Department of Clinical Pharmacology and Therapeutics, ICMR Advance Centre for Clinical Pharmacodynamic, Nizam's Institute of Medical Sciences, Hyderabad, India.
Indian J Pharmacol. 2012 Sep-Oct;44(5):571-5. doi: 10.4103/0253-7613.100375.
An experimental pain model which is sensitive and reproducible would be a useful pharmacological tool both for existing and new drugs. The aim of the present study was to establish a simple and reliable method of producing experimental pain which can be used for screening of analgesic agents.
The method was standardized by recording pain threshold and pain tolerance values in 24 healthy volunteers. Reproducibility of the test procedure was evaluated by recording the pain threshold and pain tolerance values by a single observer on two sessions (inter-day reproducibility), and second observer in one session (inter-observer reproducibility), separately. Validity of the model was further tested by evaluating the analgesic effect of tramadol in 12 healthy volunteers.
Cold pain model was found to produce low variability with coefficient of variation less than 15%. Inter-observer and inter-day reproducibility was very good as shown by Bland - Altman plot with most of the values within ± 2SD. Analgesic activity by Tramadol was statistically different from placebo (P < 0.05).
The newly developed pain model offers a stable and sensitive method for the early assessment of analgesic activity.
一种敏感且可重现的实验性疼痛模型，对于现有和新药物来说，将是一种有用的药理学工具。本研究的目的是建立一种简单可靠的产生实验性疼痛的方法，可用于筛选镇痛药。
通过记录 24 名健康志愿者的疼痛阈值和疼痛耐受值，对该方法进行了标准化。通过一名观察者在两次（日内重现性）和另一名观察者在一次（观察者间重现性）中记录疼痛阈值和疼痛耐受值，评估了该测试程序的重现性。通过评估 12 名健康志愿者曲马多的镇痛作用，进一步测试了该模型的有效性。
冷痛模型产生的变异性较低，变异系数小于 15%。观察者间和日内重现性非常好，Bland - Altman 图显示大多数值在± 2SD 内。曲马多的镇痛活性与安慰剂相比具有统计学差异（P < 0.05）。
新开发的疼痛模型为早期评估镇痛活性提供了一种稳定且敏感的方法。
