关于支气管热成形术治疗严重哮喘的一些思考
2014/10/16
摘要
哮喘是一种以气道高反应性、多变、可逆性通气障碍为特征的复杂炎症性疾病。支气管热成形术是一种新型哮喘治疗方式。该技术靶向作用于气道平滑肌,通过一根专用导管向气管壁可控制地输送一定量热能(即射频消融)。由于可减轻哮喘症状,该技术在治疗哮喘方面的潜力已被广泛讨论。对支气管热成形术的权威研究(AIR2试验)中采用了一项随机、双盲、空白对照设计的临床试验,该试验入组了来自30个美国及国际研究中心的288名重度持续性哮喘患者。AIR2试验的结果显示,接受手术1年后,试验组相比对照组临床获益显著,包括哮喘相关生活质量的提升,严重发作次数降低32%,因哮喘症状急诊就医次数下降84%,因哮喘症状损失的工作/学习/其他日常生活时间降低66%。临床前研究证明,在进行支气管热成形术后至少三年的时间内,支气管平滑肌细胞数量都少于治疗前。在一篇最近发表的文献中,AIR2临床试验研究团队评估了支气管热成形术对重症持续性哮喘患者的长期安全性和有效性,研究发现经过治疗后,患者在至少五年内哮喘发作减少、因呼吸症状急诊就诊或住院的次数下降,证明了该技术可在五年内有效控制症状且安全性卓越。目前,迫切需要阐明的是支气管热成形术的作用机制及输送的热量如何转化为临床疗效,另外还需要进一步的调查以明晰疾病种类及患者特征、进行精确患者分型,使真正适合疗法的病人获益并避免造成不必要的使用及相关风险。
(苏楠 审校)
Minerva Med. 2014 Jul 4. [Epub ahead of print]
Bronchial thermoplasty in severe asthma: food for thoughts.
Bezzi M1, Solidoro P, Patella V, Contoli M, Scichilone N.
ABSTRACT
Asthma is a complex inflammatory disorder of the airways characterized by airway hyper-responsiveness and variable, reversible, airflow obstruction. Bronchial thermoplasty (BT) is a new modality for treating asthma. It targets airway smooth muscles (ASM) by delivering a controlled specific amount of thermal energy (radiofrequency ablation) to the airway wall through a dedicated catheter. The use of bronchial thermoplasty has been widely discussed for its potential in the treatment of asthma, since it seems to be able to reduce the symptoms of asthma. The definitive study for BT (AIR2 trial) employed a randomized, double-blind, sham-controlled design and enrolled 288 subjects with severe persistent asthma from 30 US and international centers. The results of the AIR2 trial demonstrated clinically significant benefits of BT compared with the sham group at one year post-treatment, including an improvement in asthma-related quality of life, 32% reduction in severe exacerbations, 84% reduction in emergency department visits for asthma symptoms, and a 66% reduction in time lost from work/school/other daily activities because of asthma symptoms. Preclinical work showed that ASM is reduced after BT by at least 3 years after treatment. The recent article from the ARI2 trial study group analyses the long-term safety and effectiveness of BT in patients with severe persistent asthma and demonstrates the 5-year durability of the benefits of BT in the control of symptoms and safety. It supports the evidence that reduction in asthma attacks, ER visits, and hospitalizations for respiratory symptoms are maintained for at least 5 years. There is a pressing need to understand the underlying mechanism(s) of BT and how the delivered heat is translated into clinical benefit. This necessitates additional investigation to identify disease and patient characteristics that would enable accurate phenotyping of positive responders to avoid unnecessary procedures and risks.
Minerva Med. 2014 Jul 4. [Epub ahead of print]
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从实际应用角度评估奥马珠单抗在西班牙治疗重症持续性哮喘的成本效益
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高剂量白细胞去除疗法治疗难治性哮喘的安全性和有效性