Bernardeschi Daniele, Nguyen Yann, Russo Francesca Yoshie, Mosnier Isabelle, Ferrary Evelyne, Sterkers Olivier
AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d'Oto-Rhino-Laryngologie, Département d'Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France ; Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France ; Inserm UMR-S 1159, "Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l'Audition", 75018 Paris, France.
Biomed Res Int. 2015;2015:242319. doi: 10.1155/2015/242319. Epub 2015 Oct 4.
To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 when used in the mastoid and epitympanic obliteration for chronic otitis surgery.
Forty-one cases have been included in this prospective study. Cutaneous tolerance was clinically evaluated 1 week, 1 month, and 3 months after surgery with a physical examination of the retroauricular and external auditory canal (EAC) skin and the presence of otalgia; the inner ear tolerance was assessed by bone-conduction hearing threshold 1 day after surgery and by the presence of vertigo or imbalance.
All surgeries but 1 were uneventful: all patients maintained the preoperative bone-conduction hearing threshold except for one case in which the round window membrane was opened during the dissection of the cholesteatoma in the hypotympanum and this led to a dead ear. No dizziness or vertigo was reported. Three months after surgery, healing was achieved in all cases with a healthy painless skin. No cases of revision surgery for removal of the granules occurred in this study.
The bioactive glass S53P4 is a well-tolerated biomaterial for primary or revision chronic otitis surgery, as shown by the local skin reaction which lasted less than 3 months and by the absence of labyrinthine complications.
评估生物活性玻璃S53P4用于慢性中耳炎手术的乳突及上鼓室填塞时的皮肤及内耳耐受性。
本前瞻性研究纳入41例患者。术后1周、1个月和3个月通过对耳后及外耳道（EAC）皮肤进行体格检查及评估是否存在耳痛来临床评估皮肤耐受性；通过术后1天的骨导听力阈值以及是否存在眩晕或平衡失调来评估内耳耐受性。
除1例手术外，所有手术均顺利进行：除1例在鼓室窦胆脂瘤切除术中打开圆窗膜导致患耳失聪外，所有患者均维持术前骨导听力阈值。未报告头晕或眩晕情况。术后3个月，所有病例均实现愈合，皮肤健康且无痛。本研究中未出现因去除颗粒而进行翻修手术的病例。
生物活性玻璃S53P4是一种耐受性良好的生物材料，可用于初次或翻修慢性中耳炎手术，其局部皮肤反应持续时间不到3个月且未出现迷路并发症即表明了这一点。
