新型改性透明质酸钠凝胶抗中耳术后粘连的实验研究
发布时间：2018-07-14 16:37
【摘要】：研究内容： 针尖使得鼓膜造孔后对鼓岬表面近圆窗处粘膜制造新鲜创伤后放置中耳填充材料的测试实验；研究目标： 评估医用自交联透明质酸钠凝胶在中耳粘膜创伤后中耳腔内应用情况。研究目的： 通过听性脑干反应测试(ABR)、电耳镜大体观察、组织学观察评估多种中耳填充材料(PureRegen Gel Oto I、 Gelfoam、MeroGel、PureRegen Gel Oto II)在ME粘膜创伤后应用的效果。研究方法： 听反应阈正常豚鼠,均先在鼓膜针尖造孔,约5mm×3mm,后随机分为6组。根据实验条件具体分组如下：A组为鼓膜造孔后,不划伤鼓岬,填充PureRegen Gel OtoI材料；B组为鼓膜造孔后,划伤鼓岬后不填充任何材料；C组为鼓膜造孔后,划伤鼓岬填充PureRegen Gel Oto I材料；D组为鼓膜造孔后,划伤鼓岬后填充Gelfoam;E组为鼓膜造孔后,划伤鼓岬填充MeroGel; F组为鼓膜造孔后,划伤鼓岬填充PureRegen Gel Oto II。鼓岬划伤标准为鼓岬表面近圆窗处粘膜制造2mm×2mm新鲜创面,但不累及骨质；填充材料体积约3mm X5mm X8mm,覆盖鼓岬粘膜创面、圆窗及部分中、后鼓室。并于各组豚鼠术后1周、2周、4周、6周分别行ABR检查记录听反应阈、电耳镜大体评分及组织学切片评分。研究结果： 1.听反应阈 术后1周B、D组听力下降明显,D组听力最差,与A、C、E、F各组比较的差异统计学上显著。A, C、E、F各组听力接近正常,组间差异统计学上不显著。术后2周时,B组听力仍较差,与其余各组差异的统计学上不显著。术后4周时,B组听力达到最差,D组听力较2周时有下降,与A、C、E、F各组比较的差异统计学上显著。术后6周时,B、D组听力都较4周有所恢复,D组恢复至术前听阈上限,但与A、C、E、F组间差异依然存在。B组听力未恢复至正常,与其余5组组间差异统计学上显著。 2.填塞材料吸收情况 术后1周E组中耳腔内残余材料占原体积0-25%之间,而A、C、F组中耳腔内残余材料占原体积25-50%之间,D组中耳腔内残余材料占原体积75-100%；术后2周A、C、E、F组中耳腔内填充材料基本被全部吸收或经由咽鼓管排出；术后6周D组中耳腔内填充材料基本被全部吸收或经由咽鼓管排出,但见新生结缔组织。 3.TM愈合情况及鼓室粘膜粘连情况 鼓膜造孔填塞实验材料PureRegen Gel Oto I的A组未见鼓室粘膜的炎性反应及渗出、粘连。 划伤鼓岬粘膜后,B、C、D、E、F组中耳腔均可见炎性反应。根据鼓膜愈合、中耳粘膜及中耳腔渗出得分情况对比,未填塞实验材料的B组与填塞Gelfoam的D组炎症反应较重,C、E、F组炎症反应较轻。B、D组与其余各组间的差异在统计学上显著。A、 C、 E、 F各组间差异在统计学上不显著。 A组豚鼠鼓膜穿孔在术后1周时均已完全愈合且无瘢痕形成；C、E、F组豚鼠鼓膜在术后1周时全部愈合且无瘢痕形成；D组在术后1周时75%豚鼠耳的鼓膜愈合且无瘢痕形成,其它25%豚鼠耳的鼓膜愈合但有瘢痕形成；B组术后1周时有25%豚鼠的鼓膜没有愈合,25%豚鼠的鼓膜愈合且有瘢痕形成,50%豚鼠的鼓膜愈合且无瘢痕形成。 4.术后感染发生率 A、 C、D、E、F组豚鼠耳在术后均未发生中耳腔内感染；B组豚鼠在术后4周时有1耳观察到鼓室脓性分泌物,为继发中耳感染。 5.组织切片观察 A组鼓岬无创伤填塞试验材料组未见局部粘膜炎性反应。鼓岬粘膜划伤的5组豚鼠在术后均出现创伤处鼓岬粘膜明显的炎性反应,包括局部粘膜增厚、肿胀、血管扩张。所有实验组动物中耳未见明确骨质增生。 各组炎性反应术后2周时,C、D、E、F各组间组织学结果差异统计学上不显著,而B组与其它5组结果差异统计学上显著,中耳粘膜炎症反应更严重,证明中耳填充材料对减轻损伤的中耳粘膜的炎症反应的有效性；术后1周、6周时,D组的中耳粘膜炎症反应都较其它各组严重。研究结论： PureRegen Gel Oto I和PureRegen Gel Oto II安全性佳,未引起完整中耳粘膜炎性反应,且对创伤的中耳粘膜有保护作用,能有效防止粘连形成。临床操作简单,能减少因反复操作引起中耳医源性感染的可能性。在中耳残存时间适中。故考虑PureRegen Gel Oto I和PureRegen Gel Oto II可作为中耳填充材料应用于临床。
[Abstract]:Study Content :
a test experiment of placing a middle ear filling material after the tip of the needle tip is made to make the tympanic membrane pore at the near circular window of the surface of the drum head and then place the middle ear filling material ;
Study Objectives :
To evaluate the application of medical self - crosslinking sodium hyaluronate gel in middle ear cavity after middle ear mucosa trauma .
