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对接受特比萘芬和伊曲康唑治疗甲真菌病患者的肝酶异常情况的回顾性分析。

Retrospective Analysis of Liver Enzyme Abnormalities in Patients Prescribed Terbinafine and Itraconazole for Onychomycosis.

作者信息

Etgü Fatma

机构信息

Dermatology, Ordu University, Ordu, TUR.

出版信息

Cureus. 2023 Sep 8;15(9):e44914. doi: 10.7759/cureus.44914. eCollection 2023 Sep.

Abstract

Introduction Onychomycosis (OM) is defined as a nail fungal infection. Its prevalence increases with advancing age. Human-to-human transmission makes it a serious public health risk. Although OM is not a life-threatening disease, it has a detrimental effect on patients' quality of life. Due to the long therapy duration and potential side effects of systemic antifungal medicines, physicians may be reluctant to treat OM orally. In this study, we aimed to evaluate the effect of terbinafine and itraconazole on liver transaminases, the side effects of these treatments, and patients' adherence to systemic treatment of OM. Methods This is a retrospective study conducted in our dermatology department (Ordu University, Ordu) between June 2020 and October 2021. Hospital records were analyzed, and patients with the diagnosis of tinea unguium (ICD code B35.1) were investigated. Patients who were prescribed terbinafine or itraconazole were included in the study. Following a clinical diagnosis of OM, the researchers first tried to confirm it through direct microscopic examination with potassium hydroxide (KOH). If the direct microscopic examination was negative but the suspicion about OM continued, confirmation was done through a fungal culture. Results This study included 735 patients, of whom 409 (55.6%) were female and 326 (44.4%) were male. The research covered all of the patients who were given one of these two medications. To find patients who could apply to other hospitals, the Turkish National Healthcare System was checked in addition to hospital information. To identify patients who could apply to other healthcare institutions, all hospitals share their data with this national healthcare system. Terbinafine was used by 433 patients (76.4%), 75 patients (13.2%), and 37 patients (6.5%), respectively, for one, two, and three months. A total of 119 patients (70.8%) took itraconazole for a month, 32 patients (19%) took it for two months, and four patients (2.33%) took it for three months. At the end of the first month, the proportion of the patients with elevated aspartate transaminase (AST) levels was 5.2% for terbinafine and 0% for itraconazole. Eighteen (8.4%) patients with terbinafine had elevated alanine aminotransferase (ALT) levels, and four patients (7.5%) who were on itraconazole treatment had high ALT levels. None of the patients reported cutaneous adverse drug reactions, gastrointestinal disturbances, or headaches due to OM treatment. Also, no patients discontinued treatment because of hepatotoxicity. Conclusion In this study, none of the patients discontinued the treatment because of hepatotoxicity. According to the results of this study, oral terbinafine and itraconazole can be used with close follow-up. Baseline and regular laboratory monitoring for AST and ALT should be done to monitor liver toxicity with terbinafine and itraconazole. Besides, we did not observe other side effects like cutaneous or cardiac side effects or drug-drug interactions.

摘要

引言

甲癣(OM)被定义为一种指甲真菌感染。其患病率随年龄增长而增加。人际传播使其成为严重的公共卫生风险。尽管甲癣并非危及生命的疾病,但它对患者的生活质量有不利影响。由于全身用抗真菌药物治疗疗程长且有潜在副作用,医生可能不愿口服治疗甲癣。在本研究中,我们旨在评估特比萘芬和伊曲康唑对肝转氨酶的影响、这些治疗的副作用以及患者对甲癣全身治疗的依从性。

方法

这是一项于2020年6月至2021年10月在我们皮肤科(ordu大学,ordu)进行的回顾性研究。分析医院记录,并对诊断为甲癣(ICD编码B35.1)的患者进行调查。开具特比萘芬或伊曲康唑的患者纳入研究。在临床诊断为甲癣后,研究人员首先尝试通过氢氧化钾(KOH)直接显微镜检查来确诊。如果直接显微镜检查为阴性但对甲癣的怀疑仍然存在,则通过真菌培养进行确诊。

结果

本研究纳入735例患者,其中409例(55.6%)为女性,326例(44.4%)为男性。该研究涵盖了所有接受这两种药物之一治疗的患者。为了找到可能转至其他医院就诊的患者,除了医院信息外,还查询了土耳其国家医疗保健系统。为了识别可能转至其他医疗机构的患者,所有医院都与这个国家医疗保健系统共享其数据。433例(76.4%)患者使用特比萘芬,分别为1个月、2个月和3个月的患者有75例(13.2%)和37例(6.5%)。共有119例(70.8%)患者服用伊曲康唑1个月,32例(19%)服用2个月,4例(2.33%)服用3个月。在第一个月末,特比萘芬组天冬氨酸转氨酶(AST)水平升高的患者比例为5.2%,伊曲康唑组为0%。18例(8.4%)使用特比萘芬的患者丙氨酸转氨酶(ALT)水平升高,4例(7.5%)接受伊曲康唑治疗的患者ALT水平升高。没有患者报告因甲癣治疗出现皮肤药物不良反应、胃肠道不适或头痛。此外,没有患者因肝毒性而停药。

结论

在本研究中,没有患者因肝毒性而停药。根据本研究结果,口服特比萘芬和伊曲康唑可在密切随访下使用。应进行基线和定期实验室监测AST和ALT,以监测特比萘芬和伊曲康唑的肝毒性。此外,我们未观察到其他副作用,如皮肤或心脏副作用或药物相互作用。

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