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Ke hoʻomau nei nā haʻawina preclinical like ʻole o ka stent Eustachian tube (ET) i kūkulu ʻia, akā ʻaʻole i hoʻohana ʻia i ka hana lapaʻau. I loko o nā haʻawina preclinical, ua kaupalena ʻia nā scaffolds ET i ka hoʻonui ʻana o ka ʻiʻo scaffold-induced. Ua aʻo ʻia ka maikaʻi o ka cobalt-chromium sirolimus-eluting stent (SES) i ke kāohi ʻana i ka hoʻonui ʻia ʻana o ka ʻiʻo ma hope o ka hoʻokomo ʻana i ka stent i loko o kahi ʻano porcine ET. Ua māhele ʻia nā puaʻa ʻeono i ʻelua pūʻulu (ʻo ia hoʻi ka pūʻulu mana a me ka pūʻulu SES) me ʻekolu puaʻa i kēlā me kēia hui. Ua loaʻa i ka pūʻulu hoʻomalu kahi stent cobalt-chromium uncoated (n = 6), a ua loaʻa i ka pūʻulu SES kahi stent cobalt-chromium me kahi uhi sirolimus-eluting (n = 6). ʻO nā hui āpau i mōhai ʻia 4 mau pule ma hope o ke kau ʻana i ka stent. Ua kūleʻa ka hoʻokomo ʻana i ka stent ma nā ET a pau me ka ʻole o nā pilikia e pili ana i ke ʻoki. ʻAʻole hiki i kekahi o nā stents ke hoʻopaʻa i ko lākou ʻano poepoe maoli, a ua ʻike ʻia ka hōʻiliʻili ʻana o ka mucus i loko a puni nā stents i nā hui ʻelua. Ua hōʻike ʻia ka nānā ʻana i ka mōʻaukala ʻo ka wahi o ka hoʻonui ʻana o ka ʻili a me ka mānoanoa o ka submucosal fibrosis i ka hui SES he haʻahaʻa haʻahaʻa loa ma mua o ka pūʻulu mana. He mea maikaʻi ka SES i ka pale ʻana i ka hoʻonui ʻana o ka ʻiʻo scaffold-induced i nā puaʻa ET. Eia nō naʻe, pono nā noiʻi hou e hōʻoia i nā mea kūpono no nā stents a me nā lāʻau antiproliferative.
He mau hana ko'iko'i ko ka Eustachian tube (ET) ma ka pepeiao waena (e la'a, ka ho'oku'u 'ana, ka pale 'ana i ka ho'ololi 'ana o nā pathogens a me nā mea huna i ka nasopharynx)1. Hoʻopili pū kekahi i ka pale ʻana i nā kani nasopharyngeal a me ka regurgitation2. Paʻa maʻamau ka ET, akā wehe ʻia me ka ʻai ʻana, ka ʻuā, a i ʻole ka nau ʻana. Eia nō naʻe, hiki ke hana ʻino ʻo ET inā ʻaʻole wehe a pani pono ka paipu3,4. ʻO ka dilated (obstructive) dysfunction o ET e hoʻohaʻahaʻa i ka hana ET a, inā ʻaʻole mālama ʻia kēia mau hana, hiki ke ulu i loko o ka otitis media maʻi a i ʻole ka maʻi maʻamau, kekahi o nā maʻi maʻamau i ka hana ENT. Hoʻohana ʻia nā lāʻau lapaʻau i kēia manawa no ET dysfunction (e laʻa, ke ʻoki ʻana i ka ihu, ka hoʻokomo ʻana i ka paipu hoʻoheheʻe, a me ka lāʻau lapaʻau) i nā maʻi. Eia nō naʻe, he liʻiliʻi ka maikaʻi o kēia mau lāʻau lapaʻau a hiki ke alakaʻi i ka ET obstruction, maʻi, a me ka perforation membrane tympanic ireversible3,6,7. Ua hoʻokomo ʻia ʻo Eustachian tube balloon angioplasty ma ke ʻano he lapaʻau ʻē aʻe no ka dilated ET 8 dysfunction. ʻOiai ua hōʻike ʻia kekahi mau haʻawina mai ka makahiki 2010 e ʻoi aku ka maikaʻi o ka hoʻoponopono ʻana i ka baluna tube Eustachian ma mua o ka mālama maʻamau no ka dysfunction ET, ʻaʻole pane kekahi mau maʻi i ka dilatation8,9,10,11. No laila, ʻo ka stenting paha kahi koho lapaʻau kūpono12,13. ʻOiai ka nui o nā noiʻi preclinical e loiloi ana i ka hiki ʻana o ka ʻenehana a me ka pane ʻana o ka ʻiʻo ma hope o ka hoʻokomo ʻana i ka stent ma ET, ʻo ka hyperplasia o ka stent-induced tissue ma muli o ka pōʻino mechanical e noho mau ana i ka hoʻopiʻi postoperative nui 14,15,16,17,18,19. hoʻopili ʻia i ka lāʻau, hoʻopiha ʻia me nā mea anti-proliferative e hoʻomaikaʻi i kēia kūlana.
