先天性耳廓畸形的自愈性及耳廓矫正器治疗效果分析

先天性耳廓畸形的自愈性及耳廓矫正器治疗效果分析

谢园李靖宇孙蕾李玲李莹莹吴玉蓉邹健

本文来源：《中华整形外科杂志》2023年2月第39卷第2期

DOI:10. 3760 / cma.j.cn114453-20220307-00059

作者单位：南通大学附属妇幼保健院五官科，南通226000

通信作者：邹健，Email: zoujianntfy@qq.com

引用本文

谢园, 李靖宇, 孙蕾, 等. 先天性耳廓畸形的自愈性及耳廓矫正器治疗效果分析 [J] . 中华整形外科杂志, 2023, 39(3) : 237-244. DOI: 10.3760/cma.j.cn114453-20220307-00059.

【摘要】

目的探讨先天性耳廓畸形(CAD)患儿的自愈性及采用耳廓矫正器进行治疗的效果。

方法以2020年1至12月在南通大学附属妇幼保健院出生的CAD患儿为研究对象，根据患儿家长意愿进行分组：不同意采用耳廓矫正器进行治疗但愿意接受随访者纳入观察组，在出生后1个月和1年通过电话或微信进行随访，统计患儿耳廓自愈比例(痊愈和有效耳数占该组患耳总数的比例)；同意采用耳廓矫正器进行治疗者纳入无创矫正组，并根据患儿初始矫正年龄分为≤7 d、8~28 d和>28 d 3个亚组，该组患儿采用国产耳廓矫正器进行治疗，在治疗结束后1个月和1年通过电话或微信进行随访，统计耳廓治疗有效比例(痊愈和有效耳数占该组患耳总数的比例)，并对初始矫正年龄≤7 d、8~28 d、>28 d 3个亚组的耳廓矫正器佩戴时间进行统计分析，3组间总体比较采用方差分析，组间两两比较采用LSD-t检验，P<0.05为差异有统计学意义。

结果观察组共纳入43例患儿(71只耳)，男21例，女22例，出生后(2.1±0.3) d，左侧34只，右侧37只。无创矫正组纳入24例患儿(41只耳)，男8例，女16例，出生后(29.1±23.8) d，左侧20只，右侧21只；初始矫正年龄≤7 d组有6例(10只耳)，8~28 d组有6例(9只耳)，>28 d组有12例(22只耳)。通过随访观察，43例观察组患儿(71只耳)出生后1个月和1年自愈比例分别为29/71和30/71，其中垂耳分别为23/31和24/31，扇贝耳均为3/6，复合畸形均为3/3，其他畸形均为0。24例无创矫正组患儿(41只耳)在治疗结束后1个月和1年有效比例分别为41/41和35/41，其中耳轮畸形均为12/12，垂耳均为3/3,杯状耳分别为7/7和5/7，扇贝耳均为4/4，环缩耳分别为6/6、5/6，招风耳分别为2/2和0,复合畸形分别为6/6和5/6，小耳畸形(Ⅰ度)均为1/1，治疗结束后1年共有4例患儿(6只耳)出现了反弹。初始矫正年龄≤7 d、8~28 d和>28 d 3组患儿耳廓矫正器佩戴时间分别为(31.8±11.2) d、(31.3±10.1) d和(41.8±13.8) d，3组比较差异有统计学意义(F＝3.42，P＝0.043)；≤7 d与8~28 d组间比较差异无统计学意义(P＝0.936)，≤7 d与>28 d(P＝0.043)、8~28 d与>28 d(P＝0.041)组间分别比较，差异均有统计学意义。

结论 CAD具有一定的自愈性，其中垂耳、扇贝耳的自愈能力较高；国产耳廓矫正器治疗CAD具有较好的效果，初始矫正年龄越大需要的矫正时间越长，CAD类型对矫正效果有一定的影响。

【关键词】外耳；先天性耳廓畸形；耳廓矫正器；婴幼儿

基金项目： 2020年南通市卫健委科研立项课题（MB2020042）

Self-healing of congenital auricular deformity and efficacy of auricle correctors

Xie Yuan, Li Jingyu, Sun Lei, Li Ling, Li Yingying, Wu Yurong, Zou Jian

Department of Otolaryngology, Affiliated Maternity and Child Health Care Hospital of Nantong University, Nantong 226000, China

Corresponding author: Zou Jian, Email: zoujianntfy@qq.com

【Abstract】

Objective To investigate the self-healing of congenital auricular deformity (CAD) and the efficacy of the auricle corrector in infants.

