注射用交联透明质酸钠凝胶用于鼻部塑形的有效性及安全性研究  

Clinical study on the effi cacy and safety of cross-linked sodium hyaluronate gel for nasal contouring

作　　者：杨洋 钱文江[1] 李传颖[1] 鲍世威[1] 任荣鑫[1] 赵红艺 Yang Yang;Qian Wenjiang;Li Chuanying;Bao Shiwei;Ren Rongxin;Zhao Hongyi(Department of Plastic Surgery,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Beijng 100730,China;Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100005,China)

机构地区：[1]北京医院整形外科国家老年医学中心中国医学科学院老年医学研究院,北京100730 [2]北京协和医学院中国医学科学院,北京100005

出　　处：《中国医刊》2025年第4期405-409,共5页Chinese Journal of Medicine

基　　金：北京市科技计划(Z221100007422120)。

摘　　要：目的评价一种新型注射用交联透明质酸钠凝胶用于鼻部塑形的有效性及安全性。方法本研究为前瞻性、随机化、评估者设盲的平行对照试验。2023年1月至2024年8月于北京医院整形外科招募48例有鼻背和/或鼻根塑形意愿的受试者,采用区组随机化的方法按1﹕1的比例随机分为观察组和对照组,每组24例。观察组采用交联透明质酸钠凝胶注射,对照组采用修饰透明质酸钠凝胶注射。比较两组患者的一般资料,注射塑形后鼻背和/或鼻根体积、鼻背高度、鼻额角相对基线的变化值,全局美容效果(GAIS)评分,疼痛视觉模拟量表(VAS)评分以及不良反应发生情况。结果48例受试者中43例完成随访评估,其中观察组20例,对照组23例。48例受试者平均年龄(37.8±10.8)岁,女性占95.8%。均采用多点注射法,平均注射点数(4.1±0.8)处,平均注射剂量(0.71±0.17)ml。注射塑形后6个月两组患者鼻背和/或鼻根体积、鼻背高度、鼻额角相对基线的变化值及GAIS评分比较差异均无统计学意义(P>0.05)。注射时观察组的VAS评分明显低于对照组,差异有统计学意义(P<0.05)。观察组不良反应发生率为33.3%,对照组为4.2%,均在3个月内自行缓解。结论注射用交联透明质酸钠凝胶可有效用于鼻背和/或鼻根的塑形,且安全性较好。Objective To evaluate the efficacy and safety of a novel injectable sodium hyaluronate gel for nasal contouring.Method This study was a prospective,randomized,evaluator-blinded,parallel-controlled trial.From January 2023 to August 2024,a total of 48 subjects who wished to contour their nasal dorsum and/or nasal root were recruited from the Plastic Surgery Department of Beijing Hospital.Block randomization was used to generate a random code table for grouping,and subjects were randomly divided into the experimental group(n=24)and the control group(n=24)at a ratio of 1﹕1.The observation group received cross-linked sodium hyaluronate gel injections,while the control group received modified sodium hyaluronate gel injections.The general information of the subjects,Global Aesthetic Improvement Scale(GAIS)scores,Visual Analogue Scale(VAS)scores for pain,and adverse reactions were compared and analyzed between the two groups to assess the efficacy and safety of the cross-linked sodium hyaluronate gel for nasal contouring.Result Among the 48 subjects,43 completed the follow-up assessments,with 20 in the experimental group and 23 in the control group.The average age of the subjects was(37.8±10.8)years,and 95.8%were female.The multi-point injection method was used in all cases,with an average of(4.1±0.8)injection points and an average injection dose of(0.71±0.17)ml.At 6 months after injection,there were no statistically significant differences between the two groups in terms of changes in nasal dorsum and/or radix volume,nasal dorsum height,nasofrontal angle,or GAIS scores(P>0.05).The VAS pain score during injection was significantly lower in the observation group compared to the control group(P<0.05).The incidence of related adverse reactions after treatment was 33.3%in the experimental group and 4.2%in the control group,and all resolved spontaneously within 3 months.Conclusion The injectable cross-linked sodium hyaluronate gel can be effectively used for the contouring of the nasal dorsum and/or nasal root,and it has

关 键 词：隆鼻术 透明质酸 注射填充 并发症 

分 类 号：R622[医药卫生—整形外科]