PDF(Pubmed)
Abstract：
BACKGROUND: Azvudine (FNC) is a novel small molecule antiviral drug for treating COVID-19 that is available only on the Chinese market. Despite being recommended for treating COVID-19 by the Chinese guidelines, its efficacy and safety are still unclear. This study aimed to evaluate the protective effect of FNC on COVID-19 outcomes and its safety.
METHODS: We followed the PRISMA 2020 guidelines and searched the PubMed, Embase, Web of Science, Scopus, and China National Knowledge Infrastructure (CNKI) databases to evaluate studies on the effectiveness of FNC in treating COVID-19 in China, focusing on mortality and overall outcomes. Additionally, its impact on the length of hospital stay (LOHS), time to first nucleic acid negative conversion (T-FNANC), and adverse events was evaluated. The inclusion criterion was that the studies were published from July 2021 to April 10, 2024. This study uses the ROBINS-I tool to assess bias risk and employs the GRADE approach to evaluate the certainty of the evidence.
RESULTS: The meta-analysis included 24 retrospective studies involving a total of 11 830 patients. Low-certainty evidence revealed no significant difference in mortality (OR = 0.91, 95% CI: 0.76-1.08) or LOHS (WMD = -0.24, 95% CI: -0.83 to 0.35) between FNC and Paxlovid in COVID-19 patients. Low-certainty evidence shows that the T-FNANC was longer (WMD = 1.95, 95% CI: 0.36-3.53). Compared with the Paxlovid group, low-certainty evidence shows the FNC group exhibited a worse composite outcome (OR = 0.77, 95% CI: 0.63-0.95) and fewer adverse events (OR = 0.63, 95% CI: 0.46-0.85). Compared with supportive treatment, low certainty shows FNC significantly reduced the mortality rate in COVID-19 patients (OR = 0.61, 95% CI: 0.51-0.74) and decreased the composite outcome (OR = 0.67, 95% CI: 0.50-0.91), and very low certainty evidence shows significantly decreased the T-FNANC (WMD = -4.62, 95% CI: -8.08 to -1.15). However, in very low certainty, there was no significant difference in LOHS (WMD = -0.70, 95% CI: -3.32 to 1.91) or adverse events (OR = 1.97, 95% CI: 0.48-8.17).
CONCLUSIONS: FNC appears to be a safe and potentially effective treatment for COVID-19 in China, but further research with larger, high-quality studies is necessary to confirm these findings. Due to the certainty of the evidence and the specific context of the studies conducted in China, caution should be exercised when considering whether the results are applicable worldwide.
BACKGROUND: PROSPERO number: CRD42024520565.
METHODS: We followed the PRISMA 2020 guidelines and searched the PubMed, Embase, Web of Science, Scopus, and China National Knowledge Infrastructure (CNKI) databases to evaluate studies on the effectiveness of FNC in treating COVID-19 in China, focusing on mortality and overall outcomes. Additionally, its impact on the length of hospital stay (LOHS), time to first nucleic acid negative conversion (T-FNANC), and adverse events was evaluated. The inclusion criterion was that the studies were published from July 2021 to April 10, 2024. This study uses the ROBINS-I tool to assess bias risk and employs the GRADE approach to evaluate the certainty of the evidence.
RESULTS: The meta-analysis included 24 retrospective studies involving a total of 11 830 patients. Low-certainty evidence revealed no significant difference in mortality (OR = 0.91, 95% CI: 0.76-1.08) or LOHS (WMD = -0.24, 95% CI: -0.83 to 0.35) between FNC and Paxlovid in COVID-19 patients. Low-certainty evidence shows that the T-FNANC was longer (WMD = 1.95, 95% CI: 0.36-3.53). Compared with the Paxlovid group, low-certainty evidence shows the FNC group exhibited a worse composite outcome (OR = 0.77, 95% CI: 0.63-0.95) and fewer adverse events (OR = 0.63, 95% CI: 0.46-0.85). Compared with supportive treatment, low certainty shows FNC significantly reduced the mortality rate in COVID-19 patients (OR = 0.61, 95% CI: 0.51-0.74) and decreased the composite outcome (OR = 0.67, 95% CI: 0.50-0.91), and very low certainty evidence shows significantly decreased the T-FNANC (WMD = -4.62, 95% CI: -8.08 to -1.15). However, in very low certainty, there was no significant difference in LOHS (WMD = -0.70, 95% CI: -3.32 to 1.91) or adverse events (OR = 1.97, 95% CI: 0.48-8.17).
