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1.
BMJ Case Rep ; 14(1)2021 Jan 11.
Artículo en Inglés | MEDLINE | ID: mdl-33431538

RESUMEN

Stiff-Person syndrome (SPS) is a rare autoimmune neurological disorder characterised by episodic painful muscle rigidity and violent spasms. A significant trigger for the painful spasms experienced by patients is pain itself, making optimal pain management and avoidance a necessity. While first-line and second-line therapies for spasm prevention and termination are known, there is a paucity of evidence to guide pain management. We report the case of a 26-year-old woman with SPS referred for excruciating muscle cramping and rigidity with pain lasting beyond the episodes themselves. We report the novel use of ketamine and intravenous magnesium sulfate which may provide analgesia, spasm avoidance and early termination of exacerbations in SPS.


Asunto(s)
Espasticidad Muscular/tratamiento farmacológico , Manejo del Dolor/métodos , Dolor Intratable/tratamiento farmacológico , Síndrome de la Persona Rígida/complicaciones , Adulto , Analgesia Controlada por el Paciente/métodos , Analgésicos/administración & dosificación , Anticonvulsivantes/administración & dosificación , Femenino , Humanos , Sulfato de Magnesio/administración & dosificación , Relajantes Musculares Centrales/administración & dosificación , Espasticidad Muscular/diagnóstico , Espasticidad Muscular/etiología , Espasticidad Muscular/rehabilitación , Dimensión del Dolor , Dolor Intratable/diagnóstico , Dolor Intratable/etiología , Dolor Intratable/rehabilitación , Índice de Severidad de la Enfermedad , Síndrome de la Persona Rígida/diagnóstico
2.
Brasília; CONITEC; nov. 2020.
No convencional en Portugués | BRISA/RedTESA | ID: biblio-1145537

