Hospital Provincial del Centenario, University of Rosario School of Medicine, Urquiza 3101, 2000 Rosario, Argentina.
Hospital de Clínicas, Facultad de Medicina, UdelaR, Av Italia s/n, 11600 Montevideo, Uruguay.
Int J Mol Sci. 2016 Feb 29;17(3):313. doi: 10.3390/ijms17030313.
Drug induced liver injury (DILI) is a rare but well recognized serious adverse reaction. Pre-marketing studies may not detect liver injury, and DILI becomes very often apparent after the drug is launched to the market. Specific biomarkers for DILI prediction or diagnosis are not available. Toxic liver reactions present with a wide spectrum of phenotypes and severity, and our knowledge on the mechanisms underlying idiosyncratic reactions and individual susceptibility is still limited. To overcome these limitations, country-based registries and multicenter research networks have been created in Europe and North America. Reliable epidemiological data on DILI in Latin America (LA), a region with a large variety of ethnic groups, were however lacking. Fortunately, a LA network of DILI was set up in 2011, with the support of the Spanish DILI Registry from the University of Malaga. The primary aim of the Latin DILI Network (LATINDILIN) Registry was to prospectively identify bona fide DILI cases and to collect biological samples to study genetic biomarkers. Physicians involved in the project must complete a structured report form describing the DILI case presentation and follow-up which is submitted to a Coordinator Center in each country, where it is further assessed for completeness. During the last four years, several LA countries (Argentina, Uruguay, Chile, Mexico, Paraguay, Brazil, Ecuador, Peru, Venezuela and Colombia) have joined the network and committed with this project. At that point, to identify both our strengths and weaknesses was a very important issue. In this review, we will describe how the LATINDILI Registry was created. The aims and methods to achieve these objectives will be discussed in depth. Additionally, both the difficulties we have faced and the strategies to solve them will be also pinpointed. Finally, we will report on our preliminary results, and discuss ideas to expand and to keep running this network.
药物性肝损伤（DILI）是一种罕见但已被充分认识的严重不良反应。上市前研究可能无法检测到肝损伤，并且在药物投放市场后，DILI 经常变得明显。目前尚无用于预测或诊断 DILI 的特定生物标志物。毒性肝反应表现出广泛的表型和严重程度，我们对特异质反应和个体易感性的机制的了解仍然有限。为了克服这些限制，已在欧洲和北美创建了基于国家的登记处和多中心研究网络。然而，拉丁美洲（LA）缺乏关于 DILI 的可靠流行病学数据，该地区有多种族群体。幸运的是，2011 年在西班牙马拉加大学的 DILI 登记处的支持下，建立了一个 LA 的 DILI 网络。拉丁 DILI 网络（LATINDILIN）登记处的主要目的是前瞻性地识别真正的 DILI 病例，并收集生物样本以研究遗传生物标志物。参与该项目的医生必须填写一份描述 DILI 病例表现和随访的结构化报告表，然后将其提交给每个国家的协调中心，在那里进一步评估其完整性。在过去的四年中，一些 LA 国家（阿根廷、乌拉圭、智利、墨西哥、巴拉圭、巴西、厄瓜多尔、秘鲁、委内瑞拉和哥伦比亚）已加入该网络并承诺参与该项目。在这一点上，确定我们的优势和劣势是一个非常重要的问题。在这篇综述中，我们将描述 LATINDILI 登记处是如何创建的。我们将深入讨论实现这些目标的目的和方法。此外，我们还将指出我们所面临的困难和解决这些困难的策略。最后，我们将报告我们的初步结果，并讨论扩展和继续运行该网络的想法。
