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一款4.5毫米宽骨锚式听力植入物的稳定性、存活率及耐受性:来自一项随机对照临床试验的6个月数据。

Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial.

作者信息

Nelissen Rik C, den Besten Christine A, Mylanus Emmanuel A M, Hol Myrthe K S

机构信息

Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands.

出版信息

Eur Arch Otorhinolaryngol. 2016 Jan;273(1):105-11. doi: 10.1007/s00405-015-3593-x. Epub 2015 Mar 20.

Abstract

The objective of this study was to compare the stability, survival, and tolerability of 2 percutaneous osseointegrated titanium implants for bone conduction hearing: a 4.5-mm diameter implant (test) and a 3.75-mm diameter implant (control). Fifty-seven adult patients were included in this randomized controlled clinical trial. Sixty implants were allocated in a 2:1 (test-control) ratio. Follow-up visits were scheduled at 7, 14, 21, and 28 days; 6 and 12 weeks; and 6 months. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification. Implants were loaded with the bone conduction device at 3 weeks. Hearing-related quality of life was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Glasgow Benefit Inventory (GBI), and the Glasgow Health Status Inventory (GHSI). ISQ values were statistically significantly higher for the test implant compared to the control implant. No implants were lost and soft tissue reactions were comparable for both implants. Positive results were reported in the hearing-related quality of life questionnaires. These 6-month results indicate that both implants and their corresponding hearing devices are safe options for hearing rehabilitation in patients with the appropriate indications. Loading at 3 weeks did not affect the stability of either implant.

摘要

本研究的目的是比较两种用于骨传导听力的经皮骨整合钛植入物的稳定性、存活率和耐受性:一种直径为4.5毫米的植入物(试验组)和一种直径为3.75毫米的植入物(对照组)。57名成年患者纳入了这项随机对照临床试验。60枚植入物按2:1(试验组-对照组)的比例分配。随访安排在第7、14、21和28天;6周和12周;以及6个月。每次随访时,通过共振频率分析(RFA)记录植入物稳定性商(ISQ)值,并根据霍尔格斯分类法评估皮肤反应。在3周时给植入物佩戴骨传导装置。使用助听器益处简表(APHAB)、格拉斯哥益处量表(GBI)和格拉斯哥健康状况量表(GHSI)评估听力相关生活质量。试验组植入物的ISQ值在统计学上显著高于对照组植入物。没有植入物丢失,两种植入物的软组织反应相当。听力相关生活质量问卷报告了阳性结果。这些6个月的结果表明,对于有适当适应症的患者,两种植入物及其相应的听力装置都是听力康复的安全选择。3周时佩戴装置并未影响任何一种植入物的稳定性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce9/4705128/96654d0fc463/405_2015_3593_Fig1_HTML.jpg

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