Ua hoʻohana ʻia nā stents lāʻau lapaʻau e pale i ka restenosis in-stent i hoʻokumu ʻia e ka ʻiʻo a me ka hyperplasia neointimal ma hope o ke kau ʻana i ka stent. ʻO ka maʻamau, uhi ʻia nā scaffolds stent a i ʻole linings me nā lāʻau lapaʻau (e laʻa, everolimus, paclitaxel, a sirolimus)20,23,24. ʻO Sirolimus kahi lāʻau antiproliferative maʻamau e kāohi ana i kekahi mau ʻanuʻu o ka restenosis cascade (e laʻa, ʻā, neointimal hyperplasia, a me collagen synthesis)25. No laila, ua manaʻo kēia haʻawina e hiki i nā stents-coated sirolimus ke pale i ka hyperplasia kiko o ka stent-induced i nā puaʻa ET (Figure 1). ʻO ka pahuhopu o kēia noiʻi ʻana ʻo ia ka noiʻi ʻana i ka maikaʻi o ka sirolimus-eluting stents (SES) i ka pale ʻana i ka hoʻonui ʻia ʻana o ka ʻiʻo ma hope o ka hoʻokomo ʻana i ka stent i kahi kumu hoʻohālike porcine ET.
Hōʻike kiʻi kiʻi o ka cobalt-chromium sirolimus-eluting stent (SES) no ka mālama ʻana i ka maʻi Eustachian tube dysfunction, e hōʻike ana i ka sirolimus-eluting stent ke kāohi nei i ka hoʻonui ʻana o ka ʻiʻo.
Ua hana ʻia nā stents alloy Cobalt-chromium (Co-Cr) e ka ʻoki ʻana i ka laser Co-Cr alloy tubes (Genoss Co., Ltd., Suwon, Korea). Hoʻohana ka stent platform i kahi paʻa pālua hāmama me kahi hoʻolālā hoʻohui no ka hoʻololi kiʻekiʻe me ka ikaika radial maikaʻi loa, pōkole a me ka hoʻokō. He 3 mm ke anawaena o ka stent, he 18 mm ka lōʻihi, a he 78 µm ka mānoanoa strut (Fig. 2a). Ua hoʻoholo ʻia nā ana o ke kāʻei huila Co-Cr ma muli o kā mākou noiʻi mua.
Cobalt-chromium (Co-Cr) alloy stent a me ka pahu alakaʻi metala no ka hoʻokomo ʻana i ka stent tube Eustachian. Hōʻike nā kiʻi i (a) he stent alloy Co-Cr a (b) he catheter baluna i hoʻopaʻa ʻia. (c) Hoʻopili piha ʻia ka catheter baluna a me ka stent. (d) Ua hoʻomohala ʻia kahi pahu alakaʻi metala no ke kumu hoʻohālike puaʻa Eustachian tube.
Ua hoʻohana ʻia ʻo Sirolimus i ka ʻili o ka stent me ka hoʻohana ʻana i ka ʻenehana ultrasonic spray. Hoʻolālā ʻia ʻo SES e hoʻokuʻu i kahi kokoke i 70% o ka ukana lāʻau mua (1.15 µg/mm2) i loko o nā lā 30 mua ma hope o ke kau ʻana. Hoʻopili wale ʻia kahi ʻāpana 3 µm ultra-thin i ka ʻaoʻao kokoke o ka stent no ka hoʻokō ʻana i ka ʻaoʻao hoʻokuʻu lāʻau i makemake ʻia a hoʻemi i ka nui o ka polymer; Aia i loko o kēia uhi biodegradable kahi copolymer o nā waikawa lactic a me glycolic a me kahi hui pono o ka poly(1)-lactic acid)26,27. Hoʻopili ʻia nā stents alloy Co-Cr ma luna o nā catheters baluna 3 mm ke anawaena a me 28 mm ka lōʻihi (Genoss Co., Ltd.; Fig. 2b). Loaʻa kēia mau stents ma South Korea no ka mālama ʻana i ka maʻi naʻau coronary.
ʻO ka pūpū alakaʻi metala hou i kūkulu ʻia no ke ʻano puaʻa ET i hana ʻia me ke kila kila (Fig. 2c). ʻO nā anawaena o loko a me waho o ka pūpū he 2 mm a me 2.5 mm, kēlā me kēia, ʻo 250 mm ka lōʻihi. Ua hoʻokuʻu ʻia ka ʻūhā 30 mm mamao i kahi J-like ma kahi kihi 15 ° i ke axis e hiki ai ke komo maʻalahi mai ka ihu a i ka puka nasopharyngeal o ka ET i ke ʻano puaʻa.
Ua ʻae ʻia kēia haʻawina e ka Institutional Animal Care and Use Committee o ka Asan Institute of Life Science (Seoul, South Korea) a e hoʻokō me nā National Institutes of Health Guidelines for the Humane Treatment of Laboratory Animals (IACUC-2020-12-189). . Ua mālama ʻia ka haʻawina e like me nā kuhikuhi ARRIVE. Ua hoʻohana kēia haʻawina i ka 12 ETs i nā puaʻa 6 e kaupaona ana i ka 33.8-36.4 kg ma 3 mau mahina. Ua māhele ʻia nā puaʻa ʻeono i ʻelua pūʻulu (ʻo ia hoʻi ka pūʻulu mana a me ka pūʻulu SES) me ʻekolu puaʻa i kēlā me kēia hui. Ua loaʻa i ka pūʻulu hoʻomalu kahi stent Co-Cr alloy uncoated, ʻoiai ua loaʻa i ka hui SES kahi stent Co-Cr alloy eluting sirolimus. Loaʻa i nā puaʻa āpau ke komo manuahi i ka wai a me ka hānai a mālama ʻia ma 24 ° C ± 2 ° C no kahi pōʻai 12-hola i ka pō. Ma hope mai, ua mōhai ʻia nā puaʻa a pau i 4 mau pule ma hope o ke kau ʻana i ka stent.
Ua loaʻa i nā puaʻa āpau kahi hui o 50mg / kg zolazepam, 50mg / kg teletamide (Zoletil 50; Virbac, Carros, Farani) a me 10mg / kg xylazine (Rompun; Bayer HealthCare, Les Varkouzins, Kelemānia). a laila ua kau ʻia ka paipu tracheal e ka inhalation o 0.5-2% isoflurane (Ifran®; Hana Pharm. Co., Seoul, Korea) a me ka oxygen 1: 1 (510 ml / kg / min) no ka anesthesia. Ua hoʻonoho ʻia nā puaʻa ma ke kūlana supine a ua hana ʻia ka endoscopy baseline (VISERA 4K UHD rhinolaryngoscope; Olympus, Tokyo, Iapana) e nānā i ka orifice nasopharyngeal o ET. Ua hoʻonui ʻia kahi pahu alakaʻi metala ma ka puka ihu a hiki i ka puka nasopharyngeal o ET ma lalo o ka mana endoscopic (Fig. 3a, b). Hoʻokomo ʻia kahi catheter baluna, he stent corrugated, ma o ka mea hoʻokomo i loko o ka ET a hiki i kona kihi e hālāwai ai me ke kū'ē i ka osteochondral isthmus o ka ET (Fig. 3c). Ua hoʻopiha piha ʻia ka catheter baluna me ka paʻakai i 9 mau ea, e like me ka mea i hoʻoholo ʻia e ka monitor manometer (Fig. 3d). Ua wehe ʻia ka catheter baluna ma hope o ka hoʻokomo ʻana i ka stent (Fig. 3f), a ua loiloi maikaʻi ʻia ka wehe ʻana o ka nasopharyngeal endoscopy no nā pilikia o ke kaʻina (Fig. 3f). Hoʻopau nā puaʻa a pau i ka endoscopy ma mua a ma hope koke o ka stenting, a me 4 mau pule ma hope o ka stenting, e loiloi i ka patency o ka pūnaewele stent a me nā huna huna.
Nā ʻanuʻu ʻenehana no ke kau ʻana i kahi stent i loko o ka eustachian tube (ET) o kahi puaʻa ma lalo o ka mana endoscopic. (a) Kiʻi endoscopic e hōʻike ana i ka wehe ʻana o ka nasopharyngeal (arrow) a hoʻokomo ʻia i ka pahu alakaʻi metala (arrow). (b) Hoʻokomo ʻana i kahi pū metala (pua) i loko o ka puka nasopharyngeal. (c) Hoʻokomo ʻia kahi catheter baluna i hoʻopaʻa ʻia i ka stent (arrow) i loko o ka ET ma o kahi pū (arrow). (d) Ua hoʻonui piha ʻia ka catheter baluna (arrow). (e) Puka ka hope o ka stent mai ka puka ET o ka nasopharynx. (f) Kiʻi endoscopic e hōʻike ana i ka stent lumen patency.
Hoʻopau ʻia nā puaʻa a pau ma o ka hoʻohana ʻana i ka 75 mg/kg potassium chloride ma o ka hoʻoheheʻe ʻana i ka vein pepeiao. Hana ʻia nā ʻāpana sagittal Median o ke poʻo puaʻa me ka hoʻohana ʻana i kahi kaulahao i ukali ʻia e ka unuhi ʻana me ka noʻonoʻo ʻana i nā ʻāpana kiko scaffold ET no ka nānā ʻana i ka histological (Supplementary Fig. 1a,b). Ua hoʻopaʻa ʻia nā laʻana kikoo ET i 10% neutral buffered formalin no 24 mau hola.
Ua hoʻomaʻemaʻe ʻia nā laʻana o ET me ka waiʻona o nā ʻano ʻokoʻa. Hoʻokomo ʻia nā laʻana i loko o nā poloka resin ma ka infiltration me ka ethylene glycol methacrylate (Technovit 7200® VLC; Heraus Kulzer GMBH, Wertheim, Kelemānia). Hana ʻia nā ʻāpana Axial ma nā kikoʻī kikoʻī ET i hoʻokomo ʻia i loko o nā ʻāpana proximal a me distal (Supplementary Fig. 1c). A laila ua kau ʻia nā poloka polymer ma nā kiʻi aniani acrylic. ʻO nā paheʻe paheʻe resini he microground a hoʻomaʻamaʻa ʻia me ka pepa silicon carbide o nā mānoanoa like ʻole a hiki i ka mānoanoa o 20 µm me ka hoʻohana ʻana i kahi ʻōnaehana grid (Apparatebau GMBH, Hamburg, Kelemānia). Hoʻopili ʻia nā paheʻe a pau i ka loiloi histological me ka hematoxylin a me ka eosin staining.
Hana ʻia ka loiloi mōʻaukala e loiloi i ka pakeneka o ka hoʻonui ʻana o ka ʻiʻo, ka mānoanoa o ka submucosal fibrosis, a me ke kiʻekiʻe o ka infiltration cell inflammatory. Ua helu ʻia ka pākēneka o ka maʻi hyperplasia me kahi ʻāpana keʻa ET ma ka hoʻoholo ʻana i ka hoohalike:
Ua ana ʻia ka mānoanoa o ka fibrosis submucosal mai ka stent struts a i ka submucosa. ʻO ka degere o ka infiltration cell inflammatory i hoʻoholoʻia e ka māhele a me ka nui o nā pūnaewele inflammatory,ʻo ia hoʻi: 1st degree (mild) - hoʻokahi leukocyte infiltration; 2nd degere (maʻalahi a haʻahaʻa) - hoʻokomo leukocyte focal; 3rd degere (moderate) - hui ʻia. me nā leukocytes hiki ʻole ke hoʻokaʻawale i waena o kēlā me kēia loci; papa 4 (maʻalahi a koʻikoʻi) leukocytes diffusely infiltrating i ka submucosa holoʻokoʻa, a me ka papa 5 (koʻikoʻi) diffuse infiltration me ka nui foci o necrosis. Ua loaʻa ka mānoanoa o ka submucosal fibrosis a me ke kiʻekiʻe o ka infiltration cell inflammatory ma o ka awelika ʻana i ʻewalu mau kiko a puni ka ʻāpana. Hana ʻia ka kānana histological o ET me ka microscope (BX51; Olympus, Tokyo, Iapana). Ua loaʻa nā ana me ka polokalamu CaseViewer (CaseViewer; 3D HISTECH Ltd., Budapest, Hungary). Hoʻokumu ʻia ka ʻikepili o ka ʻikepili histological ma ka ʻae ʻana o nā mea nānā ʻekolu i komo ʻole i ka haʻawina.
