两种不同关节软骨替代材料对兔肝肾功能毒性的比较*★

背景：目前已对纳米羟基磷灰石/聚乙烯醇水凝胶及聚乙烯醇/吡咯脘酮水凝胶材料进行了细胞毒性、致敏、刺激及局部反应试验，证明均具有良好的生物相容性和安全性，但是对肝肾功能的影响尚不清楚。 目的：观察两种不同关节软骨替代材料纳米羟基磷灰石/聚乙烯醇水凝胶及聚乙烯醇/吡咯脘酮水凝胶植入兔骨组织后对其肝肾功能的毒性反应。 设计、时间及地点：血液生化指标观察，随机对照动物实验，于2008-11/2009-03在解放军南京军区总医院比较医学科完成。 材料：纳米羟基磷灰石/聚乙烯醇水凝胶及聚乙烯醇/吡咯脘酮水凝胶均由南京理工大学生物材料研究所熊党生教授提供。 方法：健康清洁级新西兰大白兔30只，随机分成3组，纳米羟基磷灰石/聚乙烯醇水凝胶组10只，聚乙烯醇/吡咯脘酮水凝胶组10只，空白对照组10只。分别将两种关节软骨材料植入已制备好的兔模型股骨软骨缺损部位。空白对照组施行同样的手术，但不作任何材料植入。 主要观察指标：于术后1，4，8，12周行肝肾功能检测，对比3组动物植入前后肝肾功能变化。 结果：植入前3组肝肾功能指标差异无显著性意义(P均 > 0.05)。3组植入后丙氨酸转氨酶、天冬氨酸转氨酶、白蛋白、球蛋白、尿素氮、肌酐水平分别与植入前比较，差异无显著性意义(P均 > 0.05)。植入后3组各项肝肾功能指标差异也无显著性意义(P均>0.05)。 结论：两种不同的软骨替代材料对兔肝肾功能无影响。 关键词：纳米羟基磷灰石/聚乙烯醇水凝胶；聚乙烯醇/吡咯脘酮水凝胶；关节软骨；肝肾功能；毒性

Toxicity effect of two articular cartilage substitute materials on hepatic and renal function in rabbits

BACKGROUND: Cytotoxicity, sensitization, stimulation and local reaction tests are demonstrated that nano-hydroxyapatite and Poly(vinyl alcohol) Hydrogels (n-HA/PVA) and Poly(vinyl alcohol) and poly(vinyl pyrrolidone) blended (PVA/PVP) have favorable biocompatibility and safety. However, the effects of n-HA/PVA and PVA/PVP on hepatic and renal function are poorly understood. OBJECTIVE: To assess the toxicity of n-HA/PVA and PVA/PVP on hepatic and renal function after implanted into bone tissues of rabbits. DESIGN, TIME AND SETTING: Blood biochemical index observation, and randomized control experiment. The experiment was performed at the Department of comparative medicine, Nanjing General Hospital of Nanjing Military Command, from November 2008 to March 2009. MATERIALS: The n-HA/PVA and PVA/PVP were supplied by Xiong Dang-sheng, a professor of institute of biological materials, Nanjing University of Science and Technology. METHODS: A total of 30 New Zealand white rabbits with clean grade, were randomly divided into 3 groups, with 10 animals in each group. In the n-HA/PVA group and PVA-PVP group, two materials were implanted to repair cartilage defects. There was no material implantation in the control group. MAIN OUTCOME MEASURES: Changes of hepatic and renal function were compared at weeks 1, 4, 8, and 12 after operation. RESULTS: The differences of hepatic and renal function were had no significance among three groups prior to implantation (Pall > 0.05). After implantation, the levels of alanine aminotransferase, aspartate aminotransferase, albumin, globulin, urea nitrogen and creatinine had no obvious changes compared to prior to implantation (Pall > 0.05). Moreover, there was no significantly difference among three groups after implantation (Pall > 0.05). CONCLUSION: Two different alternative materials have no effects on rabbit hepatic and renal function.