Dano hepático induzido por medicamentos: estudo de concordância diagnóstica das escalas Rucam, Maria & Victorino e Naranjo

• Autor(a) principal: Rego, Patricia da Silva
• Data de Publicação: 2010
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Biblioteca Digital de Teses e Dissertações da UERJ
• Texto Completo: http://www.bdtd.uerj.br/handle/1/4450
• topic: Liver Injury; Drug; Scales; DILI; Agreement; Dano Hepático; Medicamento; Escalas; Concordância; RAM; CNPQ::CIENCIAS DA SAUDE::SAUDE COLETIVA

ADR (Adverse Drug Reaction) is defined as a response to a drug that is noxious and unintended. Drug induced liver injury (DILI) is a type of ADR that can be very severe and result in liver failure and death. The lack of specific biomarkers or diagnostic tests for DILI led to the development of numeric scales to assess the imputability of drug in DILI cases. The aim of this present work was to describe the types of DILI and assess the agreement of three scales used for its identification: RUCAM, Maria & Victorino and Naranjo. It is a sectional study was conducted at a university hospital in Rio de Janeiro. The target population was composed of 230 inpatients between June 2006 and November 2007, who had liver injury classified according to the criteria of CIOMS (Council for Internacional Organizations of Medical Science) that consider the results of liver tests and the enzyme levels. With the use of CIOMS criteria and after the exclusion of alternative causes of liver injury, 41 inpatients were identified as suspected DILI cases. Drug causality was assessed through the use of specific scales to study cases of hepatotoxicity, RUCAM and Maria & Victorino, and with Naranjo scale, used in the evaluation of any type of ADR. Kappa statistical test was used to assess the agreement between the scales. Twenty-three men and 18 were women were evaluated. The great majority of patients (87.8%) had cholestatic liver injury. All men had cholestatic liver injury, while for women, 72.2% of the cases were cholestatic, 22.2% were hepatocelular and 5.6% were mixed cases. For each suspected drug taken by the patients, the three scales were used, with a total of 166 ratings generated for each scale. The agreement between RUCAM and M & V was Кw = 0. 2492, CI 95% (0.1293 0.3617), as compared to RUCAM and Naranjo (Кw = 0.0006). The comparison between M&V and Naranjo (Кw= 0.013) showed low agreement. Results showed low agreement between the scales used for the diagnostic of DILI. As expected, the results were a little bit higher when assessment was made with specific scales for hepatotoxicity (RUCAM and M&V), as compared to the agreement made with these scales and the global scale Naranjo, which was designed to assess all types of RAM. The use of scales to assess hepatotoxicity are an alternative to diagnosis based only on clinical judgment. However, the low agreement between the scales shows that there are limitations in definitions and methods adopted by the scores that should be reconsidered. It is hoped that a consensus on common definitions, diagnostic criteria and terminology guide the construction of a new instrument to assess causality.