[Pharmacotherapy of psychomotor developmental delay in 6-12 months preterm infants with hypoxic-ischemic encephalopathy (the double-blind comparative multicenter placebo-controlled study)].

Autor: Zavadenko NN; Pirogov Russian National Research Medical University, Moscow, Russia., Guzeva VI; St. Petersburg State Pediatric Medical University, St. Petersburg, Russia., Gaynetdinova DD; Kazan State Medical University, Kazan, Russia., Davydova LA; Pirogov Russian National Research Medical University, Moscow, Russia., Zavadenko AN; Pirogov Russian National Research Medical University, Moscow, Russia., Romanova TA; Samara State Medical University, Samara, Russia.
Jazyk: ruština
Zdroj: Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova [Zh Nevrol Psikhiatr Im S S Korsakova] 2019; Vol. 119 (10), pp. 30-39.
DOI: 10.17116/jnevro201911910130
Abstrakt: Aim: To evaluate the efficacy and safety of hopantenic acid (Pantogam) in the complex treatment of prematurely born infants, aged 6-12 months, with psychomotor developmental delay due to hypoxic-ischemic encephalopathy.
Material and Methods: Eighty-seven patients were randomized into two groups: 44 received standardized treatment and pantogam for two months, 43 standardized treatment and placebo. Pantogam (syrup 100 mg/ml) or placebo were prescribed orally 15-30 minutes after feeding, twice a day, in a daily dosage of 30-50 mg/kg body weight. The assessment of psychomotor development from birth to two years was performed with the Griffiths Mental Development Scales (GMDS-ER) twice (before and after completion of therapy).
Results: The response to two month therapy determined as the reduction of developmental delay for more than 6% of the initial GMDS-ER general quotient (GQ) score was significantly better in the group I after pantogam treatment (63.6% of patients) compared to group II (36.4%, p=0.021). Group I demonstrated the significant decrease of the developmental delay in two domains ('Personal-Social' and 'Performance') and a trend to overcome the delay in three other domains: 'Locomotor', 'Hearing and Speech', 'Eye and Hand Coordination'. The improvement after pantogam treatment was more obvious in the subgroup of infants born late preterm (gestational age 34-36 weeks) compared to infants born moderate preterm (gestational age 32-33 weeks). The favorable safety profile of pantogam was confirmed, comparable to that of placebo.
Conclusion: Pantogam is efficient and safe medication in the complex treatment of psychomotor developmental delay in preterm infants, aged 6-12 months.
Databáze: MEDLINE