Szczypior Michał, Połom Wojciech, Markuszewski Marcin, Ciura Krzesimir, Buszewska-Forajta Magdalena, Jacyna Julia, Markuszewski Michał, Matuszewski Marcin
a Department of Urology , Medical University of Gdansk , Gdansk , Poland.
b Department of Physical Chemistry , Medical University of Gdansk , Gdansk , Poland.
Scand J Urol. 2017 Dec;51(6):474-478. doi: 10.1080/21681805.2017.1362467. Epub 2017 Aug 17.
The aim of this study was to test the addition of methylene blue (MB) to onabotulinum toxin A (BTX-A) solution in overactive bladder (OAB) treatment, as a means of facilitating observation of the injection site and assessing the distribution of the drug under the bladder mucosa during injection. Pharmacological interactions between BTX-A and MB were also evaluated.
The study was conducted between December 2014 and April 2016 on 30 patients: six males and 24 females (median age 57.7, range 23-80 years) diagnosed with OAB, who qualified for intravesical BTX-A injection. Each received 100 IU of BTX-A (Botox; Allergan), dissolved in 9.5 ml of 0.9% NaCl with the addition of 0.5 ml of MB. Cystoscopy with submucosal injection of the solution was performed systematically, including the bladder triangle. For pharmacological evaluation, quantitative determination of MB was performed on a capillary electrophoresis system with diode array detection.
In the course of 600 injections, the addition of MB facilitated the observation of the procedure; the exact distribution of the solution could not be observed in only 43 injections in seven patients. The range of distribution of the drug varied from 1 to 2.5 cm. Pharmacological evaluation based on visual observations and experiments showed that pharmaceutical interactions do not occur between MB and this commercially available formulation of BTX-A.
Applying a coloured solution of BTX-A significantly facilitates observation of the procedure and assessment of drug distribution. There are no pharmaceutical interactions between MB and BTX-A.
本研究旨在测试在膀胱过度活动症（OAB）治疗中，向A型肉毒毒素（BTX-A）溶液中添加亚甲蓝（MB），作为一种便于观察注射部位并评估注射过程中药物在膀胱黏膜下分布的方法。同时还评估了BTX-A与MB之间的药理相互作用。
该研究于2014年12月至2016年4月对30例患者进行：6例男性和24例女性（中位年龄57.7岁，范围23 - 80岁），均被诊断为OAB，符合膀胱内注射BTX-A的条件。每位患者接受100 IU的BTX-A（保妥适；艾尔建公司），溶解于9.5 ml的0.9%氯化钠溶液中，并添加0.5 ml的MB。系统地进行了膀胱镜下黏膜下注射该溶液的操作，包括膀胱三角区。为进行药理评估，使用带二极管阵列检测的毛细管电泳系统对MB进行定量测定。
在600次注射过程中，添加MB便于观察操作过程；仅7例患者的43次注射中无法观察到溶液的确切分布情况。药物分布范围为1至2.5 cm。基于视觉观察和实验的药理评估表明，MB与这种市售的BTX-A制剂之间不存在药物相互作用。
应用有色的BTX-A溶液可显著便于观察操作过程及评估药物分布。MB与BTX-A之间不存在药物相互作用。
