Figure 1.
Efficacy of hormone therapy treatment groups
| Number of patients (%) | ||
|---|---|---|
| Group 1 (tetracosactide + valproate) n = 79 | Group 2 (dexamethasone + valproate) n = 18 | |
| Cessation of IS | ||
| First 5 days of therapy | 40 (50.6%) | 7 (38.7%) |
| Days 6–10 | 24 (34%) | 4 (22.2%) |
| Days 11–30 | 9 (11.4%) | 2 (11.1%) |
| IS ongoing | ||
| 6 (7.6%) (p = 0.0017) | 5 (28%) (p = 0.0017) | |
| EEG on Days 10-11 of hormone therapy | ||
| Without epileptiform discharges | 59 (74.7%) (p = 0.4) | 7 (38.9%) (p = 0.04) |
| Multiregional epileptiform discharges | 1 (1.3%) | 6 (33.3%) |
| Focal epileptiform discharges | 14 (17.7)% | 3 (16.7%) |
| Hypsarrhythmia | 5 (6.%) | 2 (11.1%) |
Description of epileptic syndrome in treatment groups
| Number of patients % | ||
|---|---|---|
| Group 1 (tetracosactide + valproate) n = 79 | Group 2 (dexamethasone + valproate) n = 18 | |
| Epilepsy etiology | ||
| Hypoxic Ischemic Neonatal Encephalopathy | 51 (64.6%) | 13 (72.2%) |
| Malformations of cerebral cortical development | 11 (13.9%) | 2 (11.1%) |
| Metabolic disorders | 5 (6.3%) | 0 |
| Chromosomal disorders | 2 (2.5%) | 0 |
| Neuroinfections | 2 (2.5%) | 0 |
| Cerebral hemorrhage | 1 (1.3) | 1 (5.5%) |
| Cryptogenic IS | 7 (8.9%) | 2 (11.1%) |
| Spasm types | ||
| Flexor IS | 48 (60.7%) | 12 (66.6%) |
| Extensor IS | 12 (15.1%) | 3 (16.6%) |
| Asymmetrical IS | 4 (5.1%) | 1 (5.5%) |
| Combination of IS | 15 (18.9%) | 2 (11.1%) |
| Clusters daily | ||
| Up to 5 | 61 (77.2%) | 15 (83.3%) |
| Up to 10 | 13 (16.5%) | 1 (5.5%) |
| < 10 | 5 (6.3%) | 2 (11.1%) |
| Spasms per cluster | ||
| Up to 5 | 1 (1.2%) | 0 |
| Up to 10 | 46 (58.2%) | 11 (61%) |
| Dozens | 32 (40.5%) | 7 (39%) |
| Hypsarrhythmia types | ||
| classical | 21 (26.6%) | 3 (16.6%) |
| synchronized | 17 (21.5%) | 5 (28%) |
| asymmetric | 5 (6.3%) | 0 |
| with a consistent focus | 13 (16.4%) | 3 (16.6%) |
| high amplitude asynchronous | 4 (5.1%) | 1 (5.5%) |
| suppression-burst pattern | 16 (24.1%) | 6 (33.3%) |
Adverse effects and their frequency in hormone therapy combined with valproates
| Number of patients (%) | ||
|---|---|---|
| Group 1 (tetracosactide + valproate) n = 79 | Group 2 (dexamethasone + valproate) n = 18 | |
| Upper respiratory infections | 21 (26.6%) | 4 (22.2%) |
| Mucous membrane candidiasis | 16 (20.2%) | 1 (5.5%) |
| Hypopotassemia | 12 (15.1%) | 2 (11.1%) |
| Hypocalcemia | 3 (3.8%) | 1 (5.5%) |
| Thrombocytopenia | 5 (6.3%) | 0 |
| Hyponatremia | 0 | 1 (5.5%) |
Demographic data in treatment groups
| No. of patients | ||
|---|---|---|
| Group 1 (tetracosactide + valproate) | Group 2 (dexamethasone + valproate) | |
| Total | 79 | 18 |
| Median age (months) | 5.8 | 7.3 |
| Male | 53 | 13 |
| Female | 26 | 5 |
| Male vs Female | 2.04 | 2.6 |