健康受试者联用磷酸瑞格列汀片与缬沙坦的安全性及耐受性研究  

Safety and tolerability of combination of retagliptin and valsartan in healthy volunteers

作　　者：雍小兰[1] 李楠[1] 冯仕银[1] 王蓝天[1] 康辉[1] 

机构地区：[1]中国人民解放军成都军区总医院,成都610083

出　　处：《中国新药杂志》2015年第21期2476-2479,共4页Chinese Journal of New Drugs

摘　　要：目的：评价健康志愿者同时口服磷酸瑞格列汀和缬沙坦的安全性和耐受性。方法：采用二阶段交叉试验设计,纳入18~45岁健康受试者16例,按照AB,BA给药序列随机分为2组,每个序列组8例,男女各半。各阶段间隔6 d洗脱期,第2阶段2个序列组交叉给药。观察生命体征、实验室检查指标、临床症状和不良事件等。结果：16例受试者全部完成试验。联用磷酸瑞格列汀片与缬沙坦胶囊后生命体征、实验室检查、心电图等均未出现有临床意义的异常变化。两药联用的不良事件主要为乳酸脱氢酶升高、感冒、腹泻、白细胞降低等,不良事件发生率为31.3%。这些事件的严重程度均为轻度,试验过程中未发生严重不良事件。结论：磷酸瑞格列汀与缬沙坦联用的安全性和耐受性良好。Objective： To evaluate the safety and tolerability of combination of orally administered retagliptin and valsartan in healthy volunteers. Methods： According to randomized,two-stage cross-over design principle,16 healthy volunteers were divided into two groups（ n = 8） in which retagliptin and valsartan were administered orally on the basis of two dosing sequences namely AB or BA. Washout period was 6 d. Vital signs,laboratory examination,clinical symptoms and adverse events were recorded during the clinical trial. Results： Sixteen healthy volunteers all completed the scheduled trial. There were no clinically significant changes in terms of vital signs,laboratory examination,electrocardiogram and so forth after oral administration of retagliptin and valsartan. The incidence of adverse events was 31. 3%,mainly including elevated lactate dehydrogenase,common cold,diarrhea,reduced white blood cells,etc. The above-mentioned adverse events were mild,and serious adverse events were not observed during the course of trials. Conclusion： Combination of retagliptin and valsartan possesses favorable safety and tolerability.

关 键 词：瑞格列汀 缬沙坦 安全性 耐受性 

分 类 号：R977.15[医药卫生—药品]