Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series.
| Autor: | Vester JC; Department of Biometry and Clinical Research, idv Data Analysis and Study Planning, Gauting, Germany., Buzoianu AD; Department of Pharmacology, Toxicology and Clinical Pharmacology, 'Iuliu Hatieganu' University of Medicine and Pharmacy, Cluj-Napoca, Romania., Florian SI; Department of Neurosciences, 'Iuliu Hatieganu' University of Medicine and Pharmacy, Cluj-Napoca, Romania., Hömberg V; Department of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany., Kim SH; Department of Neurosurgery, Ajou University School of Medicine, Suwon, South Korea., Lee TMC; State Key Laboratory of Brain and Cognitive Sciences, the University of Hong Kong, Hong Kong, China., Matula C; Department of Neurosurgery, Medical University of Vienna, Vienna, Austria., Poon WS; Division of Neurosurgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong, China., Sandesc D; Department of Anesthesia and Intensive Care, 'V. Babes' University of Medicine and Pharmacy, Timisoara, Romania., von Steinbüchel N; Institute of Medical Psychology and Medical Sociology, University Medical Centre Göttingen, Göttingen, Germany., Strilciuc S; Department of Neurosciences, 'Iuliu Hatieganu' University of Medicine and Pharmacy, Cluj-Napoca, Romania.; RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 400487, Cluj-Napoca, Cluj, Romania., Vos PE; Department of Neurology, Slingeland Hospital, Doetinchem, The Netherlands., von Wild K; Medical Faculty, Westphalia Wilhelm's University, Münster, Germany., Muresanu D; Department of Neurosciences, 'Iuliu Hatieganu' University of Medicine and Pharmacy, Cluj-Napoca, Romania. dafinm@ssnn.ro.; RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 400487, Cluj-Napoca, Cluj, Romania. dafinm@ssnn.ro. |
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| Jazyk: | angličtina |
| Zdroj: | Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology [Neurol Sci] 2021 Nov; Vol. 42 (11), pp. 4531-4541. Date of Electronic Publication: 2021 Feb 23. |
| DOI: | 10.1007/s10072-020-04974-6 |
| Abstrakt: | Introduction: This prospective meta-analysis summarizes results from the CAPTAIN trial series, evaluating the effects of Cerebrolysin for moderate-severe traumatic brain injury, as an add-on to usual care. Materials and Methods: The study included two phase IIIb/IV prospective, randomized, double-blind, placebo-controlled clinical trials. Eligible patients with a Glasgow Coma Score (GCS) between 6 and 12 received study medication (50 mL of Cerebrolysin or physiological saline solution per day for ten days, followed by two additional treatment cycles with 10 mL per day for 10 days) in addition to usual care. The meta-analysis comprises the primary ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses based on multivariate, directional tests. Results: A total 185 patients underwent meta-analysis (mean admission GCS = 10.3, mean age = 45.3, and mean Baseline Prognostic Risk Score = 2.8). The primary endpoint, a multidimensional ensemble of functional and neuropsychological outcome scales indicated a "small-to-medium" sized effect in favor of Cerebrolysin, statistically significant at Day 30 and at Day 90 (Day 30: MW Discussion: The meta-analysis of the CAPTAIN trials confirms the safety and efficacy of Cerebrolysin after moderate-severe TBI, opening a new horizon for neurorecovery in this field. Integration of Cerebrolysin into existing guidelines should be considered after careful review of internationally applicable criteria. (© 2021. Fondazione Società Italiana di Neurologia.) |
| Databáze: | MEDLINE |
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