RESUMEN

INTRODUÇÃO: Esclerose múltipla (EM) é uma doença neurológica crônica, inflamatória, que ocorre em pessoas geneticamente suscetíveis. A doença é caracterizada por infiltração de células imunes, perda de mielina e axônios e formação de placas multifocais no cérebro e medula espinhal. A prevalência média global da EM é de 33 por 100.000 pessoas, com variação entre os diferentes países. As taxas de prevalência no Brasil variaram de 1,36/100.000 a 27,2/100.000 habitantes dependendo da região. A espasticidade, percebida pelos pacientes como rigidez e espasmos musculares, é um sintoma comum na EM e está associado ao comprometimento funcional que pode exacerbar outros sintomas e reduzir a qualidade de vida. A espasticidade ocorre entre 60 a 84% dos pacientes, sendo os sintomas mais comuns associados: rigidez, espasmos e restrições de mobilidade, que ocorrem em cerca de três quartos dos pacientes, avaliados pelos médicos. Outros sintomas comuns incluem fadiga, dor e disfunção da bexiga. O tratamento não farmacológico geralmente inclui evitar fatores desencadeantes e fisioterapia regular. No Sistema Único de Saúde (SUS) está disponível para tratamento da espasticidade, de acordo com o Protocolo Clínico e Diretrizes Terapêuticas de Espasticidade, duas apresentações de toxina botulínica tipo A. A literatura descreve outros tratamentos como baclofeno, tizanidina e gabapentina. PERGUNTA: Tetraidrocanabinol + canabidiol (Mevatyl®) é eficaz e seguro para o tratamento da espasticidade moderada à grave associada à EM em pacientes adultos? EVIDÊNCIAS CLÍNICAS: Após a análise das evidências apresentadas pelo demandante foram incluídos sete ensaios clínicos, uma análise derivada de ensaio clínico e uma revisão sistemática. O demandante apresentou uma meta-análise, no entanto, como alguns estudos permitiram doses superiores a 12 sprays/dia, mesmo que a dose média dos estudos tenha sido menor que a estabelecida em bula, a Secretaria Executiva da Conitec optou por refazer as análises separando estes estudos. Em todas as avaliações, o THC:CBD foi associado a uma melhora média maior da espasticidade quando avaliada pela escala de Ashworth em comparação com o placebo, mão não foi estatisticamente significativo. Quando avaliada pela escala subjetiva foi associado a uma melhora significativa. Adicionalmente, o THC:CBD proporcionou uma redução significativa de ≥ 30% no escore de espasticidade avaliada pela escala NRS, considerada uma diferença clinicamente importante. A evidência foi considerada de baixa qualidade. AVALIAÇÃO ECONÔMICA: Com o preço proposto para incorporação de R$ 1.445,24, o custo mensal de THC:CBD como adjuvante a terapia padrão seria de R$ 1.597,36. Foi estimado um ganho de 0,55 anos de vida ajustados pela qualidade a mais com o tratamento com THC:CBD comparado ao tratamento padrão isolado, e 1,98 meses de controle da doença a mais que a terapia padrão. O custo incremental do tratamento com THC:CBD ao longo de 30 anos foi estimado em R$ 11.724,82 a mais que o custo do tratamento padrão, resultando em uma RCEI de R$21.271,79/QALY. O custo incremental por mês de controle da doença foi de R$ 5.438,76, resultando em uma RCEI de R$2.743,29/mês de espasticidade controlada. Há incertezas no desfecho por QALY pois a na estimativa da utilidade não incluiu população brasileira. ANÁLISE DE IMPACTO ORÇAMENTÁRIO: O demandante estimou que entre 823 a 859 pacientes seriam elegíveis e teriam acesso ao medicamento em cinco anos, com impacto orçamentário ao SUS estimado entre R$ 1,3 milhões, chegando a R$ 9,1 milhões no último ano dependendo da difusão de mercado adotada (Caso-base: 10% ao ano e Caso-alternativo: primeiro ano de 25%, com crescimento de 10% ao ano até 65% em 5 anos). Entretanto, foram identificadas algumas discrepâncias na população do modelo apresentado pelo demandante, com a população passando para 918 no primeiro ano a 958 no quinto ano. O impacto orçamentário utilizando a distribuição de mercado do caso-base, no primeiro ano seria de R$ 1,49 milhão, chegando a R$ 7,8 milhões em cinco anos. Já para o cenário do caso alternativo, no primeiro ano o impacto seria de 3,7 milhões e no quinto ano, com 65% dos pacientes recebendo o tratamento, 10,14 milhões. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Para a elaboração desta seção, realizaram-se buscas estruturadas nos campos de pesquisa das bases de dados ClinicalTrials.gov e Cortellis™, a fim de localizar medicamentos potenciais para tratamento sintomático da espasticidade moderada a grave relacionada à esclerose múltipla. Dessa forma, foram detectados dois medicamentos potenciais para a indicação terapêutica em questão, o arbaclofeno e o dronabinol. CONSIDERAÇÕES FINAIS: O THC:CBD proporciona uma diminuição da espasticidade subjetiva quando comparados com placebo, mas não apresentou nenhuma alteração na espasticidade medida objetivamente (escalas de Ashworth e Ashworth modificada). Embora o número total de eventos adversos seja maior que o placebo, o medicamento foi seguro no tratamento da espasticidade em pacientes com EM. As evidências foram consideradas de baixa qualidade. Não há evidências de estudos que avaliem a eficácia de canabinoides em comparação com outros tratamentos ativos. RECOMENDAÇÃO PRELIMINAR DA CONITEC: No dia 06 de agosto de 2020, em sua 89ª reunião de plenário, os membros da Conitec recomendaram preliminarmente a não incorporação da associação tetraidrocanabinol + canabidiol como tratamento adjuvante para melhoria dos sintomas de pacientes adultos com espasticidade moderada a grave devido à esclerose múltipla que não responderam adequadamente a outra terapia. O plenário considerou que o medicamento só apresentou benefício quando avaliado por escala subjetiva e a ausência de eficácia do fitofármaco na redução da espasticidade por escala objetiva comparado ao placebo, além disso os estudos apresentaram médio a alto risco de viés, o que tornou a evidência de baixa qualidade. A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: o Relatório de Recomendação da Conitec foi disponibilizado por meio da Consulta Pública nº 04/2020 entre os dias 15/09/2020 e 05/10/2020. Foram recebidas 306 contribuições, sendo 4 técnico-científicas e 302 contribuições de experiência ou opinião. Os principais temas presentes nas contribuições de experiência e opinião foram referentes a: eficácia; qualidade de vida; melhora da dor e segurança do tratamento. Foram recebidas referências estudos científicos, no entanto não foram consideradas no presente documento por não se enquadrarem na pergunta PICO. A Beaufour Ipsen Ltda - empresa fabricante da tecnologia avaliada reforçou os dados de eficácia do THC:CBD na redução da gravidade da espasticidade relacionada à EM e sintomas associados, como espasmos ou distúrbios do sono. Também abordaram a validade da escala NRS, por se tratar de muitas vezes ser desfecho primário dos estudos clínicos, incluindo ensaios controlados e de vida real e se tratar de um desfecho centrado no paciente com relevância clínica. Com relação a parte econômica, o demandante retrata que realizou vários cenários na avaliação de custo-efetividade: 1) inclusão de probabilidade e de custos relacionados a eventos adversos; 2) utilização do desfecho clínico NRS ≥ 30% (diferença clinicamente importante); 3) sub análise considerando o fornecimento gratuito de Mevatyl® no primeiro mês de tratamento; 5) comparador baclofeno, tizanidina e diazepam. No entanto, de modo geral, os resultados sofreram poucas alterações em relação àquelas apresentadas no documento de submissão. RECOMENDAÇÃO FINAL DA CONITEC: Os membros da Conitec presentes na 92ª reunião ordinária, no dia 03 de novembro de 2020, deliberaram por unanimidade recomendar a não incorporação tetraidrocanabinol (THC) 27 mg/ml + canabidiol (CBD) 25 mg/ml como tratamento adjuvante para melhoria dos sintomas de pacientes adultos com espasticidade moderada a grave devido à esclerose múltipla que não responderam adequadamente a outra terapia. Os membros presentes na reunião consideraram que não houve evidências adicionais para mudar a recomendação preliminar e que ainda há incertezas sobre a eficácia do fitofármaco. Também foi pontuado que existem outros tratamentos para espasticidade, assim há uma necessidade de avaliação ampla dessas tecnologias. Foi assinado o Registro de Deliberação nº 572/2020. DECISÃO: Não incorporar o tetraidrocanabinol 27mg/ml + canabidiol 25mg/ml para o tratamento sintomático da espasticidade moderada a grave relacionada à esclerose múltipla, no âmbito do Sistema Único de Saúde - SUS, conforme Portaria nº 59, publicada no Diário Oficial da União nº 228, seção 1, página 717, em 1º de dezembro de 2020.


