喉咽反流疾病新临床仪器的研发：国际耳鼻咽喉科学会联合会年轻耳鼻咽喉科医生国际项目
The development of new clinical instruments in laryngopharyngeal reflux disease: The international project of young otolaryngologists of the International Federation of Oto-rhino-laryngological Societies.
作者信息
Lechien J R, Schindler A, Hamdan A L, Bobin F, Barillari M R, Harmegnies B, Dequanter D, Rodriguez A, Bartaire E, Ayad T, Karkos P, Crevier-Buchman L, Finck C, Saussez S
机构信息
Laryngopharyngeal Reflux Study Group of Young Otolaryngologists of International Federation of Oto-rhino-laryngological Societies, Belgium; Department of Anatomy and Experimental Oncology, Mons School of Medicine, UMONS Research Institute for Health Sciences and Technology, University of Mons (UMons), Mons, Belgium; Laboratory of Phonetics, Faculty of Psychology, Research Institute for Language Sciences and Technology, University of Mons (UMons), Mons, Belgium; Department of Otorhinolaryngology and Head and Neck Surgery, CHU Saint-Pierre, Université Libre de Bruxelles, School of Medicine, Brussels, Belgium.
Laryngopharyngeal Reflux Study Group of Young Otolaryngologists of International Federation of Oto-rhino-laryngological Societies, Belgium; Department of Biomedical and Clinical Sciences, Phoniatric Unit, L. Sacco Hospital, University of Milan, Milan, Italy.
出版信息
Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Sep;135(5S):S85-S91. doi: 10.1016/j.anorl.2018.05.013. Epub 2018 Aug 28.
INTRODUCTION
To analyze the epidemiological characteristics of placebo controlled randomized trials (RCTs) that evaluated the effectiveness of medical treatments over placebo in laryngopharyngeal reflux (LPR).
MATERIAL AND METHODS
PubMed, Cochrane database, and Scopus were assessed for subject headings using the PRISMA recommendations. Placebo RCTs published between 1990 and 2018 describing clinical evolution throughout LPR treatment were extracted and analyzed for evidence-based level, number of patients, inclusion and exclusion criteria, gender, age, symptoms and signs used as therapeutic outcomes, and treatment schemes.
RESULTS
The database search identified 15 placebo RCTs with a total of 763 patients. The mean age of patients was 48.59 years and 52.68% of patients were female. Among the 15 placebo RCTs, 9 have demonstrated a partial or total superiority of a medical treatment over placebo. Most of authors based the LPR diagnosis on symptoms and signs without additional examination. Our analysis reveals an important heterogeneity between studies with regard to the diagnosis criteria, treatment schemes and signs and symptoms used as therapeutic outcomes. Many commonly reported signs and symptoms related to LPR were not used as therapeutic outcomes. Half of the authors did not prescribe diet and behavioral changes along the treatment.
CONCLUSION
The controversy in the RCTs about the superiority of medical treatment over placebo in LPR disease is probably due to discrepancies in the diagnosis method, exclusion criteria, therapeutic schemes and the lack of comprehensive tools for the assessment of signs and symptoms. In this context, the LPR Study Group of Young-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies developed two new instruments to precisely assess signs and symptoms throughout the treatment. These two instruments could be used in future trials comparing medical treatment over placebo in LPR disease.
引言
分析评估医学治疗在喉咽反流（LPR）中优于安慰剂疗效的安慰剂对照随机试验（RCT）的流行病学特征。
材料与方法
依据PRISMA建议，对PubMed、Cochrane数据库和Scopus进行主题词评估。提取并分析1990年至2018年间发表的描述LPR治疗全过程临床进展的安慰剂RCT，内容包括循证水平、患者数量、纳入和排除标准、性别、年龄、用作治疗结果的症状和体征以及治疗方案。
结果
数据库检索识别出15项安慰剂RCT，共763例患者。患者平均年龄为48.59岁，52.68%为女性。在这15项安慰剂RCT中，9项显示某种医学治疗在部分或整体上优于安慰剂。大多数作者基于症状和体征诊断LPR，未进行额外检查。我们的分析揭示，各研究在诊断标准、治疗方案以及用作治疗结果的体征和症状方面存在重要异质性。许多与LPR相关的常见体征和症状未被用作治疗结果。一半的作者在治疗过程中未规定饮食和行为改变。
结论
RCT中关于医学治疗在LPR疾病中优于安慰剂的争议，可能归因于诊断方法、排除标准、治疗方案的差异以及缺乏用于评估体征和症状的综合工具。在此背景下，国际耳鼻咽喉科学会联合会青年耳鼻咽喉科医生LPR研究组开发了两种新工具，以在整个治疗过程中精确评估体征和症状。这两种工具可用于未来比较LPR疾病中医学治疗与安慰剂疗效的试验。
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