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头孢吡肟诱导的神经毒性:一项在印度南部三级医疗机构进行的回顾性队列研究。

Cefepime-induced Neurotoxicity: A Retrospective Cohort Study in a South-Indian Tertiary Healthcare Facility.

作者信息

Alijani Erfan, Miraj Sonal Sekhar, Kurian Shilia Jacob, Rao Mahadev, Saravu Kavitha

机构信息

Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka-576104, India.

Manipal Center for Infectious Diseases, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka-576104, India.

出版信息

Curr Drug Saf. 2023;18(1):69-78. doi: 10.2174/1574886317666220309090408.

Abstract

BACKGROUND

Cefepime is a fourth-generation cephalosporin with a broad spectrum coverage and anti-pseudomonal activity. The safety profile of cefepime was relatively favourable until neurotoxicity was first reported in 1999. Despite cefepime-induced neurotoxicity (CIN), it continues to be a principal part of parenteral treatment for various infections.

OBJECTIVE

The study aimed to determine the incidence and risk factors for CIN compared to other antibiotics.

METHODS

A retrospective cohort study was conducted involving 738 patients over eight months in Kasturba Medical College and Hospital, Manipal, India. Patients with cefepime were selected as study cohort (SC; n= 496), and other antibiotics were included in the reference cohort (RC; n=242).

RESULTS

The results showed that 53 (10.7%) patients developed neurotoxicity in the SC, whereas 12 (5%) patients in the RC. A significant association was found between neurotoxicity and cefepime use (X =6.641; p=0.01). SC has a 2.29 times increased risk of neurotoxicity than RC (OR: 2.29; 95% CI: 1.2-4.38). Risk estimation showed that renal failure patients had a 5.5 times higher risk for CIN than non-renal failure patients (OR: 5.5; 95% CI: 2.98 - 10.17). CIN symptoms were disorientation (38.5%), loss of consciousness (23.1%), drowsiness (18.5%), etc. The calculated number needed to harm (NNH) for cefepime was 17.2.

CONCLUSION

The study found a higher incidence of CIN compared to other antibiotics-induced neurotoxicity and a harmful association between cefepime use and CIN development. Besides, renal failure is a risk factor for CIN. Therefore, the study warrants the use of cefepime, where no other alternatives are available.

摘要

背景

头孢吡肟是一种具有广谱抗菌活性和抗假单胞菌活性的第四代头孢菌素。在1999年首次报道神经毒性之前,头孢吡肟的安全性相对良好。尽管存在头孢吡肟诱导的神经毒性(CIN),但它仍然是各种感染肠外治疗的主要组成部分。

目的

本研究旨在确定与其他抗生素相比,CIN的发生率和危险因素。

方法

在印度马尼帕尔卡斯图尔巴医学院和医院进行了一项为期八个月的回顾性队列研究,涉及738例患者。选择使用头孢吡肟的患者作为研究队列(SC;n = 496),其他抗生素使用者纳入对照队列(RC;n = 242)。

结果

结果显示,SC组中有53例(10.7%)患者发生神经毒性,而RC组中有12例(5%)患者发生神经毒性。神经毒性与头孢吡肟的使用之间存在显著关联(X = 6.641;p = 0.01)。SC组发生神经毒性的风险比RC组高2.29倍(OR:2.29;95% CI:1.2 - 4.38)。风险评估显示,肾衰竭患者发生CIN的风险比非肾衰竭患者高5.5倍(OR:5.5;95% CI:2.98 - 10.17)。CIN症状包括定向障碍(38.5%)、意识丧失(23.1%)、嗜睡(18.5%)等。头孢吡肟的伤害所需人数(NNH)计算为17.2。

结论

该研究发现,与其他抗生素诱导的神经毒性相比,CIN的发生率更高,且头孢吡肟的使用与CIN的发生之间存在有害关联。此外,肾衰竭是CIN的一个危险因素。因此,在没有其他替代药物的情况下,本研究证明了头孢吡肟使用的合理性。

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