Novel Capsaicin Challenge Methodology: a New Diagnostic Endpoint?

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Abstract

Background: Capsaicin cough challenge is used in pre-clinical and clinical studies to evaluate mechanisms, however standard methods and endpoints discriminate poorly between healthy volunteers (HV) and refractory chronic cough (RCC) patients. Aims: We aimed to assess the ability of capsaicin dose response curves to differentiate RCC from HV using receiver operator characteristic (ROC) curve analysis. Methods: 93 HV (median age 39yrs (IQR 29-52), 47 females) and 51 RCC (age 59yrs (53-67), 31 females) performed a full dose response cough challenge, inhaling doubling doses of capsaicin (0.48-1000µmol/L) four times up to the maximum tolerated dose. The number of coughs evoked in 15s following inhalation was recorded. Emax (maximum number of coughs evoked by any dose) and ED50 (dose evoking at least half of the Emax) were derived. Results: Emax was significantly higher in the RCC group compared with HV (median(IQR) 27(21-37) coughs vs. 13(9-19), p<0.001) and ED50 was significantly reduced (median(IQR) 15.6(3.9-31.3) vs. 31.3(15.6-125.0), p=0.001). These endpoints were significantly influenced by gender (females, higher Emax/lower ED50) but not by age, BMI, lung function. Area under the curve values suggested Emax (0.83, 95%CI 0.75-0.90) was superior to ED50 (0.66, 95%CI 0.57-0.76) (Fig1). Conclusion: ROC curve analysis suggests capsaicin evoked Emax discriminates well between RCC and HV therefore showing promise as a diagnostic test for RCC.

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Diagnosis,Pharmacology,Cough

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【要点】：本研究提出了一种新的辣椒素挑战方法，通过评估辣椒素剂量反应曲线的Emax值来区分难治性慢性咳嗽（RCC）患者与健康志愿者，结果显示Emax值具有较好的诊断价值。

【方法】：使用受试者操作特征（ROC）曲线分析，对93名健康志愿者和51名RCC患者进行全剂量反应咳嗽挑战，记录吸入不同剂量辣椒素后的咳嗽次数，计算Emax和ED50值。

【实验】：实验中，参与者吸入0.48-1000µmol/L的倍增剂量辣椒素，直至最大耐受剂量，记录15秒内的咳嗽次数。结果显示，RCC组的Emax值显著高于健康志愿者组，而ED50值显著降低。这些指标受性别影响显著，但不受年龄、BMI和肺功能影响。Emax值的ROC曲线下面积（AUC）为0.83，表明其诊断RCC的潜力优于ED50值。