3D个性化定制人工材料耳支架在一期全耳再造术中的应用
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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

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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力计划(JYLJ202206)


Application of 3D patient-specific custom-made artificial material ear scaffolds in one-stage ear reconstruction for microtia
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    摘要:

    目的 评价3D个性化定制人工材料耳支架在先天性小耳畸形一期全耳再造术中的临床效果与优势。方法 选择2021年6月—2022年3月接收并行手术治疗的先天性单侧小耳畸形患者,将其随机分为实验组(n=12)和对照组(n=12),实验组采用3D个性化定制的人工材料支架,对照组采用常规需术中拼接的成品耳支架,均行支架植入-颞浅筋膜瓣转移的一期全耳廓再造术,伴或不伴同期听力重建。记录手术耗时,术后随访观察临床效果和并发症发生率,并行耳廓对称度、精细结构评分以及家属满意度调查。结果 所有病例手术均成功,无不良事件和并发症发生。同期行听力重建者听力得到改善,术后言语识别阈平均改善38.6dBHL,术后最大言语识别率均达到100%。经统计学分析,耳廓对称度和精细结构评分实验组优于对照组(p<0.05);手术耗时实验组较对照组短(p<0.01);家属满意度调查结果中最终每项平均得分实验组(9.7)高于对照组(8.9)。结论:3D个性化定制耳支架植入耳再造术安全有效,可同期行听力重建,临床效果优越,可成为先天性小耳畸形耳廓再造术的更优选择。

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    Objective To evaluate the clinical results and advantages of 3D patient-specific custom-made artificial material ear scaffolds in one-stage ear reconstruction for microtia. Methods From June 2021 to March 2022, patients with unilateral microtia from the Department of Otorhinolaryngology Head and Neck Surgery of the Ninth People Hospital Affiliated to Shanghai Jiao Tong University School of Medicine were selected, then randomly divided into two groups. Patients in experimental group (n=12) underwent one-stage ear reconstruction using 3D patient-specific custom-made artificial material auricular scaffolds, while the control group (n=12) used off-the-shelf two-piece artificial material auricular scaffolds which requires assembling during the surgery, with or without simultaneous hearing reconstruction. Operation duration, operation success rate, scores of symmetry of the auricle and fine structure of the auricle, patient satisfaction together with surgical complications were recorded respectively. Results All reconstructive operations were successful, with no report of adverse event or complications. The mean speech recognition threshold was improved by 43.46 dB HL and all maximum speech recognition scores reached 100%. The experimental group shows better outcomes than the control group regarding to symmetry and fineness (p<0.05). The experimental group required fewer operation hours than the control group (p<0.01). The final mean score on each item from patient satisfaction questionnaire of the experimental group (9.7 points) was higher than the control group (8.9 points) . Conclusion One-stage ear reconstruction for microtia using 3D patient-specific custom-made artificial material ear scaffolds proves to be safe and effective, which also available for simultaneous hearing reconstruction. in one-stage ear reconstruction for microtia which can be used as one of the methods of auricular reconstruction. Clinical utility suggests 3D patient-specific custom-made artificial material ear scaffolds to be an excellent choice for auricular reconstruction.

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  • 收稿日期:2023-02-10
  • 最后修改日期:2023-04-22
  • 录用日期:2023-04-24
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