肝癌单抗^131I—HAb18放免治疗剂长期毒性试验

肝癌单抗＾１３１Ｉ－ＨＡｂ１８放免治疗剂申报国家一类新药，需进行长期毒性以评价其安全性，方法：用ＳＤ大鼠，分为４组，每组２０只，雌雄各半，＾１３１Ｉ－ＨＡｂ１８放免治疗剂低剂量组：９２．５ＭＢｑ／ｋｇ；中剂量组“２７７．５ＭＢｑ／ｋｇ；高剂量组：９２５ＭＢｑ／ｋｇ；正常对照组用等体积的生理盐水。

Long term toxicity tests of radioimmunotreating injection 131 I HAb18

Objective: The safety of Iodine 131 ( 131 I) and HAb18 antihepatoma monoclonal antibody conjugates should be evaluated through long term toxicity tests to report it as the first class national new drug. Methods: The inbreed strain SD rats were divided into four groups, twenty per group, half of male and female, 131 I HAb18 conjugate 92.5 MBq/kg was administered to the low dose group; 277.5 MBq/kg to the middle dose group and 925 MBq/kg to the high dose group. The contrast group was given normal saline. These rats were injected twice a month for three months, then some of them were observed duing their recovery for two months. Results: After five months observation, the three dose groups showed different reaction respectively. The low dose group did not show any toxicity; In the middle and high dose groups, toxic reaction became serious with increasing the does, and some morphological changes occurred in thyroid glandular cells and liver cells. Conclusion: 131 I HAb18 radioimmunotreating drug 92.5 MBq/kg is safe dose. 277.5 MBq/kg showed toxic reaction and the serious toxic reaction would appear at the dosage of 925 MBq/kg. Thyroid gland and liver are major organs of toxic damage. The sensitivity of toxic damage is showed in WBC of blood.