一种猪源可吸收防粘连材料的免疫学风险评价

doi:10.3969/j.issn.1004-616x.2025.02.011

摘要/Abstract

摘要： 目的：评价一种猪源可吸收防粘连材料的免疫学风险。方法：SPF级BALB/c小鼠60只，雌雄各半。随机分为空白对照组、阳性对照组和受试物组，每组20只。空白对照组仅进行手术操作，不植入材料。阳性对照组小鼠皮下注射牛血清白蛋白与完全弗氏佐剂等体积混合物，每周免疫1次，共免疫4次。受试物组小鼠在背部皮下植入7 cm²的一种猪源可吸收防粘连材料。受试物植入4和8周后，每组小鼠分别处死10只(雌雄各半)，然后收集小鼠的血液、脾脏、胸腺、植入物及其周围组织等标本。采用酶联免疫吸附试验检测血清中的总抗体浓度，采用细胞因子微球检测技术检测血清细胞因子IFN-γ、IL-6和IL-12p70的浓度，采用CCK-8法检测淋巴细胞增殖情况，用电子天平称取脾脏和胸腺的质量，采用HE染色分析脾脏、胸腺及局部植入物组织病理学变化。结果：与空白对照组相比，受试物植入4周和8周后的总抗体浓度、细胞因子表达浓度、淋巴细胞增殖、免疫器官质量及系数差异均无统计学意义(P>0.05)。植入4周后，受试物组小鼠的组织切片空腔边缘可见一些不规则分布的红染植入物，组织学评分为27.7分。植入8周后，受试物组小鼠组织切片内未见植入物，组织学评分为3.4分。结论：在本试验条件下，猪源可吸收防粘连材料皮下植入后未对小鼠免疫系统造成明显不良影响，发生免疫毒性的风险较低。

关键词: 猪源可吸收防粘连材料, 免疫学风险, 局部组织病理, 小鼠

Abstract: OBJECTIVE：To evaluate the immunological risk of a porcine-derived absorbable anti-adhesion material. METHODS：SPF-grade BALB/c mice were randomly divided into a blank control，a positive control，and a test material groups，with 20 mice in each group，equally divided by gender. The blank control group underwent surgical operations without the implantation of materials. The positive control group was subcutaneously injected with a mixture of bovine serum albumin and complete Freund's adjuvant in equal volumes，immunized once a week for a total of 4 times. The test material group was implanted subcutaneously with 7 cm² of a porcine-derived absorbable anti-adhesion material on the back. After 4 and 8 weeks of implantation，10 mice from each group were sacrificed (equally divided by gender)，and specimens such as mouse blood，spleen，thymus，and the implanted material and surrounding tissues were collected. Enzyme-linked immunosorbent assay (ELISA) was used to detect the total antibody levels in the serum. Cytokine Bead Assay detection technology was used to detect the levels of serum cytokines IFN-γ，IL-6，and IL-12p70. The CCK8 method was used to detect the proliferation level of lymphocytes. And an electronic balance was used to weigh the spleen and thymus，and HE staining was used to analyze the histopathology of the spleen，thymus，and local implanted material tissues. RESULTS：Compared with the blank control group，the test material group showed no statistically significant differences in total antibody levels，cytokine expression levels，lymphocyte proliferation，immune organ weight and coefficient (P>0.05). After 4 weeks of implantation，the tissue sections of the test material group mice showed some irregularly red-staining around the implants，with a histological score of 27.7 points. After 8 weeks of implantation，no implants were seen in the tissue sections of the test material group mice，with a histological score of 3.4 points. CONCLUSION：In this study，the subcutaneous implantation of the porcine-derived absorbable anti-adhesion material did not cause significant adverse effects on the immune system of mice，and the risk of immunotoxicity is low.

Key words: porcine-derived absorbable anti-adhesion material, immunological risk, local histopathology, mouse

中图分类号:

R318

邵安良, 陈丽媛, 藤川佳之, 矢贺雄太, 陈亮. 一种猪源可吸收防粘连材料的免疫学风险评价[J]. 癌变·畸变·突变, 2025, 37(2): 157-161.

SHAO Anliang, CHEN Liyuan, FUJIKAWA Yoshiyuki, YAGA Yuta, CHEN Liang. Immunological risk assessment of a porcine-derived absorbable anti-adhesion material[J]. Carcinogenesis, Teratogenesis & Mutagenesis, 2025, 37(2): 157-161.

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