Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)
Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)
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DOI：
10.1136/thoraxjnl-2019-213879
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发表时间：
2020-02-01
期刊：
影响因子：
10
通讯作者：
Brown, Sarah
中科院分区：
文献类型：
--
作者：
Higginson, Irene J.;Wilcock, Andrew;Brown, Sarah
需要新的治疗方法来治疗晚期疾病中的严重呼吸困难。我们在改良医学研究理事会呼吸困难量表评分>= 3的成人中进行了一项米氮平治疗28天的随机可行性试验。64例患者接受了随机化（409例接受了筛选），达到了我们招募的主要可行性终点。大多数患者患有COPD或间质性肺病; 52例（81%）完成了试验。安慰剂和米氮平之间在耐受性或安全性方面没有差异，并且保持盲态。第28天（主要临床活动终点）的最差呼吸急促评分为7.1（SD 2.3，安慰剂）和6.3（SD 1.8，米氮平）。米氮平的III期试验表明。
New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score >= 3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated.