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功能性内镜鼻窦手术后可吸收鼻腔填塞的内镜结果:一项多中心前瞻性随机对照研究。

Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study.

作者信息

Berlucchi Marco, Castelnuovo Paolo, Vincenzi Andrea, Morra Bruno, Pasquini Ernesto

机构信息

Department of Otorhinolaryngology, University of Brescia, Brescia, Italy.

出版信息

Eur Arch Otorhinolaryngol. 2009 Jun;266(6):839-45. doi: 10.1007/s00405-008-0841-3. Epub 2008 Oct 23.

Abstract

Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery (FESS), but traditional non-resorbable stents have several inherent drawbacks. We performed a randomized, controlled, multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis. A total of 66 patients for 88 nasal cavities were randomized to receive either hyaluronan resorbable packing (MeroGel) or standard non-resorbable nasal dressing after FESS. All underwent preoperative rhinoscopy, CT of sinuses, and, after surgery, were reassessed by rhinoscopy at 2, 4, and 12 weeks in blinded fashion. A total of 44 nasal cavities (MeroGel-group) received resorbable packing, whereas the remaining 44 were packed with non-resorbable nasal dressing. At follow-up endoscopic visit, the presence of nasal synechia was evaluated as primary outcome. Moreover, the tolerability and surgical handling properties of MeroGel and its comfort were assessed by surgeons and patients. Preoperative severity of rhinosinusitis was similar in both groups. No significant adverse events were observed in all patients. Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel-group at both 4 (P = 0.041) and 12 weeks (P < 0.001). Moreover, an improvement of other endoscopic nasal findings such as re-epithelialization, presence of granulation tissue, and appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel-group. Tolerability and surgical handling properties of MeroGel were positively rated by clinicians and the overall patient judged comfort of MeroGel was favorable. In conclusion, MeroGel can be considered a valid alternative to standard non-resorbable nasal dressings. It is safe, well-accepted, well-tolerated, and has significant advantage of being resorbable. Moreover, it may favor improved healing in patients undergoing FESS and reduce formation of adhesions.

摘要

鼻填塞物有助于功能性鼻内镜鼻窦手术(FESS)术后控制出血和促进愈合,但传统的不可吸收支架有几个固有的缺点。我们进行了一项随机、对照、多中心临床试验,以评估可吸收鼻填塞物在接受FESS治疗慢性鼻窦炎患者中的疗效。共有66例患者的88个鼻腔被随机分为两组,在FESS术后分别接受透明质酸可吸收填塞物(MeroGel)或标准不可吸收鼻敷料。所有患者术前均接受鼻内镜检查、鼻窦CT检查,术后在2周、4周和12周时以盲法再次接受鼻内镜检查。共有44个鼻腔(MeroGel组)接受了可吸收填塞物,其余44个鼻腔用不可吸收鼻敷料填塞。在随访内镜检查时,将鼻粘连的存在作为主要观察指标。此外,外科医生和患者对MeroGel的耐受性、手术操作特性及其舒适度进行了评估。两组患者术前鼻窦炎的严重程度相似。所有患者均未观察到明显的不良事件。随访鼻内镜检查显示,MeroGel组在4周(P = 0.041)和12周(P < 0.001)时鼻粘连的比例较低。此外,在MeroGel组中观察到FESS术后其他鼻内镜检查结果有所改善,如再上皮化、肉芽组织的存在以及鼻腔黏膜外观。临床医生对MeroGel的耐受性和手术操作特性给予了积极评价,总体患者对MeroGel舒适度的评价也较好。总之,MeroGel可被视为标准不可吸收鼻敷料的有效替代品。它安全、易于接受、耐受性良好,并且具有可吸收的显著优势。此外,它可能有利于接受FESS治疗的患者改善愈合并减少粘连的形成。

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