78例单侧耳蜗植入术后短期康复效果真实世界研究  

A Real-world Short-term Rehabilitation Performance Evaluation in 78 Unilateral Cochlear Implantation Recipients

作　　者：崔经伟 曾顺年 周小慧 倪逸菲 施通 祝道桂 张劲 CUI Jingwei;ZENG Shunnian;ZHOU Xiaohui;NI Yifei;SHI Tong;ZHU Daogui;ZHANG Jin(Department of Otolaryngology,Boao Super Hospital,Qionghai 571400,China;不详)

机构地区：[1]海南博鳌超级医院耳鼻喉科,琼海571400 [2]领先仿生医疗器械(上海)有限公司

出　　处：《中华耳科学杂志》2024年第2期201-206,共6页Chinese Journal of Otology

摘　　要：目的 收集双耳重度或极重度感音神经性听力损失患者术前、术中、术后各项真实世界数据,评估单侧人工耳蜗植入对该类患者的术后短期听觉及言语康复效果,同时评估真实环境中Ultra植入体的安全性和有效性。方法 选取2020年9月1日—2021年12月22日在海南博鳌超级医院接受人工耳蜗植入(植入年龄>12个月)的78例双侧重度、极重度感音神经性听力损失的患者为研究对象,对所有受试者进行术前基线评估;比较术后患者听力改善、言语能力改善、听觉功能康复,以及术中、术后随访期不良事件发生情况,于人工耳蜗开机当天、开机后1个月±7 d、开机后3个月±14 d、开机后6个月±30 d以进行临床随访,分析患者术前裸耳、术后助听听阈测试及其他各项测试结果的前后变化。结果 术后开机、开机后1、3、6个月,所有患者平均助听听阈随康复时间的延长而逐渐减小,与术前裸耳比较,差异有统计学意义(<3岁:χ^(2)=1341.97,P<0.05;3~5岁:χ^(2)=912.81,P<0.05;6岁及以上:χ^(2)=1 495.36,P<0.05);言语识别率随康复时间的延长而提升,与术前裸耳比较,差异有统计学意义(3~5岁单音节:χ^(2)=239.08, P<0.05;3~5岁双音节:χ^(2)=153.66, P<0.05;6岁及以上单音节:χ^(2)=281.31, P<0.05;6岁及以上双音节:χ^(2)=152.44, P<0.05;6岁及以上语句:χ^(2)=197.06, P<0.05)。研究中未发生因器械不良反应而导致退出的不良事件。结论单侧植入人工耳蜗的双侧重度或极重度听力损失患者能够在术后短期内获得良好的听力重建效果,本研究中获得的真实世界数据能够为Ultra植入体的临床应用提供可靠证据。Objective To evaluate the short-term hearing and speech rehabilitation of unilateral Ultra cochlear implantation(CI)and its safety and efficacy in the real world.Methods Patients with bilateral severe to profound sensorineural hearing loss(n=78)underwent unilateral CI surgery and completed preoperative baseline assessment,evaluation of hearing improvement,speech development and auditory rehabilitation,as well as adverse events during and after the surgery.Follow-ups were scheduled on the day of switch-on and completed at 1 month±7 days,3 months±14 days and 6 months±30 days after activation respectively.Hearing and speech performance before and after the surgery were analyzed using the SPSS 22.0 software.Results Aided hearing thresholds gradually improved along with rehabilitation after activation,and significantly better than unaided preoperative thresholds(χ^(2)=1341.97,P<0.05 for those<3 years;χ^(2)=912.81,P<0.05 for those 3 to 5 years;andχ^(2)=1495.36,P<0.05 for those 6 years and older,respectively).Speech recognition scores also improved along with rehabilitation,especially as compared to preoperative results(χ^(2)=239.08,P<0.05 with monosyllable words andχ^(2)=153.66,P<0.05 with disyllable words for those 3 to 5 years;χ^(2)=281.31,P<0.05 with monosyllable words,χ^(2)=152.44,P<0.05 with disyllable words andχ^(2)=197.06,P<0.05 with sentences for those 6 years and older).No adverse events resulting in withdrawal from the study.Conclusion Patients with bilateral severe to profound sensorineural hearing loss can achieve significant speech and hearing performance improvement even within relatively short time of unilateral CI use.The real world data from this study provides reliable evidence supporting clinical application of Ultra CI.

关 键 词：真实世界数据研究 特许药械 人工耳蜗 听觉言语康复 言语识别率 

分 类 号：R764.9[医药卫生—耳鼻咽喉科]