Hexsel Doris, Rutowitsch Marcio S, de Castro Lia Cândida M, do Prado Débora Zechmeister, Lima Maryelle Moreira
School of Medicine, University of Passo Fundo, Brazil.
Dermatol Surg. 2009 Jun;35(6):933-9; discussion 940. doi: 10.1111/j.1524-4725.2009.01158.x. Epub 2009 Apr 21.
It is recommended that attention be given to the shelf life of botulinum toxin type A (BT-A) after its reconstitution.
To assess the efficacy and safety of 500 U of BT-A after reconstitution up to 15 days after injection.
BT-A vials were diluted 15 days, 8 days, and 8 hours before injection. One hundred five volunteers were randomized to one of three treatment groups, according to dilution dates. They were evaluated at baseline and 28, 56, 84, and 112 days after treatment. At each visit, the investigator and the volunteer evaluated the motility of the treated area using a 4-point qualitative scale. Five independent specialists, who scored the motility of the treated area on the same scale, blind analyzed photographs taken at each visit. The reconstituted vials of BT-A were stored and analyzed before and after the study.
No significant difference was shown between the groups. No evidence of contamination was found in the BT-A vials.
The results confirm the possibility of injecting 500 U of BT-A up to 15 days after its reconstitution safely and without loss of efficacy.
建议关注A型肉毒毒素（BT-A）复溶后的保质期。
评估复溶后长达注射后15天的500 U BT-A的疗效和安全性。
BT-A小瓶在注射前15天、8天和8小时进行稀释。105名志愿者根据稀释日期随机分为三个治疗组之一。在治疗前的基线以及治疗后的28天、56天、84天和112天对他们进行评估。每次随访时，研究者和志愿者使用4分制定性量表评估治疗区域的运动功能。五名独立专家以相同量表对治疗区域的运动功能进行评分，对每次随访拍摄的照片进行盲法分析。复溶后的BT-A小瓶在研究前后进行储存和分析。
各治疗组之间未显示出显著差异。在BT-A小瓶中未发现污染迹象。
结果证实了复溶后长达15天安全注射500 U BT-A且不丧失疗效的可能性。