Methods The infants with CAD who were born in the Affiliated Maternity and Child Health Care Hospital of Nantong University from January to December 2020 were collected. The patients who disagreed with the use of auricle corrector were included in the observation group. The patients were followed up on the day of one month and one year after birth by phone or WeChat, and the self-healing rate (the proportion of the number of ears found to be healed in the total number of affected ears after follow-up) of auricle was calculated. The patients treated with auricle corrector were included in the non-invasive correction group, which was treated with domestic auricle corrector. And according to the initial correction age, the patients were divided into ≤7 d, 8-28 d and >28 d three subgroups. The patients were followed up on the day of one month and one year after treatment by phone or WeChat, and the effective rate(the proportion of healed ears to the total number of affected ears after treatment) was calculated. And statistical analysis was used in the three subgroups of initial correction age ≤7 d, 8-28 d, >28 d. Variance analysis was used for general comparison between three groups, and LSD-t test for the comparison between two groups. P<0.05 was considered statistically significant.

Results A total of 43 children (71 ears, 34 left ears and 37 right ears) were included in the observation group, including 21 males and 22 females, (2.1±0.3) days after birth. In the non-invasive correction group, 24 children (41 ears, 20 left ears and 21 right ears) were included, including 8 males and 16 females, (29.1±23.8) days after birth. There were 6 cases (10 ears) in the initial correction age group ≤7 days, 6 cases (9 ears) in the 8-28 days group, and 12 cases (22 ears) in the >28 days group. In the observation group (71 ears), the rates of self-healing on the day of one month and one year after birth were 29/71 and 30/71, respectively, including 23/31 and 24/31 for lop ear, 3/6 for Stahl’s ear, 3/3 for complex deformity, and 0 for other ear deformities. The effective rates were 41/41 and 35/41 one month and one year after treatment in the 24 children (41 ears) in the non-invasive correction group, respectively. Among them, the helical rim deformity was 12/12, lop ear 3/3, cup ear 7/7 and 5/7, Stahl’s ear 4/4, contracted ear 6/6, 5/6, prominent ear 2/2 and 0, the complex deformity 6/6 and 5/6, and microtia(Ⅰ) 1/1. The auricular deformities reoccurred in a total of 4 children (6 ears) 1 year after the end of treatment. According to the initial correction age into three groups, the treatment duration of the auricle corrector was (31.8±11.2) days, (31.3±10.1) days and (41.8±13.8) days, and the difference among the three groups was statistically significant (F=3.42, P=0.043). There was no statistical significance between the groups ≤7 days and 8-28 days (P=0.936), but there was statistical significance in the treatment duration between the groups ≤7 days and >28 days (P=0.043), and between the groups 8-28 days and > 28 days (P=0.041).

Conclusion CAD can self-heal to some extent. Self-healing rate is higher in lop ear and Stahl’s ears. The domestic auricle corrector has a good effect on CAD. The older the age of initial correction is, the longer the time of correction is. The type of CAD has a certain influence on the correction effect.

【Key words】Ear, external; Congenital auricular deformity; Auricle corrector; Infants

Fund program: 2020 Nantong Municipal Health Commission Scientific Research Project（MB2020042）

Disclosure of Conflicts of Interest: The authors have no financial interest to declare in relation to the content of this article.

Ethical Approval: This study was conducted in accordance with the Helsinki Declaration.

