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A型肉毒毒素(MASPORT)与 DYSPORT 治疗眉间纹的疗效和安全性的 III 期临床研究。

A Phase III Clinical Study of the Efficacy and Safety of Botulinum Toxin Type A (MASPORT) with DYSPORT for the Treatment of Glabellar Lines.

机构信息

Pasteur Institute of Iran, Tehran, Iran.

Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Aesthetic Plast Surg. 2024 Feb;48(3):324-332. doi: 10.1007/s00266-023-03766-5. Epub 2024 Jan 17.

Abstract

BACKGROUND

Botulinum toxin type A is a widely used treatment of facial wrinkles. The objective of this study was to compare the efficacy and safety of a new botulinum toxin type A (Masport [abobotulinum toxin A], MasoonDarou Co) with DYSPORT for the treatment of glabellar lines.

METHODS

262 subjects with moderate-to-severe glabellar lines received either a fixed dose of 50 units of MASPORT or DYSPORT (Ipsen Company, England). Subjects were followed up at 14, 30, 60, 90 and 120 days after injection. Efficacy was assessed by investigator at maximum frown and rest and also by Subject Global Assessment of Change (SGA). The responders were defined as persons with +2 grade improvement from baseline for both investigator and patient assessment. The occurrence and duration of adverse effects were recorded up throughout the study.

RESULTS

According to the investigator evaluations, the responder rate at maximum frown were 94.5% for MASPORT and 95.6% for DYSPORT group on day 30 and at rest were 85.45% and 85.68% for MASPORT and DYSPORT group, respectively. According to the subject self-assessment, the proportion of responders in MASPORT group at day 30 was 95.28% versus 97.04% for DYSPORT group. No serious drug related adverse effect was recorded in either study groups, and the rates of adverse effects were similar for both groups.

CONCLUSION

Abobotulinum toxin A [MASPORT] is equally safe and effective as commercial product [DYSPORT] for the treatment of glabellar lines with the dose of 50 units, up to 120 days.

LEVEL OF EVIDENCE I

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

摘要

背景

肉毒毒素 A 型被广泛用于治疗面部皱纹。本研究的目的是比较一种新型肉毒毒素 A(Masport[阿 Botulinum 毒素 A],MasonDarou 公司)与 Dysport 治疗眉间纹的疗效和安全性。

方法

262 例中重度眉间纹患者分别接受 50 单位 MASPORT 或 Dysport(英国 Ipsen 公司)固定剂量治疗。注射后 14、30、60、90 和 120 天进行随访。疗效由研究者在最大皱眉和休息时评估,并由患者总体评估变化(SGA)评估。应答者定义为研究者和患者评估均从基线改善+2 级。记录整个研究过程中的不良反应发生情况和持续时间。

结果

根据研究者评估,MASPORT 组在第 30 天最大皱眉时的应答率为 94.5%,Dysport 组为 95.6%,在休息时 MASPORT 组和 Dysport 组分别为 85.45%和 85.68%。根据患者自我评估,MASPORT 组在第 30 天的应答者比例为 95.28%,Dysport 组为 97.04%。两组均未记录到严重的药物相关不良反应,两组不良反应发生率相似。

结论

50 单位剂量的阿 Botulinum 毒素 A[MASPORT]治疗眉间纹与商业产品[Dysport]同样安全有效,120 天内有效。

证据水平 I:本杂志要求作者为每篇文章分配一个证据水平。有关这些循证医学评级的完整描述,请参阅目录或在线作者指南 www.springer.com/00266

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