医用自交联透明质酸钠凝胶预防兔硬膜外粘连的安全性研究

目的利用体感诱发电位及运动功能评分,评价医用自交联透明质酸钠凝胶预防椎板切除术后硬膜外粘连的安全性。方法将L5全椎板切除的新西兰兔24只随机分为4组,A组为对照组:术区生理盐水冲洗后关闭切口;B组、C组、D组均为实验组:均在术区硬脊膜暴露区覆盖医用自交联透明质酸钠凝胶,而覆盖剂量各不相同,分别为0.5、0.75和1.0ml。分别于麻醉后,椎板切除术后,闭合手术切口之后,术后8周这4个时间点进行体感诱发电位监测并记录潜伏期值。并分别于术前,术后1d,术后8周对各组动物进行后肢运动功能评分。结果麻醉后和椎板切除术后各组潜伏期值无统计学差异(P0.05)。在关闭切口后测定各组的潜伏期值显示:A组和B组潜伏期值均无延迟(P0.05),C组和D组潜伏期值出现明显延迟(P0.05)。在术后8周复测各组潜伏期值,均处于正常范围(P0.05)。运动功能评分结果:术前所有动物评分均正常。在术后1d,A组和B组动物的评分仍然正常,C组和D组的动物评分下降。在术后8周,各组动物的运动功能评分均再次正常。结论体感诱发电位是测定脊髓损伤的敏感指标;椎板切除术后局部覆盖预防粘连剂有剂量的要求,0.5ml的医用自交联透明质酸钠凝胶不会对该动物模型的脊髓的电生理功能及后肢运动功能产生影响。

Safety study on medical self-crosslinked sodium hyaluronic gel for prevention of epidural adhesions in rabbits

Objective To investigate the safety of medical self-crosslinked sodium hyaluronic gel(HyaRegen/SPI)on the prevention of epidural adhesions after laminectomy by using cortical somatosensory evoked potentials(CSEP)and motor scoring.Methods Twenty-four New Zealand white rabbits with lumbar laminectomy at L5 were randomly divided into four groups:group A as control group,in which only saline was used to flush the laminectomy area before wound closure,group B,C and D as treated groups,in which the exposed dura were covered with 0.5,0.75 and 1.0 ml of the medical self-crosslinked sodium hyaluronic gel(HyaRegen/SPI)respectively before wound closure.The CSEP with latency was monitored and recorded after anesthesia,laminectomy and wound closure and at 8 weeks post-surgery.Motor scoring was also conducted at the time of pre-surgery and also 1 day and 8 weeks post-surgery.Results There were no significant difference in CSEP latency among groups after anesthesia and laminectomy(P>0.05).The latency in group C and D(covered with 0.75 and 1.0 ml HyaRegen/SPI respectively)was significantly prolonged(P<0.05)after wound closure,while there was no prolongation in group A(control group)and B(covered with 0.5 ml HyaRegen/SPI)(P>0.05).However,the latency in all groups was all in the normal range(P>0.05)at 8 weeks post-surgery.The evaluation of motor scores revealed that all animals had a normal motor function before surgery and at 1 day and 8 weeks post-surgery,except a lower motor score in group C and D on 1t hday post-surgery.Conclusion The CSEP is a sensitive indicator of spinal cord injury.There is a dosage limitation in the application of agent on the prevention of epidural adhesions after laminectomy.The application of medical self-crosslinked sodium hyaluronic gel(HyaRegen/SPI)0.5 ml do not affect the electrophysiological function of spine and motor function in this animal model.