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"documento" => "article" "crossmark" => 0 "licencia" => "http://creativecommons.org/licenses/by-nc-nd/4.0/" "subdocumento" => "edi" "cita" => "Ann Hepatol. 2017;16:322-3" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:2 [ "total" => 87 "formatos" => array:3 [ "EPUB" => 24 "HTML" => 26 "PDF" => 37 ] ] "en" => array:8 [ "idiomaDefecto" => true "titulo" => "Persistence of Virologic Response after Liver Transplant in Hepatitis C Patients Treated with Ledipasvir/Sofosbuvir Plus Ribavirin Pretransplant" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "322" "paginaFinal" => "323" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Carmen Vinaixa, Marina Berenguer" "autores" => array:2 [ 0 => array:2 [ "nombre" => "Carmen" "apellidos" => "Vinaixa" ] 1 => array:2 [ "nombre" => "Marina" "apellidos" => "Berenguer" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1665268119304004?idApp=UINPBA00004N" "url" => "/16652681/0000001600000003/v1_201905301200/S1665268119304004/v1_201905301200/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "titulo" => "Prospective Indian Study of DILI with Confirmed Causality Using the Roussel Uclaf Causality Assessment Method (RUCAM): A Report of Excellence" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "324" "paginaFinal" => "325" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Rolf Teschke, Gaby Danan" "autores" => array:2 [ 0 => array:4 [ "nombre" => "Rolf" "apellidos" => "Teschke" "email" => array:1 [ 0 => "rolf.teschke@gmx.de" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "aff1" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor1" ] ] ] 1 => array:3 [ "nombre" => "Gaby" "apellidos" => "Danan" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">**</span>" "identificador" => "aff2" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Hanau, Teaching Hospital of the Medical Faculty, Goethe University Frankfurt / Main, Germany" "etiqueta" => "*" "identificador" => "aff1" ] 1 => array:3 [ "entidad" => "Pharmacovigilance Consultancy, Paris, France" "etiqueta" => "**" "identificador" => "aff2" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor1" "etiqueta" => "*" "correspondencia" => "Correspondence and reprint request:" ] ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="p0120" class="elsevierStylePara elsevierViewall">One of the highlights of this issue of <span class="elsevierStyleItalic">Annals of Hepatology</span> is the analysis of DILI cases from India by Rathi, <span class="elsevierStyleItalic">et al</span>., since all cases were prospectively evaluated with RU-CAM, the widely used tool for causality assessment worldwide. This approach provided valuable well-established results on various aspects of DILI.</p><p id="p0125" class="elsevierStylePara elsevierViewall">The study of Rathi, <span class="elsevierStyleItalic">et al.</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> from the Department of Gas-troenterology of the Lokmanya Tilak Municipal Medical College and General Hospital in Sion, Mumbai, Maharashtra in India is an outstanding report on drug induced liver injury (DILI) and will serve as a paradigm how future cases of DILI should be analyzed and prepared for publication. Their careful analysis of a 2-year single center prospective cohort study illustrates the challenging aspects of DILI and especially causality assessment.</p><p id="p0130" class="elsevierStylePara elsevierViewall">The authors Rathi, <span class="elsevierStyleItalic">et al.</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> decided to use prospectively the Roussel Uclaf Causality Assessment method (RU-CAM), a structured, standardized diagnostic approach specific to liver injury established in 1993<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">2,3</span></a> and updated in 2016.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Since its launch 25 years ago, RUCAM has been the most applied causality assessment method (CAM) for DILI and herb induced liver injury (HILI) worldwide, as evidenced by the high numbers of published epidemiological studies and case reports using this method.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Consequently, RUCAM-based results in India<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> can easily be compared with those obtained in other countries such as Iceland,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">5</span></a> Spain,<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">6</span></a> or China.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">7</span></a></p><p id="p0135" class="elsevierStylePara elsevierViewall">Because the Indian study was a prospective cohort study, the suspected DILI cases were well defined and a complete case data collection as well as causality assessment were possible while the patient was still under medical care.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> The prospective use is one of the cornerstones of RUCAM and strongly recommended.