Asunto(s)
Humanos , Dronabinol/uso terapéutico , Cannabidiol/uso terapéutico , Esclerosis Múltiple/etiología , Espasticidad Muscular/tratamiento farmacológico , Evaluación de la Tecnología Biomédica , Sistema Único de Salud , Brasil , Análisis Costo-Beneficio/economía
3.
Toxicon ; 188: 48-54, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33045238

RESUMEN

Our objective was to systematically review literature regarding the rationale and current evidence for peri-operative Botulinum Neurotoxin (BoNT) injection to improve outcomes of surgeries on spastic limbs. We conducted a systematic search of databases MEDLINE, EMBASE, and Cochrane Central Register of Controlled until March 2020, using the PRISMA guidelines. After assessing all titles and abstracts against inclusion criteria, full texts were reviewed for studies of potential interest. The inclusion criteria were studies on humans with any study design, published in all languages. Participants had to have underlying limb spasticity and be scheduled to undergo surgery on one or more spastic limb(s). BoNT had to be administered peri-operatively to improve surgical outcomes and not solely for the purpose of alleviating spasticity. The risk of bias was evaluated using the Physiotherapy Evidence Database (PEDro) scoring system for randomized controlled trials (RCTs) and the Downs and Black tool for RCTs and non-randomized trials. Further, the level of evidence was evaluated using a five-level scale (simplified form of Sackett). Five studies met our inclusion criteria comprising a total of 90 participants, of both pediatric and adult age groups, with underlying limb spasticity, who received BoNT perioperatively to improve outcomes of the surgeries performed on spastic limbs. Interventions were intramuscular BoNT injection prior to, at the time of, or after surgery on a spastic limb for the purpose of improving surgical outcomes, and not solely for alleviating muscle spasticity. Outcome measures were surgical success/failure, post-operative pain and analgesic use, sleep quality, adverse events, spasticity control e.g. Modified Ashworth Scale. Our literature search yielded 5 articles that met the inclusion criteria. Current evidence supports peri-operative injection of BoNT to improve outcomes of surgeries performed on spastic limbs. There is level 1 evidence that BoNT administered pre-operatively is effective for reducing pain, spasticity, and analgesic use in pediatric patients with cerebral palsy (CP). This is supported by level 4 evidence from a retrospective case series. Level 5 evidence from case reports highlights the potential for the use of BONT in the peri-operative period. There is level 1 evidence that BoNT administered intra-operatively is not effective for reducing pain and analgesic use in pediatric patients with CP. This lack of benefit may reflect sub-optimal timing of injections, different methods of injection, different timing of the primary outcome measure, and/or differences in adjunctive therapies, but further research is required.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Espasticidad Muscular/cirugía , Toxinas Botulínicas Tipo A/administración & dosificación , Parálisis Cerebral/tratamiento farmacológico , Humanos , Inyecciones Intramusculares , Espasticidad Muscular/tratamiento farmacológico , Fármacos Neuromusculares/uso terapéutico
4.
J Stroke Cerebrovasc Dis ; 29(10): 105160, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32912522

RESUMEN

BACKGROUND AND PURPOSE: Botulinum toxin (BoNT) is a commonly used agent in the treatment of stroke-related spasticity. Sleep disorders can often be seen as a comorbidity or complication in stroke patients. Based on the data that spasticity is associated with sleep disorders, in this study, we aimed to evaluate whether sleep quality has changed in patients with stroke treated with BoNT. METHODS: Thirty five (17 female / 18 male) stroke patients with gastrocnemius and / or soleus spasticity were included in this observational cross-sectional study. In clinical evaluation before and three months after BoNT injection; for spasticity evaluation modified Ashworth scale (MAS), pain assessment visual analog scale (VAS), functional evaluation; passive joint range of motion (ROM) measurement, functional independence measurement (FIM), lower limb Brunstrom staging, life quality assessment short form-36 (SF-36) quality of life scale, and sleep quality assessment Pittsburgh sleep quality index (PSQI) scales were used. RESULTS: After the BoNT injection, there was a statistically significant decrease in MAS and VAS scores, a significant increase in passive ROM measurements, FIM, lower limb Brunstrom staging, and SF-36 physical function sub parameter. There was also a significant decrease in PSQI scores. Before and after treatment, there was no correlation found between PSQI values with pain and spasticity. However, there was a weak negative correlation between post-treatment PSQI values, passive ROM, SF-36 physical function and SF-36 physical role sub parameters (respectively: r: -0.335 p: 0.049, r: -0.364, 0.032, r: -0.404, p: 0.016). Conlusion: The results of our study suggest that BoNT, which is frequently used in the treatment of spasticity in stroke patients, has positive effects on sleep quality.


