Huang Jincheng, Zou Kun, Yuan Ping, Yang Min, Miao Yunqi, Zhao Li, Fan Yanjun
Chengdu Center for Disease Control and Prevention, Sichuan Province, 610041, China.
West China Second Hospital/West China Maternity and Children's Hospital, Chengdu, Sichuan province, 610041, China; West China Research Centre for Rural Health Development, Sichuan University, Chengdu, Sichuan province, 610041, China.
Int J Pediatr Otorhinolaryngol. 2024 Apr;179:111903. doi: 10.1016/j.ijporl.2024.111903. Epub 2024 Mar 13.
To assess the effectiveness and safety of ear moulds for congenital auricle deformities.
Databases including Medline, EMBASE, Cochrane Library, Chinese BioMedical Literature Database (CBM) and Web of Science were systematically reviewed. Randomised controlled trials (RCT), non-randomised control trials (non-RCT), quasi-randomised control trials (quasi-RCT) and self-controlled before-after trials were also included. Data extraction was independently conducted by two authors. The Risk Of Bias In Non-randomised Studies of Interventions (ROBIN-I) was used to evaluate the risk bias. Heterogeneity was assessed using I and chi-square tests. Effective rate, adverse reaction rate and their 95%CI were calculated. Funnel plots, Begg's test as well as sensitivity and subgroup analyses were performed.
The analysis encompassed ten studies, comprising one RCT and nine self-controlled before-after trials, involving 1860 ears (1248 children). The pooled effective rate and adverse reaction rate of ear mould were 91% (95% CI: 0.87-0.94) and 9% (95%CI: 0.02-0.17), respectively. No serious adverse reactions were reported. The effective rate of ear mould intervention showed no significant difference between age at correction≤42 days group (90%, 95%CI: 0.85-0.94) and that >42 days group (93%, 95%CI: 0.83-0.99). Similarly, there was no statistical difference in the correction efficiency between duration of wearing ear mould≤30 days group (90%, 95%CI: 0.85-0.94) and that >30 days group (92%, 95%CI: 0.86-0.96). The effective rate for correcting cryptotia ear (98%, P < 0.001), cup ear (93%, P = 0.004) and prominent ear (90%, P = 0.014) was higher than that of helical rim deformity (66%).
In the short term, the use of ear moulds is effective and safe in correcting congenital auricle deformities. Notably, the correction efficacy for cryptotia, cup ear and prominent ear deformities surpasses that of helical rim deformities. However, further research is required to ascertain the impact of the duration of wearing on the correction of congenital auricle deformities.
评估耳模治疗先天性耳廓畸形的有效性和安全性。
系统检索包括Medline、EMBASE、Cochrane图书馆、中国生物医学文献数据库（CBM）和科学引文索引数据库在内的数据库。纳入随机对照试验（RCT）、非随机对照试验（非RCT）、半随机对照试验（半RCT）和自身前后对照试验。由两名作者独立进行数据提取。采用干预性非随机研究的偏倚风险（ROBIN-I）评估风险偏倚。使用I²和卡方检验评估异质性。计算有效率、不良反应率及其95%置信区间。绘制漏斗图、进行Begg检验以及敏感性和亚组分析。
分析纳入10项研究，包括1项RCT和9项自身前后对照试验，涉及1860只耳朵（1248例儿童）。耳模的合并有效率和不良反应率分别为91%（95%CI：0.87 - 0.94）和9%（95%CI：0.02 - 0.17）。未报告严重不良反应。耳模干预的有效率在矫正年龄≤42天组（90%，95%CI：0.85 - 0.94）和>42天组（93%，95%CI：0.83 - 0.99）之间无显著差异。同样，佩戴耳模持续时间≤30天组（90%，95%CI：0.85 - 0.94）和>30天组（92%，95%CI：0.86 - 0.96）的矫正效率无统计学差异。隐耳（98%，P < 0.001）、杯状耳（93%，P = 0.004）和招风耳（90%，P = 0.014）的矫正有效率高于耳廓缘畸形（66%）。
短期内，使用耳模矫正先天性耳廓畸形有效且安全。值得注意的是，隐耳、杯状耳和招风耳畸形的矫正效果优于耳廓缘畸形。然而，需要进一步研究以确定佩戴持续时间对先天性耳廓畸形矫正的影响。
