文献解读:一种起效更快、持续时间更长的A型肉毒毒素——“AboBoNT-A”

2021-06-16 高德美院 网络

本资料旨在向且仅向医疗专业人士提供科学信息。如果您不是医疗专业人士,请勿阅读或传播其中的内容。

     “最是人间留不住,朱颜辞镜花辞树”,衰老是不可抵抗的自然之力,尤其是面部脂肪的减少和面部皱纹的侵蚀。而随着医疗美容业的发展,A型肉毒毒素创造了去皱美容的神话,已连续多年位于非手术整形美容治疗的榜首。A型肉毒毒素通过抑制神经元中乙酰胆碱的释放,从而减少肌肉收缩,达到有效祛除皱纹,保持面部年轻的功效。

      然而,现有市场A型肉毒毒素产品鲜能同时平衡的兼顾快速起效、超长疗效、安全可靠。因此选择一款A型肉毒毒素产品并不简单。 

      一款疗效和安全性俱佳的A型肉毒毒素产品——AboBoNT-A,不失为求美者提供了一个新的选择。AboBoNT-A作为面部美容年轻化的选择之一,有着悠久的历史,其在1990年首次获批治疗适应症,并于2009年经FDA批准获得医美适应症。大量临床研究证实其快速起效和持续时间长的特点。

   一项前瞻性、随机、双盲、安慰剂、平行对照的三期临床试验评估了与安慰剂相比,单次给药AboBoNT-A矫正中、重度皱眉纹的有效性、安全性,以及起效时间和持续时间的差异1

  研究纳入158名中度至重度皱眉纹受试者,并按2:1比例随机接受AboBoNT-A(n=105)或安慰剂(n=53)治疗,在基线时,受试者在皱眉肌和降眉间肌5个部点进行等效剂量的注射,并随访180天以评估治疗效果的持续时间。主要研究终点是在第30天将皱眉纹完全消除或减至轻度的情况1

图. 在眉间区5个注射点给予治疗

(每个注射点10单位/0.05 mL)

 

 该研究主要得出以下几个结论

AboBoNT-A治疗中重度眉间纹疗效显著

  首先,该研究将应答者定义为:在治疗30天后,眉间纹严重程度从基线时的中度或重度(GLSS评分2-3分)改善为无或轻度(GLSS评分0-1)。研究显示在第30天,在研究者和受试者评估(共同主要终点)中,AboBoNT-A组的应答者比例显著高于安慰剂组(研究者评估:89.5% vs.7.5%,p<.001;受试者评估:75.7%vs.9.8%,p<.001)。

AboBoNT-A起效迅速,中位起效时间为3天

  相较于安慰剂组15天起效,AboBoNT-A起效更快,中位起效时间为3天。AboBoNT-A治疗组中,50%的受试者表示在治疗后48小时内就起效(15%的受试者表示在治疗后24小时起效,35%的受试者表示在治疗后48小时起效)。并且,治疗后第14天,AboBoNT-A组应答者比例为87.6%,安慰剂组仅为24.5% (p<.001)。 

AboBoNT-A持续时间长,中位持续时间为85天,且至120天疗效仍有统计学意义

      根据研究者和受试者评估,AboBoNT-A组的中位反应持续时间为85天,并且在第120天,AboBoNT-A组的应答者比例显著高于安慰剂组(研究者评估:24.24%vs4.08%,p=0.002;受试者评估:20.20%vs6.12%,p=0.03)。这表明AboBoNT-A疗效更持久。

AboBoNT-A安全性良好,与安慰剂相当

  AboBoNT-A与安慰剂治疗期间出现的不良事件(TEAEs)的受试者百分比相似,其安全性与安慰剂相当,并且未出现中和抗体。

 

结 语

  A型肉毒毒素是由150-kDa神经毒素和辅助蛋白组成,研究显示150-kDa神经毒素具有相似性、辅助蛋白复溶后会解离,也就是说A型肉毒毒素的作用机制是相似的,但其临床效果却存在差异。AboBoNT-A通常在2-3天内起效,临床效果可持续5个月2,也由此得到了较高的治疗满意度。那么AboBoNT-A到底凭何维持如此超长疗效呢?

  在一篇综述中我们可以得到答案,该综述从AboBoNT-A用于美容治疗的注射剂量和注射技术等方面阐明了其持续时间持久的原因2

注射剂量

  临床证据显示,作用持续时间与活性神经毒素的含量相关,含量越高,作用持续时间也就更长。一项研究测量了三种商业A型肉毒毒素中按每治疗剂量注射的活性神经毒素的含量,结果显示AboBoNT-A按每治疗剂量注射时活性神经毒素含量最多。

注射技术

  正确的注射技术,包括合适的针头、精准的注射角度,都有助于将肉毒毒素更精确地送达肌肉,从而达到更持久的疗效。AboBoNT-A使用无菌29-30G针头、以正确角度进针3,从而保证注射器准确测量注射深度和注射位置。

 

  更多的活性神经毒素含量、正确的注射技术使AboBoNT-A治疗的作用持续时间更持久。总的来说,AboBoNT-A起效快,持续时间长,改善皱纹疗效显著,且安全性良好。

END

CN/DYS/0249/0820d

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/19549186/

参考文献:

1. Brandt F, Swanson N, Baumann L, Huber B. Randomized, placebo-controlled study of a new botulinum toxin type a for treatment of glabellar lines: efficacy and safety. Dermatol Surg. 2009 Dec;35(12):1893-901. 

2. Warren H, Welch K, Coquis-Knezek S. AbobotulinumtoxinA for Facial Rejuvenation: What Affects the Duration of Efficacy? Plast Surg Nurs. 2020 Jan/Mar;40(1):37-44. 

3. 吉适Dysport ®说明书

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    2021-06-18 zhwj
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