Asunto(s)
Inhibidores de la Liberación de Acetilcolina/uso terapéutico , Toxinas Botulínicas/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Músculo Esquelético/efectos de los fármacos , Trastornos del Sueño-Vigilia/prevención & control , Sueño , Accidente Cerebrovascular/fisiopatología , Inhibidores de la Liberación de Acetilcolina/efectos adversos , Adulto , Anciano , Toxinas Botulínicas/efectos adversos , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Espasticidad Muscular/etiología , Espasticidad Muscular/fisiopatología , Músculo Esquelético/fisiopatología , Calidad de Vida , Trastornos del Sueño-Vigilia/etiología , Trastornos del Sueño-Vigilia/fisiopatología , Accidente Cerebrovascular/complicaciones , Resultado del Tratamiento
5.
Artículo en Ruso | MEDLINE | ID: mdl-32790979

RESUMEN

OBJECTIVE: A retrospective analysis of the experience of using Incobotulinum toxin A injections for the treatment of spasticity in children with cerebral palsy (CP). MATERIAL AND METHODS: One hundred and eighty-five children with spastic forms of CP, including 114 boys (61,6%), were studied. The average age of the patients was 3,8±2,5 years; the average weight was 14,2±6,9. The patients received injections of Incobotulinum toxin A according to registered indications or recommendations of a consultation of specialists and voluntary informed consent of the patient's representative. At least 1 point decrease of muscle tone according to the modified Ashworth scale was used as a criterion of the antispastic effect of Incobotulinum toxin A. RESULTS: The total dose of Incobotulinum toxin A for the whole group of patients with CP was 154,5±67,7 U and 11,6±4,7 U per kg/body weight. The gracilis muscle (65,4% of cases, 95%CI 58,1-72,2) and the gastrocnemius muscle (49,4% of cases, 95%CI 41,8-56,6) were the most frequently injected targets in the lower extremities, and the pronator teres muscle (58,9% of cases, 95%CI 51,5-66,1) - in the upper extremities. Adverse events were observed in 13 patients (7,0%). They were mild in 9 patients and moderate in 4 patients. CONCLUSION: Our data confirmed the effectiveness and safety of Incobotulinum toxin A injections in spastic CP. The calculated average doses of Incobotulinum toxin A for target muscles and the frequency of different spasticity patterns could serve as a reference for the botulinum therapy planning.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Parálisis Cerebral/tratamiento farmacológico , Fármacos Neuromusculares/uso terapéutico , Niño , Preescolar , Humanos , Inyecciones Intramusculares , Masculino , Espasticidad Muscular/tratamiento farmacológico , Estudios Retrospectivos , Resultado del Tratamiento
6.
NeuroRehabilitation ; 46(4): 519-528, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32508341

RESUMEN

BACKGROUND: Backward walking is recommended to improve the components of physiological gait in neurological disease. Botulinum toxin type A is an effective safe first line-treatment for post-stroke spasticity. OBJECTIVE: To compare the effects of backward treadmill training (BTT) versus standard forward treadmill training (FTT) on motor impairment in patients with chronic stroke receiving botulinum toxin type A therapy. METHODS: Eighteen chronic stroke patients were randomly assigned to receive BTT (n = 7) or FTT (n = 11) as adjunct to botulinum toxin type A therapy. A total of twelve 40-minute sessions (3 sessions/week for 4 weeks) of either BTT or FTT were conducted. A blinded assessor evaluated the patients before and after treatment. The primary outcome was the 10-meter Walking Test (10 MWT). Secondary outcomes were the modified Ashworth Scale, gait analysis, and stabilometric assessment. RESULTS: Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment. CONCLUSIONS: Greater improvement in gait and balance was noted after BTT than after FTT as an adjunct to botulinum toxin therapy in patients with chronic stroke.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Terapia por Ejercicio/métodos , Marcha , Fármacos Neuromusculares/uso terapéutico , Equilibrio Postural , Rehabilitación de Accidente Cerebrovascular/métodos , Adulto , Anciano , Toxinas Botulínicas Tipo A/administración & dosificación , Terapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Fármacos Neuromusculares/administración & dosificación , Método Simple Ciego , Accidente Cerebrovascular/complicaciones
7.
J Rehabil Med ; 52(6): jrm00076, 2020 Jun 30.
Artículo en Inglés | MEDLINE | ID: mdl-32556354

RESUMEN

OBJECTIVES: To investigate whether botulinum toxin type A (BTX-A) injection is more effective than radial extracorporeal shock wave therapy in reducing plantar flexor muscle spasticity in subjects with cerebral palsy. METHODS: A total of 68 subjects with cerebral palsy were randomly allocated to BTX-A injection (Group 1) or radial extracorporeal shock wave therapy (Group 2) (first experiment; E1). Outcome was evaluated using the Tardieu V1 and V3 stretches, at 3 weeks, 2 months (M2) and M3 after baseline. At M6 subjects in Group 1 received radial extracorporeal shock wave therapy and subjects in Group 2 received BTX-A injection (second experiment; E2); outcome was evaluated as in E1. Treatment success was defined as improvement in foot dorsiflexion ≥10° when performing the V3 stretch at M2 in both experiments. RESULTS: In both experiments mean V1 and V3 significantly improved over time. In E1 both treatments resulted in similar treatment success. In E2 fewer subjects treated with BTX-A injection reached the criteria of treatment success than did subjects treated with radial extracorporeal shock wave therapy, which was due to a carry-over effect from E1. No significant complications were observed. CONCLUSION: BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Parálisis Cerebral/tratamiento farmacológico , Tratamiento con Ondas de Choque Extracorpóreas/métodos , Espasticidad Muscular/tratamiento farmacológico , Adulto , Toxinas Botulínicas Tipo A/farmacología , Estudios Cruzados , Femenino , Humanos , Masculino , Resultado del Tratamiento
8.
Arch Phys Med Rehabil ; 101(9): 1485-1496, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32497599

