观察重组人肝细胞生长因子裸质粒表达产物在人体血液中的含量及其抗原性变化  

Content of recombinant human hepatocyte growth factor naked plasmid expression product and its antigenicity in the human body

作　　者：陈鹏[1] 王育琴[1] 谷涌泉[2] 崔世军[2] 丁大有[3] 汤晓闯[3] 

机构地区：[1]首都医科大学宣武医院药剂科,北京100053 [2]首都医科大学宣武医院血管外科,北京100053 [3]北京诺思兰德生物技术股份有限公司,北京100085

出　　处：《国际外科学杂志》2010年第3期155-158,F0003,共5页International Journal of Surgery

摘　　要：目的研究血浆中重组人肝细胞生长因子裸质粒（pCK—HGFX7）表达产物肝细胞生长因子（hepatocyteg rowth factor，HGF）含量在体内的变化，以及应用本品后是否发生免疫反应产生HGF抗体。方法选择21例严重下肢缺血性疾病患者（Rutherford分级4—6级），随机分为4mg、8mg、12mg、16mg4个剂量组。将每组剂量等量平分后在试验期第1天及第15天于下肢缺血部位的供血动脉走行和侧支循环可能建立的部位肌内注射给药。采集第1（第1次给药前）、8、15（第2次给药前）、21、59天血浆样本测定HGF含量；采集第1、15、28、59、91天血浆样本测定HGF抗体含量。结果（1）局部肌内注射给药后受试者血浆中HGF含量范围为216～1189．75pg／mL；（2）未检测到受试者血浆中存在HGF抗体，提示外周血中未见HGF抗体生成。结论重组人肝细胞生长因子裸质粒局部肌内注射后，其表达产物HGF在外周血中含量未见明显异常波动，应用本品后人体没有发生免疫反廊。Objective Study the concentration of the hepatocyte growth factor （HGF） the expression product of recombinant human hepatocyte growth factor naked plasmid , and whether the body generates im- mune responseafter wsing HGF. Methods Selected 21 patients with severe ischemie disease of lower ex- tremity （ Rutherford classification 4-6 class）, after signing the informed consent and divided them into four dosage groups（ 4 mg, 8 mg, 12 mg and 16 mg） random. In each group the dosage was the lower limbs part- ly intramuscular injection following the feeding artery in experimental stage D1 and D15. The plasma samples were collected to determine the HGF concentration in D1 （before administration） , D8. D15 （before adminis- tration）, D21, D59, and the HGF-antibody concentration in D1, D15, D28, D59, D91. Results （1）The concentrations of HGF in the subjects ranged from 216 pg/mL to 1189.75 pg/mL. （2） HGF-antibodies were not dectected in the subjects＇ plasma. Conclusions After using recombinant human HGF naked plas- mid through intramuscular injection, the concentration of HGF expression product in subjects＇ peripheral blood does not have abnormally changed and using the drug the human body immune response does not generate.

关 键 词：HGF HGF抗体 免疫反应 

分 类 号：R654.4[医药卫生—外科学]