个性化设计3D打印鼻前庭支撑器用于鼻前庭区狭窄治疗的随机对照研究
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1.上海交通大学医学院附属第九人民医院 耳鼻咽喉头颈外科;2.上海交通大学医学院附属第九人民医院 D打印中心

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上海交通大学医学院附属第九人民医院临床研究助推计划(临+计划)(Clinical Research Program of 9th People’s Hospital, Shanghai Jiao Tong University School of Medicine) (项目编号:JYLJ202009)


Randomized Controlled Trial on individually designed 3D printed nasal vestibular support for the treatment of nasal vestibular stenosis
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Department of Otolaryngology Head Neck Surgery,Shanghai Ninth People’s Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai

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    摘要:

    目的 分析个性化设计3D打印鼻前庭器支撑扩张和常规支撑扩张对鼻前庭区狭窄治疗后鼻腔通气功能和前鼻孔形态上恢复疗效的评价。 方法 73例单侧外伤性鼻前庭区狭窄的患者,随机分为两组,对照组35例采用常规支撑扩张),试验组38例采用3D打印鼻前庭器支撑扩张,分别从主观评价指标、客观的局部形态结构参数和数值模拟鼻腔气流动力学参数等方面来评价两组患者术前和支撑扩张治疗后鼻腔局部形态和功能恢复情况。 结果 两组患者支撑治疗后鼻塞主观感觉和鼻孔对称性满意度视觉模拟评分(VAS)均较术前有明显改善(P<0.01),在鼻孔对称性满意度方面试验组评分高于对照组(P=0.007<0.01);支撑扩张治疗后两组的鼻瓣区截面积(对照组0.86±0.29cm2和试验组0.71±0.26cm2)均较手术前明显增加(P<0.01), 其中对照组鼻瓣区截面积均值大于试验组(P=0.021<0.05),但鼻孔形态学参数显示支撑扩张治疗后试验组Δ长轴比值和Δ短轴比值的值均小于对照组(P<0.05),在恢复鼻孔形态上个性化设计3D打印的鼻前庭支撑器支撑扩张治疗更优;支撑扩张治疗后两组的狭窄侧鼻腔阻力均分别低于术前(P<0.05),并且试验组(0.022±0.008 Pa.s.mL-1)比对照组(0.028±0.012 Pa.s.mL-1)有更小的狭窄侧鼻腔阻力值(P=0.011<0.05),但两组的总鼻腔阻力值差别不明显(P=0.64>0.05);鼻腔气流温湿度调节功能参数结果显示,支撑扩张治疗后对照组(94.55±2.54%)和试验组(95.26±3.21%)患者的鼻腔气流的加温效率均较手术前(对照组95.45±2.93%和试验组96.14±2.63%)有明显减小(P<0.01),但总鼻腔加温效率和加湿效率在对照组和试验组间并未显示有明显差异(PNWE=0.30>0.05,PNHE=0.44>0.05)。 结论 个性化设计3D打印鼻前庭支撑器用于前鼻孔狭窄患者的术后支撑扩张治疗使前鼻孔外形、鼻腔的正常的通气功能和鼻腔气流的温湿度调节作用均有较好的恢复,能够体现个性化治疗的优势并让患者获得更为满意的疗效,可作为临床上鼻前庭局部支撑扩张治疗的补充,其临床应用前景较好。

    Abstract:

    Objective To evaluate the efficacy of individually designed 3D printed nasal vestibular support expansion and conventional support expansion on the recovery of nasal ventilation function and anterior nostril morphology in nasal vestibular stenosis. Methods 73 patients with traumatic unilateral nasal vestibular stenosis were randomly divided into the control group of 35 cases (by conventional support expansion) and the experimental group of 38 cases (by 3D printed nasal vestibular support expansion). Morphological parameters and nasal airflow numerical simulation parameters were used to evaluate the local morphological and functional recovery of the nasal cavity before and after expansion treatment. Results The VAS score of subjective nasal patency and nostril symmetry satisfaction in the control group and the experimental group were both significantly improved after support expansion treatment compared with those before operation (P<0.01),the VAS score of nostril symmetry satisfaction in the experimental group was higher than that in the control group (P=0.007<0.01). The cross-sectional area of nasal valve in the both groups after support expansion treatment (0.86±0.29cm2 in the control group and 0.71±0.26cm2 in the experimental group) was significantly increased compared with that before operation (P<0.01), and the mean cross-sectional area of nasal valve in the control group was larger than that in the experimental group. (P=0.021<0.05). However, it showed that the Δ long-axis ratio and Δ short-axis ratio of the experimental group were both lower than those of the control group after the support expansion treatment (P<0.05). So 3D-printed nasal vestibular support was better than conventional nasal vestibular support in restoring the nostril shape. The stenotic side nasal resistance in both groups after support expansion treatment were both lower than that before operation (P<0.05). The stenotic side nasal resistance in the experimental group was smaller (P=0.011<0.05) compare to the control group, but the difference of total nasal resistance between them was not significant (P=0.64>0.05). The results showed that the intranasal airflow heating efficiency were (94.55±2.54%) in the control group and (95.26±3.21%) in experimental group after support and expansion treatment, which had a significant decrease than those before operation (95.45±2.93% in the control group and 96.14±2.63% in the experimental group) (P<0.01). However, total nasal heating efficiency and total nasal humidification efficiency did not show significant difference between two groups (P ValueNWE=0.30>0.05, P ValueNHE=0.44>0.05). Conclusion 3D printed nasal vestibular support by personalized design for postoperative support expansion on patients with anterior nostril stenosis could restore the anterior nostril normal shape, the normal nasal ventilation function and the nasal airflow temperature and humidity regulation function , it can reflect the advantages of personalized treatment and allow patients to obtain more satisfactory result. 3D printed nasal vestibular support can be used as clinical supplement for the nasal vestibular local support expansion treatment, its clinical application prospect is good.

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  • 收稿日期:2022-10-11
  • 最后修改日期:2022-11-27
  • 录用日期:2022-11-28
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