RESUMEN

OBJECTIVE: To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DESIGN: Prospective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial. SETTING: Seven university hospitals in the Republic of Korea. PARTICIPANTS: Patients (N=220) with poststroke upper limb spasticity. INTERVENTIONS: All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group). MAIN OUTCOME MEASURES: The primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention. RESULTS: The primary outcome was found to be -1.32±0.69 and -1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures. CONCLUSIONS: MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Fármacos Neuromusculares/uso terapéutico , Accidente Cerebrovascular/complicaciones , Anciano , Toxinas Botulínicas Tipo A/efectos adversos , Evaluación de la Discapacidad , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares/efectos adversos , Estudios Prospectivos , República de Corea , Rehabilitación de Accidente Cerebrovascular/métodos , Extremidad Superior
9.
Rehabilitación (Madr., Ed. impr.) ; 54(2): 137-141, abr.-jun. 2020. tab, graf
Artículo en Español | IBECS | ID: ibc-196651

RESUMEN

Pacientes con daño cerebral y espasticidad son candidatos a terapia de baclofeno intratecal (ITB) cuando dosis máximas de antiespásticos orales no son efectivas. Algunos autores describen una mejora en el nivel de consciencia en pacientes con daño cerebral y alteraciones del nivel de consciencia. Presentamos el caso de una paciente de 43 años con daño cerebral, espasticidad y estado vegetativo persistente que presentó mejora del nivel de consciencia tras administrar ITB para el manejo de la espasticidad. Durante la prueba de infusión de baclofeno intratecal monitorizamos la espasticidad según la Escala modificada de Ashworth y el nivel de consciencia mediante Coma Recovery Scale-Revised. Tras observar mejoría en Escala modificada de Ashworth y en Coma Recovery Scale-Revised, decidimos implantar la bomba de ITB y la paciente emergió de estado vegetativo persistente a estado de mínima consciencia. Sugerimos el beneficio añadido de ITB sobre el nivel de consciencia en pacientes con daño cerebral, alteraciones del nivel de consciencia y espasticidad, no existiendo evidencia suficiente para prescribirlo en el tratamiento de alteraciones del nivel de consciencia


Patients with brain injury and spasticity are candidates for intrathecal baclofen therapy (ITB) when maximal doses of oral antispastic drugs fail. Some authors have described an improvement in the level of consciousness in patients with brain injury and disorder of consciousness treated with ITB for spasticity. We present the case of a 43-year-old patient with brain injury, spasticity, and permanent vegetative state (PVS) who showed an improvement in the level of consciousness after ITB for spasticity. We performed an ITB infusion test, assessing the spasticity with the Modified Ashworth Scale (MAS) and level of consciousness with the Coma Recovery Scale-Revised (CRS-R) and observed an improvement in the spasticity and the level of consciousness. Consequently, the ITB pump was implanted and the patient recovered from PVS to minimal conscious state (MCS). We conclude that ITB is indicated in patients with brain injury and spasticity. We suggest the improvement in the level of consciousness as a possible additional benefit. There is a lack of evidence to recommend ITB in patients with altered level of consciousness


Asunto(s)
Humanos , Femenino , Adulto , Cuadriplejía/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Baclofeno/uso terapéutico , Rehabilitación de Accidente Cerebrovascular/métodos , Accidente Cerebrovascular/tratamiento farmacológico , Estado Vegetativo Persistente/rehabilitación , Inyecciones Espinales/métodos , Trastornos de la Conciencia/tratamiento farmacológico , Bombas de Infusión Implantables , Resultado del Tratamiento
10.
J Rehabil Med ; 52(6): jrm00068, 2020 Jun 11.
Artículo en Inglés | MEDLINE | ID: mdl-32451555

RESUMEN

Botulinum toxins, such as abobotulinumtoxinA, are used to treat spasticity (muscle overactivity) in arm muscles. Spasticity in shoulder muscles occurs in many patients following a stroke. Shoulder spasticity can be painful and limit limb movement. This paper compares the results from patients who did and those who did not receive abobotulinumtoxinA injections in shoulder muscles (among other arm muscles) in 2 studies. In both studies, the results showed that more patients receiving treatment in shoulder muscles chose pain as a key goal for treatment and had reduced pain following treatment compared with patients not treated in the shoulder. In addition, patients receiving shoulder injections showed further improvement in arm movement compared with those not receiving shoulder injections. Overall, these results suggest that abobotulinumtoxinA treatment in shoulder muscles may improve outcomes for patients with arm spasticity involving the shoulder.


Asunto(s)
Inhibidores de la Liberación de Acetilcolina/uso terapéutico , Toxinas Botulínicas Tipo A/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Fármacos Neuromusculares/uso terapéutico , Hombro/anomalías , Inhibidores de la Liberación de Acetilcolina/farmacología , Adulto , Toxinas Botulínicas Tipo A/farmacología , Femenino , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares/farmacología , Resultado del Tratamiento
11.
World Neurosurg ; 139: e652-e657, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32339729

RESUMEN

BACKGROUND: Intrathecal baclofen (ITB) is an effective treatment for spasticity, and therapeutic levels may be optimized using surgically implanted pumps. Though these devices are effective, complications can pose significant challenges to patients, decreasing the therapeutic effect and potentially requiring reoperation. As such, it is critical that complications associated with ITB be effectively characterized. METHODS: We queried the Manufacturer and User Facility Device Experience (MAUDE) database for cases reported during the past 3 years documenting adverse events specifically related to ITB pumps. We identified 1935 adverse events that were individually analyzed and categorized by type of complication. RESULTS: Out of the 1935 unique adverse events identified from the MAUDE database, 25.7% were device-related complications (n = 497). Of those, 50.3% were catheter-specific (n = 250), 21.3% (n = 106) were pump-specific, and 28.3% (n = 141) were included, more generally, in catheter or device erosion. CONCLUSIONS: The MAUDE database may be a useful resource for evaluating ITB pump complications across a larger data set. By characterizing the complications and providing values for their total occurrences, patients and physicians may have more realistic expectations for the outcomes and morbidity of this device.


