RESUMO
BACKGROUND AND PURPOSE: The neuroregenerative drug Cerebrolysin has demonstrated efficacy in improving cognition in adults with stroke and Alzheimer's disease. The aim of this study was to determine the efficacy and safety of Cerebrolysin in the treatment of communication defects in infants with severe perinatal brain insult. METHODS: A randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6-21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study. The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections). The placebo group (n=60) received the same amount and number of normal saline injections. RESULTS: The baseline Communication and Symbolic-Behavior-Scale-Developmental Profile scores were comparable between the two groups. After 3 months, the placebo group exhibited improvements in the social (p<0.01) and speech composite (p=0.02) scores, with 10% and 1.5% increases from baseline, respectively. The scores of the Cerebrolysin group changed from concern to no concern, with increases of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social (p<0.001), speech (p<0.001), symbolic (p<0.001), and total (p<0.001) scores. CONCLUSIONS: Cerebrolysin dramatically improved infants' communication especially symbolic behavior which positively affected social interaction. These findings suggest that cerebrolysin may be an effective and feasible way equivalent to stem cell therapy.
RESUMO
BACKGROUND: Free oxygen radicals might have an adverse effect on platelets which might be reflected either on its count and/or degree of bleeding severity. AIM: To assess oxidant-antioxidant systems and evaluate effect of antioxidant therapy on platelet count (PC) and bleeding score (BS) in children and adolescents with ITP. METHODS: Six months prospective randomized single blind study registered as (NCT 01763658) including 39 patients with newly diagnosed (ND) ITP; group 1 (G1) and 39 patients with chronic ITP (G2), each group was randomly allocated (2:1) to one of two subgroups respectively; (G1A and G2A) interventional arm received daily antioxidant therapy, while G1B and G2B; received a placebo. Both groups were compared with healthy controls (n = 39). The primary efficacy endpoints were the difference in the change from baseline to 6 month in ITP specific bleeding assessment tool (ITP-BAT), PC, total antioxidant capacity (TAC), catalase (CAT), reduced glutathione (GSH) and serum malondialdehyde (MDA). RESULTS: Baseline TAC was significantly lower in patients with (ND) ITP compared to patients with chronic ITP (P < 0.05), both showed significantly lower levels than healthy controls (P < 0.001). At end of study both BS and PC significantly improved in patients receiving antioxidant compared to placebo (P < 0.05). Patients with chronic ITP receiving antioxidant showed better improvement. CONCLUSION: Reduced antioxidant mechanisms were reported in patients with ITP. Antioxidant therapy ameliorated the oxidative stress in both ND and chronic ITP groups which might explain the improvement in both BS and PC.
