关于抗病毒治疗对新冠后遗症疗效的新临床数据-动脉网

New Clinical Data on the Efficacy of Antiviral Treatments for Post-COVID-19 Condition

盐野义等信源发布 2025-11-05 10:33

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· In a large-scale post-marketing clinical study conducted by Tokushukai Medical Group, the incidence of post-COVID-19 conditions (PCC) (commonly referred to as Long COVID) was approximately 26% among patients who did not receive oral antiviral treatment.

· 在德洲会医疗集团开展的一项大规模上市后临床研究中，未接受口服抗病毒治疗的患者中，新冠后遗症（PCC）（通常称为“长新冠”）的发病率为26%左右。

· Oral antiviral treatment reduced the risk of developing PCC by a statistically significant 14% compared to no antivirals.

· 口服抗病毒治疗使PCC的发生风险相比未使用抗病毒药物降低了具有统计学意义的14%。

· These findings suggest that oral antiviral treatment may help prevent the onset of PCC.

这些研究结果表明，口服抗病毒治疗可能有助于预防PCC的发生。

OSAKA, Japan, November 5, 2025 -

日本大阪，2025年11月5日 -

General Incorporated Association Tokushukai (Location: Chiyoda-ku, Tokyo; Chairperson of the Board: Shinichi Higashiue, M.D.; hereinafter “Tokushukai Medical Group”) and Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') announced new clinical data from the ANCHOR study, a large-scale post-marketing clinical study conducted by Tokushukai Medical Group in patients diagnosed with COVID-19.

一般社团法人德洲会（地址：东京都千代田区；理事长：东植伸一，医学博士；以下简称“德洲会医疗集团”）和盐野义制药株式会社（总部：日本大阪；首席执行官：手代木功，理学博士；以下简称“盐野义”）宣布了由德洲会医疗集团在确诊为COVID-19的患者中进行的大规模上市后临床研究ANCHOR的新临床数据。

The primary endpoint results were presented at the 8th ISRV-AVG Meeting and 3rd IMRP held in Singapore (September 17–20, 2025), and secondary endpoint results were presented at APCCMI 2025 in Thailand (November 2–4, 2025)..

主要终点结果在2025年9月17日至20日在新加坡举行的第8届ISRV-AVG会议暨第3届IMRP上公布，次要终点结果在2025年11月2日至4日在泰国举行的APCCMI 2025上公布。

The World Health Organization (WHO) defines PCC as occurring in individuals with a history of probable or confirmed SARS-CoV-2 infection, typically around three months after the onset of COVID-19, with symptoms lasting for at least two months and not explainable by an alternative diagnosis

世界卫生组织 (WHO) 将PCC定义为发生在有疑似或确诊SARS-CoV-2感染史的个体中，通常在COVID-19发病后大约三个月出现，症状持续至少两个月，并且无法用其他诊断解释。

. Common symptoms include fatigue, shortness of breath, loss of taste or smell, cognitive dysfunction but also others which generally have an impact on everyday functioning

常见症状包括疲劳、呼吸急促、味觉或嗅觉丧失、认知功能障碍，但也包括其他通常对日常功能产生影响的症状。

. PCC is a significant challenge not only in Japan but globally. However, evidence supporting the effectiveness of antiviral in preventing these symptoms has been limited. In response, the Tokushukai Medical Group conducted a large-scale clinical study (ANCHOR study) targeting outpatients diagnosed with COVID-19.

PCC不仅在日本，在全球范围内也是一个重大挑战。然而，支持抗病毒药物在预防这些症状方面有效性的证据有限。为此，德洲会医疗集团开展了一项大规模临床研究（ANCHOR研究），针对门诊诊断为COVID-19的患者。

This study evaluated the impact of antiviral use on the PCC..

本研究评估了抗病毒药物使用对PCC的影响。

This multi-center, nationwide, prospective observational study enrolled outpatients aged ≥12 years diagnosed with COVID-19 at 51 Tokushukai Group hospitals across Japan. As a collaborative research partner, Shionogi contributed to the execution of this study.

这项多中心、全国性、前瞻性观察研究在日本全国51家德洲会集团医院招募了年龄≥12岁、诊断为COVID-19的门诊患者。作为合作研究伙伴，盐野义制药公司对本研究的实施做出了贡献。

The clinical study presented this time included approximately 9,000 cases enrolled between February 1 and October 31, 2024. The primary endpoint of this study, “the incidence of PCC,” in the antiviral and non-antiviral group, defined as persistence of any of five pre-specified symptoms (fatigue, dyspnea or respiratory distress, cough, smell disorder, taste disorder) on both Days 28 and 84, excluding symptoms not attributed to COVID-19.

