Yuen Eunice S M, Sims John R
Eli Lilly and Company, Erl Wood Manor, Windlesham, Surrey GU20 6PH, United Kingdom.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
Seizure. 2014 Jun;23(6):490-3. doi: 10.1016/j.seizure.2014.03.011. Epub 2014 Mar 28.
Human photosensitive epilepsy models have been used as proof of principle (POP) trials for epilepsy. Photosensitive patients are exposed to intermittent photic stimulation and the reduction in sensitivity to the number of standard visual stimulation frequencies is used as an endpoint. The aim of this research was to quantify the predictive capabilities of photosensitive POP trials, through a survey of current literature.
A literature search was undertaken to identify articles describing photosensitive POP trials. Minimally efficacious doses (MEDs) in epilepsy were compared to doses in the POP trials that produced 50-100% response (ED50-100). Ratios of these doses were calculated and summarised statistically.
The search identified ten articles describing a total of 17 anti-epileptic drugs. Of these, data for both MED and ED50-100 were available for 13 anti-epileptic drugs. The average ratio of MED to ED50-100 was 0.95 (95% CI 0.60-1.30). The difference in MED to ED50-100 ratios between partial epilepsy (0.82) was not significantly different from that of generalised epilepsy (1.08) (p=0.51).
Photosensitive POP trials are a useful tool to quantitatively predict efficacy in epilepsy, and can be useful as early and informative indicators in anti-epileptic drug discovery and development.
人类光敏性癫痫模型已被用作癫痫的原理验证（POP）试验。光敏性患者接受间歇性光刺激，并将对标准视觉刺激频率数量的敏感性降低作为一个终点指标。本研究的目的是通过对现有文献的调查，量化光敏性POP试验的预测能力。
进行文献检索以识别描述光敏性POP试验的文章。将癫痫中的最小有效剂量（MEDs）与在POP试验中产生50-100%反应的剂量（ED50-100）进行比较。计算这些剂量的比率并进行统计学汇总。
检索确定了十篇描述总共17种抗癫痫药物的文章。其中，13种抗癫痫药物同时有MED和ED50-100的数据。MED与ED50-100的平均比率为0.95（95%可信区间0.60-1.30）。部分性癫痫（0.82）的MED与ED50-100比率与全身性癫痫（1.08）的差异无统计学意义（p=0.51）。
光敏性POP试验是定量预测癫痫疗效的有用工具，并且在抗癫痫药物发现和开发中可作为早期且有信息量的指标。
