Blayney A W, Bebear J P, Williams K R, Portmann M
J Laryngol Otol. 1986 Dec;100(12):1359-66. doi: 10.1017/s0022215100101148.
The biocompatibility of the bioactive glass-ceramic Ceravital was investigated experimentally both in vivo and in vitro. In the former, ceramic discs were interposed in 30 rat middle ears for periods ranging from 6 weeks to 12 months. In the latter, Ceravital otological prosthesis were placed in human fibroblast culture. Reactions to the biomaterial were assessed by means of scanning electron microscopy (SEM) with chemical analysis facilities (EDAX, WDAX) and light microscopy. The interface reactions were similar in both in vivo and in vitro studies and confirmed the findings of other authors regarding the implants' biocompatibility and bioactivity. The technique of ion etching, however, enabled clear demonstration of this bioactivity on the implant surface, exposed merely to the middle-ear secretions, thus questioning the necessity of placing bone pâté on the implant head at surgery, in order to encourage bioactive bonding with the overlying drum. A clinical trial of Ceravital in 128 patients with an average follow-up period of 2 years is reported. Forty per cent of these patients underwent a type II tympanoplasty, 60 per cent a type III. Though relatively short-term, the results to date have been encouraging: 88 per cent of the implants have been well-tolerated; 70 per cent of the cases have yielded a satisfactory hearing result; and only 3 per cent of the implanted prostheses have been extruded.
对生物活性玻璃陶瓷Ceravital的生物相容性进行了体内和体外实验研究。在体内实验中，将陶瓷盘植入30只大鼠的中耳，时长从6周持续到12个月。在体外实验中，将Ceravital耳科假体置于人成纤维细胞培养物中。通过带有化学分析设备（能谱仪、波谱仪）的扫描电子显微镜（SEM）和光学显微镜评估对生物材料的反应。体内和体外研究中的界面反应相似，证实了其他作者关于植入物生物相容性和生物活性的研究结果。然而，离子蚀刻技术能够清晰显示仅暴露于中耳分泌物的植入物表面的这种生物活性，因此对手术时在植入物头部放置骨糊以促进与上方鼓膜的生物活性结合的必要性提出了质疑。报告了对128例患者使用Ceravital的临床试验，平均随访期为2年。这些患者中40%接受了II型鼓室成形术，60%接受了III型鼓室成形术。尽管是相对短期的，但迄今为止的结果令人鼓舞：88%的植入物耐受性良好；70%的病例听力结果令人满意；只有3%的植入假体被挤出。
