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6个月随访,试验组研究者和患者评价GAIS应答率为97.48%(116/119)(PPS)与97.69%(27/30)(FAS),对照组研究者评价GAIS应答率为3.33%(1/30)(FAS,PPS),患者评价GAIS应答率为0(0/30)(FAS,PPS),2组间比较,研究者和患者GAIS应答率差异均有统计学意义(P均<0.01)。注射后6个月,试验组与对照组面颊部容积与基线差值比较差异均有统计学意义[(1.65±1.40)ml(PPS)vs.(0.12±0.85)ml;(1.55±1.44)ml(FAS)vs.(0.12±0.85)ml;P均<0.001]。试验组注射后6个月随访,1例失访,PPS中满意81例,非常满意34例,中立3例;对照组患者中立29例,不满意1例。试验组共128例患者发生了注射部位反应,包括肿胀、发硬、触痛、疼痛和肿块(隆起)、淤青,超过75%的患者8 d内自行缓解,3例采取热敷处理,28 d内缓解,1例注射后1 d左下睑肿胀,局部按压3个月后缓解;对照组有1例在试验开始12个月后出现循环缺血、颈动脉硬化。结论注射用修饰透明质酸钠凝胶DX23通过局部增容来纠正面中部凹陷,具有安全且持续的特点。
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 selected for analysis.Inferential analysis used t-tests and chi-square tests,with P<0.05 considered statistically significant.Results A total of 164 patients were enrolled.The experimental group included 134 patients(7 males and 127 females)with an average age of 43.0±9.7 years(ranging from 21.6 to 66.6 years).The control group included 30 patients(5 males and 25 females)with an average age of 39.3±11.1 years(ranging from 25.6 to 43.5 years).The experimental group received bilateral midface depression filling,with an initial use of injectable modified sodium hyaluronate gel DX23 at a volume of(4.07±1.28)ml.In the experimental group,3 cases were lost to follow-up at 30 days,2 cases at 60 days,and 10 cases were excluded due to protocol violations.Fifteen patients entered FAS but not PPS.Ultimately,119 patients completed the trial.The MAS response rates in the experimental group at 6 and 12 months post-treatment were 94.96%(113/119)and 56.30%(67/119),respectively.The control group’s MAS response rate at 6 months was 3.33%(1/30).At the 6-month follow-up post-treatment,the GAIS response rates evaluated by researchers and patients in the experimental group were 97.48%(116/119)(PPS)and 97.69%(27/30)(FAS),respectively.In the control group,the GAIS response rate evaluated by researchers was 3.33%(1/30)(FAS,PPS),and the patient GAIS response rate was 0%(0/30)(FAS,PPS).There were statistically significant differences between the two groups in both researcher and patient GAIS response rates(both P<0.01).At 6 months post-injection,comparisons of midface volume changes from baseline between the experimental and control groups showed statistically significant differences[(1.65±1.40)ml(PPS)vs.(0.12±0.85)ml;(1.55±1.44)ml(FAS)vs.(0.12±0.85)ml;both P<0.001].At the 6-month follow-up in the experimental group,1 case was lost to follow-up.In the PPS,81 patients were"satisfied,"34 were"very satisfied,"and 3 were"neutral."In the control group,29 patients were"neutral,"and 1 was"dissatisfied."A total of 128 patients in the experimental group experienced injection site reactions,including swelling,hardness,tenderness,pain,lumps(protrusions),and bruising.Over 75%of patients resolved spontaneously within 8 days.Three cases received hot compress treatment and resolved within 28 days.One case experienced swelling of the left lower eyelid 1 day after injection,which resolved after local compression for 3 months.In the control group,1 case developed circulatory ischemia and carotid atherosclerosis 12 months after the trial began.Conclusion Injectable modified sodium hyaluronate gel DX23 corrects midface depression through local volume augmentation and is characterized by safety and durability.
作者
金燕
胡振生
张志华
刘培
李文志
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)
出处
《中华整形外科杂志》
CSCD
北大核心
2024年第11期1175-1183,共9页
Chinese Journal of Plastic Surgery
关键词
凝胶类
透明质酸
注射剂
面中部凹陷
修饰
Gels
Sodium hyaluronate
Filler
Midface depression
Modification