透明质酸填充剂HYC-24/HYC-24+治疗中国中、重度鼻唇沟皱褶患者满意度的真实世界研究  

Real-world patient satisfaction with hyaluronic acid filler HYC-24/HYC-24+for the treatment of moderate to severe nasolabial folds in China

作　　者：曹令 宋为民 徐士亮 隋志甫 Joy Maglambayan Vaishali Patel Cao Ling;Song Weimin;Xu Shiliang;Sui Zhifu;Joy Maglambayan;Vaishali Patel(Department of Plastic Surgery,Beijing Lidu Medical Beauty Hospital,Beijing 100101,China;Department of Aesthetic Dermatology,Hangzhou Yanshu Yuerong Medical Aesthetic Clinic,Hangzhou 310008,China;Department of Plastic Surgery,Guangzhou Yuexiu Plastic Surgery Hospital,Guangzhou 510600,China;Allergan Aesthetics(an AbbVie Company),Singapore 117439;Allergan Aesthetics(an AbbVie Company),Irvine,CA 92612,USA)

机构地区：[1]北京丽都医疗美容医院整形外科,北京100101 [2]杭州颜术悦容医疗美容诊所美容皮肤科,杭州州310008 [3]广州粤秀整形外科医院整形外科,广州1510600 [4]Allergan Aesthetics(艾伯维旗下公司),新加坡117439 [5]AllerganAesthetics(艾伯维旗下公司),美国加利福尼亚州尔湾市92612

出　　处：《中华整形外科杂志》2024年第4期436-443,共8页Chinese Journal of Plastic Surgery

摘　　要：目的评估中国中度至重度鼻唇沟皱褶(NLF)患者在真实的临床实践环境中接受HYC-24/HYC-24+治疗后的结局满意度。方法本研究是一项前瞻性、观察性、多中心、真实世界队列研究。纳入2018年8月至2020年8月于北京丽都医疗美容医院、杭州颜术悦容医疗美容诊所和广州粤秀整形外科医院接受HYC-24/HYC-24+治疗,并随访长达1年的中国患者,年龄18至65岁、患有中度至重度NLF,且在研究入组前6个月内未接受过NLF的美容治疗。在第1、6、9和12个月进行治疗后研究访视,仅第6个月和第9个月为必须进行的访视。患者报告结局的主要终点包括:FACE-Q结局满意度问卷总分(评分范围为0~100分,分数越高表示结局越好,患者越满意),FACE-Q皱纹评估-NLF问卷总分较基线的平均变化(评分范围为0~100分,评分越高表示患者在过去1周内越不受到NLF的困扰),以及在FACE-Q患者感知年龄视觉模拟评分法(VAS)上报告比实际年龄看起来更年轻的患者比例。研究者评估终点包括整体美容效果改善量表(GAIS)评分≥1分的患者比例,以及使用鼻唇沟皱褶严重程度量表(NLFSS)评估NLF严重程度改善≥1分的患者比例。使用SAS 9.4软件进行统计分析,计量资料采用±s表示,计数资料用例数(%)表示,不同访视时间与基线的比较,采用Wilcoxon符号秩检验。结果共52例患者入组并接受治疗,其中,7例因访视时间超出访视评估窗而未被纳入第6个月有效性的分析数据集,仅9例患者完成了第12个月的访视。所有患者均为中国籍女性,年龄26~62岁,平均为40.7岁。FACE-Q结局满意度问卷总分第6个月时为(68.76±21.03)分(38~100分),第9个月时为(65.44±18.24)分(24~100分),表明患者对治疗的满意度较高。FACE-Q皱纹评估-NLF问卷总分基线时为(42.4±15.1)分(10~69分),第6个月时为(76.9±20.6)分(36~100分),第9个月时为(74.2±16.7)分(36~100分),均较基线得分明显升高(P均<0.01),第6个月ObjectiveTo assess the real-world patient satisfaction with the outcomes in Chinese patients who received HYC-24/HYC-24+for the treatment of moderate to severe nasolabial folds(NLF).MethodsThis study was a prospective,observational,multicenter,real-world cohort study in which patients accepted treatment with HYC-24/HYC-24+in China during a period from August 2018 to August 2020 at Beijing Lidu Medical Beauty Hospital,Hangzhou Yanshu Yuerong Medical Aesthetic Clinic,and Guangzhou Yuexiu Plastic Surgery Hospital and were followed up for up to 1 year.Patients were adults aged 18 to 65 years with moderate to severe NLF who had not received cosmetic treatment for NLF within 6 months prior to study enrollment.Post-treatment study visits were conducted at Months 1,6,9,and 12,but only Months 6 and 9 were required visits.The primary patient-reported outcomes endpoints included the FACE-Q satisfaction with outcome total score(a score from 0 to 100:a higher score indicates better outcomes and higher patient satisfaction),FACE-Q appraisal of lines-NLFs total questionnaire score mean change from baseline(a score from 0 to 100:a higher score indicates the patient was less troubled by NLF in the past week),and proportion of patients who reported that they looked younger than the actual age on the FACE-Q patient perceived age visual analog scale(VAS).Investigator-assessed endpoints included the proportion of patients with a global aesthetic improvement scale(GAIS)score of≥1 point and the proportion of patients with an improvement in NLF severity of≥1 point using the nasolabial fold severity scale(NLFSS).Statistical analyses were performed with SAS software,version 9.4.Measurement data were expressed as Mean±SD,and count data were expressed using cases(%).For both measurement and count data,P values were calculated on the difference between score values at different time points versus baseline using the Wilcoxon signed rank test.ResultsA total of 52 subjects were enrolled and treated.Among these subjects,7 were not included

关 键 词：鼻唇沟 鼻唇褶 透明质酸 患者满意度 亚裔 整形手术 

分 类 号：R622[医药卫生—整形外科]