title: Safety and efficacy of intrathecal baclofen infusion by implantable pump for the treatment of severe spinal spasticity: a spanish multicenter study.
abstract: Objective. To assess long-term efficacy, safety and functional benefit of intrathecal baclofen for severe spinal spasticity. Materials and Methods. This prospective multicenter study was performed in two stages: the first one consisted of an intrathecal bolus injection of baclofen, and the second of a continuous intrathecal baclofen infusion by means of an implantable pump. The sample consisted of 72 adult patients with severe spinal spasticity. Sixty-four were implanted and followed for 36 months. Muscular tone, spasms, and functional scales were evaluated before and periodically after administration of the drug, with a follow-up period of 36 months. Results. A very significant decrease in tone and spasms was observed in all cases (p < 0.001). Tolerance appeared during the first 12 months, increasing doses from a mean initial dose of 83.2 μg (range 25-200 μg) to a mean final dose of 270 μg (range 25-800 μg). Later on, efficacy remained stable, except in cases of mechanical problems of the infusion system.
authors.affiliation: Instituto Guttman, Barcelona; Hospital Universitario La Fe, Valencia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Vidal
authors.forename: P
authors.initials: P
authors.lastname: Fenollosa
authors.forename: E
authors.initials: E
authors.lastname: Martin
authors.forename: J
authors.initials: J
authors.lastname: Barberá
authors.forename: F J
authors.initials: FJ
authors.lastname: Robaina
authors.forename: M
authors.initials: M
authors.lastname: Fuentes
authors.forename: M
authors.initials: M
authors.lastname: Rodriguez Palmero
authors.forename: C
authors.initials: C
authors.lastname: Aréchaga
authors.forename: M L
authors.initials: ML
authors.lastname: Franco
authors.forename: E
authors.initials: E
authors.lastname: Rodriguez Del Barrio