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1.
Brasília; CONITEC; nov. 2020.
Não convencional em Português | BRISA/RedTESA | ID: biblio-1145537

RESUMO

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.


Assuntos
Humanos , Dronabinol/uso terapêutico , Canabidiol/uso terapêutico , Esclerose Múltipla/etiologia , Espasticidade Muscular/tratamento farmacológico , Avaliação da Tecnologia Biomédica , Sistema Único de Saúde , Brasil , Análise Custo-Benefício/economia
2.
J Pediatr Rehabil Med ; 13(3): 379-384, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33164962

RESUMO

The COVID-19 pandemic has been a challenge to healthcare systems around the world. Within pediatric rehabilitation medicine, management of intrathecal baclofen has been particularly challenging. This editorial reviews how programs in the US and Canada coped with the quickly changing healthcare environment and how we can learn from this pandemic to be prepared for future crises.


Assuntos
Baclofeno/administração & dosagem , Espasticidade Muscular/tratamento farmacológico , Pandemias , Criança , Comorbidade , Humanos , Injeções Espinhais , Relaxantes Musculares Centrais/administração & dosagem , Espasticidade Muscular/epidemiologia , Resultado do Tratamento
3.
Toxicon ; 188: 48-54, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33045238

RESUMO

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.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Espasticidade Muscular/cirurgia , Toxinas Botulínicas Tipo A/administração & dosagem , Paralisia Cerebral/tratamento farmacológico , Humanos , Injeções Intramusculares , Espasticidade Muscular/tratamento farmacológico , Fármacos Neuromusculares/uso terapêutico
4.
J Stroke Cerebrovasc Dis ; 29(10): 105160, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32912522

RESUMO

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.


Assuntos
Inibidores da Liberação da Acetilcolina/uso terapêutico , Toxinas Botulínicas/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Músculo Esquelético/efeitos dos fármacos , Transtornos do Sono-Vigília/prevenção & controle , Sono , Acidente Vascular Cerebral/fisiopatologia , Inibidores da Liberação da Acetilcolina/efeitos adversos , Adulto , Idoso , Toxinas Botulínicas/efeitos adversos , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/etiologia , Espasticidade Muscular/fisiopatologia , Músculo Esquelético/fisiopatologia , Qualidade de Vida , Transtornos do Sono-Vigília/etiologia , Transtornos do Sono-Vigília/fisiopatologia , Acidente Vascular Cerebral/complicações , Resultado do Tratamento
5.
Artigo em Russo | MEDLINE | ID: mdl-32790979

RESUMO

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.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Paralisia Cerebral/tratamento farmacológico , Fármacos Neuromusculares/uso terapêutico , Criança , Pré-Escolar , Humanos , Injeções Intramusculares , Masculino , Espasticidade Muscular/tratamento farmacológico , Estudos Retrospectivos , Resultado do Tratamento
6.
J Neuroeng Rehabil ; 17(1): 102, 2020 07 23.
Artigo em Inglês | MEDLINE | ID: mdl-32703213

RESUMO

BACKGROUND: Spasticity is a key motor impairment that affects many hemispheric stroke survivors. Intramuscular botulinum toxin (BT) injections are used widely to clinically manage spasticity-related symptoms in stroke survivors by chemically denervating muscle fibers from their associated motor neurons. In this study, we sought to understand how BT affects muscle activation, motor unit composition and voluntary force generating capacity over a time period of 3 months. Our purpose was to characterize the time course of functional changes in voluntary muscle activity in stroke survivors who are undergoing BT therapy as part of their physician-prescribed clinical plan. METHOD: Our assessment of the effects of BT was based on the quantification of surface electromyogram (sEMG) recordings in the biceps brachii (BB), an upper arm muscle and of voluntary contraction force. We report here on voluntary force and sEMG responses during isometric elbow contractions across consecutive recording sessions, spread over 12 weeks in three segments, starting with a preliminary session performed just prior to the BT injection. At predetermined time points, we conducted additional clinical assessments and we also recorded from the contralateral limbs of our stroke cohort. Eight subjects were studied for approximately 86 experimental recording sessions on both stroke-affected and contralateral sides. RESULTS: We recorded an initial reduction in force and sEMG in all subjects, followed by a trajectory with a progressive return to baseline over a maximum of 12 weeks, although the minimum sEMG and minimum force were not always recorded at the same time point. Three participants were able to complete only one to two segments. Slope values of the sEMG-force relations were also found to vary across the different time segments. While sEMG-force slopes provide assessments of force generation capacity of the BT injected muscle, amplitude histograms from novel sEMG recordings during the voluntary tasks provide additional insights about differential actions of BT on the overall motor unit (MU) population over time. CONCLUSIONS: The results of our study indicate that there are potential short term as well as long term decrements in muscle control and activation properties after BT administration on the affected side of chronic stroke survivors. Muscle activation levels as recorded using sEMG, did not routinely return to baseline even at three months' post injection. The concurrent clinical measures also did not follow the same time course, nor did they provide the same resolution as our experimental measures. It follows that even 12 weeks after intramuscular BT injections muscle recovery may not be complete, and may thereby contribute to pre-existing paresis.


