重组人酸性成纤维细胞生长因子Ⅰ期临床研究  

A Phase Ⅰ clinical trial for recombinant human acidic fibroblast growth factor

作　　者：许华[1] 郑青[1] 吴晓萍[1] 付小兵[2] 曹之舫 李校坤[4] 

机构地区：[1]暨南大学药学院,广州510632 [2]解放军304医院,北京100037 [3]上海万兴生物制药有限公司,上海201206 [4]暨南大学医药生物技术研究开发中心,广州510632

出　　处：《中国新药杂志》2005年第12期1476-1479,共4页Chinese Journal of New Drugs

基　　金：国家863重大专项资助项目(2002AA2Z3318)

摘　　要：目的:确定人体对重组人酸性成纤维细胞生长因子(rhaFGF)的耐受性程度并研究其在人体的药动学特性。方法:将36例深Ⅱ°烧伤患者随机分为5组,分别在创面滴注不同剂量的rhaFGF(25,50,100,200和300 U.cm-2),qd,直至创面愈合,或用至21 d。比较各组创面愈合时间和愈合率,定期测定体温、脉搏、血压、呼吸及血尿常规、肝肾功能。并用ELISA方法测定血清rhaFGF的浓度。结果:除4例发生局部疼痛外,各剂量组均未见明显不良反应;该药很少经表皮创面吸收进入血液,各剂量组在用药后不同时间点均未能在血清中测到rhaFGF;各剂量组创面愈合时间以100 U.cm-2剂量组最短。结论:rhaFGF按剂量25,50,100,200和300 U.cm-2用于烧伤患者是安全的,以100 U.cm-2剂量组创面愈合所需时间最短。推荐Ⅱ期临床试验中使用剂量为100 U.cm-2。Objective：To study the toleranee and pharmacokinetic profiles of recombinant human acidic fibroblast growth factor （rhaFGF）, Methods： 36 patients with deep burn wound （degree Ⅱ ） wererandomly dripped with one of five rhaFGF doses （25, 50, 100, 200, or 300 U·cm^-2） onto the bum wound surface once a day until either wounds healing or for 21 days, whenever it was earlier. The efficacy of the therapy was assessed based on complete healing time and healing rates of wounds together with the changes of certain physical specifications, such as body temperature, pulse rate, blood pressure, breath rate and blood/ urinary lab tests. The serum rhaFGF concentrations were measured using ELISA. Results： No serum rhaFGF concentrations were measured in any groups, suggesting that the rhaFGF not to be absorbed into the body from the bum wound surface. The patients administered with 100U·cm^-2 of rhaFGF were healed the most rapidly. Only a few local pain events were reported, which were not associated with rhaFGF. No any other adverse events were reported in the study. Patients were tolerated well for the rhaFGF. Conclusion： The dose of 100 U·cm^-2 should be recommended in phase Ⅱ clinical trial.

关 键 词：重组人酸性成纤维细胞生长因子 创伤 耐受性 药动学 Ⅰ期临床试验 

分 类 号：R969.4[医药卫生—药理学] R977.1[医药卫生—药学]