摘要
目的评价国产注射用交联透明质酸钠凝胶纠正中重度鼻唇沟皱纹(NLF)的安全性和有效性。方法本研究采用多中心、前瞻性、评价者-受试者双盲、随机对照的非劣效试验设计,自2021年4月至2023年4月在首都医科大学附属北京友谊医院、河南科技大学第一附属医院、沧州市人民医院和应急总医院4个研究中心前瞻性纳入296例中重度NLF患者作为研究对象。按照1∶1比例随机分为国产组和进口组,每组各148例。国产组注射用交联透明质酸钠凝胶,进口组注射用修饰透明质酸钠凝胶。注射后0.5、1、2 h,采用视觉模拟评分法(VAS)评估受试者两侧面部的疼痛情况;比较两组注射后1、3、6、12个月的鼻唇沟皱纹严重程度分级(WSRS)和面部整体美容效果改善分级(GAIS);比较两组受试者不良事件及实验室检查结果。结果注射后0.5、1、2 h,国产组与进口组两侧面部的VAS评分比较,差异均无统计学意义(P>0.05)。国产组注射1、3、6、12个月的WSRS改善率分别为96.62%、89.19%、91.22%、35.14%,进口组分别为97.30%、90.54%、90.54%、29.73%,两组WSRS改善率比较,差异均无统计学意义(P>0.05)。注射后1、3、6、12个月,国产组与进口组的GAIS改善情况比较,差异均无统计学意义(P>0.05)。本次试验无严重不良事件发生且实验室常规检查及生命体征组间均正常。结论国产注射用交联透明质酸钠凝胶在纠正中重度NLF的效果和安全性与进口产品相当。
Objective To evaluate the safety and efficacy of domestic crosslinked sodium hyaluronate gel in correcting moderate to severe nasolabial fold(NLF).Methods This study adopted a multicenter,prospective,evaluator subject double-blind,randomized controlled non inferiority trial design.From April 2021 to April 2023,296 patients with moderate to severe NLF were prospectively enrolled in four research centers:Beijing Friendship Hospital,Capital Medical University,First Affiliated Hospital of Henan University of Science and Technology,People's Hospital of Cangzhou City,and Emergency General Hospital.They were randomly divided into the domestic group and the imported group in a 1∶1 ratio,with 148 cases in each group.The domestic group was injected with cross-linked sodium hyaluronate gel,and the imported group was injected with modified sodium hyaluronate gel.At 0.5,1,and 2 hours after injection,the pain on both sides of the subject's face was evaluated using visual analog scale(VAS);the improvement in bilateral nasolabial wrinkle severity rating scale(WSRS)and the global aesthetic improvement scale(GAIS)at 1,3,6,and 12 months after injection were compared between the two groups;adverse events and laboratory test results were compared between the two groups of subjects.Results At 0.5,1,and 2 hours after injection,there were no statistically significant differences in VAS scores between the domestic group and the imported group on both sides of the face(P>0.05).The improvement rates of WSRS in the domestic group at 1,3,6 and 12 months after injection were 96.62%,89.19%,91.22%and 35.14%,respectively,those in the imported group were 97.30%,90.54%,90.54%and 29.73%,respectively.There were no statistically significant differences in the improvement rates of WSRS between the two groups(P>0.05).At 1,3,6,and 12 months after injection,there was no statistically significant difference in the improvement of GAIS between the domestic group and the imported group(P>0.05).There was no serious adverse event in this test,and routine laboratory examination and vital signs were normal between the two groups.Conclusion The efficacy and safety of domestic crosslinked sodium hyaluronate gel in correcting moderate to severe nasolabial wrinkles are equivalent to that of imported products.
作者
江萌
李妍
禚风麟
徐薇
李邻峰
JIANG Meng;LI Yan;ZHUO Feng-lin(Department of Dermatology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)
出处
《临床和实验医学杂志》
2024年第6期670-672,F0003,共4页
Journal of Clinical and Experimental Medicine
