Chang Yongjoon, Yun Hyunjong, Choi Jong Woo, Suh Joong Min, Jeong Woo Shik, Park Hojin, Kang Min Kyu, Shin Yongho, Kim Kuylhee, Chung Chul Hoon
Department of Plastic and Reconstructive Surgery, Kangdong Sacred Heart Hospital, Seoul, Korea.
Department of Plastic and Reconstructive Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Arch Craniofac Surg. 2022 Aug;23(4):152-162. doi: 10.7181/acfs.2022.00668. Epub 2022 Aug 20.
The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants.
We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery.
The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26 ± 17.24 in the study group and 18.27 ± 17.60 in the control group (p = 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p = 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p = 0.515).
Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.
评估马软骨作为一种合格的隆鼻异种移植材料的有效性和安全性，并与使用硅胶植入物隆鼻的结果进行比较。
我们进行了一项多中心、双盲、非劣效性随机验证性研究。56例患者按1:1随机分为研究组（使用MegaCartilage-E）和对照组（使用硅胶植入物）。在术后12个月内获取隆鼻结果评估（ROE）评分、照片记录、全球美学改善量表（GAIS）及不良事件数据。在改良意向性治疗组中评估主要疗效，即术后6个月ROE评分的变化。在符合方案组中通过评估术后6个月和12个月ROE评分的变化以及术后1、6和12个月的鼻额角、鼻根高度和GAIS来评估次要疗效。
研究组ROE评分的变化不劣于对照组；研究组增加了24.26±17.24，对照组增加了18.27±17.60（p=0.213）。两组中所有次要结局指标均有所增加，但无统计学差异。在安全性组中，研究组10例患者（35.71%）发生治疗中出现的不良事件，对照组6例患者（21.43%）发生（p=0.237）。研究组有13例器械相关不良事件，对照组有6例器械相关不良事件（p=0.515）。
加工后的马软骨可有效且安全地用作隆鼻的异种移植材料。
