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标题：Efficacy and safety of equine cartilage for rhinoplasty: a multicenter double-blind non-inferiority randomized confirmatory clinical trial
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作者：Yongjoon Chang ; Hyunjong Yun ; Jong Woo Choi 等
期刊名称：Archives of Craniofacial Surgery
印刷版ISSN：2287-1152
出版年度：2022
卷号：23
期号：4
页码：152-162
DOI：10.7181/acfs.2022.00668
语种：English
出版社：KoreaMed Synapse
摘要：Background 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. Methods 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. Results 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). Conclusion Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.
关键词：Cartilage;Heterografts;Nasal cartilages;Rhinoplasty