硅凝胶植入小鼠淋巴细胞表型的变化

背景：硅凝胶乳房植入体在长期的使用中一直存在着与自身免疫性疾病之间是否存在因果联系的争议，尚需对其进行免疫学上的评价。 目的：通过分析硅凝胶植入后小鼠淋巴细胞表型的变化，探讨其对免疫系统的影响。 设计、时间及地点：随机对照动物实验，于2007-07/09中国药品生物制品检定所医疗器械检测中心实验室完成。 材料：6~8周龄SPF级雌性BALB/c小鼠50只，随机分成5组：阴性对照组、阳性对照组、硅凝胶低、中、高剂量组，10只/组。硅凝胶填充人工乳房植入体成品为深圳维恩杰科技有限公司产品。 方法：阴性对照组皮下注射磷酸盐缓冲液；阳性对照组皮下注射与福氏完全佐剂1∶1混合的BSA溶液；硅凝胶低、中、高剂量组先将人工乳房植入体成品中充填的硅凝胶在无菌条件下分装入注射器中，在小鼠背部皮肤穿刺后接注射器分别注入硅凝胶0.6，1.2，1.8 mL。材料植入28 d后，分离小鼠脾脏制备脾淋巴细胞悬液，调整细胞浓度至1×109 L-1。 主要观察指标：流式细胞仪检测淋巴细胞表型及表型频数。 结果：与阴性对照组比较，硅凝胶低、中、高剂量组各淋巴细胞表型参数均值差异均无显著性意义（P > 0.05）。代表T淋巴细胞的CD3+，CD4+，CD8+频数分析结果显示，硅凝胶低、中、高剂量组分别有4，3，6例样本超出阴性对照组均值±2SD范围，并分别有2，3，4例样本超出阴性对照组均值±3SD范围。 结论：硅凝胶植入28 d后，BALB/c小鼠脾淋巴细胞表型统计学分析无显著差异，但对频数分析结果有一定影响，提示硅凝胶对免疫系统可能产生影响。

Changes of lymphocyte immunophenotype in mice following silicone gel implantation

BACKGROUND: Silicone gel breast implant has been used for a long time, but the dispute of whether it has the causal association with autoimmune disease still exists. So it needs to evaluation the silicone gel breast implant on immunology. OBJECTIVE: To research the effect of silicone gel implantation on immune system by analyzing the changes of lymphocyte phenotype. DESIGN, TIME AND SETTING: The randomized controlled animal trial was performed at the Laboratory of Medical Equipment Detection Center, National Institute for the Control of Pharmaceutical and Biological Products from July to September 2007. MATERIALS: Fifty SPF-grade, female, BALB/c mice, aging 6-8 weeks were randomly divided into the negative control, positive control, low, middle and high dose silicone gel groups, with 10 animals in each group. The silicone gel breast implant was provided by Shenzhen Weienjie Technology Company. METHODS: BALB/c mice were implanted with buffer phosphate, BSA solution, silicone gel of three different doses and exposed to silicone gel 28 days, respectively. Then mice spleens were removed and teased into single cell preparations with the concentration of 1×109/ L. MAIN OUTCOME MEASURES: The lymphocyte phenotype and frequency distribution were measured by flow cytometry. RESULTS: There were no significantly statistical differences of the phenotype in the silicone gel implantation groups and the negative control (P > 0.05). However, the frequency analyses results showed that the samples number of the CD3+, CD4+ and CD8+ expression in the silicone gel implantation with low dose, middle dose and high dose groups exceed average±2SD than the negative control group were 4/10, 3/10, 6/10, respectively, and the samples number of they exceed average±3 SD of the negative control group were 2/10, 3/10, 4/10, respectively. CONCLUSION: At 28 days after implantation, there is no obvious difference in splenic lymphocyte phenotype of BALB/c mice, but silicone gel influence the frequency distribution, which demonstrates that maybe it has certain effect on the immune system.