Long-term efficacy of botulinum toxin A for treatment of blepharospasm,hemifacial spasm, and spastic entropion: a multicentre study using two drug-dose escalation indexes

PURPOSE: To investigate the long-term effectiveness and safety of botulinum neurotoxin A (BoNT-A) treatment in patients with blepharospasm (BEB), hemifacial spasm (HFS), and entropion (EN) and to use for the first time two modified indexes, 'botulin toxin escalation index-U' (BEI-U) and 'botulin toxin escalation index percentage' (BEI-%), in the dose-escalation evaluation. METHODS: All patients in this multicentre study were followed for at least 10 years and main outcomes were clinical efficacy, duration of relief, BEI-U and BEI-%, and frequency of adverse events. RESULTS: BEB, HFS, and EN patients received a mean BoNT-A dose with a significant inter-group difference (P<0.0005, respectively). The mean (+/-SD) effect duration was statistically different (P=0.009) among three patient groups. Regarding the BoNT-A escalation indexes, the mean (+/-SD) values of BEI-U and BEI-% were statistically different (P=0.035 and 0.047, respectively) among the three groups. In BEB patients, the BEI-% was significantly increased in younger compared with older patients (P=0.008). The most frequent adverse events were upper lid ptosis, diplopia, ecchymosis, and localized bruising. CONCLUSIONS: This long-term multicentre study supports a high efficacy and good safety profile of BoNT-A for treatment of BEB, HFS, and EN. The BEI indexes indicate a significantly greater BoNT-A-dose escalation for BEB patients compared with HFS or EN patients and a significantly greater BEI-% in younger vsolder BEB patients. These results confirm a greater efficacy in the elderly and provide a framework for long-term studies with a more flexible and reliable evaluation of drug-dose escalation

Botulinum toxin type A in the treatment of hemifacial spasm: an 11-year experience Toxina botulínica tipo A no tratamento do espasmo hemifacial: 11 anos de experiência

In order to evaluate the long-term effect of botulinum toxin type A (BTX) in the treatment of hemifacial spasm (HFS), a retrospective analysis of patients treated at the Movement Disorders Unit of the Division of Neurology, Clinical Hospital, University of São Paulo, School of Medicine from 1993 to 2004 was made. A total of 808 injections with BTX were administered to 54 patients with HFS. The mean duration of improvement per application was 3.46 months and the mean rate of improvement using subjective judgement by the patient was of 83%. Adverse effects, mostly minor, were observed in 64.8% of patients at least once along the period of follow-up and the most frequent of them was orbicularis oris paralysis (38.8%). There was no decrement in response when compared the first and the last injection recorded.<br>Para avaliar o efeito em longo prazo da toxina botulínica tipo A (TXB) no tratamento do espasmo hemifacial (EHF), foi feita uma análise retrospectiva de pacientes tratados no Ambulatório de Distúrbios do Movimento da Divisão de Clínica Neurológica - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo no período de 1993 a 2004. Um total de 808 aplicações de TXB foram administradas a 54 pacientes com EHF. A duração média de melhora foi de 3,46 meses e a taxa média de melhora segundo avaliação subjetiva do paciente foi de 83%. Efeitos adversos, em sua maioria menores, foram observados em 64,8% dos pacientes ao menos uma vez durante o seguimento e o mais freqüente foi paralisia do orbicular da boca (38,3%). Não se observou decremento na resposta quando se comparou a primeira com a última aplicação anotada