Efficacy and Safety of Azvudine in Patients With COVID-19 in China: A Meta-Analysis of Observational Studies

IF 1.9 4区医学 Q3 RESPIRATORY SYSTEM Clinical Respiratory Journal Pub Date : 2024-07-12 DOI:10.1111/crj.13798

Tao Dong, Wentao Zhang, Tingting Wu, Yongxiang Ge, Qi Yang, Jia Xu, Yuna Liu

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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.

Trial Registration

PROSPERO number: CRD42024520565

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阿兹夫定对中国 COVID-19 患者的疗效和安全性：观察性研究的 Meta 分析。

背景：阿兹夫定（FNC）是一种治疗 COVID-19 的新型小分子抗病毒药物，仅在中国市场有售。尽管中国指南推荐用于治疗 COVID-19，但其疗效和安全性仍不明确。本研究旨在评估FNC对COVID-19结果的保护作用及其安全性：我们遵循 PRISMA 2020 指南，检索了 PubMed、Embase、Web of Science、Scopus 和中国国家知识基础设施（CNKI）数据库，评估 FNC 在中国治疗 COVID-19 的有效性研究，重点关注死亡率和总体预后。此外，还评估了其对住院时间（LOHS）、首次核酸阴转时间（T-FNANC）和不良事件的影响。纳入标准为研究发表于 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：荟萃分析包括 24 项回顾性研究，共涉及 11 830 名患者。低确定性证据显示，在COVID-19患者中，FNC和Paxlovid在死亡率（OR = 0.91，95% CI：0.76-1.08）或LOHS（WMD = -0.24，95% CI：-0.83-0.35）方面无明显差异。低确定性证据显示，T-FNANC的时间更长（WMD = 1.95，95% CI：0.36-3.53）。低确定性证据显示，与 Paxlovid 组相比，FNC 组的综合结果更差（OR = 0.77，95% CI：0.63-0.95），不良事件更少（OR = 0.63，95% CI：0.46-0.85）。与支持性治疗相比，低确定性证据显示，FNC可显著降低COVID-19患者的死亡率（OR = 0.61，95% CI：0.51-0.74），减少综合结果（OR = 0.67，95% CI：0.50-0.91），极低确定性证据显示，FNC可显著降低T-FNANC（WMD = -4.62，95% CI：-8.08至-1.15）。然而，在极低确定性证据中，LOHS（WMD = -0.70，95% CI：-3.32 至 1.91）或不良事件（OR = 1.97，95% CI：0.48-8.17）没有明显差异：在中国，FNC似乎是治疗COVID-19的一种安全且潜在有效的方法，但有必要通过更大规模、高质量的研究进一步证实这些发现。由于证据的确定性和在中国进行的研究的特殊背景，在考虑这些结果是否适用于全球时应谨慎：试验注册：PROSPERO 编号：CRD42024520565。

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来源期刊

Clinical Respiratory Journal 医学-呼吸系统

CiteScore

3.70

自引率

0.00%

发文量

104

审稿时长

>12 weeks

期刊介绍： Overview Effective with the 2016 volume, this journal will be published in an online-only format. Aims and Scope The Clinical Respiratory Journal (CRJ) provides a forum for clinical research in all areas of respiratory medicine from clinical lung disease to basic research relevant to the clinic. We publish original research, review articles, case studies, editorials and book reviews in all areas of clinical lung disease including: Asthma Allergy COPD Non-invasive ventilation Sleep related breathing disorders Interstitial lung diseases Lung cancer Clinical genetics Rhinitis Airway and lung infection Epidemiology Pediatrics CRJ provides a fast-track service for selected Phase II and Phase III trial studies. Keywords Clinical Respiratory Journal, respiratory, pulmonary, medicine, clinical, lung disease, Abstracting and Indexing Information Academic Search (EBSCO Publishing) Academic Search Alumni Edition (EBSCO Publishing) Embase (Elsevier) Health & Medical Collection (ProQuest) Health Research Premium Collection (ProQuest) HEED: Health Economic Evaluations Database (Wiley-Blackwell) Hospital Premium Collection (ProQuest) Journal Citation Reports/Science Edition (Clarivate Analytics) MEDLINE/PubMed (NLM) ProQuest Central (ProQuest) Science Citation Index Expanded (Clarivate Analytics) SCOPUS (Elsevier)