注射用法罗培南钠Ⅰ期临床耐受性试验  

PhaseⅠclinical tolerability trial of faropenem sodium for injection

作　　者：孙黎[1,2] 姚晓东[3] 苏克剑[3] 朱珺[1] 

机构地区：[1]上海交通大学胸科医院药剂科,上海200030 [2]医学院仁济医院药剂科,上海200001 [3]上海交通大学医学院仁济医院药剂科,上海200001

出　　处：《上海交通大学学报（医学版）》2010年第3期329-332,共4页Journal of Shanghai Jiao tong University:Medical Science

基　　金：国家科技部“重大新药创制”科技重大专项基金(2008ZX09312-007)~~

摘　　要：目的评价健康人体对法罗培南钠注射液的耐受性。方法将31名健康志愿受试者随机分为单次给药组(n=24,单次静脉滴注法罗培南钠200、400、800、1 000和1 200 mg)和多次给药组(n=7,以400 mg bid的剂量连续用药7 d)。观察用药前后受试者生命体征、心电图和血生化指标的变化,并观察和记录药物不良反应。结果单次给药后1、8及24 h,受试者生命体征、心电图及血生化指标均未发现有临床意义的异常变化。1名受试者发生与药物无关的不良事件,主要表现为腹痛、腹泻症状,程度较轻,1 d后自行恢复。多次给药耐受性实验结果显示,给药后第4天和第8天,受试者生命体征、心电图及血生化指标均未发现有临床意义的异常变化;且未发生任何不良事件。结论健康人体单次静脉滴注200～1200 mg及多次静脉滴注400 mg法罗培南钠是安全且可以耐受的,该药有进一步开发的价值。Objective To evaluate the tolerability of healthy subjects to faropenem sodium injection. Methods Thirty- one healthy volunteers were randomly divided into single-dose group （n =24; 200, 400, 800, 1 000 and 1 200 mg faropenem sodium by intravenous drip） and multiple-dose group （ n = 7; 400 mg faropenem sodium, Bid, 7 d）. Vital signs, electrocardiogram and serum biochemical indicators were observed before and after faropenem sodium administration, and adverse effects were recorded. Results There were no abnormal findings in vital signs, electrocardiogram and serum biochemical indicators 1, 8 and 24 h after single-dose administration. One subject experienced mild drug-unrelated adverse effects of diarrhea and bellyache, and recovered 1 d later. There were no abnormal findings in vital signs, electrocardiogram and serum biochemical indicators 4 and 8 d after multiple-dose administration, and no adverse event occurred. Conclusion Faropenem sodium for injection is safe at a dose of 200 mg to 1 200 mg as single-dose administration or at a dose of 400 mg as multiple-dose administration.

关 键 词：注射用法罗培南钠 单次给药 多次给药 耐受性试验 

分 类 号：R969.4[医药卫生—药理学]