文献解读:兼具疗效与患者满意度的新选择-含麻透明质酸填充剂用于亚洲人群全脸美学改善

2021-07-07 高德美研习社 网络

兼具疗效与患者满意度的新选择

      透明质酸填充剂注射已成为目前最受欢迎的医学美容手段之一,但在注射治疗过程中,常常需要麻醉来减轻疼痛,目前最常用的是表面麻醉,然而表面麻醉不足以完全消除疼痛且用药后需要较长时间才能起效。为了更好地减轻疼痛,提高求美者满意率,来自台湾的一项本土研究评估了含麻透明质酸填充剂用于亚洲人群全脸美学改善的疗效与安全性。

01 研究设计
  • 为期24个月,评估者盲,非对照,多中心研究。

  • 纳入100名平均年龄40岁(27-49岁),具有中国汉族面部外观的受试女性。在上脸颊、鼻唇沟、颞部、鼻子和下巴使用由NASHA技术制造的含麻透明质酸填充剂3-5ml进行注射。

  • 主要终点为首次治疗后6个月与基线相比的面部美观改善程度,受试者自行采用面部整体美容改善量表(GAIS)进行评估。首次治疗后随访24个月。

02 注射方案

图1 治疗时间表

首次治疗的平均注射剂量为4.7mL,再次治疗的94位受试者的平均注射剂量为3.1mL。

                       
03 研究成果
01

1.疗效

总体疗效

受试者自我评估:

  • 首次注射后6个月,95%的求美者认为自己的注射部位美观程度得到改善(图2)。

  • 首次注射后12个月,仍有88%的求美者认为其注射部位美观程度得到改善;再次注射后第12个月,有93%的求美者认为其注射部位美观程度得到改善(图2)。

研究者评估:

  • 首次注射后6个月,至少94%的求美者面部美观程度得到改善。

  • 首次和再次注射后第12个月,≥82%的求美者面部美观程度得到改善(图2)。

设盲评估者评估

  • 首次注射后6个月,74%的面部美观程度得到改善;首次和再次注射后第12个月,≥70%的求美者得到改善。

图2 GAIS改善*的受试者

*改善/明显改善/极大改善

图3 受试者照片:(A)基线(B)注射后3个月(C)注射后12个月(D)注射后24个月

 

上脸颊:

  • 首次注射后6个月,至少66%受试者的上脸颊得到改善,第二次注射后6个月,至少67%的受试者得到改善(较基线改善≥1级)。

  •  二次注射后的长期(注射后12个月)改善率(≥69%)较首次注射(≥38%)更好(P<0.0001;图4)。

图4 上脸颊改善*情况-研究者评估

*较基线至少改善1级

 

下巴及下颌缘:

亚组分析:79名女性受试者被纳入到下巴评估亚组中,患者均接受下巴注射,平均注射剂量为1.6 mL。

首次注射后第6个月,大部分(94%)受试者的下巴通过2D图片评估得到改善(图5)。

图5 GAIS改善的受试者-下巴

  • 在下巴后缩的受试者中(n=64),与仅接受首次治疗相比,接受二次治疗者下巴后缩状况改善更加明显,二次治疗后第12个月GCRS的改善率最高(63%),二次治疗后JSS的改善率也更高,第6个月为57%,第12个月为52%(图6)。

图 6 GCRS与JSS改善情况-下巴

备注:GCRS:Galderma Chin Retrusion Scale;JSS:Jawline Sagging Scale

 

02
2.满意度

近90%受试者对治疗效果表示满意

  • 首次注射后3个月,受试者对自身面部外观的满意度由基线的15%上升到88%

  • ≥80%的受试者对注射后的长期改善效果表示满意。

 

03
3.安全性
  • 所有注射相关不良事件均为轻中度,最常见的不良事件为注射部位疼痛(5%)和注射部位淤青(6%)。

  • 在二次治疗后,报告的不良事件由20例降为9例。

  • 所有报告的不良症状均在注射3天后自行缓解,并在注射后第14天消失。

 

总 结

      以上研究结果显示,含麻透明质酸填充剂用于亚洲人群的面部年轻化治疗疗效显著,具有长期的美学改善效果。因这类产品中含有局部麻醉剂利多卡因,能有效减轻注射者疼痛,因此在求美者中的满意度较高,且二次治疗的耐受性也较好。

END

 CN/RES/2000005

材料仅供医疗卫生专业人士学习交流

不作为临床使用推荐及其他用途

相关临床应用应符合中国国家药品监督管理局批准的使用说明书

https://pubmed.ncbi.nlm.nih.gov/33026748/

参考文献:

1.Huang SH, Tsai TF. Safety and Effectivenessof Hyaluronic Acid Fillers With Lidocaine for Full-Face Treatment in AsianPatients. J Drugs Dermatol. 2020 Sep 1;19(9):836-842.

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    2021-07-07 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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