简介:许多研究探索了尼马特雷韦-利托那韦和阿兹夫定对老年COVID-19患者的治疗效果。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老年早期感染患者中的安全性和有效性,为临床治疗提供策略。方法:纳入中国2022年冬季流行期间住院的老年COVID-19患者(年龄≥65岁),分为尼马特雷韦-利托那韦和阿兹夫定。人口统计,用药信息,实验室参数,并收集治疗结果.全因28天死亡率,增量循环阈值(ΔCt),核酸阴性转化时间,不良事件发生率定义为结局.倾向得分匹配(PSM),Kaplan-Meier,Cox比例风险模型,亚组分析,并选择列线图来评估结局.结果:共筛查了1,508例老年COVID-19患者。根据纳入和排除标准,1,075名患者符合该研究的条件。PSM之后,纳入研究的老年COVID-19患者的最终人数为375例,两组之间的人口学特征无显著差异(p>0.05).与阿兹夫定组相比,Nirmatrelvir-Ritonavir组的多种不良事件发生率较高(12.8%vs5.2%,p=0.009)。Nirmatrelvir-利托那韦组与肾功能异常相关的不良事件发生率高于Azvudine组(13.6%vs7.2%,p=0.045)。两组在全因28天死亡率方面没有显着差异(HR=1.020,95%CI:0.542-1.921,p=0.951),而核酸阴性转化时间(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)存在显著差异。结论:阿兹夫定和尼马特雷韦-利托那韦在降低死亡风险方面具有相当的有效性。Azvudine在核酸阴性转化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更好的安全性。需要更大样本量的进一步研究来验证结果。
Introduction: 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. Methods: 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. Results: 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 (p > 0.05). Compared to the Azvudine group, the Nirmatrelvir-Ritonavir group showed a higher incidence of multiple adverse events (12.8% vs 5.2%, p = 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%, p = 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, p = 0.951), whereas there were significant differences in nucleic acid negative conversion time (HR = 1.659, 95% CI: 1.166 - 2.360, p = 0.005) and ΔCt values (HR = 1.442, 95% CI: 1.084 - 1.918, p = 0.012). Conclusion: 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.