静脉滴注泰克吉宁注射液人体耐受性试验  

Clinical Tolerance Trial on Intravenously Taikejining in Healthy Volunteers

作　　者：侯鑫[1] 徐楠[1] 刘春涛[1] 郑莉[1] 王颖[1] 

机构地区：[1]四川大学华西医院药物临床研究机构,四川成都610041

出　　处：《华西医学》2008年第4期759-761,共3页West China Medical Journal

摘　　要：目的:评价健康志愿者对泰克吉宁注射液单次和连续静脉给药的耐受性,为制定Ⅱ期临床试验给药方案提供依据。方法:38名受试者接受单次给药耐受试验,分别为50、100、200、350、500、650和750mg7个剂量组。6名健康受试者接受400mg bid5天连续给药耐受试验。结果:试验中未发生严重不良事件,多次给药中1名受试者用药后第5天出现头晕等症状,试验结束经处理后症状消失。单次给药200mg组,1例受试者给药后尿酸增高,未经处理5天后复查正常。50mg组用药后血WBC较用药前增高,650mg组用药后血WBC较用药前降低,差异有统计学意义,但两组受试者血WBC均在正常范围内,可能与药物无关。结论:单次静脉滴注泰克吉宁注射液在750mg剂量范围内及连续5d滴注400mg bid安全、耐受,400mg bid可作为Ⅱ期临床试验推荐给药方案。Objective：To assess the tolerance of intravenously Taikejining in healthy volunteers to confirm the phase Ⅱ clinical trial.Methods：Thirty-eight healthy subjects in single-does group,received does of Taikejining at 50,100,200,350,500,650 and 750 mg,respectively.Six healthy subjects in continuous-does group,were given 400 mg bid for five days.Results：No severe adverse event happened in the trial.One subject complained of dizzy on the fifth day in the continuous-does group,back to normal after treatment when the test was over.In 200mg does group,one subject,uric acid level increased,without any treatment,five days later the level were normal.In 50mg does group,WBC of blood routine examination after administration was higher than before,but in 650mg does group,WBC of blood routine examination after administration was lower,the difference had statistical significance,as the WBC of the two groups were all in normal range,they maybe not related to the drug.Conclusion：It is safe and tolerated to take Taikejining under 750 mg in single intravenous infusion administration and 400 mg bid administrating in continuous infusion for five days.Therefore,400 mg bid as the administrating protocol in phase Ⅱ clinical test is feasible.

关 键 词：泰克吉宁注射液 静脉滴注 耐受性试验 

分 类 号：R969.4[医药卫生—药理学]