Ua hoʻohana ʻia ka Mann-Whitney U-test no ka nānā ʻana i nā ʻokoʻa ma waena o nā pūʻulu inā pono. ʻO ka p <0.05 i manaʻo nui ʻia. ʻO ka p <0.05 i manaʻo nui ʻia. Значение p < 0,05 считалось статистически значимым. Ua manaʻo ʻia ka waiwai p <0.05 i ka helu helu. p < 0.05 被认为具有统计学意义。 p <0.05 p < 0,05 считали статистически значимым. p <0.05 ua manaʻo ʻia he mea nui. Ua hana ʻia kahi hoʻāʻo ʻo Mann-Whitney U i hoʻoponopono ʻia ʻo Bonferroni no nā helu p <0.05 e ʻike i nā ʻokoʻa pūʻulu (p <0.008 ma ke ʻano he koʻikoʻi helu). Ua hana ʻia kahi hoʻāʻo ʻo Mann-Whitney U i hoʻoponopono ʻia e Bonferroni no nā helu p <0.05 e ʻike i nā ʻokoʻa o ka hui (p <0.008 ma ke ʻano he koʻikoʻi helu). U-критерий Манна-Уитни с поправкой на Бонферрони был выполнен для значений p <0,05 для выявления групления групления групвый (8 plis <0ч0йх статистически значимое). Ua hana ʻia ʻo Bonferroni-adjusted Mann-Whitney U hoʻāʻo no nā helu p <0.05 e ʻike i nā ʻokoʻa pūʻulu (p<0.008 ma ke ʻano he koʻikoʻi helu).对p 值< 0.05 进行 Bonferroni 校正的Mann-Whitney U 检验以检测组差异（p < 0.008 具有统计幦意。对p 值< 0.05 进行Bonferroni 校正的Mann-Whitney U U-критерий Манна-Уитни с поправкой на Бонферрони был выполнен для значений p < 0,05 для выявления групления групвих (0 <8 бпочвих статистически значимым). Ua hana ʻia ʻo Bonferroni-adjusted Mann-Whitney U-test no p <0.05 e ʻike i nā ʻokoʻa o ka hui (p <0.008 he mea nui i ka helu).Hana ʻia ka ʻikepili helu me ka polokalamu SPSS (version 27.0; SPSS, IBM, Chicago, IL, USA).
Ua holomua nā hoʻokomo ʻana i ka stent porcine a pau. Ua hoʻokomo maikaʻi ʻia kahi puʻu alakaʻi metala i loko o ka puka nasopharyngeal o ET ma lalo o ka mana endoscopic, ʻoiai ua ʻike ʻia ka ʻeha mucosal me ke koko pili i ka 4 o 12 specimens (33.3%) i ka wā o ka hoʻokomo ʻana i ka pū. Ma hope o nā pule he 4, ua ho'ōki ʻia ke koko palpable. Ua ola nā puaʻa a pau a hiki i ka pau ʻana o ke aʻo ʻana me ka ʻole o nā pilikia pili i ka stent.
Hōʻike ʻia nā hopena Endoscopy ma ke Kiʻi 4. I ka wā o ka hahai ʻana o 4 mau pule, ua paʻa nā stents i nā puaʻa āpau. Uaʻikeʻia ka hōʻiliʻiliʻana o ka mucus i loko a puni ka stent ET i nā (100%) ETs i ka hui hoʻomalu a meʻekolu (50%) o nā ETʻeono i ka hui SES, aʻaʻohe mea likeʻole i ka hopena ma waena o nā huiʻelua (p = 0.182). ʻAʻole hiki i kekahi o nā stents hoʻokomo ke mālama i ke ʻano poepoe.
ʻO nā kiʻi endoscopic o ka Eustachian tube (ET) o kahi puaʻa i loko o ka pūʻulu mana a me ka hui me ka cobalt-chromium stent (CXS) eluting sirolimus. (a) Kiʻi endoscopic kumu i lawe ʻia ma mua o ke kau ʻana o ka stent e hōʻike ana i ka wehe ʻana o ka nasopharyngeal (arrow) o ET. (b) Kiʻi ʻia ke kiʻi endoscopic ma hope koke o ka hoʻokomo ʻana i ka stent e hōʻike ana iā ET o kahi kau stent. Ua ʻike ʻia ke kahe koko ma muli o ke kumu alakaʻi metala (arrow). (c) ʻO ke kiʻi endoscopic i lawe ʻia i nā pule he 4 ma hope o ke kau ʻana o ka stent e hōʻike ana i ka hōʻiliʻili ʻana o ka mucus a puni ka stent (arrow). (d) Kiʻi endoscopic e hōʻike ana ʻaʻole hiki i ka stent ke noho poepoe (arrow).
