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非过敏性鼻炎新型药物治疗的临床相关疗效指标

Clinically relevant outcome measures of novel pharmacotherapy for nonallergic rhinitis.

作者信息

Brown Kari R, Bernstein Jonathan A

机构信息

aDivision of Allergy/Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center bDivision of Immunology/Allergy, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.

出版信息

Curr Opin Allergy Clin Immunol. 2015 Jun;15(3):204-12. doi: 10.1097/ACI.0000000000000166.

Abstract

PURPOSE OF REVIEW

The purpose of this review is to briefly provide the current understanding of the pathogenesis of nonallergic rhinitis (NAR), currently available pharmacotherapies as well as some recent advancement in pharmacotherapy for this condition. With this background on NAR, we then describe and contrast outcome measures used in previous NAR and allergic rhinitis clinical trials. Finally, we conclude with a brief discussion on which of these outcomes might be most suitable for future NAR clinical trials.

RECENT FINDINGS

NAR is a heterogeneous condition in which multiple mechanisms have been postulated to be involved. Patients with NAR commonly experience chronic nasal congestion and anterior and/or posterior drainage, which significantly affects their quality of life. Current standard of care is primarily symptom based, as specific therapies that target the underlying mechanisms of this condition are lacking. As there are no current treatment algorithms for NAR, clinical response and outcomes can vary widely between patients. Intranasal corticosteroids and intranasal antihistamines have been found to be effective in well designed clinical trials in the treatment of NAR and are therefore considered first-line therapies. Recently, studies investigating a combination of intranasal antihistamine/corticosteroid and an intranasal decongestant and with an intranasal corticosteroid have shown promise for allergic rhinitis and may also be more effective than monotherapy for NAR. Multiple outcome measures have been used in previous NAR trials, the most common being variations of nasal symptoms scores. Given the differences in prominent symptoms typically experienced by allergic rhinitis and NAR, accurate clinical outcomes used to evaluate new treatments for these two patient groups will likely differ. Further studies specifically designed to investigate the efficacy of various therapeutic agents in NAR are required to improve the management and outcomes of this chronic condition.

SUMMARY

Further research is required to expand our understanding of the pathobiology of NAR that should lead to novel therapeutic approaches for managing this condition. It will be necessary to have well established validated NAR outcomes that can be used to study these novel therapies.

摘要

综述目的

本综述旨在简要介绍目前对非过敏性鼻炎(NAR)发病机制的认识、现有的药物治疗方法以及该疾病药物治疗的一些最新进展。基于NAR的这一背景,我们随后描述并对比先前NAR和过敏性鼻炎临床试验中使用的疗效指标。最后,我们简要讨论这些指标中哪些可能最适合未来的NAR临床试验。

最新研究发现

NAR是一种异质性疾病,已推测其涉及多种机制。NAR患者通常会经历慢性鼻充血以及鼻前和/或鼻后分泌物增多,这会显著影响他们的生活质量。目前的标准治疗主要基于症状,因为缺乏针对该疾病潜在机制的特异性疗法。由于目前尚无NAR的治疗方案,患者之间的临床反应和疗效可能差异很大。在精心设计的临床试验中,鼻内用皮质类固醇和鼻内用抗组胺药已被证明对NAR治疗有效,因此被视为一线治疗药物。最近,对鼻内用抗组胺药/皮质类固醇与鼻内用减充血剂联合使用以及与鼻内用皮质类固醇联合使用的研究已显示出对过敏性鼻炎有前景,并且可能对NAR比单一疗法更有效。先前的NAR试验中使用了多种疗效指标,最常见的是鼻症状评分的变化。鉴于过敏性鼻炎和NAR通常经历的突出症状存在差异,用于评估这两组患者新治疗方法的准确临床疗效可能会有所不同。需要进一步专门设计的研究来调查各种治疗药物在NAR中的疗效,以改善这种慢性病的管理和疗效。

总结

需要进一步研究以扩展我们对NAR病理生物学的理解,这应该会带来管理该疾病的新治疗方法。必须有经过充分验证的NAR疗效指标,可用于研究这些新疗法。

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