Article record

可生物吸收鼻中隔植入物治疗软骨性鼻中隔偏曲的安全性与有效性

Safety and Effectiveness of a Bioabsorbable Septal Implant for Cartilaginous Nasal Septal Deviation.

临床研究鼻科IF 2.1Q2

文献信息

PMID	42827590
原文	在 PubMed 查看原文 ↗
发表日期	2026
作者	Thomas S Higgins 查看其他 7 位作者 Henry P Barham；Greg E Davis；Steven E Davis；Adil Fatakia；Nora W Perkins；Michael Sillers；David M Yen
作者单位	Kentuckiana ENT, a Division of ENT Care Centers Louisville Kentucky USA. 查看其他 9 条单位信息 Otolaryngology-Head and Neck Surgery, University of Louisville School of Medicine Louisville Kentucky USA.；Otolaryngology, Sinus and Nasal Specialists of Louisiana Baton Rouge Louisiana USA.；Proliance Surgeons Seattle Washington USA.；Breathe Clear Institute Torrance California USA.；ENT & Allergy of New Orleans New Orleans Louisiana USA.；Albany ENT & Allergy Services, PC Albany New York USA.；Otolaryngology-Head and Neck Surgery, University of Alabama at Birmingham Birmingham Alabama USA.；Specialty Physician Associates Bethlehem Pennsylvania USA.；Otolaryngology-Head and Neck Surgery, St. Luke's University Health Network Bethlehem Pennsylvania USA.
期刊	Laryngoscope investigative otolaryngology
SCI 分区	Q2
IF	2.1
研究类型	临床研究 · 临床
所属专科	鼻科

中文摘要

目的： 鼻气道阻塞（NAO）可由软骨性和骨性鼻中隔偏曲引起。矫正尾侧软骨性鼻中隔在技术上可能具有挑战性。本研究旨在评估一种可生物吸收黏膜下鼻中隔植入物（SeptAlign；Spirair Inc.）用于微创矫正软骨性鼻中隔偏曲（NSD）的安全性和有效性。
方法： 这是一项在美国九家耳鼻咽喉科诊所开展的前瞻性队列研究。受试者接受单独植入物置入或同时行下鼻甲减容术（ITR）。在术后3个月和6个月计算平均鼻阻塞症状评估（NOSE）评分相对于基线的百分比降低。
结果： 在80名受试者中（92.5%为中度至重度NSD），NOSE评分降低了63.2%（从基线的67.5降至3个月时的26.0和6个月时的23.6；p值<0.0001）。总体而言，3个月时85.9%的受试者和6个月时89.9%的受试者被视为应答者。同时行鼻甲减容术的亚组在6个月时有88.2%的应答者，而单独植入物亚组有91.4%的应答者。受试者在手术后中位1天返回工作，其中46.3%的病例在局部麻醉下于诊室完成。
结论： 该鼻中隔植入物通过修复NSD有效治疗NAO症状，且总体安全且耐受良好。它通过机械牵引使软骨性NSD变直，无需切除，可能成为传统鼻中隔成形术的有吸引力的替代方案。
证据等级： 3。

英文摘要

OBJECTIVE: Nasal airway obstruction (NAO) can be due to deviation of the cartilaginous and bony nasal septum. Correcting the caudal cartilaginous septum can be technically challenging. This study aims to evaluate the safety and effectiveness of a bioabsorbable submucosal septal implant (SeptAlign; Spirair Inc.) for minimally invasive correction of cartilaginous nasal septal deviation (NSD).
METHODS: This was a prospective cohort study conducted at nine otolaryngology clinics in the USA. Subjects underwent placement of the implant alone or with concurrent inferior turbinate reduction (ITR). Percentage reductions relative to baseline in the mean Nasal Obstruction Symptom Evaluation (NOSE) score were calculated at 3 and 6 months postprocedure.
RESULTS: In 80 subjects (92.5% with moderate-to-severe NSD), NOSE scores decreased by 63.2% (from 67.5 at baseline to 26.0 at 3 months and 23.6 at 6 months; p values < 0.0001). Overall, 85.9% of subjects at 3 months and 89.9% at 6 months were considered responders. The sub-group with concurrent turbinate reduction had 88.2% responders and the sub-group with the implant alone had 91.4% responders at 6 months. Subjects returned to work a median of 1 day after the procedure, which was performed in-office under local anesthesia in 46.3% of cases.
CONCLUSION: The septal implant was an effective treatment for NAO symptoms via NSD repair and was generally safe and well tolerated. It straightens cartilaginous NSD via mechanical traction without the need for resection and may be an attractive alternative to conventional septoplasty.
LEVEL OF EVIDENCE: 3.