注射用交联透明质酸钠凝胶矫正中重度鼻唇沟皱纹的临床研究  

Clinical trail on safety and efficacy of an injectable cross-linked sodium hyaluronate gel for moderate and severe nasolabial groove

作　　者：周志强[1] 隋志甫[1] 刘畅[1] 赵志力[1] 石成方[1] 王晓莎 杨蓉娅[1] 

机构地区：[1]北京军区总医院全军皮肤损伤修复研究所整形美容中心,北京100700 [2]常州药物研究所有限公司

出　　处：《实用皮肤病学杂志》2016年第1期20-23,共4页Journal of Practical Dermatology

摘　　要：目的以注射用修饰透明质酸钠凝胶（瑞蓝2型,瑞典Q-Med公司）为产品对照,评价注射用修饰透明质酸钠凝胶（益舒美~,常州药物研究所有限公司）在注射填充矫正中重度鼻唇沟皱纹方面的有效性和安全性。方法采用随机、单盲、自身平行对照的非劣效研究,对鼻唇沟部皱纹严重程度分级在中度以上的患者实施注射填充治疗（每侧〈1.5 ml）,随访时间24周。于注射前,注射后即刻,注射后4周、12周、24周,分别由医生和受试者根据皱纹严重程度分级标准进行评分,记录不良事件。筛选期及治疗后4周时进行常规实验室检查。结果共入组30例受试者,注射后左右两侧鼻唇沟皱纹严重程度分级（wrinkle severity rating scale,WSRS）的评分均较注射前下降;注射后即刻及注射后24周研究者与受试者评价双侧鼻唇沟WSRS的应答率差异均无统计学意义（P〉0.05）;受试者自我评价面部整体美容效果的改善程度（global aesthetic improvement scale,GAIS）,组间整体美容改善差异无统计学意义（P〉0.05）。试验过程中不良事件共发生2例,1例与研究材料可能有关,为注射次日晨起后试验侧注射区域明显肿胀,1~2 d缓解。注射后局部多出现发红、肿胀、疼痛、触痛、淤青等,大部分在1周内缓解。结论益舒美？用于矫正鼻唇沟皱纹与瑞蓝2型疗效相同,安全可靠。Objective To investigate safety and efficacy of yishumei—a injectable cross-linked sodium hyaluronate gel on alleviating moderate and severe nasolabial groove. Methods A randomized, single-blind, parallel controlled study was conducted on selected volunteers with moderate and severe nasolabial groove. Restylane~ Ⅱor yishumei~（1.5 ml） was injected either side to correct nasolabial groove. Bilateral nasolabial wrinkle severity rating scale（WSRS） and adverse events were evaluated by surgeon and volunteers independently at preoperative and immediately, 4 weeks, 12 weeks, 24 weeks after procedure. SPSS13.0 software was used for statistical analysis. Results The average age of 30 selected volunteers（28 female, 2 male） was 45.8. Bilateral nasolabial WSRS declined after procedure, and the difference between WSRS of immediately and of 24 weeks later has no statistically significance（P〈0.05）. Two cases of adverse events（2/30, 6.67%） occurred during the test, and one case thought to be related to the research materials. Conclusion Yishumei~ injectable cross-linked sodium hyaluronate gel has consistent efficacy and safety with restylane~Ⅱ on alleviating moderate and severe nasolabial groove.

关 键 词：皱纹 鼻唇沟 透明质酸钠凝胶 临床观察 

分 类 号：R622[医药卫生—整形外科]