二咖啡酰奎尼酸片Ⅰ期临床耐受性研究

目的评价健康志愿者单次口服二咖啡酰奎尼酸片的安全性和耐受性。方法按照GCP要求设计试验方案。单剂量耐受试验将60名受试者随机分为7个剂量组，每组男（2～5）名，女（2～5）名，从低剂量开始给药，观察指标为临床症状、生命体征和实验室检查指标等，采用描述性分析及SAS软件进行统计学处理。结果在单剂量给予二咖啡酰奎尼酸片耐受性试验中，各组受试者入选时各项指标均在正常范围，条件均衡，具有可比性。共报告6人6件被研究者判定为可能与研究药物有关的不良事件，且未经处理均消失。不良事件主要表现为窦性心动过缓、血白细胞降低，无自觉症状，均完成临床试验，其他均未见有临床意义的改变。结论60名健康受试者单次口服二咖啡酰奎尼酸片，最大剂量至1200mg，均安全且能够很好耐受。

Clinical Tolerability of 1,5-Dicaffeoylquinicacid Tablets

Aim To evaluate the safety and tolerability of 1,5-dicaffeoylquinic acid tablets in Chinese healthy volunteers. Methods The protocol was designed according to the Good Clinical Practice （GCP）. Sixty healthy volunteers were randomly divided into 7 dosage groups （50,200,400,600,800,1 000 and 1 200mg） with 2 -5 males and 2 -5 females in each group . Clinical symptoms, vital signs, and laboratory tests were observed before and after 1,5-dicaffeoylquinic acid tablets administration to evaluate the adverse events. Results Most vital signs,clinical symptoms and laboratory tests were normal in the volunteers with a single dose 1,5-dicaffeoylquinic acid tablets. Only 6 cases of slight and tolerable adverse drug reaction were observed. Conclusion A single-dose （ as much as 1200mg） of 1 ,5-dicaffeoylquinic acid tablets is safe and tolerable.