Becker Matheus William, Schwambach Karin Hepp, Lunardelli Michele, Blatt Carine Raquel
Graduate Program in Medicine-Hepatology, Federal University of Health Sciences of Porto Alegre, Porto Alegre 90050-170, RS, Brazil.
World J Gastrointest Pharmacol Ther. 2021 May 5;12(3):40-55. doi: 10.4292/wjgpt.v12.i3.40.
Adverse drug reactions are responsible for increased costs and morbidity in the health system. Hepatotoxicity can be induced both by non-prescription drugs and by those used for chronic diseases. It is the main cause of safety-related drug marketing withdrawals and could be responsible for irreversible and fatal injuries.
To identify and to summarize Brazilian studies reporting the drug-induced liver injury.
A systematic review of Brazilian studies was carried out until June 2020. It was found 32 studies, being 10 retrospective cohorts, 12 prospective cohorts, 5 cross-sectional, 3 case-control, one case series and one randomized clinical trial. In most studies were investigated tuberculosis patients followed by other infectious conditions like human immunodeficiency virus (HIV) and hepatitis C virus. The hepatotoxicity ranged from one to 57%, led by isoniazid, rifampicin, and pyrazinamide. Few studies reported algorithm to assess causality. In most studies, there were moderate outcomes and it was necessary drug interruption. However, few severe outcomes, such as chronic liver damage and liver transplantation were reported.
Twenty-two different criteria for hepatotoxicity were found. The great heterogeneity did not allow a meta-analysis. Standardization of parameter of drug-induced liver injury and greater effort in pharmacovigilance could contribute to learn more about drug-induced liver injury (DILI)'s epidemiology in Brazil.
The development of strategic public health policies seems to have an influence on the DILI scientific evidence in Brazil due to main studies are in HIV and tuberculosis line care, two strategic health policies in Brazil.
药物不良反应会增加卫生系统的成本和发病率。非处方药和用于慢性病的药物都可能诱发肝毒性。它是与药物安全性相关的撤市的主要原因，可能导致不可逆转的致命伤害。
识别并总结巴西关于药物性肝损伤的研究。
对截至2020年6月的巴西研究进行系统综述。共找到32项研究，其中10项为回顾性队列研究，12项为前瞻性队列研究，5项为横断面研究，3项为病例对照研究，1项为病例系列研究，1项为随机临床试验。大多数研究调查的是结核病患者，其次是其他感染性疾病，如人类免疫缺陷病毒（HIV）和丙型肝炎病毒。肝毒性范围为1%至57%，主要由异烟肼、利福平和平吡嗪酰胺引起。很少有研究报告评估因果关系的算法。在大多数研究中，结果为中度，需要中断用药。然而，很少有严重后果的报告，如慢性肝损伤和肝移植。
发现了22种不同的肝毒性标准。巨大的异质性不允许进行荟萃分析。药物性肝损伤参数的标准化以及加强药物警戒工作，可能有助于更多地了解巴西药物性肝损伤（DILI）的流行病学。
由于主要研究集中在HIV和结核病一线治疗这两项巴西的战略卫生政策上，战略公共卫生政策的制定似乎对巴西DILI的科学证据产生了影响。
