高胰岛素正常血糖葡萄糖钳夹技术进行国产与进口重组人胰岛素注射液的生物等效性临床研究  

Clinical study on bioequivalence of domestic and imported recombinant human insulin injection with high insulin normal glucose clamp technique

作　　者：张锦娟 孙飞 吴彩斌 戚瑞 任丽丽 ZHANG Jin-juan;SUN Fei;WU Cai-bin(Department of Endocrinology and Metabolism,First Affiliated Hospital of Air Force Military Medical University,Xi'an Shaanxi 710032,China;Department of Internal Medicine,Xingyuan Hospital,Yulin Shaanxi 719000,China)

机构地区：[1]空军军医大学第一附属医院内分泌代谢科,陕西西安710032 [2]榆林市星元医院内科,陕西榆林719000

出　　处：《临床和实验医学杂志》2020年第24期2647-2650,共4页Journal of Clinical and Experimental Medicine

基　　金：陕西省教育厅专项科学研究计划项目(编号:16JK1867)。

摘　　要：目的采用高胰岛素正常血糖葡萄糖钳夹技术评估国产与进口重组人胰岛素注射液在健康人体内的生物等效性。方法回顾性选取2014年12月至2015年9月空军军医大学第一附属医院的健康志愿者481例,按照注射药物的不同将受试者分为实验组和对照组,各362、119例。2组患者均采用高胰岛素正常血糖葡萄糖钳夹技术进行10 h钳夹试验,实验组患者皮下注射国产重组人胰岛素注射液,对照组患者皮下注射进口重组人胰岛素注射液。比较2组受试者试验前后30 min体格检查、血常规、血生化指标[体重、舒张压(DBP)、收缩压(SBP)、心率、白细胞计数(WBC)、血小板计数(PLT)、血红蛋白(Hb)、中性粒细胞百分比、总胆红素(TBIL)、白蛋白(ALB)、丙氨酸氨基转移酶(ALT)及天门冬氨酸氨基转移酶(AST)]变化差异。结果试验前2组受试者体格检查、血常规、血生化指标比较,差异无统计学意义(P>0.05)。试验后2组体重、DBP、SBP、心率与试验前比较差异无统计学意义(P>0.05),且实验组与对照组比较差异无统计学意义(P>0.05)。试验后2组WB、PLT与试验前比较明显升高(P<0.05),Hb与试验前比较明显降低(P<0.05),中性粒细胞百分比与试验前比较差异无统计学意义(P>0.05),实验组的WBC、PLT、Hb、中性粒细胞百分与对照组比较差异无统计学意义(P>0.05)。试验后2组TBIL、ALB、ALT、AST与试验前比较明显降低(P<0.05),但实验组与对照组比较差异无统计学意义(P>0.05)。结论国产重组人胰岛素注射液和进口重组人胰岛素注射液在健康者体内试验后其体格检查、血常规、血生化指标比较差异不大,具有生物等效性,临床上可根据患者实际情况进行选择。Objective The bioequivalence of domestic and imported recombinant human insulin injection in healthy human body was evaluated by high insulin normal glucose clamp technique.Methods A total of 481 healthy volunteers from the First Affiliated Hospital of Air Force Military Medical University from December 2014 to September 2015 were selected by regression,according to the injection of drugs of different subjects were divided into trial group and control group,362,119 cases,two groups of patients with high Insulin blood sugar normal glucose clamps technique for 10 h clamps experiment,the experimental group patients with subcutaneous injections of home-made recombinant human Insulin injection Insulin(R),control group patients with subcutaneous injection of imports of recombinant human Insulin injection(optimal secrete Lin R).Comparison test before and after the two groups of 30 min physical examination,routine blood,blood biochemical index weight,and diastolic blood pressure(DBP),systolic blood pressure(SBP)and heart rate and white blood cell count(WBC),platelet count(PLT),hemoglobin(Hb),neutrophil percentage,total bilirubin(TBIL),albumin(propagated),alanine aminotransferase(ALT)and aspartate aminotransferase(AST)variations.Results Before the test,there was no statistically significant difference in physical examination,blood routine,and blood biochemical indexes of the two groups(P>0.05).There were no statistically significant differences in body weight,DBP,SBP,and heart rate between the two groups after the test and before the test(P>0.05),and there was no significant difference between the study group and the control group(P>0.05).After the test,the WBC and PLT were significantly higher than before the test(P<0.05),and the Hb was significantly lower than before the test(P<0.05).There was no statistically significant difference compared with before the experiment(P>0.05),and there was no significant difference in WBC,PLT,Hb,and neutrophil percentage of the study group compared with the control group(P>0.05).After t

关 键 词：高胰岛素正常血糖葡萄糖钳夹技术 国产重组人胰岛素注射液 进口重组人胰岛素注射液 生物等效性 

分 类 号：R587.1[医药卫生—内分泌]