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dc.contributor.authorNiu, Hao
dc.contributor.authorSanabria-Cabrera, Judith
dc.contributor.authorAlvarez-Alvarez, Ismael
dc.contributor.authorRobles-Diaz, Mercedes
dc.contributor.authorStankeviciute, Simona
dc.contributor.authorAithal, Guruprasad P
dc.contributor.authorBjornsson, Einar S
dc.contributor.authorAndrade-Bellido, Raul Jesus 
dc.contributor.authorLucena, M Isabel
dc.contributor.authorSanabria-Cabrera, Judith
dc.date.accessioned2021-12-21T12:19:18Z
dc.date.available2021-12-21T12:19:18Z
dc.date.created2021-12-21
dc.date.issued2021-02
dc.identifier.citationNiu H, Sanabria-Cabrera J, Alvarez-Alvarez I, Robles-Diaz M, Stankevičiūtė S, Aithal GP, Björnsson ES, Andrade RJ, Lucena MI. Prevention and management of idiosyncratic drug-induced liver injury: Systematic review and meta-analysis of randomised clinical trials. Pharmacol Res. 2021 Feb;164:105404. doi: 10.1016/j.phrs.2020.105404.es_ES
dc.identifier.urihttps://hdl.handle.net/10630/23498
dc.description.abstractConducting randomised clinical trials (RCTs) in idiosyncratic drug-induced liver injury (DILI) is challenging. This systematic review aims to summarise the design and findings of RCTs in the prevention and management of idiosyncratic DILI. A systematic literature search up to January 31st, 2020 was performed. Recognised scales were used to assess methodological bias and quality of the studies. Quantitative and qualitative analyses were performed. Heterogeneity was assessed with I2 statistic. Overall, 22 RCTs were included: 12 on prevention (n = 2,471 patients) and 10 in management (n = 797) of DILI/non-acetaminophen DILI-related acute liver failure (ALF). Silymarin (eight studies), bicyclol (four), magnesium isoglycyrrhizinate (three), N-acetylcysteine (three), tiopronin (one), L-carnitine (one), and traditional Chinese medicines (two) were tested in the intervention arm, while control arm mostly received standard supportive care or placebo. Main efficacy criteria in the prevention RCTs was DILI incidence or peak of liver enzymes value. In management RCTs, the efficacy parameter was usually 50 % decrease or normalisation of liver enzymes, or survival rate in DILI-related ALF patients. Overall, 15 trials described the randomisation method, eight were double-blind (n = 672) and nine had sample size esti- mation (n = 880). Four RCTs involving 377 patients used an intention-to-treat analysis. Based on the scarce number of trials available, tested agents showed limited efficacy in DILI prevention and management and a favourable safety profile. In conclusion, heterogeneity among studies in DILI case qualification and methodologic quality was evident, and the RCTs performed demonstrated limited efficacy of specific interventions. Interna- tional research networks are needed to establish a framework on RCTs design and therapeutic endpoints.es_ES
dc.description.sponsorshipThis work was supported by grants of Instituto de Salud Carlos III cofounded by Fondo Europeo de Desarrollo Regional - FEDER (contract numbers: PI18/00901; PI18/01804; PT17/0017/0020; PT 20/00127) and Agencia Espan ̃ola del Medicamento. Plataforma de Investigacio ́n Clínica and CIBERehd are funded by ISCIII. MRD holds a Joan Rodes (JR16/00015)/Accio ́n B clinicos investigadores (B-0002-2019), JSC a Rio Hortega (CM17/00243) and IAA a Sara Borrell (CD20/00083) research contract from ISCIII and Consejería de Salud de Andalucía. This publication is based upon work from COST Action “CA17112 - Pro- spective European Drug-Induced Liver Injury Network” supported by COST (European Cooperation in Science and Technology). www.cost.eues_ES
dc.language.isoenges_ES
dc.publisherElsevieres_ES
dc.rightsinfo:eu-repo/semantics/openAccesses_ES
dc.subjectHígado -- Enfermedadeses_ES
dc.subjectEnsayos clínicoses_ES
dc.subject.otherMedicamentoses_ES
dc.subject.otherPrevenciónes_ES
dc.subject.otherHigadoes_ES
dc.subject.otherEnfermedadeses_ES
dc.titlePrevention and management of idiosyncratic drug-induced liver injury: Systematic review and meta-analysis of randomised clinical trialses_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.centroFacultad de Medicinaes_ES
dc.identifier.doi10.1016/j.phrs.2020.105404
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersiones_ES


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