血脂泰分散片Ⅰ期临床人体耐受性研究  

Phase Ⅰ Clinical Tolerable Study of Xuezhitai Dispersible Tablets on Human

作　　者：周翠兰 胡思源[2] 倪天庆[2] 黄大森 张广明 

机构地区：[1]广州一品红制药有限公司研发中心,广东广州510760 [2]天津中医药大学第一附属医院儿科,天津300193

出　　处：《中国医院用药评价与分析》2017年第11期1460-1463,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：广东省重大科技专项"治疗高脂血症药物血脂泰分散片的临床研究"(No.2012A080204008);广州市重大科技专项"治疗高脂血症药物血脂泰分散片的临床研究"(No.201300000044)

摘　　要：目的:考察健康人对不同剂量血脂泰分散片的耐受性和安全性,为制定血脂泰分散片Ⅱ期临床试验给药方案提供安全的剂量范围。方法:将筛选合格的40例健康受试者,采用开放、随机、多剂量组及自身前后对照设计,按顺序进行血脂泰分散片单次给药和连续给药耐受性试验。单次给药组受试者共28例,分为5个剂量组,给药剂量分别为4、6、8、10及12片(有效部位含量为20 mg/片),1日给药1次;多次给药组受试者共12例,分为2个剂量组,给药剂量分别为10、12片,1日给药1次,连续7 d。观察指标为生命体征、理化检查、不良反应。应用SAS软件进行统计分析。结果:单次给药组和多次给药组均有1例受试者发生腹泻不良反应,其他生命体征及实验室检查未见与药物有关的具有临床意义的变化。结论:血脂泰分散片单次给药≤12片;或剂量≤1次12片,1日1次,连续给药7 d,在人体的应用是安全的。OBJECTIVE： To investigate the tolerance and safety of different dose of Xuezhitai dispersible tablets on human body,so as to provide safe dosage range of formulation of Xuezhitai dispersible tablets in phase Ⅱ clinical trials. METHODS： The opened,randomized,multi-doses,self-controlled design was adopted, single dose and continuous administration tolerance test of Xuezhitai dispersible tablets were conducted on 40 healthy volunteers. Single dose group was 28 cases,totally 5 dose groups,with administration of 4 tablets,6 tablets,8 tablets,10 tablets and 12 tablets（ the effective site content is 20 mg per tablet）,qd. And continuous administration group was 12 healthy volunteers,totally 2 dose groups,with administration of 10 and 12 tablets,qd,for 7 days. The observation indicators were respectively vital signs,physical and chemical inspection and adverse drug reactions. Statistical analysis was conducted by using SAS software. RESULTS： One case of diarrhea was found in the single dose group and the continuous administration group,and there were no other clinically significant changes in vital signs and laboratory tests. CONCLUIONS： The application of single dose of Xuezhitai dispersible tablets ≤12 tablets or 12 tablets ≤ 1 dose a day,qd,for 7 days is safe for human body.

关 键 词：血脂泰分散片 Ⅰ期临床 耐受性 

分 类 号：R965.3[医药卫生—药理学]