本次发表的临床研究纳入了 2024 年 2 月 1 日至 2024 年 10 月 31 日期间的大约 9,000 例病例。本研究的主要终点是“PCC 的发生率”，定义为在第 28 天和第 84 天均持续存在五种预先设定的症状（疲劳、呼吸困难或呼吸窘迫、咳嗽、嗅觉障碍、味觉障碍）中的任何一种，排除非新冠相关症状，在抗病毒组和非抗病毒组中进行比较。

The incidence of post-COVID-19 symptoms was then evaluated based on this definition. The incidence of PCC was approximately 26% in the non-antiviral group (N=5,518) and approximately 24% in the antiviral group (N=2,181, combined group of ensitrelvir, nirmatrelvir/ritonavir, and molnupiravir). Antiviral treatment significantly reduced the risk by about 14% (adjusted risk ratio: 0.86 [95% CI: 0.78–0.93]; P < 0.001).

基于这一定义，对新冠后症状的发生率进行了评估。在非抗病毒组（N=5,518）中，PCC的发生率约为26%，而在抗病毒组（N=2,181，包括恩司特韦、尼马曲韦/利托那韦和莫努匹韦的组合组）中，发生率约为24%。抗病毒治疗显著降低了约14%的风险（调整后的风险比：0.86 [95% CI: 0.78–0.93]；P < 0.001）。

For ensitrelvir alone, the risk was also significantly reduced by about 14% compared to non-antiviral treatment (adjusted risk ratio: 0.86 [95% CI: 0.79–0.95]; P = 0.002)..

对于单独使用恩司特韦，与非抗病毒治疗相比，风险也显著降低了约14%（调整后的风险比：0.86 [95% CI: 0.79–0.95]；P = 0.002）。

For the secondary endpoint, “Frequency of COVID-19–related re-consultations within 28 days,” no significant risk reduction was observed in the overall antiviral group compared to the non-antiviral group (adjusted risk ratio: 0.93 [95% CI: 0.83–1.04]; P = 0.266). However, ensitrelvir alone showed a significant 12% reduction in re-visit risk (adjusted risk ratio: 0.88 [95% CI: 0.78–0.99]; P = 0.030)..

对于次要终点“28天内与COVID-19相关的复诊频率”，在整个抗病毒组与非抗病毒组相比，未观察到显著的风险降低（校正风险比：0.93 [95% CI: 0.83–1.04]；P = 0.266）。然而，单独使用ensitrelvir显示出复诊风险显著降低了12%（校正风险比：0.88 [95% CI: 0.78–0.99]；P = 0.030）。

These findings suggest that oral antiviral treatment may contribute to improving acute-phase symptoms, reducing the incidence of PCC, and potentially lowering re-visit frequency.

这些研究结果表明，口服抗病毒治疗可能有助于改善急性期症状、降低PCC发生率，并可能减少复诊频率。

“Managing PCC remains a major unmet medical need. We are pleased that the ANCHOR study results indicate that antiviral treatment during the acute phase may help prevent the onset of PCC. This study represents an important step toward new directions in COVID-19 treatment and is expected to inform clinical decision-making and long-term health management,” said Dr.

“管理PCC仍然是一个亟待满足的主要医疗需求。我们很高兴ANCHOR研究结果表明，在急性期进行抗病毒治疗可能有助于预防PCC的发生。这项研究代表了COVID-19治疗新方向的重要一步，预计将为临床决策和长期健康管理提供参考。”博士说道。

Makoto Hibino, MD, principal investigator of this study, Deputy Director of Shonan Oiso Hospital, and Chair of the Tokushukai Respiratory Committee..

日比野诚，医学博士，本研究的主要研究者，湘南大矶医院副院长，德洲会呼吸委员会主席。

In the “Guidelines for the Clinical Management of COVID-19 issued by five academic societies” published on October 17, 2025, it is stated that “the fundamental principle of clinical care for infectious diseases, particularly viral infections, is early diagnosis and early treatment. This approach may help prevent severe illness, alleviate symptoms, and enable early return to social activities for individuals, while also reducing the burden on society by preventing widespread transmission and decreasing the number of hospitalized patients.”.

在2025年10月17日发布的《五个学会联合发布的新冠病毒病临床管理指南》中提到，“对传染病，尤其是病毒性感染，临床诊治的基本原则是早诊断、早治疗。这样做可能有助于预防重症、缓解症状，并帮助个人早日回归社会活动，同时通过防止大规模传播和减少住院人数来减轻社会负担。”

Based on these principles outlined in the guidelines, Tokushukai Group and Shionogi will continue to collaborate in accumulating evidence related to COVID-19 and delivering it back to clinical practice.

