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鼻窦炎:为临床研究和患者护理确立定义。

Rhinosinusitis: Establishing definitions for clinical research and patient care.

作者信息

Meltzer Eli O, Hamilos Daniel L, Hadley James A, Lanza Donald C, Marple Bradley F, Nicklas Richard A, Bachert Claus, Baraniuk James, Baroody Fuad M, Benninger Michael S, Brook Itzhak, Chowdhury Badrul A, Druce Howard M, Durham Stephen, Ferguson Berrylin, Gwaltney Jack M, Kaliner Michael, Kennedy David W, Lund Valerie, Naclerio Robert, Pawankar Ruby, Piccirillo Jay F, Rohane Patricia, Simon Ronald, Slavin Raymond G, Togias Alkis, Wald Ellen R, Zinreich S James

机构信息

Allergy and Asthma Medical Group and Research Center, Department of Pediatrics, University of California, San Diego 92123, USA.

出版信息

Otolaryngol Head Neck Surg. 2004 Dec;131(6 Suppl):S1-62. doi: 10.1016/j.otohns.2004.09.067.

Abstract

BACKGROUND

There is a need for more research on all forms of rhinosinusitis. Progress in this area has been hampered by a lack of consensus definitions and the limited number of published clinical trials.

OBJECTIVES

To develop consensus definitions for rhinosinusitis and outline strategies useful in clinical trials.

STUDY DESIGN

Five national societies, The American Academy of Allergy, Asthma and Immunology; The American Academy of Otolaryngic Allergy; The American Academy of Otolaryngology Head and Neck Surgery; The American College of Allergy, Asthma and Immunology; and the American Rhinologic Society formed an expert panel from multiple disciplines. Over two days, the panel developed definitions for rhinosinusitis and outlined strategies for design of clinical trials.

RESULTS

Committee members agreed to adopt the term “rhinosinusitis” and reached consensus on definitions and strategies for clinical research on acute presumed bacterial rhinosinusitis, chronic rhinosinusitis without polyposis, chronic rhinosinusitis with polyposis, and classic allergic fungal rhinosinusitis. Symptom and objective criteria, measures for monitoring research progress, and use of symptom scoring tools, quality-of-life instruments, radiologic studies, and rhinoscopic assessment were outlined for each condition.

CONCLUSIONS

The recommendations from this conference should improve accuracy of clinical diagnosis and serve as a starting point for design of rhinosinusitis clinical trials.

摘要

背景

对于各种形式的鼻窦炎,需要开展更多研究。该领域的进展因缺乏共识定义以及已发表的临床试验数量有限而受到阻碍。

目的

制定鼻窦炎的共识定义,并概述在临床试验中有用的策略。

研究设计

五个国家学会,即美国过敏、哮喘与免疫学会;美国耳鼻咽喉变态反应学会;美国耳鼻咽喉头颈外科学会;美国过敏、哮喘与免疫学院;以及美国鼻科学会,组建了一个多学科专家小组。在两天时间里,该小组制定了鼻窦炎的定义,并概述了临床试验设计策略。

结果

委员会成员同意采用“鼻窦炎”这一术语,并就急性疑似细菌性鼻窦炎、无息肉的慢性鼻窦炎、有息肉的慢性鼻窦炎以及典型变应性真菌性鼻窦炎的临床研究定义和策略达成共识。针对每种情况,概述了症状和客观标准、监测研究进展的措施,以及症状评分工具、生活质量量表、放射学研究和鼻内镜评估的使用方法。

结论

本次会议的建议应能提高临床诊断的准确性,并作为鼻窦炎临床试验设计的起点。

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