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A型和 B 型肉毒毒素联合用于额部皱纹:一项随机、双盲、对照的研究。

Combined use of botulinum toxin type A and B for forehead rhytides: a randomized, double-blind, split-face study.

机构信息

Department of Dermatology, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.

出版信息

J Dermatolog Treat. 2013 Apr;24(2):126-32. doi: 10.3109/09546634.2011.595772. Epub 2011 Jul 31.

Abstract

BACKGROUND

This is the first well-controlled study of the combined use of botulinum toxin type A (BoNT-A) and botulinum toxin type B (BoNT-B) for hyperkinetic lines in forehead.

OBJECTIVE

To evaluate the effectiveness and safety of a mixture of BoNT-A and BoNT-B with that of equipotent BoNT-A alone for treating patients with forehead rhytides.

MATERIALS AND METHODS

Fourteen patients with forehead wrinkles completed this clinical study. On day 0, patients received a mixture of BoNT-A (5 U) and B (500 U) on one side of the forehead and BoNT-A (10 U) symmetrically on the other side. Clinical evaluation was made at the beginning and at weeks 1, 2, 4, 8, 12, and 16. Therapeutic efficacy was evaluated using clinical improvement scale by investigators and the subjective wrinkle assessment by patients.

RESULTS

According to investigator assessment, the differences between the average improvement scores of the two differently treated sides were not statistically significant at all follow-up visits. Moreover, the plateau of the clinical benefit was achieved at week 4.

CONCLUSION

We observed the equivalent efficacy in the mixture of both toxins and BoNT-A alone.

摘要

背景

这是首次针对额部运动性皱纹联合应用 A 型肉毒毒素(BoNT-A)和 B 型肉毒毒素(BoNT-B)的对照研究。

目的

评估 BoNT-A 与 BoNT-B 混合制剂治疗额部皱纹的有效性和安全性,以及与等效剂量的 BoNT-A 单独治疗的效果。

材料和方法

14 例额部皱纹患者参与本临床研究。第 0 天,一侧额部注射 BoNT-A(5U)和 B(500U)混合制剂,另一侧注射等效剂量的 BoNT-A(10U)。分别于第 0 天、第 1、2、4、8、12、16 周进行临床评估。研究者采用临床改善量表评估治疗效果,患者采用主观皱纹评估量表评估自身疗效。

结果

根据研究者评估,两种不同治疗侧的平均改善评分在所有随访时均无统计学差异。此外,第 4 周时达到临床疗效的平台期。

结论

我们观察到两种毒素混合制剂与 BoNT-A 单独应用具有等效疗效。

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