Triple-Blind, Prospective, Internally Controlled Comparative Study Between AbobotulinumtoxinA and
Ramtin Kassir
【 文献重点摘要 】
Introduction
OnabotulinumtoxinA (ONA; Botox, Allergan, Irvine, CA) was discovered for cosmetic use in the mid-1980s for which it was FDA approved in April 2002. AbobotulinumtoxinA (ABO; Dysport, Valeant Pharmaceuticals International, Inc, Montreal, Quebec) was FDA approved in April 2009 for therapeutic and esthetic uses. The most recent studies make a comparison between the two formulations; however, information is still lacking in comparison studies. In this study, we compare efficacy and safety of a single treatment of two preparations of botulinum toxin A in patients with moderate to severe rhytids in the glabellar and crow’s feet areas.
Methods
A total of 85 patients with moderate to severe wrinkles in either the glabellar or crow’s feet area, or both, were given a single injection on day 0, with ABO and ONA injected on opposite sides of the face. Follow-up assessments were done at 2 weeks, 1 month, 3 months, 4 months, and 5 months. The study end points were onset of action, change in degree of wrinkles, patient satisfaction, duration of effect, and adverse effects.
Results
Results of onset of improvement with ABO vs. ONA in the glabellar and crow’s feet regions show higher percentage of patients with earlier onset improvement with ABO. Evaluator assessment showed ABO lasted longer after 3 months in a significant number of patients in both areas, 83% with ABO vs. 48% with ONA at 4 months in the glabellar area, and 65% with ABO vs. 47% with ONA at 4 months in the crow’s feet area.
Conclusion
Time to improvement showed earlier onset and longer duration of improvement in a higher percentage of individuals with ABO when compared with ONA. ABO provides a safe and effective alternative in a dose ratio of 2.5:1 and 3:1 in the glabellar and crow’s feet area, respectively.
Keywords
Botox; Botulinum toxin; Crow’s feet; Dermatology; Dysport; Facial rhytids; Glabella
简介
OnabotulinumtoxinA(ONA;Botox,Allergan,Irvine,CA)于20世纪80年代中期被发现用于美容,并于2002年4月获得FDA批准。AbobotinumtoxinA(ABO;DySPORT,Valeant PharmPharmticals International,Inc,蒙特利尔,魁北克)于2009年4月获得FDA批准,用于治疗和美容用途。最新的研究对这两种剂型进行了比较,但在比较研究中仍缺乏资料。在这项研究中,我们比较了两种A型肉毒毒素制剂对眉间和鱼尾区中到重度皱纹患者的单一治疗的有效性和安全性。
方法
85例中、重度皱纹患者在第0天单次注射ABO和ONA,对侧面部注射ABO和ONA。分别于2周、1个月、3个月、4个月和5个月进行随访评估。研究终点是作用开始时间、皱纹程度的变化、患者满意度、作用持续时间和不良反应。
结果
ABO与ONA在眉间和鱼尾区的起效改善结果显示,ABO起病较早改善的患者比例较高。评估者评估显示,在这两个地区的相当数量的患者中,ABO持续3个月的时间更长,在眉毛区ABO在4个月时83%,而ONA在4个月时为48%;在鱼尾区,ABO在4个月时65%,ONA在47%。
结论
与ONA相比,ABO患者的改善时间较早,持续时间较长。ABO在眉间和鱼尾区的剂量比分别为2.5:1和3:1,是一种安全有效的替代治疗方法。
关键词
肉毒杆菌毒素;肉毒毒素;鱼尾纹;皮肤科;运动障碍;面部皱纹;眉间