{"title":"口服阿唑定与Paxlovid在COVID-19合并既往高血压患者中的实际有效性和安全性：中国河南省的一项多中心、回顾性队列研究","authors":"Fuwei Wang, Bohan Jia, Guotao Li, Xiaoli Jin, Mengzhao Yang, Guangming Li, Shixi Zhang, Guowu Qian, Hong Luo, Ming Cheng, Ling Wang, Donghua Zhang, Silin Li, Hongxia Liang, Zhigang Ren","doi":"10.1136/bmjopen-2024-090230","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Setting: </strong>Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023.</p><p><strong>Participants: </strong>Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis.</p><p><strong>Primary and secondary outcome measures: </strong>The primary outcome was all-cause death and the secondary outcome was the composite disease progression.</p><p><strong>Results: </strong>Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events.</p><p><strong>Conclusions: </strong>Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events.</p><p><strong>Trial registration number: </strong>NCT06349655.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 6","pages":"e090230"},"PeriodicalIF":2.4000,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China.\",\"authors\":\"Fuwei Wang, Bohan Jia, Guotao Li, Xiaoli Jin, Mengzhao Yang, Guangming Li, Shixi Zhang, Guowu Qian, Hong Luo, Ming Cheng, Ling Wang, Donghua Zhang, Silin Li, Hongxia Liang, Zhigang Ren\",\"doi\":\"10.1136/bmjopen-2024-090230\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Setting: </strong>Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023.</p><p><strong>Participants: </strong>Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis.</p><p><strong>Primary and secondary outcome measures: </strong>The primary outcome was all-cause death and the secondary outcome was the composite disease progression.</p><p><strong>Results: </strong>Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events.</p><p><strong>Conclusions: </strong>Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events.</p><p><strong>Trial registration number: </strong>NCT06349655.</p>\",\"PeriodicalId\":9158,\"journal\":{\"name\":\"BMJ Open\",\"volume\":\"15 6\",\"pages\":\"e090230\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-06-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Open\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjopen-2024-090230\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Open","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/bmjopen-2024-090230","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
目的：阿兹夫定和Paxlovid是治疗COVID-19的主要抗病毒药物。然而，目前还没有足够的证据表明这些药物治疗合并高血压的COVID-19患者的有效性和安全性。本研究的目的是在现实世界中评估它们在这些患者中的有效性和安全性。设计：回顾性队列研究。背景：提取河南省9家医院2022年12月5日至2023年1月31日新冠肺炎合并高血压患者的电子病历数据。参与者：按照2:1的倾向评分匹配（PSM）， 996名接受阿兹夫定治疗的个体和498名接受Paxlovid治疗的个体被纳入分析。主要和次要结局指标：主要结局为全因死亡，次要结局为复合疾病进展。结果：遵循纳入和排除标准和2:1 PSM，阿兹夫定组纳入996例，Paxlovid组纳入498例。Cox回归分析显示，与Paxlovid组相比，azvudine组的全因死亡风险显著降低（HR 0.64, 95% CI 0.455 ~ 0.911, p=0.013）。然而，两组的综合疾病进展无统计学差异（HR 0.93, 95% CI 0.711 ~ 1.229, p=0.629）。亚组分析显示，与Paxlovid相比，接受阿兹夫定治疗的中度疾病患者出现复合疾病进展的风险显著降低（HR 0.46, 95% CI 0.24 ~ 0.89）。安全性分析显示，阿兹夫定组的不良事件较少。结论：在已存在高血压的COVID-19患者中，阿兹夫定在减少全因死亡和复合疾病进展方面的有效性不低于Paxlovid，且不良事件较少。试验注册号：NCT06349655。
Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China.
Objectives: Azvudine and Paxlovid are the primary antiviral agents for the management of COVID-19. However, there is currently insufficient evidence regarding the effectiveness and safety of these drugs in treating COVID-19 patients with pre-existing hypertension. The objective of this study was to assess their effectiveness and safety among those patients in a real-world context.
Design: Retrospective cohort study.
Setting: Electronic medical record data of COVID-19 patients with pre-existing hypertension were extracted from nine hospitals in Henan Province from 5 December 2022 to 31 January 2023.
Participants: Following 2:1 propensity score matching (PSM), 996 individuals who received treatment with azvudine and 498 individuals who received treatment with Paxlovid were included in the analysis.
Primary and secondary outcome measures: The primary outcome was all-cause death and the secondary outcome was the composite disease progression.
Results: Following adherence to the inclusion and exclusion criteria and 2:1 PSM, 996 individuals were included in the azvudine group and 498 in the Paxlovid group. The Cox regression analysis revealed that the azvudine group had a significantly lower risk of all-cause death compared with the Paxlovid group (HR 0.64, 95% CI 0.455 to 0.911, p=0.013). However, there was no statistically significant difference in composite disease progression between the two groups (HR 0.93, 95% CI 0.711 to 1.229, p=0.629). Subgroup analysis indicated that, compared with Paxlovid, patients with moderate disease receiving azvudine treatment exhibited a significantly reduced risk of composite disease progression (HR 0.46, 95% CI 0.24 to 0.89). The safety analysis showed that the azvudine group had fewer adverse events.
Conclusions: Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events.
期刊介绍：
BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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