Assuntos
Toxinas Botulínicas/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Músculo Esquelético/efeitos dos fármacos , Fármacos Neuromusculares/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Braço/fisiopatologia , Eletromiografia/métodos , Feminino , Humanos , Contração Isométrica/efeitos dos fármacos , Contração Isométrica/fisiologia , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/etiologia , Espasticidade Muscular/fisiopatologia , Músculo Esquelético/fisiologia , Acidente Vascular Cerebral/complicações , Sobreviventes
7.
NeuroRehabilitation ; 46(4): 519-528, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32508341

RESUMO

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.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Terapia por Exercício/métodos , Marcha , Fármacos Neuromusculares/uso terapêutico , Equilíbrio Postural , Reabilitação do Acidente Vascular Cerebral/métodos , Adulto , Idoso , Toxinas Botulínicas Tipo A/administração & dosagem , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/etiologia , Fármacos Neuromusculares/administração & dosagem , Método Simples-Cego , Acidente Vascular Cerebral/complicações
9.
Arch Phys Med Rehabil ; 101(9): 1485-1496, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32497599

RESUMO

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.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/etiologia , Fármacos Neuromusculares/uso terapêutico , Acidente Vascular Cerebral/complicações , Idoso , Toxinas Botulínicas Tipo A/efeitos adversos , Avaliação da Deficiência , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/efeitos adversos , Estudos Prospectivos , República da Coreia , Reabilitação do Acidente Vascular Cerebral/métodos , Extremidade Superior
10.
Pan Afr Med J ; 35: 55, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32523646

RESUMO

Introduction: this study aimed to evaluate the effectiveness of botulinum toxin A (BoNT-A) injection in hemiparetic patients with chronic spasticity in the upper limb resulting from stroke or traumatic brain injury. Methods: we conducted a retrospective study including 45 patients seen, in our department of Physical Medicine and Rehabilitation, between January 2014 and December 2016. All patients received an injection of BoNT-A (Dysport, 100 U/ml). Affected upper-extremity muscles could be injected as per the investigator's discretion to a maximum total dose of 1000 U. We evaluated muscle tone using Modified Ashworth Scale (MAS). Functional disability was assessed using Modified Frenchay Scale (MFS), Nine Hole Peg Test (NHPT) and Barthel Index (BI). Quality of life (QoL) was assessed using the 36-Item Short Form Health Survey (SF-36). The achievement of treatment goal was assessed by the Goal Attainment Scaling (GAS). Results: patients decreased their MAS score over the first and the third months (p<0.05). MFS showed improvement at 1 month after injection with a median change from baseline of 8 (range: 1-16; p<0.001). The change from baseline ranged from 0 to 5 points for NHPT at 1 month after injection (p< 0.001). This functional improvement was maintained to 3 months. Improvements in Barthel Index was observed at 3 months with a median change from baseline of 5 points (range 0-15; p<0.001). The mean change from baseline of SF-36 score was 4.77 ± 3.39 (p<0.001). The mean GAS T-score was 47.04 ±7.78 (median 50, IQR 7.7), giving a mean (SD) change from baseline of 25.36 ± 8.46 (95% CI 22.82 to 27.90; p <0.001). Binary logistic regression was used to identify the independent factors predicting a favorable functional outcome of Bon-T treatment. It showed that neglect was independent predictive factor treatment failure (p=0.009, OR=3.2) while previous injection of BoNT-A was an independent predictive factors of treatment success (p=0.009, OR=0.3). Conclusion: our study showed a good response to BoNT-A injection delivered in the management of chronic upper limb spasticity resulting from stroke or traumatic brain injury. It demonstrated its outcome in improving muscle tone, function and QoL. It also showed that the majority of patients achieved their goal as defined at the start of the treatment, mainly for patients who received previous injection of BoNT-A.


Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Espasticidade Muscular/tratamento farmacológico , Fármacos Neuromusculares/administração & dosagem , Paresia/tratamento farmacológico , Adulto , Idoso , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/etiologia , Paresia/etiologia , Qualidade de Vida , Estudos Retrospectivos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/tratamento farmacológico , Resultado do Tratamento , Extremidade Superior
11.
J Rehabil Med ; 52(6): jrm00076, 2020 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-32556354

RESUMO

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.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Paralisia Cerebral/tratamento farmacológico , Tratamento por Ondas de Choque Extracorpóreas/métodos , Espasticidade Muscular/tratamento farmacológico , Adulto , Toxinas Botulínicas Tipo A/farmacologia , Estudos Cross-Over , Feminino , Humanos , Masculino , Resultado do Tratamento
12.
J Rehabil Med ; 52(6): jrm00068, 2020 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-32451555

RESUMO

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.


Assuntos
Inibidores da Liberação da Acetilcolina/uso terapêutico , Toxinas Botulínicas Tipo A/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Fármacos Neuromusculares/uso terapêutico , Ombro/anormalidades , Inibidores da Liberação da Acetilcolina/farmacologia , Adulto , Toxinas Botulínicas Tipo A/farmacologia , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/farmacologia , Resultado do Tratamento
14.
Dev Med Child Neurol ; 62(9): 1047-1053, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32306392

RESUMO

AIM: To determine whether energy consumption changes after selective dorsal rhizotomy (SDR) among children with cerebral palsy (CP). METHOD: We retrospectively evaluated net nondimensional energy consumption during walking among 101 children with bilateral spastic CP who underwent SDR (59 males, 42 females; median age [5th centile, 95th centile] 5y 8mo [4y 2mo, 9y 4mo]) compared to a control group of children with CP who did not undergo SDR. The control group was matched by baseline age, spasticity, and energy consumption (56 males, 45 females; median age [5th centile, 95th centile] 5y 8mo [4y 1mo, 9y 6mo]). Outcomes were compared at baseline and follow-up (SDR: mean [SD] 1y 7mo [6mo], control: 1y 8mo [8mo]). RESULTS: The SDR group had significantly greater decreases in spasticity compared to matched controls (-42% SDR vs -20% control, p<0.001). While both groups had a modest reduction in energy consumption between visits (-12% SDR, -7% control), there was no difference in change in energy consumption (p=0.11) or walking speed (p=0.56) between groups. INTERPRETATION: The SDR group did not exhibit greater reductions in energy consumption compared to controls. The SDR group had significantly greater spasticity reduction, suggesting that spasticity had minimal impact on energy consumption during walking in CP. These results support prior findings that spasticity and energy consumption decrease with age in CP. Identifying matched control groups is critical for outcomes research involving children with CP to account for developmental changes.


Assuntos
Paralisia Cerebral/metabolismo , Paralisia Cerebral/cirurgia , Metabolismo Energético , Rizotomia , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Espasticidade Muscular/complicações , Espasticidade Muscular/tratamento farmacológico , Consumo de Oxigênio , Estudos Retrospectivos , Resultado do Tratamento , Caminhada
15.
Dev Med Child Neurol ; 62(9): 1031-1039, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32342496

RESUMO

AIM: To assess the efficacy, safety, and tolerability of oromucosal nabiximols cannabinoid medicine as adjunct therapy for children with spasticity due to cerebral palsy/traumatic central nervous system injury with inadequate response to existing treatment. METHOD: Overall, 72 patients (mean [SD] age 12y 4mo [3y 1mo], range 8-18y) were randomized at a ratio of 2:1 to receive nabiximols (n=47; 29 males, 18 females) or placebo (n=25; 15 males, 10 females) for 12 weeks (12 sprays/day max. based on clinical response/tolerability). The primary outcome was change from baseline in level of spasticity on a 0 to 10 Numerical Rating Scale (NRS), assessed by the primary caregiver at 12 weeks. Secondary outcomes included additional measures for spasticity, sleep quality, pain, health-related quality of life, comfort, depression, and safety. RESULTS: There was no significant difference in the spasticity 0 to 10 NRS between nabiximols versus placebo groups after 12 weeks. No statistically significant differences were observed for any secondary endpoint. Adverse events were predominantly mild or moderate in severity; however, three cases of hallucinations were reported. INTERPRETATION: Nabiximols was generally well tolerated; however, neuropsychiatric adverse events were observed. No significant reduction in spasticity with nabiximols treatment versus placebo was observed. WHAT THIS PAPER ADDS: Oromucosal nabiximols is generally well tolerated by paediatric patients. However, three cases of hallucinations were observed, one of which involved auditory hallucinations and a suicide attempt. Oromucosal nabiximols versus placebo did not reduce cerebral palsy/central nervous system injury-related spasticity.