Asunto(s)
Baclofeno/administración & dosificación , Baclofeno/efectos adversos , Relajantes Musculares Centrales/administración & dosificación , Relajantes Musculares Centrales/efectos adversos , Baclofeno/uso terapéutico , Infecciones Relacionadas con Catéteres/epidemiología , Catéteres/efectos adversos , Bases de Datos Factuales , Falla de Equipo , Femenino , Migración de Cuerpo Extraño , Humanos , Bombas de Infusión Implantables , Inyecciones Espinales , Masculino , Relajantes Musculares Centrales/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Estudios Retrospectivos , Resultado del Tratamiento
12.
Clin Rehabil ; 34(6): 803-811, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32336148

RESUMEN

OBJECTIVE: The aim of this study is to evaluate a novel composite measure of active range of motion (XA) and determine whether this measure correlates with active function. DESIGN: Post hoc analysis of two randomized, placebo-controlled, double-blind studies with open-label extensions exploring changes in active function with abobotulinumtoxinA. SETTING: Tertiary rehabilitation centers in Australia, Europe, and the United States. SUBJECTS: Adults with upper (n = 254) or lower (n = 345) limb spastic paresis following stroke or brain trauma. INTERVENTIONS: AbobotulinumtoxinA (⩽5 treatment cycles) in the upper or lower limb. MAIN MEASURES: XA was used to calculate a novel composite measure (CXA), defined as the sum of XA against elbow, wrist, and extrinsic finger flexors (upper limb) or soleus and gastrocnemius muscles (lower limb). Active function was assessed by the Modified Frenchay Scale and 10-m comfortable barefoot walking speed in the upper limb and lower limb, respectively. Correlations between CXA and active function at Weeks 4 and 12 of open-label cycles were explored. RESULTS: CXA and active function were moderately correlated in the upper limb (P < 0.0001-0.0004, r = 0.476-0.636) and weakly correlated in the lower limb (P < 0.0001-0.0284, r = 0.186-0.285) at Weeks 4 and 12 of each open-label cycle. Changes in CXA and active function were weakly correlated only in the upper limb (Cycle 2 Week 12, P = 0.0160, r = 0.213; Cycle 3 Week 4, P = 0.0031, r = 0.296). Across cycles, CXA improvements peaked at Week 4, while functional improvements peaked at Week 12. CONCLUSION: CXA is a valid measure for functional impairments in spastic paresis. CXA improvements following abobotulinumtoxinA injection correlated with and preceded active functional improvements.


Asunto(s)
Extremidad Inferior/fisiopatología , Espasticidad Muscular/fisiopatología , Paresia/fisiopatología , Rango del Movimiento Articular/fisiología , Recuperación de la Función/fisiología , Extremidad Superior/fisiopatología , Inhibidores de la Liberación de Acetilcolina/uso terapéutico , Adulto , Anciano , Australia , Toxinas Botulínicas Tipo A/uso terapéutico , Lesiones Encefálicas/complicaciones , Lesiones Encefálicas/fisiopatología , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Espasticidad Muscular/complicaciones , Espasticidad Muscular/tratamiento farmacológico , Músculo Esquelético/fisiopatología , Evaluación de Resultado en la Atención de Salud , Paresia/complicaciones , Paresia/tratamiento farmacológico , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/fisiopatología , Resultado del Tratamiento , Velocidad al Caminar
13.
Neurology ; 94(20): e2109-e2120, 2020 05 19.
Artículo en Inglés | MEDLINE | ID: mdl-32332130

RESUMEN

OBJECTIVE: To investigate the risk factors of neutralizing antibody (NAB)-induced complete secondary treatment failure (cSTF) during long-term botulinum neurotoxin (BoNT) treatment in various neurologic indications. METHODS: This monocenter retrospective cohort study analyzed the data of 471 patients started on BoNT therapy between 1995 and 2015. Blood samples of 173 patients were investigated for NABs using the mouse hemidiaphragm test (93 with suspected therapy failure, 80 prospective study participants). The frequency of NAB-cSTF was assessed for various indications: hemifacial spasm, blepharospasm, cervical dystonia, other dystonia, and spasticity. A priori defined potential risk factors for NAB-cSTF were evaluated, and a stepwise binary logistic regression analysis was performed to identify independent risk factors. RESULTS: Treatment duration was 9.8 ± 6.2 years (range, 0.5-30 years; adherence, 70.6%) and number of treatment cycles 31.2 ± 22.5 (3-112). Twenty-eight of 471 patients (5.9%) had NAB-cSTF at earliest after 3 and at latest after 103 treatment cycles. None of the 49 patients treated exclusively with incobotulinumtoxinA over 8.4 ± 4.2 (1-14) years developed NAB-cSTF. Independent risk factors for NAB-cSTF were high BoNT dose per treatment, switching between onabotulinumtoxinA and other BoNT formulations (except for switching to incobotulinumtoxinA), and treatment of neck muscles. CONCLUSIONS: We present a follow-up study with the longest duration to date on the incidence of NAB-cSTF in patients treated with various BoNT formulations, including incobotulinumtoxinA. Whereas the overall risk of NAB-cSTF is low across indications and BoNT formulations, our findings underpin the recommendations to use the lowest possible dose particularly in cervical dystonia, and to avoid unnecessary switching between different formulations.


