Nunes David Ricardo da Conceição Marçal Alves, Breton Michèle Claire, Monteiro Cristina Sofia de Jesus, Dos Santos Jorge Luiz
Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal.
CICS-UBI-Health Sciences Research Centre, Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal.
Healthcare (Basel). 2021 Nov 25;9(12):1630. doi: 10.3390/healthcare9121630.
Drug induced liver injury (DILI) is an adverse drug reaction that causes liver damage in a predictable (dose-dependent) or an unpredictable (idiosyncratic) fashion. We performed an assessment of DILI in Portugal, by analyzing the reports, sent to the Portuguese Pharmacovigilance System (PPS).
A search was performed on the PPS database, in a 10-year time frame, from 1 January 2010 to 31 December 2019.
There was not a prevalence of either sex in any age group. Most reports ( = 1120, 55.0%) belonged to patients in the age group 19-64 years old. Hepatitis ( = 626, 26.7%) was the most common adverse drug reaction in our study. Hepatotoxicity ( = 362, 15.5%) and hepatitis ( = 333, 14.2%) were more frequent in age group 19-64 years old. Cholestasis was more prevalent in adults independently of age. Hepatic fibrosis and encephalopathy were more common in the elderly. Most patients consumed between one and four suspected drugs ( = 1867, 92%). Most patients in our study evolved to "cure" ( = 796; 39%). Hepatotoxicity ( = 23; 13.8%) and hepatitis ( = 610; 25.9%) had a female predominancy while choluria ( = 8; 4.8%) and splenomegaly ( = 8; 4.8%) were of male predominance.
DILI is rare but can be fatal. As such, an active search of DILI is necessary.
药物性肝损伤（DILI）是一种不良药物反应，以可预测（剂量依赖性）或不可预测（特异质性）的方式导致肝损伤。我们通过分析发送至葡萄牙药物警戒系统（PPS）的报告，对葡萄牙的药物性肝损伤进行了评估。
在PPS数据库中进行了一项检索，时间范围为2010年1月1日至2019年12月31日的10年期间。
在任何年龄组中均无性别优势。大多数报告（n = 1120，55.0%）属于19 - 64岁年龄组的患者。肝炎（n = 626，26.7%）是我们研究中最常见的不良药物反应。肝毒性（n = 362，15.5%）和肝炎（n = 333，14.2%）在19 - 64岁年龄组中更为常见。胆汁淤积在成年人中更为普遍，与年龄无关。肝纤维化和肝性脑病在老年人中更为常见。大多数患者服用了1至4种可疑药物（n = 1867，92%）。我们研究中的大多数患者病情发展为“治愈”（n = 796；39%）。肝毒性（n = 23；13.8%）和肝炎（n = 610；25.9%）以女性为主，而胆尿（n = 8；4.8%）和脾肿大（n = 8；4.8%）以男性为主。
药物性肝损伤虽罕见但可能致命。因此，积极筛查药物性肝损伤很有必要。
