不同基台形貌的骨锚式听力系统（BAHS）的临床结果和微生物学特征：一项前瞻性试点研究。
The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.
作者信息
Trobos Margarita, Johansson Martin Lars, Jonhede Sofia, Peters Hanna, Hoffman Maria, Omar Omar, Thomsen Peter, Hultcrantz Malou
机构信息
Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, P.O. Box 412, 405 30, Gothenburg, Sweden.
Oticon Medical AB, Askim, Sweden.
出版信息
Eur Arch Otorhinolaryngol. 2018 Jun;275(6):1395-1408. doi: 10.1007/s00405-018-4946-z. Epub 2018 Apr 5.
PURPOSE
In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria.
METHODS
Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated.
RESULTS
The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found.
CONCLUSIONS
There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects of modified BAHS abutment properties.
LEVEL OF EVIDENCE
- Controlled prospective comparative study.
目的
在这项前瞻性临床试点研究中，比较了具有不同拓扑结构（机加工与抛光）的基台在临床结果和微生物学特征方面的差异。此外，还评估了三种不同的采样方法（基台取出、使用纸尖收集基台周围渗出液以及小块基台周围软组织活检）用于定植细菌的鉴定和定量分析。
方法
分析纳入了12名患者，其中7名使用机加工基台，5名使用抛光基台。从基线到12个月，采用定量培养法，运用三种不同的采样程序对定植细菌进行鉴定和定量分析。研究了临床结果指标（霍尔格斯评分、卫生状况、疼痛、麻木和种植体稳定性）。
结果
抛光基台和机加工基台在临床参数以及每个基台或组织活检中的总活菌数方面没有显著差异。抛光基台的厌氧菌、需氧菌和葡萄球菌的每毫米基台总菌落形成单位（CFU/mm）以及每基台周围液体空间的CFU显著更高。在植入BAHS之前，在组织活检中检测到厌氧菌。在安装BAHS后，在所有三个部位都检测到了厌氧菌和葡萄球菌属。对于大多数患者（10/12），在同一时间点的三个部位中至少有两个部位发现了相同的葡萄球菌种类。除一名患者外（11/12），在所有患者中都鉴定出了常见的皮肤定植菌表皮葡萄球菌，而在五名患者中分离出了病原菌金黄色葡萄球菌。发现了临床和微生物学参数之间的几种关联。
结论
植入后3个月和12个月时，使用抛光基台与机加工基台的临床结果没有差异。本试点试验在很大程度上证实了一种合适的研究设计、采样和分析方法，以确定改良的BAHS基台特性的影响。
证据水平
- 对照前瞻性比较研究。
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