英国纽卡斯尔弗里曼医院Sean Carrie团队研究了鼻中隔成形术治疗鼻中隔偏曲的临床效果。2023年10月18日，该研究成果发表在《英国医学杂志》。

为了评价鼻中隔成形术的临床疗效，研究组在英国国家卫生服务局的17家耳鼻喉科诊所中进行了一项多中心随机对照试验。共招募378名成年人（≥18岁，67%为男性），新转诊有鼻中隔偏曲相关的鼻阻塞症状和至少中度鼻阻塞症状（鼻阻塞和症状评估量表得分>30）。

参与者被1:1随机分组，接受鼻中隔成形术（n=188）或明确医疗管理（n=190，鼻类固醇和盐水喷雾6个月），按基线症状严重程度和性别进行分层。主要结局衡量标准是患者在六个月时在西诺鼻结果测试-22（SNOT-22）中报告的分数，其中9分被定义为最小临床重要差异。次要结局包括生活质量和客观的鼻腔气流测量。

鼻中隔成形术组（n=152，意向治疗人群）在6个月时的平均SNOT-22评分为19.9，医疗管理组（n=155）为39.5；随机接受鼻中隔成形术的参与者估计低20.0分（甚至更好）（P<0.001，根据基线连续SNOT-22评分和分层变量性别和基线NOSE严重程度类别进行校正）。

较高的基线症状严重程度评分可预测SNOT-22评分有更大的改善。鼻中隔成形术组参与者的生活质量和鼻气流测量（包括鼻吸气峰值流量和绝对吸入鼻分配比）结局改善得更多。7名参与者（174名接受过鼻中隔成形术的参与者中占4%）在鼻中隔成形术后因出血再次入院，另有20名参与者（12%）因感染需要抗生素。

研究结果表明，对于患有鼻中隔偏曲引起鼻阻塞的成年人，鼻中隔成形术是一种比使用鼻类固醇和盐水喷雾的既定医疗管理方案更有效的干预措施。

附：英文原文

Title: Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial

Author: Sean Carrie, James O’Hara, Tony Fouweather, Tara Homer, Nikki Rousseau, Leila Rooshenas, Alison Bray, Deborah D Stocken, Laura Ternent, Katherine Rennie, Emma Clark, Nichola Waugh, Alison J Steel, Jemima Dooley, Michael Drinnan, David Hamilton, Kelly Lloyd, Yemi Oluboyede, Caroline Wilson, Quentin Gardiner, Naveed Kara, Sadie Khwaja, Samuel C Leong, Sangeeta Maini, Jillian Morrison, Paul Nix, Janet A Wilson, M Dawn Teare

Issue&Volume: 2023/10/18

Abstract:

Objective To assess the clinical effectiveness of septoplasty.

Design Multicentre, randomised controlled trial.

Setting 17 otolaryngology clinics in the UK’s National Health Service.

Participants 378 adults (≥18 years, 67% men) newly referred with symptoms of nasal obstruction associated with septal deviation and at least moderate symptoms of nasal obstruction (score >30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale).

Interventions Participants were randomised 1:1 to receive either septoplasty (n=188) or defined medical management (n=190, nasal steroid and saline spray for six months), stratified by baseline symptom severity and sex.

Main outcome measures The primary outcome measure was patient reported score on the Sino-Nasal Outcome Test-22 (SNOT-22) at six months, with 9 points defined as the minimal clinically important difference. Secondary outcomes included quality of life and objective nasal airflow measures.

Results Mean SNOT-22 scores at six months were 19.9 (95% confidence interval 17.0 to 22.7) in the septoplasty arm (n=152, intention-to-treat population) and 39.5 (36.1 to 42.9) in the medical management arm (n=155); an estimated 20.0 points lower (better) for participants randomised to receive septoplasty (95% confidence interval 16.4 to 23.6, P<0.001, adjusted for baseline continuous SNOT-22 score and the stratification variables sex and baseline NOSE severity categories). Greater improvement in SNOT-22 scores was predicted by higher baseline symptom severity scores. Quality of life outcomes and nasal airflow measures (including peak nasal inspiratory flow and absolute inhalational nasal partitioning ratio) improved more in participants in the septoplasty group. Readmission to hospital with bleeding after septoplasty occurred in seven participants (4% of 174 who had septoplasty), and a further 20 participants (12%) required antibiotics for infections.

Conclusions Septoplasty is a more effective intervention than a defined medical management regimen with a nasal steroid and saline spray in adults with nasal obstruction associated with a deviated nasal septum.

DOI: 10.1136/bmj-2023-075445

Source: https://www.bmj.com/content/383/bmj-2023-075445