Department of Neurology, College of Medicine, Yeungnam University, Daegu, Korea.
J Clin Neurol. 2013 Jul;9(3):157-64. doi: 10.3988/jcn.2013.9.3.157. Epub 2013 Jul 1.
It is recommended that Botox be used within 5 hours of reconstitution, which results in substantial quantities being discarded. This is not only uneconomic, but also inconvenient for treating patients. The aim of this study was to determine the potencies of Botox used within 2 hours of reconstitution with unpreserved saline, the same Botox refrigerated (at +4℃) 72 hours after reconstitution, and during the next 4 consecutive weeks (weeks 1, 2, 3, and 4). This comparison was used to determine the length of refrigeration time during which reconstituted Botox will maintain the same efficacy as freshly reconstituted toxin.
Individual paralysis rates in the extensor digitorum brevis (EDB) compound muscle action potential (CMAP) amplitude and area were measured 1 week after injecting fresh reconstituted 2.5 MU of Botox on one side of the foot, and when the same quantity of Botox that had been refrigerated for a designated time (i.e., 72 h, or 1, 2, 3, or 4 weeks) into the other side of the foot. The EDB CMAP amplitude and area at 12 and 16 weeks postinjection were also measured to compare the efficacy durations in all five comparative groups.
Ninety-four volunteers were divided into five groups according to the refrigerator storage time of the second Botox injection. The paralysis of the EDBs was significant for each injection of Botox, both fresh and refrigerated, with no statistically significant differences between them, regardless of the refrigeration time. There was a tendency toward increased CMAP amplitude and area at 12 or 16 weeks postinjection (p<0.0001). The duration of effective muscle paralysis did not differ significantly throughout the 16-week follow-up period between all five groups.
The potency of reconstituted Botox is not degraded by subsequent refrigeration for 4 weeks. However, there are definite concerns regarding its sterility, and hence its safety, since multiple withdrawals from the same vial over long periods can introduce bacterial contamination.
建议在复溶后 5 小时内使用肉毒毒素，否则会导致大量浪费。这不仅不经济，而且对治疗患者也不方便。本研究旨在确定复溶后 2 小时内使用未保存盐水的肉毒毒素、复溶后 72 小时冷藏（+4℃）的相同肉毒毒素以及接下来连续 4 周（第 1、2、3 和 4 周）的效力。通过比较来确定冷藏时间的长度，在此期间，复溶的肉毒毒素将保持与新鲜复溶毒素相同的功效。
在注射一侧足部 2.5 MU 新鲜复溶肉毒毒素 1 周后，测量同侧伸趾短肌（EDB）复合肌肉动作电位（CMAP）幅度和面积的个体麻痹率，并在另一侧足部注射冷藏指定时间（即 72 h 或 1、2、3 或 4 周）的相同数量的肉毒毒素。还测量了注射后 12 周和 16 周的 EDB CMAP 幅度和面积，以比较所有五个比较组的疗效持续时间。
94 名志愿者根据第二次肉毒毒素注射的冰箱储存时间分为五组。无论是新鲜的还是冷藏的肉毒毒素，每次注射都会导致 EDB 麻痹，且两者之间没有统计学上的显著差异，无论冷藏时间如何。在注射后 12 周或 16 周时，CMAP 幅度和面积有增加的趋势（p<0.0001）。在整个 16 周的随访期间，所有五组之间有效肌肉麻痹的持续时间没有显著差异。
复溶的肉毒毒素的效力不会因随后冷藏 4 周而降低。然而，由于多次从同一小瓶中抽取可能会引入细菌污染，因此其无菌性和安全性存在一定的担忧。
