PURPOSE: To investigate the long-term effectiveness and safety of botulinumneurotoxin 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 escalationindex percentage' (BEI-%), in the dose-escalation evaluation. METHODS: Allpatients in this multicentre study were followed for at least 10 years and mainoutcomes were clinical efficacy, duration of relief, BEI-U and BEI-%, andfrequency of adverse events. RESULTS: BEB, HFS, and EN patients received a meanBoNT-A dose with a significant inter-group difference (P<0.0005, respectively).The mean (+/-SD) effect duration was statistically different (P=0.009) amongthree 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-% wassignificantly increased in younger compared with older patients (P=0.008). Themost frequent adverse events were upper lid ptosis, diplopia, ecchymosis, andlocalized bruising. CONCLUSIONS: This long-term multicentre study supports a highefficacy and good safety profile of BoNT-A for treatment of BEB, HFS, and EN. TheBEI indexes indicate a significantly greater BoNT-A-dose escalation for BEBpatients compared with HFS or EN patients and a significantly greater BEI-% inyounger vsolder BEB patients. These results confirm a greater efficacy in theelderly and provide a framework for long-term studies with a more flexible andreliable evaluation of drug-dose escalation.
|Number of pages||8|
|Publication status||Published - 2010|
All Science Journal Classification (ASJC) codes
- Sensory Systems