中国美容医学2012，Vol.21Issue(15)：1895-1900,6.
衡力(R)改善眉间纹的安全性和有效性
The safety and efficacy of botulinum toxin type A for injectionin the treatment of glabellar lines
陈平纡 1徐金华 2谢红付 2何黎 3姚晨 4吴强 5谢贵林 1王玉琳 1李恒进 6冯峥 6孙秋宁 7吴艳 8赵广9
作者信息
- 1. 兰州生物制品研究所有限责任公司 甘肃兰州 730046
- 2. 复旦大学附属华山医院
- 3. 昆明医学院第一附属医院
- 4. 北京大学临床研究所
- 5. 兰州生物技术开发有限公司
- 6. 中国人民解放军总医院
- 7. 中国医学科学院北京协和医院
- 8. 北京大学第一医院
- 9. 中国人民解放军空军总院
- 折叠
摘要
Abstract
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.关键词
A型肉毒毒素/降眉间肌/皱眉肌/眉间纹/衡力(R)Key words
botulinum toxin type A/ drop glabella muscle/ frown muscle/ glabella lines/ BTXA分类
医药卫生引用本文复制引用
陈平纡,徐金华,谢红付,何黎,姚晨,吴强,谢贵林,王玉琳,李恒进,冯峥,孙秋宁,吴艳,赵广..衡力(R)改善眉间纹的安全性和有效性[J].中国美容医学,2012,21(15):1895-1900,6.
