Combined therapy with Cortexin and Citicoline for cognitive and astheno-depressive disorders after gunshot-induced spinal cord injury

Objective. To evaluate the efficacy and safety of combination therapy with Cortexin and Citicoline in patients with cognitive and astheno-depressive disorders resulting from gunshot spinal cord injury (SCI). Additionally, a comparative analysis of therapeutic efficacy was conducted based on the degree of neurological deficit as measured by the ASIA scale. Material and methods. The «Phoenix» prospective, open-label, longitudinal, comparative clinical study enrolled 60 patients aged 18—55 years undergoing the second stage of medical rehabilitation. Participants were assigned to four groups based on the severity of neurological deficit (ASIA A and ASIA C) and the therapy administered. Outcomes were measured using the MoCA, HDRS-17, asthenic state scale (ASS), HADS, VAS, and MAS questionnaires on Days 1, 15±2, 30±2, and 90±7. The study groups received combined neuro-metabolic therapy: Cortexin 10 mg intramuscularly once daily for 10 days and Recognan (citicoline) oral solution 1000 mg/day (10 mL) for 30 days. The comparison groups received standard therapy, which included pharmacological management of anxiety and depressive disorders as indicated, therapeutic exercises, physiotherapy, massage, and supportive treatment. Results. In patients with ASIA A severity of SCI, by Day 90, the median increase in MoCA score was 2 [1.75; 3.25] points in the combination therapy group, compared to 1.5 [1; 2] points in the comparison group. The decrease in HDRS-17 score was –10 [–12.25; –9] points versus –5 [–5.75; –2] points, and the decrease in ASS score was –33 [–34.25; –31.75] points versus –26 [–26; –25] points, respectively. A clinically significant reduction in HDRS-17 scores (≥50% from baseline) was achieved in 90% of patients in the combination therapy group and 20% in the comparison group. Among patients with ASIA C severity of SCI, the median increase in MoCA score was 2 [2; 3] points in the combination therapy group versus 1.5 [1; 2] points in the control group. HDRS-17 scores decreased by –12.5 [–14; –9] points versus –8 [–8.75; –6.25] points, and ASS scores decreased by –31 [–32; –30] points versus –22 [–23.75; –22] points, respectively. No serious adverse events were reported. Conclusions. Combined neurometabolic therapy may represent a promising component of comprehensive medical rehabilitation for patients with sequelae of SCIs who present with cognitive and emotional impairments.