Oh Hyun-Mi, Park Joo Hyun, Song Dae Heon, Chung Myung Eun
Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea.
Department of Rehabilitation Medicine, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Wangsan-ro 180, Dongdaemoon-Gu, Seoul 02559, Korea.
Toxins (Basel). 2015 Dec 24;8(1):4. doi: 10.3390/toxins8010004.
MT10107 is botulinum neurotoxin type A derived drug which utilizes the 150 kDa portion without complexing proteins and human serum albumin contents. To evaluate the efficacy and the safety of MT10107, it was compared with onabotulinumtoxinA in this double-blind, randomized controlled trial. Twenty-five healthy males received a randomly selected dose of MT10107 into the extensor digitorum brevis (EDB) muscle of one foot, and an equivalent dose of onabotulinumtoxinA (BOTOX) was injected into the contralateral EDB muscle. While efficacy of the administered substance was determined by measuring paretic effects on the EDB, the local spread of toxin effects was evaluated by the paretic effects on the nearby abductor hallucis (AH) and abductor digiti quinti (ADQ) muscles. Paretic effects were defined as the percentage of reduction of the compound muscle action potential (CMAP) amplitudes, measured at 14, 30, 90 days after the injection, compared to the baseline value. Intergroup (MT10107 and onabotulinumtoxinA) differences were not significant in the percentage reduction of the amplitudes in the EDB muscles. In this study, there was no significant difference in efficacy and safety between the two test drugs. MT10107 may be effective and safe as much as onabotulinumtoxinA to produce the desired paretic effect.
MT10107是一种A型肉毒杆菌神经毒素衍生药物，它利用的是150 kDa的部分，且不含复合蛋白和人血清白蛋白成分。为评估MT10107的疗效和安全性，在这项双盲、随机对照试验中，将其与A型肉毒毒素进行了比较。25名健康男性在一只脚的趾短伸肌（EDB）中随机接受选定剂量的MT10107，并在对侧EDB肌肉中注射等量的A型肉毒毒素（保妥适）。通过测量对EDB的麻痹效应来确定所给药物质的疗效，通过对附近拇展肌（AH）和小指展肌（ADQ）的麻痹效应来评估毒素效应的局部扩散。麻痹效应定义为注射后14天、30天、90天测量的复合肌肉动作电位（CMAP）振幅相对于基线值降低的百分比。两组（MT10107和A型肉毒毒素）在EDB肌肉中振幅降低百分比方面的差异不显著。在本研究中，两种受试药物在疗效和安全性方面没有显著差异。MT10107在产生所需麻痹效应方面可能与A型肉毒毒素一样有效和安全。