Asunto(s)
Toxinas Botulínicas Tipo A/efectos adversos , Trastornos Distónicos/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Animales , Blefaroespasmo/inducido químicamente , Blefaroespasmo/tratamiento farmacológico , Toxinas Botulínicas Tipo A/uso terapéutico , Trastornos Distónicos/inducido químicamente , Femenino , Estudios de Seguimiento , Humanos , Masculino , Ratones , Persona de Mediana Edad , Fármacos Neuromusculares/efectos adversos , Fármacos Neuromusculares/uso terapéutico , Factores de Riesgo , Tortícolis/inducido químicamente , Tortícolis/tratamiento farmacológico
14.
J Stroke Cerebrovasc Dis ; 29(6): 104682, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32305277

RESUMEN

BACKGROUND AND AIM: Botulinum toxin type A is considered to be an effective antispasmodic in recent years. We assess the effectiveness of botulinum toxin type A for the treatment of poststroke spasticity in the upper extremity using a meta-analysis. METHODS: We searched several databases including PubMed, Web of Science, Embase, and Cochrane database for relevant studies, up until October 2017. All randomized controlled trials of botulinum toxin type A treat poststroke upper limb spasticity published were included. The primary outcome measure was modified ashworth score at the elbow, finger and wrist, pain score, and barthel index. RESULTS: Ten randomized controlled trials were identified and reported sufficient data for inclusion in the pooled analysis (n = 950). The results of modified ashworth score at different joints, pain score, barthel index showed no difference was found in the effectiveness of botulinum toxin type A compared with placebo in the treatment of the upper limb spasticity after stroke. But modified ashworth score at the elbow was improver in Dysport subgroups (standardized mean difference [SMD] = -.39, 95%CI = -.67 to -.10, P = .008) compared with Botox subgroups (SMD = .08, 95%CI = -.68 to .83, P = .84). CONCLUSIONS: The meta-analysis of these studies showed that the overall effectiveness of botulinum toxin type A does not seem to differ from placebo for poststroke Patients. But the meta-analysis yielded a favorable effect of Dysport compared with placebo based on 4 trials.


Asunto(s)
Inhibidores de la Liberación de Acetilcolina/uso terapéutico , Toxinas Botulínicas Tipo A/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Músculo Esquelético/inervación , Parasimpatolíticos/uso terapéutico , Accidente Cerebrovascular/complicaciones , Inhibidores de la Liberación de Acetilcolina/efectos adversos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Toxinas Botulínicas Tipo A/efectos adversos , Evaluación de la Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Espasticidad Muscular/diagnóstico , Espasticidad Muscular/etiología , Espasticidad Muscular/fisiopatología , Parasimpatolíticos/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/fisiopatología , Resultado del Tratamiento , Extremidad Superior , Adulto Joven
16.
BMC Neurol ; 20(1): 126, 2020 Apr 08.
Artículo en Inglés | MEDLINE | ID: mdl-32268880

RESUMEN

BACKGROUND: IncobotulinumtoxinA (Xeomin®) is a botulinum neurotoxin type A with established efficacy in the treatment of upper-limb spasticity in adults. This retrospective case series in a university hospital setting aimed to elucidate the safety and tolerability of incobotulinumtoxinA for treatment of spasticity in children with cerebral palsy. METHODS: Participants received incobotulinumtoxinA injections up to a maximum total dose of 600 U, 24 U/kg body weight. Medical records were reviewed for key demographic information, incobotulinumtoxinA exposure, and adverse effects (AEs). RESULTS: Sixty-nine children were included (mean age [SD], 8.3 [3.9] years; 44/69 [63.8%] male). One-hundred-and-ninety-one injections were administered, with mean (SD) of 2.8 (1.5) treatment cycles/participant and dosing interval of 6.0 (1.7) months. The number of muscles injected increased from 2.4 (1.2) at cycle 1 to 4.2 (1.9) at cycle 6. The mean (SD) total incobotulinumtoxinA dose increased from 191.7 (126.2) U, (8.5 [5.4] U/kg body weight) at cycle 1 to 368.0 (170.1) U, (9.9 [5.5] U/kg body weight) at cycle 6. Seventy four adverse effects (37.5% of injections) were reported, the most frequent was injection pain (93.2% of AEs). Only three AEs were considered directly treatment-related by injectors: muscle weakness, generalized weakness, and fever. CONCLUSIONS: Our clinical experience indicates that incobotulinumtoxinA is a well-tolerated treatment option for focal spasticity in children with cerebral palsy. TRIAL REGISTRATION: As the study was observational and retrospective, no EudraCT registration number was requested. The internal code assigned to the study in the administrative resolution was: 1143-N-15.


