透明质酸钠凝胶DX23治疗面中部凹陷安全性和有效性的临床验证  

Clinical validation of the safety and efficacy of sodium hyaluronate gel DX23 in the treatment of midface depression

作　　者：金燕[1] 胡振生[2] 张志华[3] 刘培[2] 李文志[1] Jin Yan;Hu Zhensheng;Zhang Zhihua;Liu Pei;Li Wenzhi(Department of Plastic and Cosmetic Surgery,Beijing Anzhen Hospital Affiliated to Capital Medical University,Beijing 100029,China;Department of Burn Plastic Surgery,Qilu Hospital of Shandong University,Jinan 250063,China;Medical Aesthetics Center,Jining First People’s Hospital,Jining 272002,China)

机构地区：[1]首都医科大学附属北京安贞医院整形美容科,北京100029 [2]山东大学齐鲁医院烧伤整形科,济南250063 [3]济宁市第一人民医院美容中心,济宁272002

出　　处：《中华整形外科杂志》2024年第11期1175-1183,共9页Chinese Journal of Plastic Surgery

摘　　要：目的探讨注射用修饰透明质酸钠凝胶DX23对填充治疗面中部凹陷的有效性和安全性。方法采用前瞻、随机、多中心、"无治疗"对照研究方法,纳入2019年3月至2021年2月在首都医科大学附属北京安贞医院、山东大学齐鲁医院、济宁市第一人民医院治疗面中部凹陷的患者。以分层区组随机方式,使用随机函数列表对患者进行分组,试验组采用注射用修饰透明质酸钠凝胶DX23治疗面中部凹陷,DX23中透明质酸钠浓度为23 mg/ml,注射器与皮肤垂直90°进针,注射层次为骨膜浅层或皮下层,注射量为1~6 ml。对照组采用无治疗对照。面中部的上界为颧弓向外延续至耳轮上缘,向内延续至外眦的连线,下界为口角至耳垂的连线。研究者用注射后6个月面中部凹陷严重程度量表(MAS)应答率为主要指标评价改善面中部凹陷严重程度的疗效,术后MAS评分较术前减少1分为应答,即有效。以末次治疗后6、12个月MAS应答率(MAS应答率=MAS应答例数/总例数×100%)、面中部三维图像容积平均变化值、面部整体美观改善量表(GAIS)应答率,以及患者评估面中部容积改善程度的满意度为次要疗效指标,并监测不良反应。使用SPSS 25.0、SAS 9.4和Stata IC 15.0软件进行数据分析,选用全分析集(FAS)和符合方案集(PPS)进行分析,推断性分析使用t检验、χ2检验,P<0.05为差异有统计学意义。结果共纳入164例患者,试验组134例,男7例,女127例,年龄(43.0±9.7)岁(21.6~66.6岁);对照组30例,男5例,女25例,年龄(39.3±11.1)岁(25.6~43.5岁)。试验组填充双侧面中部凹陷,首次使用注射用修饰透明质酸钠凝胶DX23(4.07±1.28)ml。试验组30 d后失访脱落3例,60 d后失访脱落2例,违背试验方案剔除10例,15例患者最终进入FAS但未进入PPS,最终119例患者完成试验。试验组治疗后6、12个月的MAS应答率分别为94.96%(113/119)和56.30%(67/119);对照组6个月的MAS应答率为3.33%(1/30);治疗后Objective To investigate the efficacy and safety of injectable modified sodium hyaluronate gel DX23 in filling and treating midface depression.Methods A prospective,randomized,multicenter,"no treatment"controlled study was conducted.Patients with midface depression who were treated from March 2019 to February 2021 at Beijing Anzhen Hospital Affiliated to Capital Medical University,Qilu Hospital of Shandong University,and Jining First People’s Hospital were enrolled.Patients were randomized using a stratified block randomization method with a random function list.The experimental group received injectable modified sodium hyaluronate gel DX23 to treat midface depression.The concentration of sodium hyaluronate in DX23 was 23 mg/ml.The syringe was inserted perpendicularly to the skin at a 90-degree angle,and the injection layers were the superficial periosteum or the subcutaneous layer.The injection volume ranged from 1 to 6 ml.The control group received no treatment.The upper boundary of the midface extended outward from the zygomatic arch to the upper margin of the helix and inward to the line connecting the outer canthus.The lower boundary was the line connecting the corner of the mouth to the earlobe.Researchers used the midface aesthetic scales(MAS)response rate at 6 months post-injection as the primary indicator to evaluate the efficacy in improving the severity of midface depression.A reduction of 1 point in the MAS score compared to pre-treatment was considered a response,i.e.,effective.Secondary indicators included the MAS response rates at 6 and 12 months after the last treatment(MAS response rate=number of MAS responders/total cases×100%),the average change in three-dimensional midface volume images,the global aesthetic improvement scale(GAIS)response rate,patient satisfaction regarding the degree of improvement in midface volume,and monitoring of adverse reactions.Data analysis was performed using SPSS 25.0,SAS 9.04,and StataIC 15.0 software.The full analysis set(FAS)and the per-protocol set(PPS)were s

关 键 词：凝胶类 透明质酸 注射剂 面中部凹陷 修饰 

分 类 号：R62[医药卫生—整形外科]