Assuntos
Lesões Encefálicas Traumáticas/complicações , Canabidiol/uso terapêutico , Paralisia Cerebral/complicações , Paralisia Cerebral/tratamento farmacológico , Dronabinol/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Administração Oral , Adolescente , Criança , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Masculino , Espasticidade Muscular/complicações , Resultado do Tratamento
16.
Neurology ; 94(20): e2109-e2120, 2020 05 19.
Artigo em Inglês | MEDLINE | ID: mdl-32332130

RESUMO

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.


Assuntos
Toxinas Botulínicas Tipo A/efeitos adversos , Distúrbios Distônicos/tratamento farmacológico , Espasticidade Muscular/tratamento farmacológico , Animais , Blefarospasmo/induzido quimicamente , Blefarospasmo/tratamento farmacológico , Toxinas Botulínicas Tipo A/uso terapêutico , Distúrbios Distônicos/induzido quimicamente , Feminino , Seguimentos , Humanos , Masculino , Camundongos , Pessoa de Meia-Idade , Fármacos Neuromusculares/efeitos adversos , Fármacos Neuromusculares/uso terapêutico , Fatores de Risco , Torcicolo/induzido quimicamente , Torcicolo/tratamento farmacológico
17.
World Neurosurg ; 139: e652-e657, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32339729

RESUMO

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.


Assuntos
Baclofeno/administração & dosagem , Baclofeno/efeitos adversos , Relaxantes Musculares Centrais/administração & dosagem , Relaxantes Musculares Centrais/efeitos adversos , Baclofeno/uso terapêutico , Infecções Relacionadas a Cateter/epidemiologia , Cateteres/efeitos adversos , Bases de Dados Factuais , Falha de Equipamento , Feminino , Migração de Corpo Estranho , Humanos , Bombas de Infusão Implantáveis , Injeções Espinhais , Masculino , Relaxantes Musculares Centrais/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Estudos Retrospectivos , Resultado do Tratamento
18.
Clin Rehabil ; 34(6): 803-811, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32336148

RESUMO

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.


Assuntos
Extremidade Inferior/fisiopatologia , Espasticidade Muscular/fisiopatologia , Paresia/fisiopatologia , Amplitude de Movimento Articular/fisiologia , Recuperação de Função Fisiológica/fisiologia , Extremidade Superior/fisiopatologia , Inibidores da Liberação da Acetilcolina/uso terapêutico , Adulto , Idoso , Austrália , Toxinas Botulínicas Tipo A/uso terapêutico , Lesões Encefálicas/complicações , Lesões Encefálicas/fisiopatologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/complicações , Espasticidade Muscular/tratamento farmacológico , Músculo Esquelético/fisiopatologia , Avaliação de Resultados em Cuidados de Saúde , Paresia/complicações , Paresia/tratamento farmacológico , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento , Velocidade de Caminhada
19.
J Stroke Cerebrovasc Dis ; 29(6): 104682, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32305277

RESUMO

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.


Assuntos
Inibidores da Liberação da Acetilcolina/uso terapêutico , Toxinas Botulínicas Tipo A/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Músculo Esquelético/inervação , Parassimpatolíticos/uso terapêutico , Acidente Vascular Cerebral/complicações , Inibidores da Liberação da Acetilcolina/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Toxinas Botulínicas Tipo A/efeitos adversos , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/diagnóstico , Espasticidade Muscular/etiologia , Espasticidade Muscular/fisiopatologia , Parassimpatolíticos/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento , Extremidade Superior , Adulto Jovem
20.
BMC Neurol ; 20(1): 126, 2020 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-32268880

RESUMO

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.


Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Paralisia Cerebral/tratamento farmacológico , Espasticidade Muscular/tratamento farmacológico , Fármacos Neuromusculares/uso terapêutico , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Debilidade Muscular/induzido quimicamente , Estudos Retrospectivos , Resultado do Tratamento
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