Chun-Kai Huang , Jei-Yie Huang , Chin-Hao Chang , Shang-Jie Tsai , Chin-Chung Shu , Hao-Chien Wang , Kuo-Liong Chien
{"title":"他汀类药物对活动性肺结核患者中抗结核药物诱发肝损伤风险的影响:一项队列研究","authors":"Chun-Kai Huang , Jei-Yie Huang , Chin-Hao Chang , Shang-Jie Tsai , Chin-Chung Shu , Hao-Chien Wang , Kuo-Liong Chien","doi":"10.1016/j.jmii.2024.04.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Tuberculosis (TB) remains prevalent worldwide, and anti-TB drugs are associated with drug-induced liver injury (DILI). Statins have pleiotropic effects which may decrease inflammation and achieve immunomodulation. However, few studies have investigated the pleiotropic effects of statins on the risk of DILI. The purpose of this study was to investigate whether statins prevent anti-tuberculosis DILI among active TB patients on standard anti-TB drug therapy.</p></div><div><h3>Methods</h3><p>We conducted a hospital-based retrospective cohort study using claims data from the Integrated Medical Database of National Taiwan University Hospital (NTUH-iMD). Patients with a positive TB culture were included. The use of statins was defined as a daily equivalent dose >0.5 mg of pitavastatin. Deterioration in liver function was evaluated according to elevated liver enzyme levels. The primary and secondary endpoints were the DILI and the severe DILI. The prognostic value of statins was evaluated by Kaplan–Meier analysis, and Cox proportional hazards models.</p></div><div><h3>Results</h3><p>A total of 1312 patients with a diagnosis of TB and receiving anti-TB treatment were included. During the study period, 193 patients had the DILI and 140 patients had the severe DILI. Kaplan–Meier analysis showed a significant difference between the usual statin users and controls in the DILI. In multivariable Cox proportional hazards analysis, statins showed a protective effect against the primary and secondary endpoints. In addition, the protective effect of statins showed a dose–response relationship against the DILI.</p></div><div><h3>Conclusion</h3><p>Statin treatment had a protective effect against the risk of anti-TB DILI with a positive dose–response relationship.</p></div>","PeriodicalId":56117,"journal":{"name":"Journal of Microbiology Immunology and Infection","volume":"57 3","pages":"Pages 498-508"},"PeriodicalIF":4.5000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1684118224000690/pdfft?md5=65ba8eee4a37c1368e9443e571837c9f&pid=1-s2.0-S1684118224000690-main.pdf","citationCount":"0","resultStr":"{\"title\":\"The effect of statins on the risk of anti-tuberculosis drug-induced liver injury among patients with active tuberculosis: A cohort study\",\"authors\":\"Chun-Kai Huang , Jei-Yie Huang , Chin-Hao Chang , Shang-Jie Tsai , Chin-Chung Shu , Hao-Chien Wang , Kuo-Liong Chien\",\"doi\":\"10.1016/j.jmii.2024.04.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Tuberculosis (TB) remains prevalent worldwide, and anti-TB drugs are associated with drug-induced liver injury (DILI). Statins have pleiotropic effects which may decrease inflammation and achieve immunomodulation. However, few studies have investigated the pleiotropic effects of statins on the risk of DILI. The purpose of this study was to investigate whether statins prevent anti-tuberculosis DILI among active TB patients on standard anti-TB drug therapy.</p></div><div><h3>Methods</h3><p>We conducted a hospital-based retrospective cohort study using claims data from the Integrated Medical Database of National Taiwan University Hospital (NTUH-iMD). Patients with a positive TB culture were included. The use of statins was defined as a daily equivalent dose >0.5 mg of pitavastatin. Deterioration in liver function was evaluated according to elevated liver enzyme levels. The primary and secondary endpoints were the DILI and the severe DILI. The prognostic value of statins was evaluated by Kaplan–Meier analysis, and Cox proportional hazards models.