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奈玛特韦-利托那韦与阿兹夫定治疗老年新型冠状病毒肺炎患者的安全性和有效性对比分析:一项来自中国某三级医院的回顾性研究

Comparative analysis of the safety and effectiveness of Nirmatrelvir-Ritonavir and Azvudine in older patients with COVID-19: a retrospective study from a tertiary hospital in China.

作者信息

Shang Nan, Li Xianlin, Guo Zhiyu, Zhang Lan, Wang Shanshan

机构信息

Department of Pharmacy, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.

School of Pharmacy, Shanxi Medical University, Taiyuan, Shanxi, China.

出版信息

Front Pharmacol. 2024 Jul 22;15:1362345. doi: 10.3389/fphar.2024.1362345. eCollection 2024.

DOI:10.3389/fphar.2024.1362345
PMID:39104387
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11298358/
Abstract

Numerous studies have explored the treatment outcomes of Nirmatrelvir-Ritonavir and Azvudine in older patients with COVID-19. However, direct comparisons between these two drugs are still relatively limited. This study aims to compare the safety and effectiveness of these two drugs in Chinese older patients with early infection to provide strategies for clinical treatment. Older COVID-19 patients (age ≥65) hospitalized during the winter 2022 epidemic in China were included and divided into Nirmatrelvir-Ritonavir and Azvudine. Demographics, medication information, laboratory parameters, and treatment outcomes were collected. All-cause 28-day mortality, delta cycle threshold (ΔCt), nucleic acid negative conversion time, and incidence of adverse events were defined as outcomes. Propensity score matching (PSM), Kaplan-Meier, Cox proportional hazards model, subgroup analysis, and nomograms were selected to evaluate the outcomes. A total of 1,508 older COVID-19 patients were screened. Based on the inclusion and exclusion criteria, 1,075 patients were eligible for the study. After PSM, the final number of older COVID-19 patients included in the study was 375, and there were no significant differences in demographic characteristics between the two groups ( > 0.05). Compared to the Azvudine group, the Nirmatrelvir-Ritonavir group showed a higher incidence of multiple adverse events (12.8% vs 5.2%, = 0.009). The incidence of adverse events related to abnormal renal function was higher in the Nirmatrelvir-Ritonavir group compared to the Azvudine group (13.6% vs 7.2%, = 0.045). There were no significant differences between the two groups in terms of all-cause 28-day mortality (HR = 1.020, 95% CI: 0.542 - 1.921, = 0.951), whereas there were significant differences in nucleic acid negative conversion time (HR = 1.659, 95% CI: 1.166 - 2.360, = 0.005) and ΔCt values (HR = 1.442, 95% CI: 1.084 - 1.918, = 0.012). Azvudine and Nirmatrelvir-Ritonavir have comparable effectiveness in reducing mortality risk. Azvudine may perform better in nucleic acid negative conversion time and virus clearance and shows slightly better safety in older patients. Further studies with a larger sample size were needed to validate the result.

摘要

众多研究探讨了奈玛特韦-利托那韦和阿兹夫定在老年新冠肺炎患者中的治疗效果。然而,这两种药物之间的直接比较仍然相对有限。本研究旨在比较这两种药物在中国早期感染的老年患者中的安全性和有效性,以提供临床治疗策略。纳入了在2022年冬季中国疫情期间住院的年龄≥65岁的老年新冠肺炎患者,并将其分为奈玛特韦-利托那韦组和阿兹夫定组。收集了人口统计学、用药信息、实验室参数和治疗结果。将全因28天死亡率、delta循环阈值(ΔCt)、核酸转阴时间和不良事件发生率定义为观察指标。选择倾向评分匹配(PSM)、Kaplan-Meier法、Cox比例风险模型、亚组分析和列线图来评估观察指标。共筛选出1508例老年新冠肺炎患者。根据纳入和排除标准,1075例患者符合研究条件。经过PSM后,本研究最终纳入的老年新冠肺炎患者数量为375例,两组之间的人口统计学特征无显著差异(P>0.05)。与阿兹夫定组相比,奈玛特韦-利托那韦组多种不良事件的发生率更高(12.8%对5.2%,P=0.009)。与阿兹夫定组相比,奈玛特韦-利托那韦组肾功能异常相关不良事件的发生率更高(13.6%对7.2%,P=0.045)。两组在全因28天死亡率方面无显著差异(HR=1.020,95%CI:0.542-1.921,P=0.951),而在核酸转阴时间(HR=1.659,95%CI:1.166-2.360,P=0.005)和ΔCt值(HR=1.442,95%CI:1.084-1.918,P=0.012)方面存在显著差异。阿兹夫定和奈玛特韦-利托那韦在降低死亡风险方面具有相当的疗效。阿兹夫定在核酸转阴时间和病毒清除方面可能表现更好,并且在老年患者中显示出稍好的安全性。需要更大样本量的进一步研究来验证该结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/5dabf7058982/fphar-15-1362345-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/c5a0df963282/fphar-15-1362345-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/6221af9c1b15/fphar-15-1362345-g002.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/5dabf7058982/fphar-15-1362345-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/c5a0df963282/fphar-15-1362345-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/6221af9c1b15/fphar-15-1362345-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/f207095fd24d/fphar-15-1362345-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6d0/11298358/5dabf7058982/fphar-15-1362345-g004.jpg

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