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骨整合植入物用于骨传导听力在3周时的负荷:3年稳定性、存活率及耐受性

Loading of osseointegrated implants for bone conduction hearing at 3 weeks: 3-year stability, survival, and tolerability.

作者信息

Nelissen Rik C, den Besten Christine A, Faber Hubert T, Dun Catharina A J, 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.

Department of Otorhinolaryngology/Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

出版信息

Eur Arch Otorhinolaryngol. 2016 Jul;273(7):1731-7. doi: 10.1007/s00405-015-3746-y. Epub 2015 Aug 14.

Abstract

The objective of this study was to ascertain the long-term safety of loading osseointegrated implants for bone conduction hearing 3 weeks post-surgery. Thirty consecutive adult patients were implanted with the Baha BI300 (Cochlear Bone Anchored Solutions) in our tertiary referral center. Implants were loaded with the sound processor 3 weeks post-surgery. Follow-up examinations were performed at 10 days; 3, 4, 6, 8, and 12 weeks; 6 months; and 1, 2, and 3 years after implant surgery. At each follow-up visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis, and soft tissue status was evaluated according to Holgers' classification. ISQ trends, implant survival, and soft tissue reactions were compared to a population of 52 patients with the same type of implants loaded from 6 weeks post-surgery as part of another study. Subjective benefit was measured by means of the Glasgow Benefit Inventory (GBI). After an initial dip in ISQ at 10 days after implantation, a gradually increasing trend in ISQ was found until 6 months in both populations, after which ISQ values remained above baseline values. Implant survival was 97 % in the study population and 96 % in the comparison population. Clinically relevant soft tissue reactions were found in 0.9 % (study population) and 1.7 % (comparison population) of all visits. Patients reported subjective benefit; the mean GBI score was 22.8. In conclusion, loading these implants at 3 weeks post-surgery is safe based on the current study, as long-term results show high ISQ values and good implant survival and tolerability.

摘要

本研究的目的是确定在骨传导听力植入术后3周加载骨整合植入物的长期安全性。在我们的三级转诊中心,连续30名成年患者植入了Baha BI300(科利耳骨锚式解决方案)。术后3周为植入物加载声音处理器。在植入术后10天、3周、4周、6周、8周、12周、6个月以及1年、2年和3年进行随访检查。每次随访时,通过共振频率分析记录植入稳定性商(ISQ)值,并根据霍尔格斯分类法评估软组织状况。将ISQ趋势、植入物存活率和软组织反应与另一项研究中的52名患者群体进行比较,该群体在术后6周加载相同类型的植入物。通过格拉斯哥效益量表(GBI)测量主观获益。在植入后10天ISQ出现初始下降后,在两个群体中均发现ISQ呈逐渐上升趋势,直至6个月,此后ISQ值一直高于基线值。研究人群中的植入物存活率为97%,比较人群中的为96%。在所有就诊病例中,0.9%(研究人群)和1.7%(比较人群)出现了临床相关的软组织反应。患者报告有主观获益;GBI平均得分为22.8。总之,根据目前的研究,术后3周加载这些植入物是安全的,因为长期结果显示ISQ值高,植入物存活率和耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b96/4899513/a2c967e933fc/405_2015_3746_Fig1_HTML.jpg

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