对照试验(INNOVATE;EXTRA)。将BT治疗后期与正在接受OM治疗的情况进行比较,结果显示,重度加重的率比(RRs)(BT与OM的RR = 0.91 [95%CI:0.64,1.30];p = 0.62)或住院率(RR = 0.57 [95%CI:0.17,1.86];p = 0.53)无显著差异;BT使急诊就诊次数显著减少了75%(RR = 0.25 [95%CI:0.07,0.91];p = 0.04);哮喘生活质量问卷中具有临床意义反应的患者比例相当(RR = 1.06 [95%CI:0.86,1.34];p = 0.59)。在AIR2研究的整个研究期间,加重的RR在统计学上更有利于OM(RR = 1.50 [95%CI:1.11,2.02];p = 0.009),这可能反映了BT围治疗期事件的短暂增加。

结论

考虑到纳入试验中患者群体的差异,对ITC的解读应谨慎。然而,基于分析,BT与一种可能成本更高的哮喘药物疗法相比效果良好。评估使用这些治疗方法相对优点的临床医生应考虑全部证据和患者偏好,以做出明智的决定。

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