5%新型复方氨基酸(19)丙谷二肽注射液(创伤用)在健康受试者中的安全性、耐受性研究——滴速考察试验

A new type of compound amino acid (19) injection containing N-(2)-L-alanyl-L-glutamine (used for trauma) in healthy subjects:the safety and tolerability study for dropping speed test

目的 观察新型复方氨基酸（19）丙谷二肽注射液（创伤用）不同滴速在健康受试者中的安全性、耐受性.方法 滴速试验采用逐渐递增的探索性研究方法.录入24例健康受试者,分为3组,每组男女各半,分别按照1.0、2.0、3.0mL/min的滴速进行给药,给药量均为500 mL,规格为250 mL：12.6 g（氨基酸/丙谷二肽）（5％）.晨起早餐后30 min经由外周静脉滴注给药.观察受试者的生命体征、实验室指标、心电图及不良事件.结果 共24例健康志愿者完成了滴速考察耐受性试验.共发生7个不良事件,其中3个可能与试验药物有关.试验中未发生严重不良事件.受试者的生命体征、实验室指标及心电图均未发现有临床意义的异常.结论 单次静脉滴注5％新型复方氨基酸（19）丙谷二肽注射液（创伤用）,在1.0 ～ 3.0 mL/min滴速范围之内,对中国健康受试者,安全且能够很好耐受.

Objective To assess the safety and tolerability of a new type of compound amino acid（19） injection containing N-（2）-L-alanyl-L-glutamine （used for trauma）by different dropping speed in healthy subjects.Methods An exploratory method with gradually increased dropping speed was used in this study.12 male and 12 female subjects were enrolled and were divided into 3 groups equally.Each group received the drug with a dose of 500 mL（content was 5％）,and the dropping speed was 1.0,2.0,3.0 mL/min respectively.The drug was administered through intravenous infusions 30 min after the breakfast.The physical signs,laboratory index,electrocardiogram and the drug-related adverse events of the subjects were observed closely.Results The dropping speed test was finished in all the subjects.Serious adverse event was not found in this study except 7 ordinary adverse events,which may have relevance with the experimental drug.No abnormity with clinical significance was found in the subjects＇physical signs,laboratory index and electrocardiogram.Conclusion The new type of compound amino acid（19） injection containing N-（2）-L-alanyl-L-glutamine（used for trauma and the content was 5％）is safety and well-tolerated in Chinese healthy subjects with the dropping speed ranging from 1.0 to 3.0 mL/min.