An open-label clinical study on the efficacy and tolerability of magnesium sulfate combined with adrenocorticotropic hormone treatment on infantile spasm

Abstract

Background Infantile spasm (IS) is characterized by spasm seizure, hypsarrhythmia in EEG, and psychomotor retardation. It is refractory to conventional antiepileptic drugs (AEDs). As firstline therapy for IS, adrenocorticotropic hormone (ACTH) has side effects, such as infection and hypertension. This study aims to evaluate the efficacy and tolerability of magnesium sulfate combined with ACTH treatment by open-label clinical trial.  Methods An open-label clinical study was designed. According to inclusion and exclusion criteria, objects were inpatients with IS. A total of 55 patients with IS were enrolled. After clinical data collection, standard magnesium sulfate combined with ACTH was given to the patients for 2 weeks. Efficacy and safety were assessed regularly. The evaluation parameters of efficacy included change of spasm seizure frequency and EEG after treatment. During administration process, vital signs were monitored, laboratory items were tested regularly, and adverse events were daily recorded by guardian.  Results After treatment of magnesium sulfate combined with ACTH for 2 weeks, seizure control efficiency was 78.18%(43/55), and the improvement rate of EEG was 55.77% (29/52), wherein 25 patients (45.45%) acquired seizure free, 6 patients (11.54%) presented normal in EEG examination. There were no statistical differences of the effect of different onset ages (≤ 4 months, > 4 months) on seizure control efficiency rate (χ² = 0.595, P = 0.441) and EEG improvement rate (χ² = 1.325, P = 0.250), the effect of different courses of disease (≤ 2 months, > 2 months) on seizure control efficiency rate (Fisher's exact test: P = 0.735) and EEG improvement rate ( χ² = 2.668, P = 0.102), and the effect of different etiologies (idiopathic or cryptogenic IS, symptomatic IS) on seizure control efficiency rate (Fisher's exact test: P = 1.000) and EEG improvement rate ( χ² = 2.215, P = 0.145). No adverse events, such as hypertension, occurred. After long-term (1 month, 3 months and 12 months) follow-up for 29 patients, seizure free rate remained roughly unchanged (χ² = 0.945, P = 0.815).  Conclusions For patients with IS, magnesium sulfate combined with ACTH treatment is effective and well tolerated.

doi: 10.3969/j.issn.1672-6731.2014.11.009