Cargando…
Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms
Background and Purpose: To assess the safety and effectiveness of oral methylprednisolone (oMP) in comparison with intramuscular adrenocorticotropic hormone (imACTH) and oral prednisolone (oP) therapies in children with infantile spasms (IS). Methods: In this prospective, open-label, non-blinded, un...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8727336/ https://www.ncbi.nlm.nih.gov/pubmed/35002921 http://dx.doi.org/10.3389/fneur.2021.756746 |
_version_ | 1784626502786088960 |
---|---|
author | Zhu, Hong-Min Yuan, Chun-Hui Luo, Meng-Qing Deng, Xiao-Long Huang, Sheng Wu, Ge-Fei Hu, Jia-Sheng Yao, Cong Liu, Zhi-Sheng |
author_facet | Zhu, Hong-Min Yuan, Chun-Hui Luo, Meng-Qing Deng, Xiao-Long Huang, Sheng Wu, Ge-Fei Hu, Jia-Sheng Yao, Cong Liu, Zhi-Sheng |
author_sort | Zhu, Hong-Min |
collection | PubMed |
description | Background and Purpose: To assess the safety and effectiveness of oral methylprednisolone (oMP) in comparison with intramuscular adrenocorticotropic hormone (imACTH) and oral prednisolone (oP) therapies in children with infantile spasms (IS). Methods: In this prospective, open-label, non-blinded, uncontrolled observational study, children (aged 2–24 months) with newly diagnosed IS presenting with hypsarrhythmia or its variants on electroencephalogram (EEG) were included. It was followed by imACTH, oP, or oMP (32–48 mg/day for 2 weeks followed by tapering) treatments. Electroclinical remission/spasm control, relapse, and adverse effects were evaluated in the short-term (days 14 and 42) and intermediary-term (3, 6, and 12 months) intervals. Results: A total of 320 pediatric patients were enrolled: 108, 107, and 105 in the imACTH, oMP, and oP groups, respectively. The proportion of children achieving electroclinical remission on days 14 and 42 was similar among the three groups (day 14: 53.70 vs. 60.75 vs. 51.43%, p = 0.362; day 42: 57.55 vs. 63.46 vs. 55.34%, p = 0.470). The time to response was significantly faster in the oMP group (6.5 [3.00, 10.00] days vs. 8.00 [5.00, 11.00] days for imACTH and 8.00 [5.00, 13.00] days for oP, p = 0.025). Spasm control at 3, 6, and 12 months was also similar in the three groups (P = 0.775, 0.667, and 0.779). The relapse rate in the imACTH group (24.10%) was lower than oMP (30.77%) and oP groups (33.33%), and the time taken for relapse in the imACTH group (79.00 [56.50, 152.00] days) was longer than oMP (62.50 [38.00, 121.75] days) and oP groups (71.50 [40.00, 99.75] days), but the differences were not statistically significant (p = 0.539 and 0.530, respectively). The occurrence of adverse effects was similar among the three groups. Conclusions: The short and intermediary-term efficacy and recurrence rates of oMP are not inferior to those of imACTH and oP for the treatment of IS. Significantly, the time to achieve electroclinical remission with oMP was quicker than that with imACTH and oP. Considering its convenience, affordability, and the absence of irreversible side effects, oMP can serve as a form of first-line treatment for newly diagnosed IS. |
format | Online Article Text |
id | pubmed-8727336 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-87273362022-01-06 Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms Zhu, Hong-Min Yuan, Chun-Hui Luo, Meng-Qing Deng, Xiao-Long Huang, Sheng Wu, Ge-Fei Hu, Jia-Sheng Yao, Cong Liu, Zhi-Sheng Front Neurol Neurology Background and Purpose: To assess the safety and effectiveness of oral methylprednisolone (oMP) in comparison with intramuscular adrenocorticotropic hormone (imACTH) and oral prednisolone (oP) therapies in children with infantile spasms (IS). Methods: In this prospective, open-label, non-blinded, uncontrolled observational study, children (aged 2–24 months) with newly diagnosed IS presenting with hypsarrhythmia or its variants on electroencephalogram (EEG) were included. It was followed by imACTH, oP, or oMP (32–48 mg/day for 2 weeks followed by tapering) treatments. Electroclinical remission/spasm control, relapse, and adverse effects were evaluated in the short-term (days 14 and 42) and intermediary-term (3, 6, and 12 months) intervals. Results: A total of 320 pediatric patients were enrolled: 108, 107, and 105 in the imACTH, oMP, and oP groups, respectively. The proportion of children achieving electroclinical remission on days 14 and 42 was similar among the three groups (day 14: 53.70 vs. 60.75 vs. 51.43%, p = 0.362; day 42: 57.55 vs. 63.46 vs. 55.34%, p = 0.470). The time to response was significantly faster in the oMP group (6.5 [3.00, 10.00] days vs. 8.00 [5.00, 11.00] days for imACTH and 8.00 [5.00, 13.00] days for oP, p = 0.025). Spasm control at 3, 6, and 12 months was also similar in the three groups (P = 0.775, 0.667, and 0.779). The relapse rate in the imACTH group (24.10%) was lower than oMP (30.77%) and oP groups (33.33%), and the time taken for relapse in the imACTH group (79.00 [56.50, 152.00] days) was longer than oMP (62.50 [38.00, 121.75] days) and oP groups (71.50 [40.00, 99.75] days), but the differences were not statistically significant (p = 0.539 and 0.530, respectively). The occurrence of adverse effects was similar among the three groups. Conclusions: The short and intermediary-term efficacy and recurrence rates of oMP are not inferior to those of imACTH and oP for the treatment of IS. Significantly, the time to achieve electroclinical remission with oMP was quicker than that with imACTH and oP. Considering its convenience, affordability, and the absence of irreversible side effects, oMP can serve as a form of first-line treatment for newly diagnosed IS. Frontiers Media S.A. 2021-12-22 /pmc/articles/PMC8727336/ /pubmed/35002921 http://dx.doi.org/10.3389/fneur.2021.756746 Text en Copyright © 2021 Zhu, Yuan, Luo, Deng, Huang, Wu, Hu, Yao and Liu. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Neurology Zhu, Hong-Min Yuan, Chun-Hui Luo, Meng-Qing Deng, Xiao-Long Huang, Sheng Wu, Ge-Fei Hu, Jia-Sheng Yao, Cong Liu, Zhi-Sheng Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms |
title | Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms |
title_full | Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms |
title_fullStr | Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms |
title_full_unstemmed | Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms |
title_short | Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms |
title_sort | safety and effectiveness of oral methylprednisolone therapy in comparison with intramuscular adrenocorticotropic hormone and oral prednisolone in children with infantile spasms |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8727336/ https://www.ncbi.nlm.nih.gov/pubmed/35002921 http://dx.doi.org/10.3389/fneur.2021.756746 |
work_keys_str_mv | AT zhuhongmin safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT yuanchunhui safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT luomengqing safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT dengxiaolong safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT huangsheng safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT wugefei safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT hujiasheng safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT yaocong safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT liuzhisheng safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms |