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, unc...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2021-12-01
|
| Series: | Frontiers in Neurology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2021.756746/full |
| _version_ | 1819100115706576896 |
|---|---|
| author | Hong-Min Zhu Chun-Hui Yuan Meng-Qing Luo Meng-Qing Luo Xiao-Long Deng Sheng Huang Ge-Fei Wu Jia-Sheng Hu Cong Yao Zhi-Sheng Liu |
| author_facet | Hong-Min Zhu Chun-Hui Yuan Meng-Qing Luo Meng-Qing Luo Xiao-Long Deng Sheng Huang Ge-Fei Wu Jia-Sheng Hu Cong Yao Zhi-Sheng Liu |
| author_sort | Hong-Min Zhu |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-22T00:57:39Z |
| format | Article |
| id | doaj.art-7d97c1422b424e77860b0de795f13d3f |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-12-22T00:57:39Z |
| publishDate | 2021-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-7d97c1422b424e77860b0de795f13d3f2022-12-21T18:44:17ZengFrontiers Media S.A.Frontiers in Neurology1664-22952021-12-011210.3389/fneur.2021.756746756746Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile SpasmsHong-Min Zhu0Chun-Hui Yuan1Meng-Qing Luo2Meng-Qing Luo3Xiao-Long Deng4Sheng Huang5Ge-Fei Wu6Jia-Sheng Hu7Cong Yao8Zhi-Sheng Liu9Department of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Laboratory Medicine, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Rehabilitation Medicine, Wuhan First Hospital, Wuhan, ChinaDepartment of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaHealth Care Department, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaBackground 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.https://www.frontiersin.org/articles/10.3389/fneur.2021.756746/fullinfantile spasmsmethylprednisoloneprednisoloneACTHelectroclinical remission |
| spellingShingle | Hong-Min Zhu Chun-Hui Yuan Meng-Qing Luo Meng-Qing Luo Xiao-Long Deng Sheng Huang Ge-Fei Wu Jia-Sheng Hu Cong Yao Zhi-Sheng Liu Safety and Effectiveness of Oral Methylprednisolone Therapy in Comparison With Intramuscular Adrenocorticotropic Hormone and Oral Prednisolone in Children With Infantile Spasms Frontiers in Neurology infantile spasms methylprednisolone prednisolone ACTH electroclinical remission |
| 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 | infantile spasms methylprednisolone prednisolone ACTH electroclinical remission |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2021.756746/full |
| work_keys_str_mv | AT hongminzhu safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT chunhuiyuan safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT mengqingluo safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT mengqingluo safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT xiaolongdeng safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT shenghuang safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT gefeiwu safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT jiashenghu safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT congyao safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms AT zhishengliu safetyandeffectivenessoforalmethylprednisolonetherapyincomparisonwithintramuscularadrenocorticotropichormoneandoralprednisoloneinchildrenwithinfantilespasms |