黄芪甲苷葡萄糖注射液Ⅰ期耐受性临床试验  

Study on phaseⅠ clinical tolerance of the astragalus a glycoside of glucose injection

作　　者：陈光宇[1] 丁红[1] 刘永家[1] 蒋伟勇 

机构地区：[1]成都中医药大学附属医院,成都610072 [2]上海金桥国际科技发展实业总公司,上海201206

出　　处：《中药药理与临床》2012年第6期134-136,共3页Pharmacology and Clinics of Chinese Materia Medica

摘　　要：目的:评价健康志愿者对黄芪甲苷葡萄糖注射液静脉给药的耐受性,为制定Ⅱ期临床试验给药方案提供依据。方法:单次给药组33名健康受试者被随机分配到7个剂量组,分别静脉滴注试验药20、50、100、150、200、250、320ml。连续给药组12名健康受试者被随机分配到100ml和200ml两个剂量组,1次/日静脉滴注,连续7天。观察给药后健康人体对试验药反应和耐受性。结果:试验中未发生严重不良事件。其中250ml组1例出现局部静脉炎;连续给药100ml组有1例出现用药后ALT、AST轻度升高。结论:健康受试者对黄芪甲苷葡萄糖注射液静脉给药的耐受性较好,个别病例出现局部静脉炎及ALT、AST升高,均未作任何处理,停药后可自行消失。推荐Ⅱ期临床试验的安全剂量范围:100ml/次,1次/日,静脉滴注。建议在Ⅱ期临床试验时加强对肝功能的监测和给药局部症状的观察。To evaluate the healthy volunteers tolerance to The astragaloside glucose injection by vein and provide a basic database for the development of Phase I1 clinical trials regimen. Methods ：The 33 healthy subjects who receive Single dose are randomly assigned to seven groups, then give them test drug intravenous infusion of 20,50,100,150,200,250,320 ml respectively. The 12 healthy subjects who receive continuous dose are randomly assigned to 2 groups, then give them test drug intravenous infusion of 100 and 200ml once a day and repeat 7 days. Observe the healthy volunteers reaction and tolerance to the test drug. Results： No serious adverse events were found in the trial, ex- cept one local phlebitis in the 250ml groups and a case that ALT and AST increased slightly in the 10Oral injection group after continuous ad- ministration. Conclusions： The healthy subjects has good tolerance to The astragaloside glucose injection by vein. Individual cases could get the local phlebitis and ALT, AST increased, while all the complications go away after stopping the injection without any treatment. Safe dose range recommended in the phase Ⅱ clinical trial is less than 100ml/day and the observation of liver function as well as the administration of local symptoms should also be recommended.

关 键 词：黄芪甲苷葡萄糖注射液 Ⅰ期临床试验 耐受性 安全性 

分 类 号：R285[医药卫生—中药学]