二咖啡酰奎尼酸片健康人体安全性及耐受性研究

Clinical tolerability of 1,5-dicaffeoylquinic acid tablets

目的：评价健康志愿者单剂量及多剂量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。单剂量给药58名受试者随机分至7个剂量组，每组4—10名，多剂量给药30名受试者随机分至3个剂量组，男女各半，从低剂量开始给药，单剂量给药结束后进行多剂量给药，多剂量给药10d；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：在单剂量及多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9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：88名健康受试者中单剂量口服二咖啡酰奎尼酸片，最大剂量至1200mg；多剂量口服二咖啡酰奎尼酸片，最大剂量至500mg，每12h1次，均安全且能很好耐受。

Objective ：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）. Fifty-eight healthy volunteers were randomly divided into 7 dosage groups treated with 50,200,400,600,800,1 000 and 1 200 mg, respectively. Thirty healthy volunteers were randomly divided into 3 dosage groups treated with 200,300,500 mR twice daily. There are 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 single dose and multiple doses of 1,5-dicaffeoylquinic acid tablets. Only 9 cases of slight and tolerable adverse drug reactions were observed. Conclusion：Single-dose regimen up to 1 200 mg and multiple dose regimen up to 500 mg, twice daily of 1,5-dicaffeoylquinic acid tablets are safe and tolerable.