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Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus

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World Journal of Gastroenterology 2016年第9期22卷 2844-2854页

作者： Neal Patel Kian Bichoupan Lawrence Ku Rachana Yalamanchili Alyson Harty Donald Gardenier Michel Ng David Motamed Viktoriya Khaitova Nancy Bach Charissa Chang Priya Grewal Meena Bansal Ritu Agarwal Lawrence Liu Gene Im Jennifer Leong Leona Kim-Schluger Joseph Odin Jawad Ahmad Scott Friedman Douglas Dieterich Thomas Schiano Ponni Perumalswami Andrea Branch Division of Liver Diseases Icahn School of Medicine at Mount Sinai Recanati Miller Transplant Institute Icahn School of Medicine at Mount Sinai

AIM: To determine the safety profile of new hepatitis C virus (HCV) treatments in liver transplant (LT) recipients with recurrent HCV ***: Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events (SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIV-infected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite ***: Median age of the 42 patients was 60 years [Interquartile Range (IQR): 56-65 years], 33% (14/42) were female, 21% (9/42) were Hispanic, and 9% (4/42) were Black. The median time from transplant to treatment initiation was 5.4 years (IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62% (8/13) patients, while 54% (7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31% (95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin (OR = 0.61 per g/dL, 95%CI: 0.40-0.88, P 2, 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin (OR = 2.43 per mg/dL, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for ***: Sofosbuvir/ribavirin will continue to be used in the post-transplant population, including those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.

关键词： Hepatitis C virus Sofosbuvir Ribavirin Anemia Hepatic decompensation serious adverse event Liver transplant

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Risk assessment of the organ and tissue donation process in a regional transplant organization 17th

Risk assessment of the organ and tissue donation process in ...

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第十七届国际工效学大会暨中国人类工效学会成立20周年庆祝大会

作者： Tommaso Bellandi Riccardo Tartaglia Centre for Clinical Risk Management and Patient Safety Tuscany Region Department of Health Via Alderotti 26n

After a serious adverse event that happened in 2007 in Tuscany’s hospitals,where three recipients got HIV from a positive donor due to a system failure,the regional transplant organization was analyzed in deep in order to understand the latent factors contributing to the breakdown and to recommend improvement *** this paper we present the systematic Failure Modes and Effects Analysis applied to the organ and tissue donation process,that was part of a wider inquiry into the transplant system

关键词： Organ FAILURE MODES Tissue Donation Risk Assessment Transplants Regional Failure Mode and Effect Analysis serious adverse event system failures Risk Management

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