急性拉沙热治疗患者的心电图改变：尼日利亚II期临床试验结果描述

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES

Journal of Infection and Public Health Pub Date : 2025-06-02 DOI:10.1016/j.jiph.2025.102858

Cyril Erameh , Oladele Oluwafemi Ayodeji , Augusto Meneguim , Kevin Okwaraeke , Osahogie Edeawe , Enomen Ekata , ThankGod Akhigbe , Nelson Adedosu , Chukwuyem Abejegah , Sampson Owhin , Liasu Ahmed , Till Omansen , Meike Pahlmann , Georg Goliasch , Alexandre Duvignaud , Peter Akhideno , Sylvanus Okogbenin , Stephan Günther , Marie Jaspard , Michael Ramharter , Mirjam Groger

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引用次数: 0

摘要

背景拉沙病毒（LASV）导致西非住院患者的高病死率。虽然该病的病理生理学知之甚少，但心脏病理被怀疑是严重拉沙热（LF）的一个重要特征。我们报告了一项比较利巴韦林和法匹拉韦治疗LF的临床试验中患者的心电图（ECG）结果分析。方法在尼日利亚两家参考医院进行的随机对照开放标签II期临床试验，比较了favipiravir与利巴韦林治疗急性LF的耐受性、安全性和药代动力学。患有rt - pcr确诊的轻度LF的住院成人受试者符合参加研究的条件。进行基线和随访心电图读数。从2021年8月到2022年10月，40例患者被纳入研究（48例 %女性），其中36例完成了10天的随访期。心电图改变在治疗组之间的分布相似，在18名（45 %）参与者中观察到，即t波反转(n = 14；35 %)，传导障碍(n = 5；13 %)，st段抬高(n = 4；10 %)和心律失常(n = 2；5 %)。36% % （n = 9）观察到的变化在研究结束时消退。解释：在两个治疗组中观察到的心电图改变与LASV的直接心脏效应相一致。随着时间的推移，新发作的胸痛结合心电图结果的演变提示在一部分患者中发生心包炎。

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Electrocardiographic alterations in patients treated for acute Lassa Fever: Description of results from a phase II clinical trial in Nigeria

Background

Lassa virus (LASV) leads to high case fatality among hospitalized patients in West Africa. While the pathophysiology of the disease is poorly understood, cardiac pathology is suspected to constitute an important feature of severe Lassa Fever (LF). We report an analysis of electrocardiogram (ECG) findings of patients enrolled in a clinical trial comparing ribavirin with favipiravir for the treatment of LF.

Methods

This randomized controlled open-label phase II clinical trial conducted at two reference hospitals for LF treatment in Nigeria, assessed the tolerability, safety and pharmacokinetics of favipiravir compared to ribavirin in the treatment of acute LF. Hospitalized adult participants with RT-PCR-confirmed mild LF were eligible to participate. Baseline and follow-up ECG readings were performed.

Findings

From August 2021 to October 2022, 40 patients were included in the study (48 % female), and 36 completed the 10-day follow-up period. ECG alterations were similarly distributed between treatment arms and observed in 18 (45 %) participants, namely, T-wave inversion (n = 14; 35 %), conduction disorders (n = 5; 13 %), ST-segment elevation (n = 4; 10 %), and arrythmia (n = 2; 5 %). 36 % (n = 9) of the alterations observed subsided by the end of the study.

Interpretation

ECG alterations observed in both treatment arms are compatible with direct cardiac effects of the LASV. The combination of new onset of chest pain combined with the evolution of ECG findings over time are suggestive for the occurrence of perimyocarditis in a subset of patients.

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来源期刊

Journal of Infection and Public Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH -INFECTIOUS DISEASES

CiteScore

13.10

自引率

1.50%

发文量

203

审稿时长

96 days

期刊介绍： The Journal of Infection and Public Health, first official journal of the Saudi Arabian Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences and the Saudi Association for Public Health, aims to be the foremost scientific, peer-reviewed journal encompassing infection prevention and control, microbiology, infectious diseases, public health and the application of healthcare epidemiology to the evaluation of health outcomes. The point of view of the journal is that infection and public health are closely intertwined and that advances in one area will have positive consequences on the other. The journal will be useful to all health professionals who are partners in the management of patients with communicable diseases, keeping them up to date. The journal is proud to have an international and diverse editorial board that will assist and facilitate the publication of articles that reflect a global view on infection control and public health, as well as emphasizing our focus on supporting the needs of public health practitioners. It is our aim to improve healthcare by reducing risk of infection and related adverse outcomes by critical review, selection, and dissemination of new and relevant information in the field of infection control, public health and infectious diseases in all healthcare settings and the community.