A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/200420 |
Resumo: | Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. ProsigneH a new released botulinum toxin serotype A may have the same effectiveness as BotoxH in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of ProsigneH with BotoxH in the treatment of spasticity. Methodology/Principal Findings: We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after ProsigneH or BotoxH administration. The main outcomes were changes in the patients’ Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the ProsigneH and BotoxH treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups. Conclusion: Our results suggest that ProsigneH and BotoxH are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity. |
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Guarany, Fábio CoelhoPicon, Paulo DornellesGuarany, Nicole RuasSantos, Antonio Cardoso dosChiella, Bianca Paula MentzBarone, Carolina RochaFendt, Lúcia Costa CabralSchestatsky, Pedro2019-10-10T03:50:17Z20131932-6203http://hdl.handle.net/10183/200420000892451Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. ProsigneH a new released botulinum toxin serotype A may have the same effectiveness as BotoxH in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of ProsigneH with BotoxH in the treatment of spasticity. Methodology/Principal Findings: We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after ProsigneH or BotoxH administration. The main outcomes were changes in the patients’ Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the ProsigneH and BotoxH treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups. Conclusion: Our results suggest that ProsigneH and BotoxH are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.application/pdfengPloS one. San Francisco. Vol. 8, no. 2 (Feb. 2013), e56479, 6 p.Espasticidade muscularToxinas botulínicas tipo AA double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticityEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT000892451.pdf.txt000892451.pdf.txtExtracted Texttext/plain25714http://www.lume.ufrgs.br/bitstream/10183/200420/2/000892451.pdf.txta43b8b6149e56e413ff38bac4166143aMD52ORIGINAL000892451.pdfTexto completo (inglês)application/pdf311803http://www.lume.ufrgs.br/bitstream/10183/200420/1/000892451.pdfe6f1f1be3a8caef0f18c9c0909b71d08MD5110183/2004202023-09-23 03:37:11.77113oai:www.lume.ufrgs.br:10183/200420Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2023-09-23T06:37:11Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity |
title |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity |
spellingShingle |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity Guarany, Fábio Coelho Espasticidade muscular Toxinas botulínicas tipo A |
title_short |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity |
title_full |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity |
title_fullStr |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity |
title_full_unstemmed |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity |
title_sort |
A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity |
author |
Guarany, Fábio Coelho |
author_facet |
Guarany, Fábio Coelho Picon, Paulo Dornelles Guarany, Nicole Ruas Santos, Antonio Cardoso dos Chiella, Bianca Paula Mentz Barone, Carolina Rocha Fendt, Lúcia Costa Cabral Schestatsky, Pedro |
author_role |
author |
author2 |
Picon, Paulo Dornelles Guarany, Nicole Ruas Santos, Antonio Cardoso dos Chiella, Bianca Paula Mentz Barone, Carolina Rocha Fendt, Lúcia Costa Cabral Schestatsky, Pedro |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Guarany, Fábio Coelho Picon, Paulo Dornelles Guarany, Nicole Ruas Santos, Antonio Cardoso dos Chiella, Bianca Paula Mentz Barone, Carolina Rocha Fendt, Lúcia Costa Cabral Schestatsky, Pedro |
dc.subject.por.fl_str_mv |
Espasticidade muscular Toxinas botulínicas tipo A |
topic |
Espasticidade muscular Toxinas botulínicas tipo A |
description |
Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. ProsigneH a new released botulinum toxin serotype A may have the same effectiveness as BotoxH in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of ProsigneH with BotoxH in the treatment of spasticity. Methodology/Principal Findings: We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after ProsigneH or BotoxH administration. The main outcomes were changes in the patients’ Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the ProsigneH and BotoxH treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups. Conclusion: Our results suggest that ProsigneH and BotoxH are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity. |
publishDate |
2013 |
dc.date.issued.fl_str_mv |
2013 |
dc.date.accessioned.fl_str_mv |
2019-10-10T03:50:17Z |
dc.type.driver.fl_str_mv |
Estrangeiro info:eu-repo/semantics/article |
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http://hdl.handle.net/10183/200420 |
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1932-6203 |
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000892451 |
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http://hdl.handle.net/10183/200420 |
dc.language.iso.fl_str_mv |
eng |
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dc.relation.ispartof.pt_BR.fl_str_mv |
PloS one. San Francisco. Vol. 8, no. 2 (Feb. 2013), e56479, 6 p. |
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info:eu-repo/semantics/openAccess |
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