Dicpinigaitis Peter V
Department of Medicine, Albert Einstein College of Medicine, 1825 Eastchester Road, Bronx, NY 10461, USA.
Pulm Pharmacol Ther. 2003;16(1):61-5. doi: 10.1016/S1094-5539(02)00149-9.
The tussive agent capsaicin has achieved common usage in clinical research because it induces cough in a safe, dose-dependent, and reproducible manner. However, the reproducibility of capsaicin challenge testing has been demonstrated only in the short term (study intervals of 20 min to 14 days). In the present study, evaluation of data from several hundred cough challenges performed in the author's laboratory yielded two groups of 40 subjects. In the short-term reproducibility group, subjects underwent cough challenge at an interval of 14 days. Subjects in the long-term reproducibility group were challenged at intervals of at least 6 months (mean 16.7+/-2.4 months, range 6-62 months). All subjects were healthy adult volunteers who underwent identical cough challenge testing, which involved inhalation of incremental, doubling concentrations (microM) of capsaicin until the concentrations inducing two or more (C(2)) and five or more coughs (C(5)) were reached. Results were evaluated in terms of the percentage of subjects whose repeat studies yielded C(2) and C(5) values within one and two doubling concentrations of the initial values. Overall, reproducibility was quite good, with 90-100% of challenges yielding C(2) and C(5) values within two doubling concentrations. Short-term reproducibility of C(5) was superior to that of C(2), suggesting that C(5) is the preferred end point for trials involving serial cough challenges performed within a 14-day period.
镇咳剂辣椒素已在临床研究中广泛应用,因为它能以安全、剂量依赖性且可重复的方式诱发咳嗽。然而,辣椒素激发试验的可重复性仅在短期内得到证实(研究间隔为20分钟至14天)。在本研究中,对作者实验室进行的数百次咳嗽激发试验数据进行评估,得到了两组各40名受试者。在短期可重复性组中,受试者每隔14天接受一次咳嗽激发试验。长期可重复性组的受试者每隔至少6个月接受一次激发试验(平均16.7±2.4个月,范围6 - 62个月)。所有受试者均为健康成年志愿者,他们接受相同的咳嗽激发试验,试验包括吸入浓度递增、成倍增加(微摩尔)的辣椒素,直至达到诱发两次或更多次(C(2))和五次或更多次咳嗽(C(5))的浓度。根据重复研究中C(2)和C(5)值在初始值的一倍和两倍浓度范围内的受试者百分比来评估结果。总体而言,可重复性相当好,90 - 100%的激发试验中C(2)和C(5)值在两倍浓度范围内。C(5)的短期可重复性优于C(2),这表明C(5)是在14天内进行的系列咳嗽激发试验的首选终点。