先天性耳廓畸形(congenital auricular deformity，CAD)在新生儿中的发病率很高，在颌面部畸形中仅次于唇腭裂畸形，居于第2位[1]。CAD在不同国家和地区的发病率为25%~55% [2,3,4]，自愈率约为30%[3]。有很多患儿家长甚至包括一些医生和护士对耳廓畸形的严重性和危害性认识不足，认为其可以自然长好，而耽误了最佳治疗时间。手术是CAD较早的治疗方法，但由于手术需要承担的风险及费用较高，给患儿和家庭带来一定的负担。日本学者Kurozumi等[5]首次提出无创矫正CAD，之后在日本和欧美一些国家相继开展，并且可以达到较好的治疗效果。近年来，我国有些医院也开始采用耳廓矫正器对CAD进行无创矫正，也获得了较好的治疗效果[6,7]。但目前多是对CAD无创矫正的治愈率等进行研究，而对CAD的自愈能力研究得比较少。本研究中，我们对未接受无创矫正的CAD患儿进行了长期随访，观察其自愈情况，同时对接受无创矫正的CAD患儿治疗有效率和治疗时间等进行了分析，为临床相关工作提供参考。

对象与方法

一、对象选择

从南通大学附属妇幼保健院2020年1至12月出生的新生儿中选择研究对象，在进行听力筛查的同时对其耳廓形态进行检查。根据患儿家长的意愿进行分组，不同意采用耳廓矫正器进行无创治疗但愿意接受随访者纳入观察组；同意进行无创治疗者纳入无创矫正组，并根据患儿初始矫正年龄分为≤7 d、8~28 d、>28 d 3个亚组。纳入标准：(1)患儿仅有耳廓畸形；(2)取得患儿家长的知情同意。排除标准：(1)失访；(2)耳部皮肤有湿疹、过敏反应、破损。本研究已参考赫尔辛基宣言，所有患儿家长均签署知情同意书。

二、方法

(一)耳廓矫正器佩戴方法

耳廓矫正器(靓耳，江苏德威兰医疗器械有限公司)的佩戴方法主要分为3步。(1)备皮：将耳廓周围的毛发去除干净，根据患耳的大小选取适合的型号。(2)固定耳托：用乙醇棉片擦拭耳廓周围皮肤，去除皮肤上的皮脂，将耳廓从耳托中拉出，撕掉耳托后的离型纸，固定在合适的位置。(3)安装牵引器：根据耳轮的位置调节牵引器的弯曲度，将牵引器与底座自带的双面胶贴合，必要时粘贴胶布固定，将耳廓固位在拟矫正的角度，最后盖上耳盖(图1)，24 h佩戴。

(二)复诊

佩戴耳廓矫正器期间每周复诊，并对矫正器的角度进行调整，达到满意效果后去除耳托和耳盖，仅佩戴牵引器和粘贴胶布强化3~4周。佩戴期间若出现湿疹、皮损、破溃等则暂时停止治疗，待痊愈后再继续进行治疗。治疗前、每次复诊及治疗后均对患儿进行拍照。

(三)效果评估

观察组患儿在出生后1个月和1年、无创矫正组在治疗结束后1个月和1年对其进行电话或微信随访，观察患儿耳廓自愈或矫正情况，并由2位耳鼻咽喉科医师共同对患儿耳廓形态进行评估：(1)痊愈，达到正常耳廓形态(耳轮弧度自然丰满，对耳轮上脚、下脚形态明显可见，三角窝和耳甲腔清晰可见，颅耳角约为30°左右[8])；(2)有效，耳廓较之前形态有所改善，但达不到正常耳廓形态；(3)无效，耳廓较之前形态无改变。若2位耳鼻咽喉科医师评估不一致则由全科室医生共同讨论决定。统计观察组患儿耳廓自愈比例和无创矫正组治疗有效比例，自愈比例和有效比例是指耳廓达到痊愈和有效的耳数占各组患耳总数的比例。

三、统计学方法

使用SPSS 20.0进行统计学分析，计量资料以x±s表示，≤7 d、8~28 d、>28 d 3个亚组间耳廓矫正器佩戴时间比较采用方差分析，组间两两比较采用LSD-t检验，P<0.05为差异有统计学意义；计数资料以频数表示。

结果

一、一般资料

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