Quagliato Elizabeth Maria Aparecida Barasnevicius, Carelli Edmur Franco, Viana Maura Aparecida
Neurology Department, Faculdade de Ciências Médicas da Universidade Estadual de Campinas, São Paulo, Brazil.
Clin Neuropharmacol. 2010 Jan-Feb;33(1):27-31. doi: 10.1097/WNF.0b013e3181c46f61.
Botulinum toxin A (BTA) is considered an effective treatment of blepharospasm and hemifacial spasm, but there are few studies to permit a comparison of its different formulations. This prospective, randomized, double-blind study compared Prosigne, a BTA of Chinese origin, with Botox to establish safety, efficacy, and equivalence of doses between those 2 formulations in blepharospasm and hemifacial spasm treatment. Fifty-seven patients participated in this study: 21 blepharospasm (from whom 11 were treated with Botox; and 10, with Prosigne) and 36 hemifacial spasm patients (17 were treated with Botox; and 19, with Prosigne). All patients were similar in age, disease time span, number of previous shots, and time elapsed since the last BTA application. Pain and burning during the injection and the result of the treatment were similar in both groups. There were no systemic adverse events, and the local ones were observed with similar intensity and frequency for both groups. The mean effect time length was similar for both blepharospasm (11.3 weeks for both toxins) and hemifacial spasm patients (12.8 weeks for Botox and 12.9 weeks for Prosigne). In both blepharospasm groups, only the 36-Item Short-Form Health Survey emotional aspects domain showed improvement from baseline after 16 weeks. There were no differences between the 36-Item Short-Form Health Survey scores before and after the treatment of all hemifacial spasm patients. Therefore, it has been concluded that Botox and Prosigne have similar efficacy, safety, and tolerability profiles, so that a dose equivalence of 1:1 may be considered for blepharospasm and hemifacial spasm treatments.
A型肉毒杆菌毒素（BTA）被认为是治疗睑痉挛和半面痉挛的有效方法，但很少有研究对其不同制剂进行比较。这项前瞻性、随机、双盲研究将中国产的BTA制剂“保妥适”（Prosigne）与“保妥适”（Botox）进行比较，以确定这两种制剂在治疗睑痉挛和半面痉挛时的安全性、有效性及剂量等效性。57名患者参与了本研究：21名睑痉挛患者（其中11名接受Botox治疗，10名接受Prosigne治疗）和36名半面痉挛患者（17名接受Botox治疗，19名接受Prosigne治疗）。所有患者在年龄、病程、既往注射次数以及上次应用BTA后的时间间隔方面均相似。两组患者注射期间的疼痛和烧灼感以及治疗结果相似。两组均未出现全身性不良事件，局部不良事件的发生强度和频率相似。睑痉挛患者（两种毒素的平均作用时长均为11.3周）和半面痉挛患者（Botox为12.8周，Prosigne为12.9周）的平均作用时长相似。在两个睑痉挛组中，仅36项简明健康调查问卷的情感方面领域在16周后较基线有所改善。所有半面痉挛患者治疗前后的36项简明健康调查问卷评分无差异。因此，得出结论：Botox和Prosigne具有相似的疗效、安全性和耐受性，因此在治疗睑痉挛和半面痉挛时可考虑1:1的剂量等效性。