Hōʻike ʻia nā ʻike mōʻaukala ma ka Figure 5 a me ka Figure Hoʻohui 2. ʻO ka hoʻonui ʻana o ka ʻiʻo a me ka hoʻonui ʻana o ka fibrous submucosal ma waena o nā pou stent i ka lumen ET o nā hui ʻelua. Uaʻoi aku ka nui o ka hapa nui o ka'āpana hyperplasia kiko ma ka pūʻulu mana ma mua o ka hui SES (79.48% ± 6.82% vs. 48.36% ± 10.06%, p <0.001). Uaʻoi aku ka nui o ka hapa nui o ka'āpana hyperplasia kiko ma ka pūʻulu mana ma mua o ka hui SES (79.48% ± 6.82% vs. 48.36% ± 10.06%, p <0.001). Средний процент площади гиперплазии тканей был значительно больше в контрольной группе, чем в группе (7 ± 48% (7 ± 6% против 48,36% ± 10,06%, p <0,001). Uaʻoi aku ka nui o ka nui o ka nui o ka nui o ka hyperplasia kiko ma ka hui hoʻomalu ma mua o ka hui SES (79.48% ± 6.82% vs. 48.36% ± 10.06%, p <0.001).SES 组（79.48% ± 6.82% vs.48.36% ± 10.06%，p <0.001）. 48.36% ± 10.06%，p <0.001）. Средний процент площади гиперплазии тканей в контрольной группе был значительно выше, чем в группе СЭС (7 ± 8% (7 ± 8% С). 48,36% ± 10,06%, p <0,001). Uaʻoi aku ka kiʻekiʻe o ka pākēneka o ka nui o ka hyperplasia kiko ma ka hui hoʻomalu ma mua o ka hui SES (79.48% ± 6.82% vs. 48.36% ± 10.06%, p <0.001). Eia kekahi, uaʻoi aku ka nui o ka mānoanoa o ka submucosal fibrosis i ka hui hoʻomalu ma mua o ka hui SES (1.41 ± 0.25 vs. 0.56 ± 0.20 mm, p <0.001). Eia kekahi, uaʻoi aku ka nui o ka mānoanoa o ka submucosal fibrosis i ka hui hoʻomalu ma mua o ka hui SES (1.41 ± 0.25 vs. 0.56 ± 0.20 mm, p <0.001). Более того, средняя толщина подслизистого фиброза также была значительно выше в контрольной группе, чем в 1 гру, 1 против 0,56 ± 0,20 мм, p <0,001). Eia kekahi, uaʻoi aku ka nui o ka mānoanoa o ka submucosal fibrosis i ka hui hoʻomalu ma mua o ka hui SES (1.41 ± 0.25 vs. 0.56 ± 0.20 mm, p <0.001).SES 组（1.41 ± 0.25 vs.0.56 ± 0.20 mm，p < 0.001）. 0.56±0.20mm，p<0.001）. Кроме того, средняя толщина подслизистого фиброза в контрольной группе также была значительно выше, чем в ,4 ±5пс (1 група против 0,56 ± 0,20 мм, p <0,001). Eia kekahi, uaʻoi aku ka nui o ka mānoanoa o ka fibrosis submucosal i loko o ka pūʻulu mana ma mua o ka hui SES (1.41 ± 0.25 vs. 0.56 ± 0.20 mm, p <0.001).Eia nō naʻe, ʻaʻohe ʻokoʻa koʻikoʻi i ke ʻano o ka infiltration cell inflammatory ma waena o nā hui ʻelua (hui mana [3.50 ± 0.55] vs. pūʻulu SES [3.00 ± 0.89], p = 0.270).
Ka nānā ʻana i ka nānā ʻana i ka histological o ʻelua mau pūʻulu stents i kau ʻia ma ka lumen Eustachian. (a, b) ʻO ka ʻāpana o ka hyperplasia tissue (1 o a a me b) a me ka mānoanoa o ka submucosal fibrosis (2 o a a me b; nā pua pālua) i ʻoi aku ka nui o ka pūʻulu mana ma mua o ka pūʻulu SES me ka strut stenting (nā kikoʻeleʻele), kahi o nā lumen liʻiliʻi (melemele) a me ka wahi stent mua (ʻulaʻula). ʻAʻole ʻokoʻa ka degere o ka infiltration cell inflammatory (3 o a a me b; pua) ma waena o nā hui ʻelua. (c) Nā hualoaʻa mōʻaukala o ka hapa pakeneka o ka ʻili hyperplasia, (d) ka mānoanoa o ka submucosal fibrosis, a me (e) degere o ka infiltration cell inflammatory 4 mau pule ma hope o ke kau ʻana i ka stent ma nā hui ʻelua. SES, cobalt-chromium sirolimus eluting stent.