</p></div><div><h3>Results</h3><p>A total of 1312 patients with a diagnosis of TB and receiving anti-TB treatment were included. During the study period, 193 patients had the DILI and 140 patients had the severe DILI. Kaplan–Meier analysis showed a significant difference between the usual statin users and controls in the DILI. In multivariable Cox proportional hazards analysis, statins showed a protective effect against the primary and secondary endpoints. In addition, the protective effect of statins showed a dose–response relationship against the DILI.</p></div><div><h3>Conclusion</h3><p>Statin treatment had a protective effect against the risk of anti-TB DILI with a positive dose–response relationship.</p></div>\",\"PeriodicalId\":56117,\"journal\":{\"name\":\"Journal of Microbiology Immunology and Infection\",\"volume\":\"57 3\",\"pages\":\"Pages 498-508\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1684118224000690/pdfft?md5=65ba8eee4a37c1368e9443e571837c9f&pid=1-s2.0-S1684118224000690-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Microbiology Immunology and Infection\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1684118224000690\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Microbiology Immunology and Infection","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1684118224000690","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
结核病(TB)在全球范围内仍然普遍存在,而抗结核药物与药物性肝损伤(DILI)有关。他汀类药物具有多效应,可减少炎症并实现免疫调节。然而,很少有研究调查他汀类药物对 DILI 风险的多效应。本研究旨在调查他汀类药物是否能预防接受标准抗结核药物治疗的活动性肺结核患者的抗结核 DILI。我们利用台湾大学医院综合医疗数据库(NTUH-iMD)中的理赔数据,开展了一项基于医院的回顾性队列研究。研究纳入了结核菌培养呈阳性的患者。他汀类药物的使用定义为每日等效剂量大于 0.5 毫克匹伐他汀。肝功能恶化根据肝酶水平升高进行评估。主要和次要终点分别为DILI和严重DILI。他汀类药物的预后价值通过 Kaplan-Meier 分析和 Cox 比例危险模型进行评估。研究共纳入了 1312 名确诊为肺结核并正在接受抗结核治疗的患者。在研究期间,193 名患者出现了 DILI,140 名患者出现了严重的 DILI。卡普兰-梅耶尔分析显示,通常使用他汀类药物的患者与对照组在DILI方面存在显著差异。在多变量考克斯比例危险分析中,他汀类药物对主要和次要终点均有保护作用。此外,他汀类药物对 DILI 的保护作用呈现剂量反应关系。他汀类药物治疗对抗结核 DILI 风险具有保护作用,且剂量与反应呈正相关。
The effect of statins on the risk of anti-tuberculosis drug-induced liver injury among patients with active tuberculosis: A cohort study
Background
Tuberculosis (TB) remains prevalent worldwide, and anti-TB drugs are associated with drug-induced liver injury (DILI). Statins have pleiotropic effects which may decrease inflammation and achieve immunomodulation. However, few studies have investigated the pleiotropic effects of statins on the risk of DILI. The purpose of this study was to investigate whether statins prevent anti-tuberculosis DILI among active TB patients on standard anti-TB drug therapy.
Methods
We conducted a hospital-based retrospective cohort study using claims data from the Integrated Medical Database of National Taiwan University Hospital (NTUH-iMD). Patients with a positive TB culture were included. The use of statins was defined as a daily equivalent dose >0.5 mg of pitavastatin. Deterioration in liver function was evaluated according to elevated liver enzyme levels. The primary and secondary endpoints were the DILI and the severe DILI. The prognostic value of statins was evaluated by Kaplan–Meier analysis, and Cox proportional hazards models.
Results
A total of 1312 patients with a diagnosis of TB and receiving anti-TB treatment were included. During the study period, 193 patients had the DILI and 140 patients had the severe DILI. Kaplan–Meier analysis showed a significant difference between the usual statin users and controls in the DILI. In multivariable Cox proportional hazards analysis, statins showed a protective effect against the primary and secondary endpoints. In addition, the protective effect of statins showed a dose–response relationship against the DILI.
Conclusion
Statin treatment had a protective effect against the risk of anti-TB DILI with a positive dose–response relationship.
期刊介绍:
Journal of Microbiology Immunology and Infection is an open access journal, committed to disseminating information on the latest trends and advances in microbiology, immunology, infectious diseases and parasitology. Article types considered include perspectives, review articles, original articles, brief reports and correspondence.
With the aim of promoting effective and accurate scientific information, an expert panel of referees constitutes the backbone of the peer-review process in evaluating the quality and content of manuscripts submitted for publication.