Efficacy of L-carnitine (ELCAR®) therapy for perinatal pathology of the nervous system and maladaptation disorders of the heart in newborns

Maladaptation circulatory disorders associated with intrauterine hypoxia are a predictor of the development of cardiovascular pathology (rhythm disturbances, vascular dystonia, etc.) in subsequent age periods, therefore, the search for safe and effective medicines that have an anti-ischemic, antioxidant, positive hemodynamic effect, reducing the electrical instability of the myocardium and stabilizing the autonomic system during the newborn period is relevant. The aim of the study was to evaluate the safety andeffectiveness of levocarnitine in the complex treatment of newborns with perinatal pathology of the nervous system and with posthypoxic cardiopathy. An open simple comparative controlled study of the effectiveness of the drug L-carnitine Elkar® (PIK-PHARMA LLC, Moscow) was conducted. The study included 128 newborns (52 boys and 76 girls) who were hospitalized in neonatal pathology departments. The examination included neurosonography, electrocardiography, echocardiography in dynamics. Therapeutic efficacy and tolerability of the drug L-carnitine Elkar® was assessed according to the dynamics of clinical signs, changes in the parameters of the functioning of the autonomic nervous and cardiovascular system, the results of neurosonography conducted before and after the end of the course of treatment, as well as in dynamics after 12 months. According to repeated neurosonographic studies, after a course of treatment with L-carnitine Elkar®, 65,7% of newborns showed a decrease in the severity of ischemia in the periventricular areas, the number of children with signs of periventricular leukomalacia decreased 2,3 times, intracranial hemorrhages were recorded 1,5 times less. A distinct positive effect was noted, confirmed by ECG studies (restoration of normal rhythm, metabolic processes, stabilization of myocardial repolarization processes), positive dynamics of linear indicators of chronotropic heart function, indicators of heart rate dispersion in 71.42% of newborns (p ˂ 0.05) receiving levocarnitine. The drug L-carnitine Elkar® (PIK-PHARMA LLC, Moscow) meets all the requirements of pharmacology, is convenient to use, is an effective, safe, and universal remedy for the treatment of perinatal central nervous system damage, as well as diseases of the cardiovascular system, which are based on hypoxic disorders and vegetative dysfunction.

1. Palchik A. B., Shabalov N. P. Gipoksicheski-ishemicheskaya entsefalopatiya novorozhdennykh [Hypoxic-ischemic encephalopathy of newborns]. 4th edition, revised and enlarged. Moscow, MEDpress-inform Publ., 2013, 288 p.

2. Galaktionova M.Yu., Osadtsiva E.A. Perinatal'nyye porazheniya nervnoy sistemy u detey i ikh posledstviya: podkhody k terapii [Perinatal lesions of the nervous system in children and their consequences: approaches to therapy]. Voprosy prakticheskoy pediatrii — Clinical Practice in Pediatrics, 2013, no.8(2), pp.23–29.

3. Neudakhin E.V. Rol' levokarnitina v reabilitatsii detey s perinatal'noy patologiyey [The role of levocarnitine in the rehabilitation of children with perinatal pathology]. Pediatriya — Pediatrics. Supplement to the journal Consilium Medicum, 2019, no.3, pp.115–121. doi: 10.26442/26586630.2019.3.190625

4. Ravarino A., Marcialis M. A., Pintus M. C., et al. Cerebral hypoxia and ischemia in preterm infants. J. Pediatr. Neonat. Individual. Med., 2014, vol.3(2), article no.e030272. doi: https://doi.org/10.7363/030272

5. Garina S.V., Balykova I.S., Belkina N.R., et al. Postgipoksicheskaya kardiopatiya u novorozhdonnykh: novyye vozmozhnosti lecheniya [Posthypoxic cardiopathy in newborns: new treatment options]. Pediatriya. Zhurnal im. G.N. Speranskogo — the Journal "Pediatria" named after G.N. Speransky, 2017, no.96(1), pp.28–36.

6. Valiulina A.Yа., Akhmadeyeva E.N., Kryvkina N.N. Problemy i perspektivy uspeshnogo vykhazhivaniya i reabilitatsii detey, rodivshikhsya s nizkoy i ekstremal'no nizkoy massoy tela [The problems and perspectives of successful resuscitation and rehabilitation children born with low and extremely low birth weight]. Vestnik Sovremennoy Klinicheskoy Mediciny — The Bulletin of Contemporary Clinical Medicine, 2013, no.6(1), pp.34–41.

7. Tumaeva T.S., Balykova L.A., Naumenko E.I., Shamova N.N. Neirovegetativnaia reguliatsiia serdechnogo ritma u nedonoshennykh detei, rozhdennykh kesarevym secheniem: kliniko-instrumental'nye osobennosti, vozmozhnosti medikamentoznoi korrektsii [Neurovegetative regulation of heart rate in premature babies born by caesarean section: clinical and instrumental features, the possibility of drug correction]. Pediatriya. Zhurnal im. G.N. Speranskogo — The Journal "Pediatria" named after G.N. Speransky, 2017, no.96(3), pp.8–15. doi: https://doi.org/10.24110/0031-403X-2017-96-3-8-15

8. Bazhenova L.K., Bukeir A., Narogan M.V. Lecheniye postgipoksicheskoy kardiopatii u novorozhdennykh na vtorom etape vykhazhivaniya [Treatment of posthypoxic cardiopathy in newborns at the second stage of nursing]. Pediatricheskaya Farmakologiya — Pediatric Pharmacology, 2003, no.1(3), pp.57–59.

