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目的:研究125I标记抗胃癌单克隆抗体MAb3H11自胃癌周围粘膜下注射后的药代动力学过程,以及患者血清人抗鼠抗体(HAMA)水平的动态变化。方法:拟行放射免疫导向手术的胃癌患者10例,经胃镜直视于癌周围胃粘膜下注射125I标记的MAb3H11(抗体剂量0.2～0.5mg/例),定时采取血样和尿样、手术中留取部分肿瘤标本,测定放射性强度;患者在抗体皮试前和注射标记抗体后每周留取血样,分离血清,ELISA法检测血清HAMA。结果:经计算机模拟,胃癌周围粘膜下注射标记抗体125I-MAb3H11后,其血浆分布、清除符合二房室模型,T1/2α:2.21±1.40小时,T1/2β:43.63±7.27小时;每克肿瘤组织对标记抗体摄取量可达注射剂量的(0.215±0.117)%;注射标记抗体对患者无明显不良影响,MAb3H11皮试前及胃粘膜下注射标记抗体后动态观测至第4～6周,未发现血清HAMA滴度明显升高。结论:125I标记抗胃癌单克隆抗体MAb3H11自癌灶周围胃粘膜下注射的方法,适用于胃癌放射免疫导向手术。
Objective: To study the pharmacokinetics of MAb3H11, a monoclonal antibody against 125I-labeled anti-gastric cancer, after submucosal injection of gastric cancer and the serum level of human anti-mouse antibody (HAMA). Methods: Ten patients with gastric cancer who underwent radiosurgery were enrolled in the study. Gastroscopy was used to directly inoculate 125I-labeled MAb3H11 (antibody dose 0.2-0.5 mg / Tumor samples were taken and the radioactivity was measured. Blood samples were collected weekly before the antibody skin test and after the labeled antibody was injected. Serum HAMA was detected by ELISA. Results: After computer simulation, the plasma distribution of 125I-MAb3H11 submucosal injection of gastric cancer was consistent with two-compartment model. T1 / 2α: 2.21 ± 1.40 hours, T1 / 2β: 43.63 ± 7.27 hours; (0.215 ± 0.117)% of the injected dose of the labeled antibody; injection of labeled antibody had no significant adverse effect on patients, MAb3H11 skin test before and after subcutaneous injection of labeled antibody dynamic observation to the first 4 to 6 weeks, was found Serum HAMA titer was significantly higher. Conclusion: 125I-labeled anti-gastric cancer monoclonal antibody MAb3H11 can be injected into gastric mucosa around the tumor for radioimmunization.