Rao Benchen, Wang Daming, Yang Mengzhao, Zhao Chunyu, Cheng Ming, Li Silin, Zhang Donghua, Luo Hong, Qian Guowu, Wang Ling, Zhang Shixi, Li Guotao, Li Guangming, Yu Zujiang, Ren Zhigang
Department of Infectious Diseases, State Key Laboratory of Antiviral Drugs, Pingyuan Laboratory, The First Affiliated Hospital of Zhengzhou University, 1#, Jianshe East Road, Zhengzhou, 450052, China.
Department of Medical Information, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.
BMC Infect Dis. 2025 Feb 25;25(1):275. doi: 10.1186/s12879-025-10643-w.
Patients with kidney disease (KD) are at high risk of contracting COVID-19 and developing severe disease. There is still a lack of guidance regarding the treatment of COVID-19 in patients with KD. The safety and effectiveness of Azvudine in treating COVID-19 patients with KD remain unknown.
This study included 32,864 COVID-19 patients from nine centers in Henan Province, China. After applying the exclusion criteria and 2:1 propensity score matching, 438 and 219 participants in the Azvudine and Paxlovid groups, respectively, were subjected to analysis.
Kaplan-Meier analysis revealed no significant differences in all-cause death or composite disease progression between the Azvudine and Paxlovid groups (all p values > 0.05). The same results were obtained in the Cox regression analysis after baseline characteristics adjustment. Three different sensitivity analyses contributed to the robustness of these findings. Subgroup analysis revealed that patients treated with Azvudine had a lower risk of composite disease progression than patients treated with Paxlovid did among patients with moderate disease (p = 0.016, HR: 0.51, 95% CI: 0.27-0.96). Safety data indicated that there was no difference in the incidence of most adverse events. Compared with the Paxlovid group, the Azvudine group had a lower incidence of hypophosphatemia (p = 0.008) and a lower PLT count (p = 0.045). Moreover, during the 15-day follow-up since drug administration, higher concentrations of lymphocytes were detected in the Azvudine group.
This study is the first to report that the safety and effectiveness of Azvudine are not inferior to those of Paxlovid in COVID-19 patients with KD. This study provides additional treatment options for COVID-19 patients with KD.
肾病（KD）患者感染新型冠状病毒肺炎（COVID-19）并发展为重症的风险很高。对于KD患者的COVID-19治疗，目前仍缺乏相关指导。阿兹夫定治疗KD合并COVID-19患者的安全性和有效性尚不清楚。
本研究纳入了来自中国河南省9个中心的32864例COVID-19患者。应用排除标准并进行2:1倾向评分匹配后，分别对阿兹夫定组和帕罗韦德组的438例和219例参与者进行分析。
Kaplan-Meier分析显示，阿兹夫定组和帕罗韦德组在全因死亡或综合疾病进展方面无显著差异（所有p值>0.05）。在调整基线特征后的Cox回归分析中也得到了相同的结果。三种不同的敏感性分析有助于这些发现的稳健性。亚组分析显示，在中度疾病患者中，接受阿兹夫定治疗的患者综合疾病进展风险低于接受帕罗韦德治疗的患者（p = 0.016，HR：0.51，95%CI：0.27-0.96）。安全性数据表明，大多数不良事件的发生率没有差异。与帕罗韦德组相比，阿兹夫定组低磷血症的发生率较低（p = 0.008），血小板计数较低（p = 0.045）。此外，在给药后的15天随访期间，阿兹夫定组检测到更高浓度的淋巴细胞。
本研究首次报道，在KD合并COVID-19患者中，阿兹夫定的安全性和有效性不劣于帕罗韦德。本研究为KD合并COVID-19患者提供了额外的治疗选择。
