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参与 P2X3 受体拮抗剂 Gefapixant 二期临床试验的难治性或不明原因慢性咳嗽患者的特征。

Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant.

机构信息

Respiratory Research Group, Hull York Medical School, Cottingham, UK.

Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.

出版信息

Lung. 2021 Apr;199(2):121-129. doi: 10.1007/s00408-021-00437-7. Epub 2021 Apr 7.

DOI:10.1007/s00408-021-00437-7
Abstract

PURPOSE

This analysis assesses clinical characteristics of patients with refractory chronic cough (RCC) or unexplained chronic cough (UCC) enrolled in a phase 2 study to better understand this patient population.

METHODS

Patients with RCC/UCC lasting for ≥ 1 year and cough severity visual analog scale (VAS) score of > 40 mm at screening were eligible. Demographics, clinical characteristics, and medical history were collected at baseline. Cough-related measures included cough severity VAS, Cough Severity Diary (CSD), Leicester Cough Questionnaire (LCQ), and a structured cough-trigger questionnaire. Medication history included all medications 30 days before screening and chronic cough treatments within 1 year before screening. Data were summarized using descriptive statistics.

RESULTS

Patients (N = 253; female, 76%; mean age, 60 years) had severe (mean cough severity VAS, 57.5 mm) and long-lasting (median duration, 11 years) cough. The most burdensome self-reported aspects included psychological and social factors (LCQ) and cough frequency and intensity (CSD). Patient-reported triggers were consistent with cough hypersensitivity (e.g., 95% to 96% reported irritation or tickle in throat). Common reported comorbidities included gastroesophageal reflux disease (GERD; 56%), allergic rhinitis (47%), and asthma (30%); 12% of patients had been diagnosed with all 3 conditions. The most common prior medications included inhaled or oral steroids (21%), antihistamines (15%), and antacids (15%).

CONCLUSION

Patients with RCC/UCC had severe, long-lasting, and burdensome cough with clinical features of cough hypersensitivity. Many patients had been diagnosed with GERD, allergic rhinitis, and asthma but had a persistent cough despite treatment of these conditions.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02612610; registered November 20, 2015.

摘要

目的

本分析评估了参加 2 期研究的难治性慢性咳嗽(RCC)或不明原因慢性咳嗽(UCC)患者的临床特征,以便更好地了解这一患者人群。

方法

符合条件的患者为 RCC/UCC 持续时间≥1 年且筛查时咳嗽严重程度视觉模拟量表(VAS)评分>40mm。在基线时收集了人口统计学、临床特征和病史。咳嗽相关措施包括咳嗽严重程度 VAS、咳嗽严重程度日记(CSD)、莱斯特咳嗽问卷(LCQ)和结构化咳嗽触发问卷。药物史包括筛查前 30 天的所有药物和筛查前 1 年内的慢性咳嗽治疗药物。使用描述性统计数据对数据进行总结。

结果

患者(N=253;女性,76%;平均年龄,60 岁)有严重(平均咳嗽严重程度 VAS,57.5mm)和长期(中位数持续时间,11 年)咳嗽。自我报告的最具负担的方面包括心理和社会因素(LCQ)以及咳嗽频率和强度(CSD)。患者报告的触发因素与咳嗽高敏性一致(例如,95%至 96%的患者报告喉咙有刺激或刺痛感)。常见的报告合并症包括胃食管反流病(GERD;56%)、过敏性鼻炎(47%)和哮喘(30%);12%的患者被诊断出同时患有这 3 种疾病。最常见的既往用药包括吸入或口服类固醇(21%)、抗组胺药(15%)和抗酸剂(15%)。

结论

RCC/UCC 患者有严重、长期且负担沉重的咳嗽,具有咳嗽高敏性的临床特征。许多患者被诊断出 GERD、过敏性鼻炎和哮喘,但尽管治疗了这些疾病,仍持续咳嗽。

试验注册

ClinicalTrials.gov,NCT02612610;注册日期:2015 年 11 月 20 日。

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2
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3
Cough persistence in adults with chronic cough: A 4-year retrospective cohort study.
慢性咳嗽中莱斯特咳嗽问卷的严重程度分级
ERJ Open Res. 2024 Jul 29;10(4). doi: 10.1183/23120541.00142-2024. eCollection 2024 Jul.
4
Comprehensive insights into potential roles of purinergic P2 receptors on diseases: Signaling pathways involved and potential therapeutics.对嘌呤能P2受体在疾病中的潜在作用的全面见解:涉及的信号通路及潜在治疗方法。
J Adv Res. 2025 Mar;69:427-448. doi: 10.1016/j.jare.2024.03.027. Epub 2024 Mar 31.
5
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Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241236025. doi: 10.1177/17534666241236025.
6
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EBioMedicine. 2024 Feb;100:104976. doi: 10.1016/j.ebiom.2024.104976. Epub 2024 Jan 19.
7
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8
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成人慢性咳嗽中持续性咳嗽:一项 4 年回顾性队列研究。
Allergol Int. 2020 Oct;69(4):588-593. doi: 10.1016/j.alit.2020.03.012. Epub 2020 Apr 20.
4
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Lancet Respir Med. 2020 Aug;8(8):775-785. doi: 10.1016/S2213-2600(19)30471-0. Epub 2020 Feb 25.
5
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J Allergy Clin Immunol Pract. 2020 May;8(5):1645-1657.e7. doi: 10.1016/j.jaip.2020.01.054. Epub 2020 Feb 12.
6
The demographic and clinical characteristics of an Italian population of adult outpatients with chronic cough.意大利成年慢性咳嗽门诊患者的人口统计学和临床特征。
Aging Clin Exp Res. 2020 Apr;32(4):741-746. doi: 10.1007/s40520-019-01464-4. Epub 2020 Jan 16.
7
ERS guidelines on the diagnosis and treatment of chronic cough in adults and children.ERS 指南:成人和儿童慢性咳嗽的诊断与治疗。
Eur Respir J. 2020 Jan 2;55(1). doi: 10.1183/13993003.01136-2019. Print 2020 Jan.
8
Risk factors for repetitive doctor's consultations due to cough: a cross-sectional study in a Finnish employed population.因咳嗽而反复就诊的风险因素:芬兰就业人群的横断面研究。
BMJ Open. 2019 Jun 11;9(6):e030945. doi: 10.1136/bmjopen-2019-030945.
9
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J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1711-1714. doi: 10.1016/j.jaip.2019.04.012. Epub 2019 Apr 17.
10
New insights in the diagnosis of chronic refractory cough.慢性难治性咳嗽的诊断新见解。
Respir Med. 2018 Aug;141:103-110. doi: 10.1016/j.rmed.2018.06.024. Epub 2018 Jun 28.