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Meta-Analysis
. 2020 May;62(5):575-580.
doi: 10.1111/dmcn.14452. Epub 2020 Jan 5.

Prednisolone/prednisone as adrenocorticotropic hormone alternative for infantile spasms: a meta-analysis of randomized controlled trials

Shaojun Li  1   2   3   4   5 , Xuefei Zhong  2   3   4   5   6 , Siqi Hong  2   3   4   5   7 , Tingsong Li  2   3   4   5   7 , Li Jiang  2   3   4   5   7
Affiliations
Free article
Meta-Analysis

Prednisolone/prednisone as adrenocorticotropic hormone alternative for infantile spasms: a meta-analysis of randomized controlled trials

Shaojun Li et al. Dev Med Child Neurol. 2020 May.
Free article

Abstract
in English, Spanish, Portuguese, Chinese

Aim: To compare the efficacy and safety of prednisolone/prednisone and adrenocorticotropic hormone (ACTH) in the treatment of infantile spasms using a meta-analysis of randomized controlled trials (RCTs).

Method: In a systematic literature search of electronic databases (MEDLINE, Embase, the Cochrane Library), we identified RCTs that assessed prednisolone/prednisone compared with ACTH/tetracosactide in patients with infantile spasms. The electroclinical response and adverse events were evaluated.

Results: Six RCTs (616 participants) were included in the meta-analysis. Compared with prednisolone/prednisone, ACTH/tetracosactide was not superior in terms of cessation of spasms at day 14 (relative risk 1.19, 95% confidence interval [CI] 0.74-1.92), day 42 (relative risk 1.02, 95% CI 0.63-1.65), and resolution of hypsarrhythmia on electroencephalogram (relative risk 1.14, 95% CI 0.71-1.81); the incidences of common adverse reactions caused by ACTH/tetracosactide were not lower than that of prednisolone/prednisone for irritability (relative risk 0.79, 95% CI 0.57-1.10), increased appetite (relative risk 0.78, 95% CI 0.57-1.08), weight gain (relative risk 0.86, 95% CI 0.56-1.32), and gastrointestinal upset (relative risk 0.60, 95% CI 0.35-1.02), though it seemed less frequent.

Interpretation: Prednisolone/prednisone elicits a similar electroclinical response as ACTH for infantile spasms, which indicates that it can be an alternative to ACTH for treating infantile spasms. What this paper adds Prednisolone/prednisone is as effective as adrenocorticotropic hormone (ACTH) in electroclinical response of infantile spasms. Prednisolone/prednisone and ACTH cause similar and tolerable adverse effects, whose incidences are comparable. High-dose prednisone/prednisolone might be preferable to low dose for achieving freedom from spasms.

Prednisolona/prednisona como alternativa a la hormona adrenocorticotrópica para los espasmos infantiles: un metanálisis de ensayos controlados aleatorios OBJETIVO: Comparar la eficacia y seguridad de la prednisolona/prednisona y la hormona adrenocorticotrópica (ACTH) en el tratamiento de los espasmos infantiles mediante un metanálisis de ensayos controlados aleatorios (ECA). MÉTODO: En una búsqueda sistemática en la literatura de bases de datos electrónicas (MEDLINE, Embase, Cochrane Library), identificamos ECA que evaluaban prednisolona/ prednisona en comparación con ACTH/tetracosactida en pacientes con espasmos infantiles. Se evaluaron la respuesta electro clínica y los eventos adversos. RESULTADOS: Seis ECA (616 participantes) se incluyeron en el metanálisis. En comparación con la prednisolona/prednisona, la ACTH/tetracosactida no fue superior en términos de cese de espasmos en el día 14 (riesgo relativo 1,19, intervalo de confianza del 95% [IC] 0,74-1,92), día 42 (riesgo relativo 1,02, IC del 95% 0,63- 1,65), y la resolución de la hipsarritmia en el EEG (riesgo relativo 1,14, IC 95% 0,71-1,81); la incidencia de reacciones adversas comunes causadas por ACTH/tetracosactida no fue inferior a la de prednisolona/prednisona para irritabilidad (riesgo relativo 0,79, IC 95% 0,57-11,10), aumento del apetito (riesgo relativo 0,78, IC 95% 0,57-1,08), aumento de peso (riesgo relativo 0,86; IC del 95%: 0,56-1,32) y malestar gastrointestinal (riesgo relativo 0,60; IC del 95%: 0,35-1,02), aunque parecía menos frecuente. INTERPRETACIÓN: La prednisolona/prednisona provoca una respuesta electro clínica similar a la ACTH para los espasmos infantiles, lo que indica que puede ser una alternativa a la ACTH para el tratamiento de los espasmos infantiles.

