肿瘤坏死因子-α单克隆抗体注射剂在中国健康成年志愿者中抗药抗体产生及其影响因素分析

发布时间：2018-03-02 13:50

本文选题：肿瘤坏死因子-α单克隆抗体　切入点：中国健康成年受试者　出处：《中国临床药理学杂志》2017年09期 　论文类型：期刊论文

【摘要】：目的研究肿瘤坏死因子-α(TNF-α)单克隆抗体药物在中国健康成年受试者中抗药抗体(ADA)产生的比率,分析其影响因素。方法按随机、平行、双盲、对照的研究方法设计,3项试验共计纳入164例中国健康成年志愿者。试验1:56例中国健康成年受试者随机分成A、B、C、D、E、F组,其中A组6例,其他每组10例,分别予以单次腹部皮下注射10,20,35,50,65,75 mg的试验药物L00653;试验2:60例中国健康成年志愿者随机分成6个剂量组,每组10例,分别予以单次腹部皮下注射5,15,30,50,75,100 mg的试验药物L02151。试验3:48例中国健康成年志愿者随机分成4组,每组12例,组内按1∶1对照以静脉滴注方式分别给予试验药物L00048或原研药。用配体结合分析法检测ADA水平。结果 164例受试者全部完成试验。试验1:A、B、C、D、E、F组的阳性率分别为17.00%,20.00%,40.00%,30.00%,0,30.00%,组间ADA阳性率与给药剂量比较差异均无统计学意义(均P0.05)。试验2:5,15,30,50,75,100 mg剂量组的阳性率分别为100.00%,100.00%,100.00%,100.00%,100.00%,70.00%,组间ADA阳性率与给药剂量比较差异均无统计学意义(均P0.05)。试验3:仅2例ADA检测阳性。结论 TNF-α单克隆抗体药物在人体内ADA的产生与单抗自身来源和结构有关,与药物剂量无密切关系。
[Abstract]:Objective to study the ratio of anti-ADAs produced by tumor necrosis factor- 伪 (TNF- 伪) monoclonal antibody in Chinese healthy adult subjects and to analyze its influencing factors. Three controlled trials were designed to include 164 Chinese healthy adult volunteers. 1:56 Chinese healthy adult subjects were randomly divided into two groups: group A (n = 6), group A (n = 6), and group A (n = 10). The experimental drug L00653 was injected subcutaneously into the abdomen with a single dose of 10 ~ (20) and 35 ~ (50) ~ (50) ~ (65) ~ (75) mg. Experiment 2: 60 Chinese healthy adult volunteers were randomly divided into 6 dose groups, 10 cases in each group, 10 cases in each group. A single abdominal subcutaneous injection of L02151mg was given to Chinese healthy adult volunteers, who were randomly divided into 4 groups (12 cases in each group). The level of ADA was measured by ligand binding analysis. Results all the 164 subjects completed the test. The positive rates of group 1: 1 were 17.00 ~ 20.00 ~ 20.00 ~ (20. 00) ~ (20. 00) ~ 40. 000 ~ 0. 000 ~ 0. 000 ~ 0. 00, respectively, and the positive rates of the group were 17. 00% ~ 20. 00% ~ 20. 00% ~ 40. 00% ~ 40. 00% ~ 0. 00% ~ 0. 00% ~ 0. 00%, respectively. There was no significant difference between the positive rate of ADA and the dosage of drug administration (P0.050.The positive rate of test 2: 51530U / 5075100mg / mg group was 100.00000.000 + 100.0000mg / kg), respectively. There was no significant difference between the positive rate of ADA and the dosage of the drug (all P0.05N). Test 3: only 2 cases of ADA. Conclusion the production of TNF- 伪 monoclonal antibody in human body is related to the origin and structure of the monoclonal antibody. There was no close relationship with the dosage of the drug.
【作者单位】：徐州医科大学药学院;北京大学人民医院药剂科;军事医学科学院放射与辐射医学研究所;
【分类号】：R969

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