9. Balykova L.A., Garina S.V., Nazarova I.S., Burenina L.V. Otsenka effektivnosti primeneniya El'kara (L-karnitin) u nedonoshennykh novorozhdennykh [Evaluation of the effectiveness of the use of Elkar (L-carnitine) in premature infants]. Vestnik Mordovskogo universiteta — Mordovia University Bulletin, 2016, no.26(2), pp.168–179. doi: https://doi.org/10.15507/0236-2910.026.201602.168-179

10. Uzunova A.N., Nazarova M.V. Vliyaniye levokarnitina v sostave kompleksnoy terapii na vegetativnuyu regulyatsiyu funktsii serdechno-sosudistoy sistemy u detey, perenesshikh tserebral'nuyu ishemiyu, v dinamike pervogo goda zhizni [The effect of levocarnitine as part of complex therapy on the autonomic regulation of the function of the cardiovascular system in children with cerebral ischemia in the dynamics of the first year of life]. Pediatriya — Pediatrics. Supplement to the journal Consilium Medicum, 2018, no.3, pp.34–39. doi: https://doi.org/10.26442/2413-8460_2018.3.34-39

11. Brin I.L., Dunaikin M.L., Lisitsina S.V. Problemy dozirovaniya preparatov karnitina v detskom vozraste [Problems in the dosing of carnitine drugs in childhood]. Rossiyskiy Vestnik Perinatologii i Pediatrii — Russian Bulletin of Perinatology and Pediatrics, 2014, no.4(59), pp.16–22.

12. Dumova S.V., Chugunova O.L. Korrektsiya vnutrikletochnogo energoobmena u nedonoshennykh novorozhdennykh detey s zaderzhkoy vnutriutrobnogo razvitiya [Correction of intracellular energy transfer in preterm newborns with intrauterine growth retardation]. Pediatriya. Zhurnal im. G.N. Speranskogo — The Journal "Pediatria" named after G.N. Speransky, 2016, no.95, pp.17–23.

13. Makarov L.M. EKG v pediatrii [ECG in pediatrics]. 3rd ed. Moscow, Med-praktika Publ., 2013. 696 p.

14. Belozerov Yu. M., Potyliko G. N., Bolbikov V. V., Gnusaev S. F. Ul'trazvukovaia semiotika i diagnostika v kardiologii detskogo vozrasta [Ultrasound semiotics and diagnostics in pediatric cardiology]. Moscow, Meditsinskie komp'iuternye sistemy Publ., 1995. 190 p.

15. Clark R. H., Chace D. H., Spitzer A. R. Impact of L-carnitine supplementation on metabolic profiles in premature infants. Journal of Perinatology, 2017, vol.37(5), pp.566–571. doi: https://doi.org/10.1038/jp.2016.253

16. Alyamovskaya G.A., Zolkina I.V., Keshishian E.S. Vtorichnaya karnitinovaya nedostatochnost' u nedonoshennykh detey s massoy tela pri rozhdenii meneye 1500 g v patogeneze energeticheskogo defitsita na pervom-vtorom godu zhizni i vozmozhnosti yeye korrektsii [Secondary carnitine deficiency in low birth weight (less than 1500 g) premature infants in the pathogenesis of energy deficiency during their first-second years of life and possibilities of its correction]. Rossiyskiy Vestnik Perinatologii i Pediatrii — Russian Bulletin of Perinatology and Pediatrics, 2012, no.4(2), pp.126–131.

17. Tumaeva T.S., Balykova L.A., Piksaykina O.A., Garina S.V., Tishkova O.E. Nedonoshennyye deti, rozhdennyye posredstvom kesareva secheniya: dinamika sostoyaniya v rannem vozraste pri ispol'zovanii v sostave kompleksnoy terapii preparata levokarnitina [Premature infants born by caesarean section: health dynamics in early childhood when using a levocarnitine as part of complex therapy]. Voprosy prakticheskoy pediatrii — Clinical Practice in Pediatrics, 2016, no.11(2), pp.31–37. doi: https://doi.org/10.20953/1817-7646-2016-2-31-37

18. Baedilova M.T., Sumenko V.V., Sukhorukov V.S., Lebedkova S.E., Trusova O.V. Effektivnost' energotropnoy terapii pri narushenii kletochnogo energoobmena u detey s prolapsom mitral'nogo klapana [Efficiency of energy-rich therapy for cellular energy metabolic disturbances in children with mitral valve prolapse]. Rossiyskiy Vestnik Perinatologii i Pediatrii — Russian Bulletin of Perinatology and Pediatrics, 2017, no.62(1), pp.74–80. doi: https://doi.org/10.21508/1027-4065-2017-62-1-74-80

19. Ledyaev M.Ya, Zayachnikova T.E. Rol' L-karnitina v lechenii postnatal'noy gipotrofii u nedonoshennykh detey posle vypiski iz neonatologicheskogo statsionara [The role of L-carnitine in the treatment of postnatal malnutrition in premature infants after discharge from a neonatal hospital]. Voprosy prakticheskoy pediatrii — Clinical Practice in Pediatrics, 2017, no.12(3), pp.7–12.