摘要
目的:评价衡力改善眉间纹的安全性和有效性。方法:采用不同剂量、多中心、随机、双盲、安慰剂平行对照的优效性试验设计,将安慰剂以及100单位/瓶和50单位/瓶衡力R用2.5ml氯化钠注射液复溶,在左右皱眉肌各取2位点,降眉间肌取1位点,每1位点肌肉内注射0.1ml。结果:对488例受试者为期120天的观察,有效性结果显示:20单位组优于10单位组,10单位组优于安慰剂组;安全性结果显示:发生不良事件81例138例次,不良反应为69例81例次,没有严重不良事件。结论:衡力R10单位、20单位,在改善眉间纹方面,与安慰剂相比,疗效确切,高剂量组(20单位)要优于低剂量组(10单位),但是,两剂量组之间不良事件和不良反应发生率在统计学上无差异。
Objective To evaluate the safety and efficacy of botulinum toxin type A for injection （BTXA） in treatment of glabellar lines. Methods A multiple-dose,multicenter, randomized, double-blind, placebo-controlled,parallel-group superiority trial of the efficacy and safety of BTXA in the treatment of glabellar lines was conducted. Placebo, BTXA 100 U/vial and BTXA 50 U/vial were solubilized with 2.5 mL of sodium chloride injection resoectively, and injected 0.1 mL to each 5 specific and distinct sites for each subjects, 2 on both left and right frown muscle, and 1 on drop glabella muscle. Results According to the investigation to 488 subjects during 120 days, efficacy measurement showed that the glabellar line reduction was significantly higher in high BTXA dose （20 U） group than in low dose （10 U） group, and in low dose （10 U） group than in placebo groups. The safety measurement showed 81 subjects and 138 incidents adverse events, 69 subjects and 81 incidents adverse reaction, and no severe adverse events. Conclusion BTXA injections （10 U, 20U） are safe, and effective in reducing the glabellar lines comparing to placebo. The effect in high BTXA dose group （20 U） was greater than low dose group （10 U）, but there were no significant difference in the events and rates of adverse reactions between these two groups.
出处
《中国美容医学》
CAS
2012年第11期1895-1900,共6页
Chinese Journal of Aesthetic Medicine
关键词
A型肉毒毒素
降眉间肌
皱眉肌
眉间纹
衡力~
botulinum toxin type A
drop glabella muscle
frown muscle
glabella lines
BTXA
