载布地奈德可降解复合止血绵的生物学性能研究

The properties investigation of a biodegradable budesonide-loaded haemostatic compound sponge

目的 探究载布地奈德壳聚糖可降解止血绵(复合绵)的生物安全性、相容性及疗效。方法 将36只SD大鼠随机分为复合绵组、纳吸绵组和对照组,各12只。无菌开放上颌窦,分别植入复合绵、纳吸绵及不植入任何异物,2周后取心脏血及鼻窦黏膜组织。行苏木素-伊红染色观察各组大鼠黏膜组织,采用酶联免疫吸附实验及色谱法检测各组大鼠血清、黏膜内炎性因子的表达量及布地奈德浓度。结果 3组大鼠鼻窦黏膜稍有炎性细胞浸润及黏膜下腺体增生,其中复合绵组炎性细胞浸润及黏膜下腺体增生程度好于其他两组。复合绵组大鼠血清、鼻窦黏膜内白介素(IL)-5、IL-8、肿瘤坏死因子(TNF)-等表达均低于纳吸绵组和对照组(均P <0.05),而3组皮质醇浓度没有明显改变。复合绵组大鼠术后不同检测时间血浆内布地奈德浓度都处于低水平。结论 复合绵性能优良,具有良好生物相容性及安全性,或可成为临床鼻窦术后填塞止血、抗炎的生物海绵。

Objective To explore the safety and efficacy of a biodegradable budesonide-loaded sponge.Methods Thirty-six adult male rats were randomly divided into compound sponge group,nasopore group and control group with twelve rats in each group.The maxillary sinus was drilled and implanted with nasopore(naspore group),compound sponge(compound sponge group),and the control group was not implanted with any foreign body.Collecting their heart blood and sinus mucosa after two weeks.The pathological reaction of mucosa was observed by hematoxylin-eosin staining.Inflammatory factors were determined by enzyme-linked immunosorbent assay(ELISA).The concentrations of budesonide was calculated by reverse-phase high-performance liquid chromatography.Results Slight inflammatory cell infiltration and submucosal gland hyperplasia were found in the sinus mucosa of all three groups,the degree of inflammatory cell infiltration and submucosal gland hyperplasia in the compound sponge group were better than those in the other two groups.The expression of interleukin-5(IL-5),IL-8 and tumor necrosis factor-(TNF-)in the serum,sinus mucosa in compound sponge group were significantly lower than those in the other two groups(allP<0.05),and there was no significant change in cortisol concentration.The concentration of budesonide in plasma of rats in the compound group was in low level range at different detection time.Conclusions The biodegradable budesonide-loaded sponge demonstrates its safety and efficacy,and it can be used as a biological sponge for clinical sinus post-operative tamponade,hemostasis and anti-inflammatory.