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Indeed, complete case data in the Indian study resulted in high RU-CAM scores and thereby high causality gradings among 90 patients.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> Causality was probable in 63/90 cases (70%), highly probable in 15/90 cases (18%), possible in 4/90 cases (5%), and unlikely or excluded in 8/90 cases (9%).</p><p id="p0140" class="elsevierStylePara elsevierViewall">The prospective use of RUCAM ensured early recognition of alternative causes in 8 cases of the Indian cohort study: Acute hepatitis E virus (HEV) in 3 patients, autoimmune hepatitis in 2 patients, and hepatitis A, B, and sar-coidosis in 1 patient each.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> HEV exclusion was systematically included in the investigations not only because HEV is endemic in India, but also because such exclusion is mandatory in any suspected DILI or HILI cases.<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">4,7-15</span></a> This study confirmed that alternative causes can be excluded only if the patients are correctly investigated at the early phase of the liver injury DILI<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">3,8,9</span></a> or HILI.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">10-15</span></a></p><p id="p0145" class="elsevierStylePara elsevierViewall">Most importantly, the Indian study convincingly demonstrated that for complete DILI case evaluation a prospective approach is feasible that includes the use of RUCAM with its many advantages (<a class="elsevierStyleCrossRef" href="#t0010">Table 1</a>) as compared to other CAMs.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Such prospective approach provides reliable results without the need of large costly DILI networks, dependent on subjective expert opinion.</p><elsevierMultimedia ident="t0010"></elsevierMultimedia><p id="p0150" class="elsevierStylePara elsevierViewall">The study of Rathi, <span class="elsevierStyleItalic">et al.,</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> although mainly based on cases due to antitubercular drugs, antiepileptic drugs, herbal complementary and alternative medicines, confirmed that DILI leads to overall mortality of 16% that could be predicted at the time of DILI recognition by the presence of jaundice and encephalopathy, and at one week by the presence of encephalopathy, high MELD score, and elevated alkaline phosphatase. These independent risk factors are those related to the severity of the liver injury due to any offending drug and need to be confirmed by other studies in different countries.</p><span id="s0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="st0010">Potential Competing Interests</span><p id="p0155" class="elsevierStylePara elsevierViewall">None.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "s0010" "titulo" => "Potential Competing Interests" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2017-03-18" "fechaAceptado" => "2017-03-18" "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "t0010" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "fuente" => "Compilation from a previous report.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> DILI: Drug induced liver injury. RU-CAM: Roussel Uclaf Causality Assessment Method" "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Advantages of RUCAM<ul class="elsevierStyleList" id="l0010"><li class="elsevierStyleListItem" id="u0010"><span class="elsevierStyleLabel">•</span><p id="p0010" class="elsevierStylePara elsevierViewall">Prospective use and timely decision.</p></li><li class="elsevierStyleListItem" id="u0015"><span class="elsevierStyleLabel">•</span><p id="p0015" class="elsevierStylePara elsevierViewall">Stepwise first clinical approach, followed by RU- CAM.</p></li><li class="elsevierStyleListItem" id="u0020"><span class="elsevierStyleLabel">•</span><p id="p0020" class="elsevierStylePara elsevierViewall">User-friendly and cost-saving method.</p></li><li class="elsevierStyleListItem" id="u0025"><span class="elsevierStyleLabel">•</span><p id="p0025" class="elsevierStylePara elsevierViewall">Effective use without the need of an expert panel.</p></li><li class="elsevierStyleListItem" id="u0030"><span class="elsevierStyleLabel">•</span><p id="p0030" class="elsevierStylePara elsevierViewall">Timely use at the bedside of the patient.</p></li><li class="elsevierStyleListItem" id="u0035"><span class="elsevierStyleLabel">•</span><p id="p0035" class="elsevierStylePara elsevierViewall">Clearly defined key items of clinical features and course.</p></li><li class="elsevierStyleListItem" id="u0040"><span class="elsevierStyleLabel">•</span><p id="p0040" class="elsevierStylePara elsevierViewall">Full consideration of comedication and alternative causes.</p></li><li class="elsevierStyleListItem" id="u0045"><span class="elsevierStyleLabel">•</span><p id="p0045" class="elsevierStylePara elsevierViewall">Consideration of prior known hepatotoxicity.