Root Zachary T, Lepley Thomas J, Kim Kanghyun, Schneller Aspen R, Zhao Songzhu, Wen Raymond, Formanek Veronica L, Sussman Sarah M, Lee Joseph S, Odeh Ahmad, Wei Lai, Kelly Kathleen M, Otto Bradley A, Zhao Kai
Department of Otolaryngology-Head and Neck Surgery The Ohio State University Wexner Medical Center Columbus Ohio USA.
Department of Biomedical Informatics and Center for Biostatistics The Ohio State University Wexner Medical Center Columbus Ohio USA.
OTO Open. 2024 Oct 16;8(4):e70036. doi: 10.1002/oto2.70036. eCollection 2024 Oct-Dec.
Topical corticosteroid irrigation plays critical role in the management of chronic rhinosinusitis (CRS). Yet, its efficacy can be highly variable. We sought to determine if personalized, 3-dimensional (3D)-printed nasal models can optimize head positioning and irrigation parameters, therefore improving patient outcomes.
Randomized, single-blinded clinical trial.
Tertiary medical center from November 2021 to July 2023.
Sixty-two patients with CRS were randomized into either control (CG), backfill (BG), or model (MG) groups; daily 2 mg mometasone irrigations were then performed for 2 months with either standard head-forward and natural side-tilt position (CG), a head tilt of 90° to the side with fluid entering the lower nostril (BG), or in an optimized position as determined by a patient-specific 3D printed irrigation model (MG), respectively.
A total of 36 patients completed the trial (CG: N = 14/23; BG N = 11/23, MG: N = 11/16). Significant posttreatment improvement in Lund-Mackay (LM) scoring was only observed in the MG (-3.73, 95% confidence interval = -5.71, -1.75; < .001). Patient-reported outcome measures (Nasal Obstruction Symptom Evaluation, Sinonasal Outcome Test-22, and Visual Analog Scale of nasal congestion) improved significantly among all groups. Optimal model penetration scores significantly correlated to posttreatment MG LM score (Spearman's = 0.65, < .05). Among all groups, patients with prior endoscopic sinus surgery (ESS) (n = 19) had objectively less opacification at baseline; however, experienced the same degree of opacification reduction and symptom reduction as those without prior ESS (n = 17).
The use of 3D printing to personalize head positioning may significantly improve objective corticosteroid irrigation outcomes. Mometasone irrigation may have similar subjective and objective effects on patients regardless of prior surgical history.
Level 1 prospective, randomized, single-blinded clinical trial NCT06118554.
局部用糖皮质激素冲洗在慢性鼻-鼻窦炎（CRS）的治疗中起着关键作用。然而，其疗效差异很大。我们试图确定个性化的三维（3D）打印鼻腔模型是否可以优化头部位置和冲洗参数，从而改善患者的治疗效果。
随机、单盲临床试验。
2021年11月至2023年7月的三级医疗中心。
62例CRS患者被随机分为对照组（CG）、回填组（BG）或模型组（MG）；然后分别采用标准的头部前倾和自然侧倾姿势（CG）、向液体流入下鼻孔一侧倾斜90°的头部姿势（BG）或根据患者特异性3D打印冲洗模型确定的优化姿势（MG），每日用2mg莫米松进行冲洗，持续2个月。
共有36例患者完成试验（CG组：N = 14/23；BG组：N = 11/23，MG组：N = 11/16）。仅在MG组观察到Lund-Mackay（LM）评分在治疗后有显著改善（-3.73，95%置信区间 = -5.71，-1.75；P <.001）。所有组患者报告的结局指标（鼻阻塞症状评估、鼻窦结局测试-22和鼻充血视觉模拟量表）均有显著改善。最佳模型穿透分数与MG组治疗后的LM评分显著相关（Spearman相关系数 = 0.65，P <.05）。在所有组中，既往有内镜鼻窦手术（ESS）史的患者（n = 19）在基线时的混浊程度客观上较轻；然而，其混浊程度降低和症状减轻的程度与无ESS史的患者（n = 17）相同。
使用3D打印来个性化头部位置可能会显著改善糖皮质激素冲洗的客观效果。无论既往手术史如何，莫米松冲洗对患者可能具有相似的主观和客观效果。
1级前瞻性、随机、单盲临床试验NCT06118554
