Soares Danny J, Dejoseph Louis M, Zuliani Giancarlo F, Liebertz Daniel J, Patel Vivek-Sagar M
*Premier Image Cosmetic & Laser Surgery and Department of Otolaryngology, Emory University, Atlanta, Georgia; †Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, Wayne State University, Detroit, Michigan; ‡Department of Otolaryngology, Wayne State University, Detroit, Michigan.
Dermatol Surg. 2015 Jun;41(6):712-7. doi: 10.1097/DSS.0000000000000365.
The efficacy of botulinum neurotoxin type A after prolonged storage at room temperature is currently unknown. This randomized, double-blinded, split-face study investigated the impact of postreconstitution 25°C storage for 1 week on the clinical efficacy of incobotulinumtoxinA in the treatment of lateral canthus lines.
Twenty-one participants with at least mild to moderate crow's feet at maximum contraction on the Crow's Feet Grading Scale (CFGS) underwent injection to each lateral canthus area with 10 U of freshly reconstituted and room temperature-stored product and followed for 4 months. Responders were defined as those demonstrating at least a 1-point improvement on their CFGS score.
At each visit (2 weeks and 1, 2, 3, and 4 months), there was no statistical difference in the rate of responders between the fresh and the stored products. In addition, the percentage of responders displaying a 2-point versus a 1-point improvement and response longevity did not statistically differ between both products for the entire 4-month study duration.
Prolonged storage of incobotulinumtoxinA at room temperature does not appear to significantly alter its efficacy or longevity in the treatment of dynamic lateral canthus lines.
目前尚不清楚A型肉毒杆菌神经毒素在室温下长期储存后的疗效。这项随机、双盲、半脸研究调查了复溶后在25°C储存1周对因卡波糖毒素A治疗外眦纹临床疗效的影响。
21名在鱼尾纹分级量表(CFGS)上最大收缩时至少有轻度至中度鱼尾纹的参与者,每侧外眦区域分别注射10 U新鲜复溶和室温储存的产品,并随访4个月。有反应者定义为CFGS评分至少提高1分的患者。
在每次随访(2周以及1、2、3和4个月)时,新鲜产品和储存产品的有反应者比例无统计学差异。此外,在整个4个月的研究期间,两种产品之间显示2分改善与1分改善的有反应者百分比以及反应持续时间在统计学上没有差异。
因卡波糖毒素A在室温下长时间储存似乎不会显著改变其在治疗动态外眦纹方面的疗效或持续时间。