The effects of various middle ear filling materials ( PureRegen Gel Oto I , Gelfoam , Gel Gel , PureRegen Gel Oto II ) on the use of various middle ear filling materials ( PureRegen Gel Oto I , Gelfoam , Gel Gel , PureRegen Gel Oto II ) were assessed by auditory brainstem response test ( ABR ) , otoscope , and histological observation .
The normal guinea pigs were randomly divided into 6 groups according to the experimental conditions .
group B , after perforation of the tympanic membrane , does not fill any material after scratching the headland ;
After perforation of the tympanic membrane , the C - group was filled with PureRegen Gel Oto I material ;
In group D , Gelfoam was filled after the formation of tympanic membrane , Gelfoam was filled after scratching the headland ; E group was the tympanic membrane pore - making , and after the F - group was the tympanic membrane - making hole , the head - cape was filled with PureRegen Gel Oto II . The scratch standard of drum head was 2 mm 脳 2 mm fresh wound surface at the near - round window of the surface of the drum , but it was not involved in the bone ;
The volume of filling material was 3 mm 脳 5 mm 脳 8 mm , covering the surface of mucosal wound , round window and middle and posterior tympanum of the promontory mucosa . ABR examination was performed at 1 week , 2 weeks , 4 weeks and 6 weeks after the operation of the guinea pigs . The results were as follows :
1 . Auditory reaction threshold
There was no significant difference between groups A , C , E and F . At 4 weeks after operation , the hearing in group B was lower than that in group A , C , E and F . The difference between group B and group D was lower than that in group A , C , E and F .
2 . Fill material absorption
In the E group , the residual material in the middle ear cavity accounted for 0 - 25 % of the original volume , while the residual material in the middle ear cavity of group A , C and F accounts for 25 - 50 % of the original volume , and the residual material in the middle ear cavity of group D accounts for 75 - 100 % of the original volume ;
After 2 weeks post - op A , C , E and F , the filling material in the middle ear cavity was completely absorbed or discharged through the eugula tube ;
At 6 weeks after surgery , the filling material in the middle ear canal was completely absorbed or discharged via the Eugula tube , but it was found in the connective tissue of the freshmen .
3 . TM healing and adhesion of tympanic membrane
None of the A groups of the PureRegen Gel Oto I of the tympanic membrane pore filling test material were seen inflammatory response and exudation of the tympanic membrane , adhesions .
The inflammatory responses of B , C , D , E and F were observed in the middle ear cavities of B , C , D , E and F groups .
The perforation of tympanic membrane in group A was completely healed at 1 week after operation without scar formation .
C 銆，
本文编号：2122261
[Abstract]:Study Content :
a test experiment of placing a middle ear filling material after the tip of the needle tip is made to make the tympanic membrane pore at the near circular window of the surface of the drum head and then place the middle ear filling material ;
Study Objectives :
To evaluate the application of medical self - crosslinking sodium hyaluronate gel in middle ear cavity after middle ear mucosa trauma .
The effects of various middle ear filling materials ( PureRegen Gel Oto I , Gelfoam , Gel Gel , PureRegen Gel Oto II ) on the use of various middle ear filling materials ( PureRegen Gel Oto I , Gelfoam , Gel Gel , PureRegen Gel Oto II ) were assessed by auditory brainstem response test ( ABR ) , otoscope , and histological observation .
The normal guinea pigs were randomly divided into 6 groups according to the experimental conditions .
group B , after perforation of the tympanic membrane , does not fill any material after scratching the headland ;
After perforation of the tympanic membrane , the C - group was filled with PureRegen Gel Oto I material ;
In group D , Gelfoam was filled after the formation of tympanic membrane , Gelfoam was filled after scratching the headland ; E group was the tympanic membrane pore - making , and after the F - group was the tympanic membrane - making hole , the head - cape was filled with PureRegen Gel Oto II . The scratch standard of drum head was 2 mm 脳 2 mm fresh wound surface at the near - round window of the surface of the drum , but it was not involved in the bone ;
The volume of filling material was 3 mm 脳 5 mm 脳 8 mm , covering the surface of mucosal wound , round window and middle and posterior tympanum of the promontory mucosa . ABR examination was performed at 1 week , 2 weeks , 4 weeks and 6 weeks after the operation of the guinea pigs . The results were as follows :
1 . Auditory reaction threshold
There was no significant difference between groups A , C , E and F . At 4 weeks after operation , the hearing in group B was lower than that in group A , C , E and F . The difference between group B and group D was lower than that in group A , C , E and F .
2 . Fill material absorption
In the E group , the residual material in the middle ear cavity accounted for 0 - 25 % of the original volume , while the residual material in the middle ear cavity of group A , C and F accounts for 25 - 50 % of the original volume , and the residual material in the middle ear cavity of group D accounts for 75 - 100 % of the original volume ;
After 2 weeks post - op A , C , E and F , the filling material in the middle ear cavity was completely absorbed or discharged through the eugula tube ;
At 6 weeks after surgery , the filling material in the middle ear canal was completely absorbed or discharged via the Eugula tube , but it was found in the connective tissue of the freshmen .
3 . TM healing and adhesion of tympanic membrane
None of the A groups of the PureRegen Gel Oto I of the tympanic membrane pore filling test material were seen inflammatory response and exudation of the tympanic membrane , adhesions .
The inflammatory responses of B , C , D , E and F were observed in the middle ear cavities of B , C , D , E and F groups .
The perforation of tympanic membrane in group A was completely healed at 1 week after operation without scar formation .
C 銆，
本文编号：2122261
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