</p></li><li class="elsevierStyleListItem" id="u0050"><span class="elsevierStyleLabel">•</span><p id="p0050" class="elsevierStylePara elsevierViewall">Incorporation of unintentional reexposure results.</p></li><li class="elsevierStyleListItem" id="u0055"><span class="elsevierStyleLabel">•</span><p id="p0055" class="elsevierStylePara elsevierViewall">Hepatotoxicity specific method.</p></li><li class="elsevierStyleListItem" id="u0060"><span class="elsevierStyleLabel">•</span><p id="p0060" class="elsevierStylePara elsevierViewall">Structured, liver related method.</p></li><li class="elsevierStyleListItem" id="u0065"><span class="elsevierStyleLabel">•</span><p id="p0065" class="elsevierStylePara elsevierViewall">Individual scoring system of all key items.</p></li><li class="elsevierStyleListItem" id="u0070"><span class="elsevierStyleLabel">•</span><p id="p0070" class="elsevierStylePara elsevierViewall">Quantitative, liver related method.</p></li><li class="elsevierStyleListItem" id="u0075"><span class="elsevierStyleLabel">•</span><p id="p0075" class="elsevierStylePara elsevierViewall">Validated method (gold standard).</p></li><li class="elsevierStyleListItem" id="u0080"><span class="elsevierStyleLabel">•</span><p id="p0080" class="elsevierStylePara elsevierViewall">Worldwide use.</p></li><li class="elsevierStyleListItem" id="u0085"><span class="elsevierStyleLabel">•</span><p id="p0085" class="elsevierStylePara elsevierViewall">Use by international registries.</p></li><li class="elsevierStyleListItem" id="u0090"><span class="elsevierStyleLabel">•</span><p id="p0090" class="elsevierStylePara elsevierViewall">Use by regulatory agencies.</p></li><li class="elsevierStyleListItem" id="u0095"><span class="elsevierStyleLabel">•</span><p id="p0095" class="elsevierStylePara elsevierViewall">Use by DILI case reports and case series.</p></li><li class="elsevierStyleListItem" id="u0100"><span class="elsevierStyleLabel">•</span><p id="p0100" class="elsevierStylePara elsevierViewall">Transparent documentation.</p></li><li class="elsevierStyleListItem" id="u0105"><span class="elsevierStyleLabel">•</span><p id="p0105" class="elsevierStylePara elsevierViewall">Possible reevaluation by peers.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Limitations of RUCAM \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="l0015"><li class="elsevierStyleListItem" id="u0110"><span class="elsevierStyleLabel">•</span><p id="p0110" class="elsevierStylePara elsevierViewall">RUCAM was not designed for suspected chronic DILI, which is mostly an unrecognized preexisting liver disease</p></li><li class="elsevierStyleListItem" id="u0115"><span class="elsevierStyleLabel">•</span><p id="p0115" class="elsevierStylePara elsevierViewall">RUCAM was also not designed when a suspected injury occurs on preexisting liver diseases, a complex condition where expert hepatologists are required.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2045027.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="sp0010" class="elsevierStyleSimplePara elsevierViewall">Advantages and limitations of RUCAM.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bs0010" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0010" "etiqueta" => "1." 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2024 November | 3 | 0 | 3 |
2024 October | 20 | 3 | 23 |
2024 September | 26 | 1 | 27 |
2024 August | 23 | 3 | 26 |
2024 July | 14 | 8 | 22 |
2024 June | 11 | 1 | 12 |
2024 May | 13 | 4 | 17 |
2024 April | 15 | 3 | 18 |
2024 March | 13 | 4 | 17 |
2024 February | 12 | 3 | 15 |
2024 January | 11 | 5 | 16 |
2023 December | 10 | 5 | 15 |
2023 November | 8 | 3 | 11 |
2023 October | 22 | 5 | 27 |
2023 September | 9 | 2 | 11 |
2023 August | 8 | 5 | 13 |
2023 July | 7 | 4 | 11 |
2023 June | 9 | 2 | 11 |
2023 May | 9 | 2 | 11 |
2023 April | 8 | 2 | 10 |
2023 March | 13 | 1 | 14 |
2023 February | 14 | 5 | 19 |
2023 January | 13 | 2 | 15 |
2022 December | 17 | 1 | 18 |
2022 November | 19 | 3 | 22 |
2022 October | 31 | 7 | 38 |
2022 September | 23 | 6 | 29 |
2022 August | 29 | 13 | 42 |
2022 July | 17 | 9 | 26 |
2022 June | 22 | 9 | 31 |
2022 May | 25 | 9 | 34 |
2022 April | 32 | 9 | 41 |
2022 March | 28 | 14 | 42 |
2022 February | 11 | 4 | 15 |
2022 January | 23 | 7 | 30 |
2021 December | 23 | 8 | 31 |
2021 November | 28 | 6 | 34 |
2021 October | 33 | 18 | 51 |
2021 September | 27 | 8 | 35 |
2021 August | 13 | 7 | 20 |
2021 July | 15 | 8 | 23 |
2021 June | 16 | 6 | 22 |
2021 May | 21 | 8 | 29 |
2021 April | 77 | 18 | 95 |
2021 March | 27 | 15 | 42 |
2021 February | 13 | 5 | 18 |
2021 January | 16 | 12 | 28 |
2020 December | 12 | 6 | 18 |
2020 November | 13 | 6 | 19 |
2020 October | 11 | 9 | 20 |
2020 September | 11 | 9 | 20 |
2020 August | 26 | 6 | 32 |
2020 July | 11 | 3 | 14 |
2020 June | 14 | 7 | 21 |
2020 May | 16 | 4 | 20 |
2020 April | 16 | 4 | 20 |
2020 March | 11 | 4 | 15 |
2020 February | 26 | 6 | 32 |
2020 January | 20 | 0 | 20 |
2019 December | 13 | 7 | 20 |
2019 November | 8 | 5 | 13 |
2019 October | 13 | 5 | 18 |
2019 September | 6 | 3 | 9 |
2019 August | 1 | 1 | 2 |
2019 July | 8 | 8 | 16 |
2019 June | 9 | 11 | 20 |
2019 May | 2 | 4 | 6 |