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哥伦比亚某大学医院药物性肝损伤的流行病学:前瞻性因果评估中使用更新的 RUCAM。

Epidemiology of drug-induced liver injury in a University Hospital from Colombia: Updated RUCAM being used for prospective causality assessment.

机构信息

Pharmaceutical Promotion and Prevention Research Group, University of Antioquia, Medellin, Antioquia, Colombia.

Pharmaceutical Promotion and Prevention Research Group, University of Antioquia, Medellin, Antioquia, Colombia.

出版信息

Ann Hepatol. 2019 May-Jun;18(3):501-507. doi: 10.1016/j.aohep.2018.11.008. Epub 2019 Apr 18.

Abstract

INTRODUCTION AND AIM

Epidemiological information regarding drug-induced liver injury in some Latin American countries remains limited. Therefore, disease prevention and health promotion strategies are imperative to reduce drug-induced liver injuries and its fatal outcomes. This study aimed to collect epidemiological data regarding drug-induced liver injury and identify associated factors in patients admitted to a university hospital in Colombia.

METHODS AND PATIENTS

A prospective study was conducted for 1 year to assess the incidence of drug-induced liver injury in patients aged >18 years who showed elevated values in liver tests. Data were collected after obtaining informed consent from the patients. The updated Roussel Uclaf Causality Assessment Method was applied to assess the causality of drug-induced liver injury.

RESULTS

The study included 286 patients with elevated values in liver tests, 18 of whom presented with drug-induced liver injury. The mean age of patients was 54.7±19.1 years. The associated pharmacological groups were anti-infectives and anticonvulsants (isoniazid, rifampicin, nitrofurantoin, phenytoin, and valproic acid), with a total of 15 drugs. The affected patients presented with cytopenia, jaundice, nausea, vomiting, or hepatomegaly. The most common type of liver injury was hepatocellular, and most patients recovered satisfactorily. The number of patients who had highly probable and probable causality grading was 1 and 9, respectively.

CONCLUSION

The incidence of drug-induced liver injury in a university hospital in Colombia was 6%. Comorbidities and concomitant drugs are risk factors for drug-induced liver injury.

TRIAL REGISTRATION

Registered in The Cuban Public Registry of Clinical Trials (identifier RPCEC00000242).

摘要

简介和目的

在一些拉丁美洲国家,药物性肝损伤的流行病学信息仍然有限。因此,必须制定疾病预防和健康促进策略,以减少药物性肝损伤及其致命后果。本研究旨在收集哥伦比亚一所大学医院药物性肝损伤的流行病学数据,并确定相关因素。

方法和患者

进行了为期 1 年的前瞻性研究,以评估年龄>18 岁的肝酶升高患者药物性肝损伤的发生率。在获得患者的知情同意后收集数据。应用更新的 Roussel Uclaf 因果关系评估方法评估药物性肝损伤的因果关系。

结果

该研究纳入了 286 例肝酶升高的患者,其中 18 例患有药物性肝损伤。患者的平均年龄为 54.7±19.1 岁。相关的药物学组为抗感染药和抗惊厥药(异烟肼、利福平、呋喃妥因、苯妥英和丙戊酸),共涉及 15 种药物。受影响的患者出现血细胞减少、黄疸、恶心、呕吐或肝肿大。最常见的肝损伤类型是肝细胞型,大多数患者恢复良好。具有高度可能和可能因果关系评分的患者分别为 1 例和 9 例。

结论

哥伦比亚一所大学医院药物性肝损伤的发生率为 6%。合并症和同时使用的药物是药物性肝损伤的危险因素。

试验注册

在古巴临床试验公共登记处(标识符 RPCEC00000242)注册。

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