【摘要】：研究?jī)?nèi)容： 針尖使得鼓膜造孔后對(duì)鼓岬表面近圓窗處粘膜制造新鮮創(chuàng)傷后放置中耳填充材料的測(cè)試實(shí)驗(yàn)；研究目標(biāo)： 評(píng)估醫(yī)用自交聯(lián)透明質(zhì)酸鈉凝膠在中耳粘膜創(chuàng)傷后中耳腔內(nèi)應(yīng)用情況。研究目的： 通過(guò)聽(tīng)性腦干反應(yīng)測(cè)試(ABR)、電耳鏡大體觀察、組織學(xué)觀察評(píng)估多種中耳填充材料(PureRegen Gel Oto I、 Gelfoam、MeroGel、PureRegen Gel Oto II)在ME粘膜創(chuàng)傷后應(yīng)用的效果。研究方法： 聽(tīng)反應(yīng)閾正常豚鼠,均先在鼓膜針尖造孔,約5mm×3mm,后隨機(jī)分為6組。根據(jù)實(shí)驗(yàn)條件具體分組如下：A組為鼓膜造孔后,不劃傷鼓岬,填充PureRegen Gel OtoI材料；B組為鼓膜造孔后,劃傷鼓岬后不填充任何材料；C組為鼓膜造孔后,劃傷鼓岬填充PureRegen Gel Oto I材料；D組為鼓膜造孔后,劃傷鼓岬后填充Gelfoam;E組為鼓膜造孔后,劃傷鼓岬填充MeroGel; F組為鼓膜造孔后,劃傷鼓岬填充PureRegen Gel Oto II。鼓岬劃傷標(biāo)準(zhǔn)為鼓岬表面近圓窗處粘膜制造2mm×2mm新鮮創(chuàng)面,但不累及骨質(zhì)；填充材料體積約3mm X5mm X8mm,覆蓋鼓岬粘膜創(chuàng)面、圓窗及部分中、后鼓室。并于各組豚鼠術(shù)后1周、2周、4周、6周分別行ABR檢查記錄聽(tīng)反應(yīng)閾、電耳鏡大體評(píng)分及組織學(xué)切片評(píng)分。研究結(jié)果： 1.聽(tīng)反應(yīng)閾 術(shù)后1周B、D組聽(tīng)力下降明顯,D組聽(tīng)力最差,與A、C、E、F各組比較的差異統(tǒng)計(jì)學(xué)上顯著。A, C、E、F各組聽(tīng)力接近正常,組間差異統(tǒng)計(jì)學(xué)上不顯著。術(shù)后2周時(shí),B組聽(tīng)力仍較差,與其余各組差異的統(tǒng)計(jì)學(xué)上不顯著。術(shù)后4周時(shí),B組聽(tīng)力達(dá)到最差,D組聽(tīng)力較2周時(shí)有下降,與A、C、E、F各組比較的差異統(tǒng)計(jì)學(xué)上顯著。術(shù)后6周時(shí),B、D組聽(tīng)力都較4周有所恢復(fù),D組恢復(fù)至術(shù)前聽(tīng)閾上限,但與A、C、E、F組間差異依然存在。B組聽(tīng)力未恢復(fù)至正常,與其余5組組間差異統(tǒng)計(jì)學(xué)上顯著。 2.填塞材料吸收情況 術(shù)后1周E組中耳腔內(nèi)殘余材料占原體積0-25%之間,而A、C、F組中耳腔內(nèi)殘余材料占原體積25-50%之間,D組中耳腔內(nèi)殘余材料占原體積75-100%；術(shù)后2周A、C、E、F組中耳腔內(nèi)填充材料基本被全部吸收或經(jīng)由咽鼓管排出；術(shù)后6周D組中耳腔內(nèi)填充材料基本被全部吸收或經(jīng)由咽鼓管排出,但見(jiàn)新生結(jié)締組織。 3.TM愈合情況及鼓室粘膜粘連情況 鼓膜造孔填塞實(shí)驗(yàn)材料PureRegen Gel Oto I的A組未見(jiàn)鼓室粘膜的炎性反應(yīng)及滲出、粘連。 劃傷鼓岬粘膜后,B、C、D、E、F組中耳腔均可見(jiàn)炎性反應(yīng)。根據(jù)鼓膜愈合、中耳粘膜及中耳腔滲出得分情況對(duì)比,未填塞實(shí)驗(yàn)材料的B組與填塞Gelfoam的D組炎癥反應(yīng)較重,C、E、F組炎癥反應(yīng)較輕。B、D組與其余各組間的差異在統(tǒng)計(jì)學(xué)上顯著。A、 C、 E、 F各組間差異在統(tǒng)計(jì)學(xué)上不顯著。 A組豚鼠鼓膜穿孔在術(shù)后1周時(shí)均已完全愈合且無(wú)瘢痕形成；C、E、F組豚鼠鼓膜在術(shù)后1周時(shí)全部愈合且無(wú)瘢痕形成；D組在術(shù)后1周時(shí)75%豚鼠耳的鼓膜愈合且無(wú)瘢痕形成,其它25%豚鼠耳的鼓膜愈合但有瘢痕形成；B組術(shù)后1周時(shí)有25%豚鼠的鼓膜沒(méi)有愈合,25%豚鼠的鼓膜愈合且有瘢痕形成,50%豚鼠的鼓膜愈合且無(wú)瘢痕形成。 4.術(shù)后感染發(fā)生率 A、 C、D、E、F組豚鼠耳在術(shù)后均未發(fā)生中耳腔內(nèi)感染；B組豚鼠在術(shù)后4周時(shí)有1耳觀察到鼓室膿性分泌物,為繼發(fā)中耳感染。 5.組織切片觀察 A組鼓岬無(wú)創(chuàng)傷填塞試驗(yàn)材料組未見(jiàn)局部粘膜炎性反應(yīng)。鼓岬粘膜劃傷的5組豚鼠在術(shù)后均出現(xiàn)創(chuàng)傷處鼓岬粘膜明顯的炎性反應(yīng),包括局部粘膜增厚、腫脹、血管擴(kuò)張。所有實(shí)驗(yàn)組動(dòng)物中耳未見(jiàn)明確骨質(zhì)增生。 各組炎性反應(yīng)術(shù)后2周時(shí),C、D、E、F各組間組織學(xué)結(jié)果差異統(tǒng)計(jì)學(xué)上不顯著,而B組與其它5組結(jié)果差異統(tǒng)計(jì)學(xué)上顯著,中耳粘膜炎癥反應(yīng)更嚴(yán)重,證明中耳填充材料對(duì)減輕損傷的中耳粘膜的炎癥反應(yīng)的有效性；術(shù)后1周、6周時(shí),D組的中耳粘膜炎癥反應(yīng)都較其它各組嚴(yán)重。研究結(jié)論： 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應(yīng),且對(duì)創(chuàng)傷的中耳粘膜有保護(hù)作用,能有效防止粘連形成。臨床操作簡(jiǎn)單,能減少因反復(fù)操作引起中耳醫(yī)源性感染的可能性。在中耳殘存時(shí)間適中。故考慮PureRegen Gel Oto I和PureRegen Gel Oto II可作為中耳填充材料應(yīng)用于臨床。
[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，

本文編號(hào)：2122261