Prednisolona/predinisona como hormônio adrenocorticotrópico alternativo para espasmos infantis: uma metanálise de estudos randomizados controlados OBJETIVO: Comparar a eficácia e segurança da prednisolona/ prednisona e hormônio adrenocorticotrópio (HACT) no tratamento de espasmos infantis usando uma metanálise de estudos randomizados controlados (ERCs). MÉTODO: Em uma busca sistemática da literatura em bases de dados eletrônicas (MEDLINE, Embase, Biblioteca Cochrane), identificamos ERCs que avaliaram a prednisolona/ prednisona em comparação com o HACT/ tetracosactídeo em pacientes com espasmos infantis. A resposta eletroclínica e eventos adversos foram avaliados. RESULTADOS: Seis ERCs (616 participantes) foram incluídos na metanálise. Comparado com a prednisolona/ prednisona , o HACT/ tetracosactídeo não foi superior em termos de cessação dos espasmos no dia 14 (risco relativo 1,19, intervalo de confiança [IC] a 95% 0,74-1,92), dia 42 (risco relativo 1,02, IC 95% 0,63-1,65), e resolução da hipsarritimia no EEG (risco relativo 1,14, IC 95% 0,71-1,81); as incidências de reações adversas comuns causadas pelo HACT/ tetracosactídeo não foram menores que as da prednisolona/ prednisona para irritabilidade (risco relativo 0,79, IC 95% 0,57-1010), aumento do apetite (risco relativo 0,78, IC 95% 0,57-1,08), ganho de peso (risco relativo 0,86, IC 95% 0,56-1,32), e mal-estar gastrointestinal (risco relativo 0,60, IC 95% 0,35-1,02), embora parecessem menos frequentes. INTERPRETAÇÃO: A prednisolona/ prednisona /prednisone elicia resposta eletroclínica similar ao HACT para espasmos infantis, o que indica que pode ser uma alternativa ao HACD para tratar espasmos infantis.

目的: 为比较泼尼松龙/泼尼松和促肾上腺皮质激素在治疗婴儿痉挛症的有效性和安全性上的差别, 本研究对目前发表的随机对照试验进行了荟萃分析。 方法: 在电子数据库（MEDLINE, Embase, the Cochrane Library）中系统检索比较了泼尼松龙/泼尼松和促肾上腺皮质激素/替可克肽治疗婴儿痉挛的随机对照试验的文章, 评估两类药物的临床电反应和副作用的差别。 结果: 荟萃分析纳入6个随机对照试验（616名患儿）。与泼尼松龙/泼尼松相比, 促肾上腺皮质激素/替可沙肽在第治疗后14天（相对危险度: 1.19,95%置信区间:0.74-1.92）、第42天（相对危险度: 1.02, 95%置信区间: 0.63-1.65）的控制痉挛发及脑电图高幅失律缓解（相对危险度: 1.14, 95%置信区间: 0.71-1.81）方面不优于泼尼松龙/泼尼松；促肾上腺皮质激素/替可克肽引起的常见不良反应如: 易激惹（相对危险度: 0.79, 95%置信区间: 0.57-1.10）、食欲增加（相对危险度: 0.78, 95%置信区间: 0.57-1.08）、体重增加（相对危险度: 0.86, 95%置信区间0.56-1.32）和胃肠道不适（相对危险度: 0.60, 95%置信区间 0.35-1.02）发生率也不低于泼尼松龙/泼尼松, 尽管看起来更少见。 结论: 泼尼松龙/泼尼松与ACTH治疗婴儿痉挛的临床电反应相似, 这表明其可以替代ACTH治疗婴儿痉挛。.

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