Barbosa Pedro Melo, Rodrigues Guilherme Ricciopo, de Oliveira Daniel Sabino, de Souza Carolina Pinto, Tumas Vitor
From the Department of Neuroscience and Behavioral Sciences, Ribeirão Preto School of Medicine, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.
Clin Neuropharmacol. 2015 Nov-Dec;38(6):221-6. doi: 10.1097/WNF.0000000000000107.
Cervical dystonia is the most frequent type of primary focal dystonia and treatment with botulinum toxin (BTX) is currently the criterion standard.
In this study, we compared the safety and efficacy of the following 2 formulations of BTXs available in Brazil: abobotulinumtoxin A (Dysport) and Lanzhou BTX type A (Prosigne), during a follow-up of 13 months.
We conducted a prospective, randomized, double blind trial with 1 group being treated with Dysport and the other with Prosigne.
Fourteen patients were randomized to receive Dysport and 20 patients to receive Prosigne, each patient was followed during 13 months and received 5 injections of BTX in this period. The dose equivalency used was 3 U of Dysport for 1 U of Prosigne. After each treatment session, we assessed improvement with the Clinician Interview-Based Impression of Change scale and asked about adverse effects and duration of improvement. We also used the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) before and after the first and fifth treatment sessions. After the first injection, mean TWSTRS values reduced 12.78 points in the Dysport group and 9.98 in the Prosigne group (P = 0.38). After the last injection, the reduction in TWSTRS values was 11.87 points for Dysport and 11.35 points for Prosigne (P = 0.86).
Our data showed similar efficacy and safety profiles when comparing both toxins in the treatment of cervical dystonia.
颈部肌张力障碍是最常见的原发性局灶性肌张力障碍类型，肉毒杆菌毒素（BTX）治疗目前是标准疗法。
在本研究中，我们比较了巴西现有的以下两种肉毒杆菌毒素制剂：a型肉毒杆菌毒素（保妥适）和兰州a型肉毒杆菌毒素（衡力）在13个月随访期内的安全性和有效性。
我们进行了一项前瞻性、随机、双盲试验，一组接受保妥适治疗，另一组接受衡力治疗。
14例患者被随机分配接受保妥适治疗，20例患者接受衡力治疗，每位患者随访13个月，在此期间接受5次肉毒杆菌毒素注射。使用的剂量等效性为1单位衡力相当于3单位保妥适。每次治疗后，我们用基于临床医生访谈的变化印象量表评估改善情况，并询问不良反应和改善持续时间。我们还在第一次和第五次治疗前后使用了多伦多西部痉挛性斜颈评定量表（TWSTRS）。第一次注射后，保妥适组TWSTRS平均分值降低12.78分，衡力组降低9.98分（P = 0.38）。最后一次注射后，保妥适组TWSTRS分值降低11.87分，衡力组降低11.35分（P = 0.86）。
我们的数据显示，在治疗颈部肌张力障碍时，比较两种毒素的疗效和安全性相似。