CONCLUSIONS: FNC appears to be a safe and potentially effective treatment for COVID-19 in China, but further research with larger, high-quality studies is necessary to confirm these findings. Due to the certainty of the evidence and the specific context of the studies conducted in China, caution should be exercised when considering whether the results are applicable worldwide.
BACKGROUND: PROSPERO number: CRD42024520565.
摘要：
背景：阿兹夫定（FNC）是一种仅在中国市场上销售的用于治疗COVID-19的新型小分子抗病毒药物。尽管中国指南建议用于治疗COVID-19，其疗效和安全性尚不清楚.本研究旨在评估FNC对COVID-19结局的保护作用及其安全性。
方法：我们遵循了PRISMA2020指南，并搜索了PubMed，Embase,WebofScience,Scopus,和中国国家知识基础设施（CNKI）数据库，以评估中国FNC治疗COVID-19的有效性研究，关注死亡率和总体结果。此外,它对住院时间（LOHS）的影响，第一次核酸阴性转化（T-FNANC）的时间，并对不良事件进行了评估。纳入标准是这些研究发表于2021年7月至2024年4月10日。本研究使用ROBINS-I工具评估偏倚风险，并采用GRADE方法评估证据的确定性。
结果：荟萃分析包括24项回顾性研究，共11830例患者。低确定性证据显示，在COVID-19患者中，FNC和Paxlovid之间的死亡率（OR=0.91，95％CI：0.76-1.08）或LOHS（WMD=-0.24，95％CI：-0.83至0.35）没有显着差异。低确定性证据表明T-FNANC更长(WMD=1.95,95%CI:0.36-3.53)。与Paxlovid组相比，低确定性证据显示，FNC组的复合结局较差（OR=0.77，95％CI：0.63-0.95），不良事件较少（OR=0.63，95％CI：0.46-0.85）。与支持治疗相比，低确定性显示FNC显着降低了COVID-19患者的死亡率（OR=0.61，95％CI：0.51-0.74），并降低了复合结局（OR=0.67，95％CI：0.50-0.91），非常低的确定性证据表明T-FNANC显着降低（WMD=-4.62，95％CI：-8.08至-1.15）。然而,在非常低的确定性下，LOHS(WMD=-0.70,95%CI:-3.32~1.91)或不良事件(OR=1.97,95%CI:0.48~8.17)无显著差异.
结论：FNC在中国似乎是COVID-19的安全且潜在有效的治疗方法，但是进一步研究，需要高质量的研究来证实这些发现。由于证据的确定性和在中国进行的研究的特定背景，在考虑结果是否适用于全球时，应谨慎行事。
背景：PROSPERO编号：CRD42024520565。
方法：我们遵循了PRISMA2020指南，并搜索了PubMed，Embase,WebofScience,Scopus,和中国国家知识基础设施（CNKI）数据库，以评估中国FNC治疗COVID-19的有效性研究，关注死亡率和总体结果。此外,它对住院时间（LOHS）的影响，第一次核酸阴性转化（T-FNANC）的时间，并对不良事件进行了评估。纳入标准是这些研究发表于2021年7月至2024年4月10日。本研究使用ROBINS-I工具评估偏倚风险，并采用GRADE方法评估证据的确定性。
结果：荟萃分析包括24项回顾性研究，共11830例患者。低确定性证据显示，在COVID-19患者中，FNC和Paxlovid之间的死亡率（OR=0.91，95％CI：0.76-1.08）或LOHS（WMD=-0.24，95％CI：-0.83至0.35）没有显着差异。低确定性证据表明T-FNANC更长(WMD=1.95,95%CI:0.36-3.53)。与Paxlovid组相比，低确定性证据显示，FNC组的复合结局较差（OR=0.77，95％CI：0.63-0.95），不良事件较少（OR=0.63，95％CI：0.46-0.85）。与支持治疗相比，低确定性显示FNC显着降低了COVID-19患者的死亡率（OR=0.61，95％CI：0.51-0.74），并降低了复合结局（OR=0.67，95％CI：0.50-0.91），非常低的确定性证据表明T-FNANC显着降低（WMD=-4.62，95％CI：-8.08至-1.15）。然而,在非常低的确定性下，LOHS(WMD=-0.70,95%CI:-3.32~1.91)或不良事件(OR=1.97,95%CI:0.48~8.17)无显著差异.
结论：FNC在中国似乎是COVID-19的安全且潜在有效的治疗方法，但是进一步研究，需要高质量的研究来证实这些发现。由于证据的确定性和在中国进行的研究的特定背景，在考虑结果是否适用于全球时，应谨慎行事。
背景：PROSPERO编号：CRD42024520565。
