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首页> 外文期刊>Journal of drugs in dermatology: JDD >Full-face injections of variable total doses of abobotulinum toxin type a: A randomized, phase IV clinical trial of safety and efficacy
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Full-face injections of variable total doses of abobotulinum toxin type a: A randomized, phase IV clinical trial of safety and efficacy

机译：全剂量注射各种剂量的a型肉毒杆菌毒素的全脸注射：安全性和有效性的随机IV期临床试验

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摘要

BACKGROUND: Botulinum toxin type A (BoNT-A) has been used for almost 20 years in cosmetic dermatology to reduce dynamic wrinkles on single or multiple facial areas. OBJECTIVE: To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A (ABO). METHODS: A total of 90 participants were enrolled. Subjects had at least two indications for BoNT-A treatments on each third of the face (upper, middle and lower). They were randomized into 3 groups, with pre-defined total dose range of ABO, varying from 120 to 250 U. RESULTS: Most of the subjects were women (96.5%). The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines, and more than 16 weeks for forehead wrinkles and crow's feet, all P<0.001, with no differences between groups. The most frequent adverse event (excessive perioral weakness) was related to high dose in the perioral area. CONCLUSIONS: This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously. As long as the recommended doses are used, concomitant injections of ABO are safe and efficient, with no increase in adverse events.
机译：背景：A型肉毒杆菌毒素（BoNT-A）在美容皮肤病学中已经使用了近20年，以减少单个或多个面部区域的动态皱纹。目的：评估各种总剂量的肉毒杆菌毒素A（ABO）全脸治疗的安全性和有效性。方法：共有90名参与者参加。受试者在面部的每三分之一（上，中，下）至少有两个BoNT-A治疗指征。他们被随机分为3组，ABO的总剂量范围从120到250 U不等。结果：大多数受试者为女性（96.5％）。毛label线与基线相比，具有统计学意义的显着改善持续了超过24周，前额皱纹和鱼尾纹持续了超过16周，所有P <0.001，两组之间无差异。最常见的不良事件（过度的口周肌无力）与口周区域的高剂量有关。结论：这是第一个比较不同剂量的ABO同时施用到整个面部的安全性和有效性的研究。只要使用推荐剂量，伴随注射的ABO是安全有效的，并且不会增加不良事件。

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