基于这些指南中概述的原则，德洲会集团和盐野义制药将继续合作，积累与 COVID-19 相关的证据，并将其回馈给临床实践。

About

关于

ANCHOR Study

锚定研究

The purpose of ANCHOR study is to collect information of the clinical course of patients with COVID-19 treated at Tokushukai hospitals with and without antiviral drugs and to explore the clinical course in the acute phase, the frequency of severe disease, and frequency of PCC by the treatment, after adjusting by patient background including risk factor(s) and symptoms at the time of registration.

ANCHOR研究的目的是收集在德洲会医院接受治疗的COVID-19患者（使用和未使用抗病毒药物）的临床病程信息，并在调整包括风险因素和注册时症状等患者背景后，探讨不同治疗方式下急性期的临床病程、重症频率以及PCC的发生频率。

In this study, Shionogi is participating as a collaborative research partner..

在这项研究中，盐野义制药公司作为合作研究伙伴参与其中。

About

关于

Tokushukai Medical Group

德洲会医疗集团

Tokushukai Medical Group philosophy is “All livin beings are created equal”. Under this philosophy, we continuously strive for realizing “Anybody in the society is to receive the best possible medical care in anywhere, at whenever necessary”. From Emergency Medical Care, an origin of medical care, to preventive health care, chronic medical care and advanced medical care, we provide the optimal medical care.

德洲会医疗集团的哲学是“一切生命皆生而平等”。在此哲学指导下，我们不断努力实现“社会中的任何人都能在任何地方、在任何必要时获得最佳的医疗服务”。从急救医疗这一医疗的起源，到预防保健、慢性病医疗和先进医疗，我们提供最优质的医疗服务。

For more information on Tokushukai Medical Group, please visit .

有关德洲会医疗集团的更多信息，请访问。

https://www.tokushukai.or.jp/en/

https://www.tokushukai.or.jp/zh/

About Shionogi & Co., Ltd.

关于盐野义制药株式会社

For over 60 years, Shionogi has been engaged in the research and development of infectious disease treatments. Identifying ' Protect people from the threat of infectious diseases' as a material issue (materiality) to be addressed, the company is working towards the realization of comprehensive infectious disease care.

六十多年来，盐野义制药一直致力于传染病治疗的研究与开发。公司将“保护人们免受传染病的威胁”确定为亟需应对的重要课题（实质性问题），并努力实现全面的传染病护理。

As a leading company in the field of infectious diseases, Shionogi is strengthening its initiatives, including collaborations with external partners, to provide healthcare solutions to a broader audience and continuously address a wide range of infectious diseases. For more information on Shionogi & Co., Ltd., please visit .

作为传染病领域的领先公司，盐野义制药正在加强其举措，包括与外部合作伙伴的合作，以为更广泛的受众提供医疗保健解决方案，并持续应对各种传染病。有关盐野义制药株式会社的更多信息，请访问。

https://www.shionogi.com/global/en

https://www.shionogi.com/global/zh

Forward-Looking Statements

前瞻性声明

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate.

本公告包含前瞻性陈述。这些陈述是基于当前可获得的信息和预期，而这些假设受到风险和不确定性的影响，可能导致实际结果与这些陈述有重大差异。风险和不确定性包括一般的国内和国际经济状况，如一般行业和市场状况，以及利率和汇率的变化。

These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations.

这些风险和不确定性尤其适用于与产品相关的前瞻性声明。产品风险和不确定性包括但不限于：临床试验的完成和中止；获得监管批准；有关产品安全性和有效性的主张和顾虑；技术进步；重要诉讼的不利结果；国内外医疗改革以及法律法规的变化。

Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise..

对于现有产品，也存在制造和市场风险，这些风险包括但不限于无法建立足够的生产能力以满足需求、原材料供应不足以及竞争产品的进入。公司否认有任何意图或义务更新或修改任何前瞻性声明，无论是否由于新信息、未来事件或其他原因。

For Further Information, Contact:

如需更多信息，请联系：

SHIONOGI Website Inquiry Form:

SHIONOGI网站咨询表：

https://www.shionogi.com/global/en/contact.html

Reference List:

参考文献列表：

1. WHO, Post COVID-19 conditions; https://www.who.int/teams/health-care-readiness/post-covid-19-condition

1. 世界卫生组织，新冠后遗症；https://www.who.int/teams/health-care-readiness/post-covid-19-condition

2. Ministry of Health, Labour and Welfare (Japan),

2. 厚生劳动省（日本），