Carey Wayne D
J Drugs Dermatol. 2014 Jun;13(6):735-8.
IncobotulinumtoxinA (INCO) was approved for aesthetic use in the United States in 2011. When reconstituted per manufacturer's instructions, diminished delivery of INCO in US may result.
Investigators sought to determine whether potential loss of decreased motor activity could be demonstrated, using a simple reconstitution technique.
In this 5-patient study, investigators added 2.0 mL of saline to INCO powder at the bottom of the first of 5 vials, swirling gently to dissolve INCO powder at the bottom. Reconstituted INCO was discarded and the cap was replaced. The "empty" vial then received 0.6 mL of saline, and was swirled and inverted 3 times to ensure dissolution. The 0.6 mL from the first vial was added to the second "empty" vial and the process was repeated for the remaining 3 vials (5 vials per patient). Patients were injected from reconstitution of "empty" vials to determine neuromodulatory activity. Pre- and post-treatment patient photographs of maximal contraction were taken.
Markedly diminished maximal frown could be observed in all 5 patients.
Improper reconstitution of INCO, or swirling without inversion of the vial following saline injection, can result in significant loss of units of the neurotoxin in the clinical setting.
2011年，英科博妥素A（INCO）在美国被批准用于美容用途。按照制造商的说明进行复溶时，在美国可能会导致INCO的递送量减少。
研究人员试图通过一种简单的复溶技术来确定是否能证明运动活性降低的潜在损失。
在这项针对5名患者的研究中，研究人员在5个小瓶中的第一个小瓶底部，向INCO粉末中加入2.0毫升生理盐水，轻轻旋转以溶解底部的INCO粉末。复溶后的INCO被丢弃，然后更换瓶盖。然后向“空”小瓶中加入0.6毫升生理盐水，旋转并倒置3次以确保溶解。将第一个小瓶中的0.6毫升溶液加入第二个“空”小瓶中，并对其余3个小瓶重复该过程（每位患者5个小瓶）。从“空”小瓶复溶后开始对患者进行注射，以确定神经调节活性。拍摄治疗前和治疗后患者最大收缩时的照片。
在所有5名患者中均观察到最大皱眉明显减少。
INCO复溶不当，或在注射生理盐水后旋转小瓶但未倒置，可能会在临床环境中导致神经毒素单位的显著损失。