Asunto(s)
Toxinas Botulínicas Tipo A/administración & dosificación , Parálisis Cerebral/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Fármacos Neuromusculares/uso terapéutico , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Debilidad Muscular/inducido químicamente , Estudios Retrospectivos , Resultado del Tratamiento
17.
BMJ Case Rep ; 13(3)2020 Mar 10.
Artículo en Inglés | MEDLINE | ID: mdl-32161077

RESUMEN

Severe hyperhomocysteinemia (>100 µmol/L) is often associated with inborn errors of homocysteine metabolism. It manifests typically in neonatal period with developmental delay, hypotonia, feeding problems or failure to thrive. Adult-onset forms are rare and include less severe manifestations. Early diagnosis is crucial because effective treatment is available. A 23-year-old man presented with a 3-week history of speech and gait impairment, and numbness in lower limbs. Neurological examination revealed dysarthria, decreased vibratory sensation in both legs and appendicular and gait ataxia. Brain MRI revealed T2-hyperintense symmetric white matter lesions and cortical atrophy. He had folate and vitamin B12 deficiency, a markedly elevated serum homocysteine and low methionine. Despite vitamin supplementation homocysteine levels remained elevated. Molecular studies of 5,10-methylenetetrahydrofolate reductase (MTHFR) gene revealed a new pathogenic mutation (c.1003C>T (p.Arg335Cys)) and a polymorphism (C677T (p.Ala222Val)) associated with hyperhomocysteinemia, both in homozygosity. The patient started betaine with clinical and biochemical improvement.


Asunto(s)
Homocistinuria/diagnóstico , Metilenotetrahidrofolato Reductasa (NADPH2)/deficiencia , Espasticidad Muscular/diagnóstico , Edad de Inicio , Betaína/uso terapéutico , Disartria/etiología , Ácido Fólico/uso terapéutico , Ataxia de la Marcha/etiología , Homocistinuria/tratamiento farmacológico , Humanos , Masculino , Espasticidad Muscular/tratamiento farmacológico , Trastornos Psicóticos/diagnóstico , Trastornos Psicóticos/tratamiento farmacológico , Temblor/etiología , Vitamina B 12/uso terapéutico , Adulto Joven
18.
Toxicon ; 177: 93-95, 2020 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-32217235

RESUMEN

INTRODUCTION: In patients taking warfarin, the level of anticoagulation status using the International Normalized Ratio (INR) is one consideration before botulinum toxin type-A (BoNTA) injections; however, there is wide diversity in physician approaches and preferences in using INR status and the INR cut-off values to determine suitability of anticoagulated patients for BoNTA injections. There is no standard approach for treating spasticity with BoNTA injections in patients who are on warfarin or direct anticoagulants (DOACs). OBJECTIVE: Our objective was to review the challenges in the use of BoNTA in patients who are receiving anticoagulants and to present highlights of the Canadian Delphi Study on the management of anticoagulated patients with limb spasticity. METHODS: We present a hypothetical case of a patient with focal spasticity who is also receiving anticoagulants. RESULTS: The results when injecting BoNTA in anticoagulated patients were as follows: 1) BoNTA injections should not be withheld purely because a patient is anticoagulated and other factors need to be considered. 2) A 25G (or higher) needle should be used when injecting into the deepleg compartment muscles. 3) The INR level ≤3.5 should be used when injecting the deep posterior leg compartment muscles. 4) The concern regarding bleeding when using DOACs remain the same as with warfarin when INR is in the therapeutic range. 6) The dose and scheduling of DOACs need not be altered prior to BoNTA injections. CONCLUSIONS: The Canadian consensus statements assist clinicians by providing a framework for consideration to navigate the challenges when injecting BoNTA in anticoagulated patients with spasticity.


Asunto(s)
Anticoagulantes/uso terapéutico , Espasticidad Muscular/tratamiento farmacológico , Fármacos Neuromusculares/uso terapéutico , Coagulación Sanguínea , Toxinas Botulínicas Tipo A/uso terapéutico , Humanos , Relación Normalizada Internacional
19.
Clin Drug Investig ; 40(4): 319-326, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32130684

RESUMEN

INTRODUCTION: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. OBJECTIVE: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. METHODS: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. RESULTS: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months' treatment and 0.127 (0.080) after 6 months' treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. CONCLUSION: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.


Asunto(s)
Cannabidiol/administración & dosificación , Dronabinol/administración & dosificación , Esclerosis Múltiple/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Adulto , Análisis Costo-Beneficio , Combinación de Medicamentos , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida
20.
Health Qual Life Outcomes ; 18(1): 51, 2020 Mar 04.
Artículo en Inglés | MEDLINE | ID: mdl-32131842

RESUMEN

BACKGROUND: We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study. METHODS: In this exploratory trial, subjects (N = 155; 18-80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks' follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3. RESULTS: The mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with 'improvement' was greater than that with 'worsening' for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as 'normal' increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of 'severe impairment'. CONCLUSION: These preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01603459. Date of registration: May 22, 2012.


Asunto(s)
Toxinas Botulínicas Tipo A/administración & dosificación , Espasticidad Muscular/tratamiento farmacológico , Fármacos Neuromusculares/administración & dosificación , Calidad de Vida , Adolescente , Adulto , Anciano , Relación Dosis-Respuesta a Droga , Extremidades/fisiopatología , Femenino , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Encuestas y Cuestionarios
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