Kōkua nā stent-eluting i ka hoʻomaikaʻi ʻana i ka stent patency a pale i ka restenosis stent20,21,22,23,24. ʻO ka stent-induced stricture ka hopena ma muli o ka hoʻokumu ʻana o ka ʻiʻo granulation a me nā loli fibrous i loko o nā ʻano non-vascular like ʻole, me ka esophagus, trachea, gastroduodenum, a me nā ducts bile. Hoʻohana ʻia nā lāʻau lapaʻau e like me dexamethasone, paclitaxel, gemcitabine, EW-7197, a me sirolimus i ka ʻili o ka uea mesh a i ʻole ka stent coating e pale a mālama i ka hyperplasia kiko ma hope o ke kau ʻana o ka stent29,30,34,35,36. ʻO nā hana hou hou i ke kahua o nā stent multifunctional e hoʻohana ana i ka ʻenehana fusion ke noiʻi ikaika ʻia nei no ka mālama ʻana i nā maʻi occlusive non-vascular37,38,39. Ma kahi noiʻi mua i loko o kahi kŘkohu porcine ET, ua ʻike ʻia ka hoʻonui ʻana o ka ʻiʻo scaffold-induced. ʻOiai ʻaʻole maopopo ka hoʻomohala ʻana o ka stent ma ET, ua ʻike ʻia ka pane ʻana o ka ʻiʻo ma hope o ke kau ʻana i ka stent e like me nā mea luminal nonvascular ʻē aʻe19. Ma ke aʻo ʻana i kēia manawa, ua hoʻohana ʻia ʻo SES no ka pale ʻana i ka hoʻonui ʻana o ka ʻiʻo scaffold-induced i loko o kahi ʻano porcine ET. He mea ʻawaʻawa ʻo Sirolimus i nā mokupuni pancreatic a me nā laina cell beta, e hōʻemi i ka hiki ke ola a hoʻonui i ka apoptosis40,41. Hiki i kēia hopena ke kōkua i ke kāohi ʻana i ka hoʻonui ʻana o ka ʻiʻo ma o ka hoʻoulu ʻana i ka make cell. Ua hōʻike kā mākou haʻawina ʻo ka hoʻohana mua ʻana i nā stents drug-eluting ma ET i kaohi pono ʻana i ka hoʻonui ʻana o ka stent-induced tissue ma ET.
Hiki ke loa'a i ka baluna-expandable Co-Cr alloy stent i ho'ohana 'ia i loko o kēia noi'i 'ana no ka mea ua ho'ohana mau 'ia ia no ka mālama 'ana i ka ma'i 'a'ai coronary 42 . Eia kekahi, loaʻa i nā huila Co-Cr nā waiwai mechanical (no ka laʻana, ka ikaika radial kiʻekiʻe a me nā ikaika inelastic) 43 . Wahi a ka endoscopy o ke aʻo ʻana i kēia manawa, ʻaʻole hiki i ka Co-Cr alloy stent i hoʻohana ʻia no ET o nā puaʻa ke mālama i kahi ʻano poepoe i nā puaʻa āpau ma muli o ka lawa ʻole o ka elasticity a ʻaʻole hiki ke hoʻonui iā ia iho. Hiki ke hoʻololi ʻia ke ʻano o ka stent i hoʻokomo ʻia e ka neʻe ʻana a puni ka ET o kahi holoholona ola (e laʻa, ka nau a me ka ʻai ʻana). Ua lilo nā ʻano mechanical o Co-Cr alloy stents i mea pōʻino i ka hoʻokomo ʻana i nā stents porcine ET. Eia kekahi, ʻo ke kau ʻana i kahi stent ma ka isthmus hiki ke hopena i ka wehe mau ʻana o ET. ʻO ka wehe ʻana a i ʻole ka lōʻihi o ka ET e hiki ai i ka haʻiʻōlelo a me nā leo nasopharyngeal, ka reflux o ka ʻōpū, a me nā pathogens1 e hele i luna i ka pepeiao waena, e hoʻoulu ai i ka mucosal a me ka maʻi. No laila, pono e pale ʻia nā puka nasopharyngeal mau. No laila, hāʻawi ʻia i ke ʻano o ka cartilage ET, ʻoi aku ka maikaʻi o ka hana ʻana i nā scaffolds mai nā mea hoʻomanaʻo hoʻomanaʻo kino me nā waiwai superelastic, e like me ka nitinol. Ma keʻano laulā, loaʻa ka hoʻokuʻu kaumaha i loko a puni ka puka nasopharyngeal o ka stent. Ma muli o ka paʻa ʻana o ka neʻe ʻana o ka mucociliary maʻamau o ka mucus, manaʻo ʻia ka mea huna e hōʻiliʻili i nā scaffolds e puka mai ana mai ka wehe ʻana o ka nasopharyngeal. ʻO ka pale ʻana i ka piʻi ʻana o ka maʻi pepeiao waena kekahi o nā pahuhopu nui o ET, a pono e pale ʻia ke kau ʻana i nā stents e kū ana ma waho o ET, no ka mea, hiki i ka hoʻopili pololei ʻana i nā stents me nā flora bacteria nasopharyngeal ke alakaʻi i ka piʻi ʻana o nā maʻi.
ʻO ka pāpaʻi baluna Eustachian tube ma o ka wehe ʻana o ka nasopharyngeal kahi lāʻau hou liʻiliʻi liʻiliʻi no ka ET dysfunction e manaʻo ana e wehe a hoʻonui i ka ʻāpana cartilaginous o ET8,9,10,46. Eia naʻe, ʻaʻole i ʻike ʻia ke ʻano o ka lāʻau lapaʻau i lalo47 a ʻo kona mau hopena lōʻihi paha he suboptimal8,9,11,46. Ma lalo o kēia mau kūlana, hiki i ka stenting metala keu ke koho lapaʻau maikaʻi no nā poʻe maʻi i pane ʻole i ka hoʻoponopono ʻana i ka balloon tube Eustachian, a ua hōʻike ʻia ke kūpono o ka stenting ET i nā haʻawina preclinical. Ua hoʻokomo ʻia nā scaffolds Poly-l-lactide ma o ka membrane tympanic i loko o nā chinchillas a me nā rabbit e loiloi i ka tolerability a me ka degradation i vivo17,18. Eia kekahi, ua hana ʻia kahi hiʻohiʻona hipa e loiloi i ka ʻike o nā stent hiki ke hoʻonui ʻia i ka baluna metala i vivo. Ma kā mākou noiʻi mua, ua hoʻomohala ʻia kahi hoʻohālike porcine ET e noiʻi i ka hiki ʻana o ka ʻenehana a me ka loiloi ʻana i nā hoʻopiʻi stent-induced, 19 e hāʻawi i kahi kumu paʻa no kēia noiʻi e noiʻi i ka pono o SES me ka hoʻohana ʻana i nā ʻano hana mua. I loko o kēia haʻawina, ua hoʻokomo maikaʻi ʻia ʻo SES i ka cartilage a pale pono i ka hoʻonui ʻana o ka ʻiʻo. ʻAʻohe pilikia pili i ka stent, akā ua ʻeha ka mucosal ma muli o ka puʻu alakaʻi metala me ke koko pili i hoʻoholo ʻia i loko o 4 pule. Hāʻawi ʻia i nā pilikia e hiki mai ana o nā sheath metala, ʻo ka hoʻomaikaʻi ʻana i ka ʻōnaehana lawe SES he wikiwiki a koʻikoʻi.
He mau palena kēia haʻawina. ʻOiai ʻokoʻa ka ʻike ʻana o ka mōʻaukala ma waena o nā pūʻulu, he liʻiliʻi loa ka heluna o nā holoholona i kēia haʻawina no kahi ʻikepili helu hilinaʻi. ʻOiai ua makapō ʻekolu mau mea nānā e loiloi i ka ʻokoʻa o ka inter-observer, ua hoʻoholo ʻia ka degere o ka submucosal inflammatory cell infiltration ma muli o ka puʻunaue a me ka nui o nā cell inflammatory ma muli o ka paʻakikī o ka helu ʻana i nā cell inflammatory. No ka mea ua hana ʻia kā mākou noiʻi ʻana me ka hoʻohana ʻana i kahi helu liʻiliʻi o nā holoholona nui, ua hoʻohana ʻia kahi ʻano o ka lāʻau lapaʻau, ʻaʻole i mālama ʻia nā haʻawina pharmacokinetic vivo. Pono nā haʻawina hou aʻe e hōʻoia i ke ʻano kūpono o ka lāʻau lapaʻau a me ka palekana o sirolimus ma ET. ʻO ka hope, ʻo ka 4-week follow-up period ka palena o ke aʻo ʻana, no laila pono nā haʻawina e pili ana i ka hopena lōʻihi o SES.
Hōʻike nā hopena o kēia haʻawina e hiki i ka SES ke kāohi pono i ka hoʻonui ʻana o ka ʻiʻo ma hope o ka hoʻokomo ʻana i nā scaffolds huila Co-Cr hiki ke hoʻonui ʻia i loko o kahi kumu hoʻohālike porcine ET. ʻEhā mau pule ma hope o ka hoʻokomo ʻana i ka stent, ʻoi aku ka haʻahaʻa o nā ʻano like ʻole e pili ana i ka hoʻonui ʻia ʻana o ka ʻiʻo stent-induced (me ka ʻāpana o ka hoʻonui ʻana o ka ʻili a me ka mānoanoa o ka submucosal fibrosis) i ka hui SES ma mua o ka pūʻulu mana. He mea maikaʻi ka SES i ka pale ʻana i ka hoʻonui ʻana o ka ʻiʻo scaffold-induced i nā puaʻa ET. ʻOiai pono ka noiʻi hou ʻana e hoʻāʻo i nā mea stent maikaʻi loa a me nā ʻano o nā moho lāʻau lapaʻau, loaʻa i ka SES nā mea lapaʻau kūloko i ka pale ʻana i ka ET tissue hyperplasia ma hope o ke kau ʻana i ka stent.
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