{"id":26856,"date":"2024-11-13T04:05:00","date_gmt":"2024-11-12T20:05:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=26856"},"modified":"2024-11-13T05:35:35","modified_gmt":"2024-11-12T21:35:35","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9aziresovir%e6%b2%bb%e7%96%97%e5%91%bc%e5%90%b8%e9%81%93%e5%90%88%e8%83%9e%e7%97%85%e6%af%92%e6%84%9f%e6%9f%93%e4%bd%8f%e9%99%a2%e5%a9%b4%e5%84%bf","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=26856","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1aZiresovir\u6cbb\u7597\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2\u611f\u67d3\u4f4f\u9662\u5a74\u513f"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n

Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection<\/h1>\n\n\n\n

Shunying\u00a0Zhao,\u00a0Yunxiao\u00a0Shang,\u00a0Yong\u00a0Yin,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med\u00a02024;391:1096-1107<\/h3>\n\n\n\n

DOI: 10.1056\/NEJMoa2313551<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h3>\n\n\n\n

Respiratory syncytial virus (RSV) is a leading cause of severe illness in infants, with no effective treatment. Results of a phase 2 trial suggested that ziresovir may have efficacy in the treatment of infants hospitalized with RSV infection.<\/p>\n\n\n\n

METHODS<\/h3>\n\n\n\n

In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted in China, we enrolled participants 1 to 24 months of age who were hospitalized with RSV infection. Participants were randomly assigned, in a 2:1 ratio, to receive ziresovir (at a dose of 10 to 40 mg, according to body weight) or placebo, administered twice daily, for 5 days. The primary end point was the change from baseline to day 3 (defined as 48 hours after the first administration) in the Wang bronchiolitis clinical score (total scores range from 0 to 12, with higher scores indicating greater severity of signs and symptoms). The intention-to-treat population included all the participants with RSV-confirmed infection who received at least one dose of ziresovir or placebo; the safety population included all the participants who received at least one dose of ziresovir or placebo.<\/a><\/p>\n\n\n\n

RESULTS<\/h3>\n\n\n\n

The intention-to-treat population included 244 participants, and the safety population included 302. The reduction from baseline in the Wang bronchiolitis clinical score at day 3 was significantly greater with ziresovir than with placebo (\u22123.4 points [95% confidence interval {CI}, \u22123.7 to \u22123.1] vs. \u22122.7 points [95% CI, \u22123.1 to \u22122.2]; difference, \u22120.8 points [95% CI, \u22121.3 to \u22120.3]; P=0.002). The reduction in the RSV viral load at day 5 was greater in the ziresovir group than in the placebo group (\u22122.5 vs. \u22121.9 log10<\/sub>\u00a0copies per milliliter; difference, \u22120.6 log10<\/sub>\u00a0copies per milliliter [95% CI, \u22121.1 to \u22120.2]).\u00a0Improvements were observed in prespecified subgroups, including in participants with a baseline bronchiolitis score of at least 8 and in those 6 months of age or younger.\u00a0The incidence of adverse events related to the drug or placebo was 16% with ziresovir and 13% with placebo. The most common adverse events that were assessed by the investigator as being related to the drug or placebo were diarrhea (in 4% and 2% of the participants, respectively), an elevated liver-enzyme level (in 3% and 3%, respectively), and rash (in 2% and 1%). Resistance-associated mutations were identified in 15 participants (9%) in the ziresovir group.<\/p>\n\n\n\n

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CONCLUSIONS<\/h3>\n\n\n\n

Ziresovir treatment reduced signs and symptoms of bronchiolitis in infants and young children hospitalized with RSV infection. No safety concerns were identified. (Funded by Shanghai Ark Biopharmaceutical; AIRFLO ClinicalTrials.gov number, NCT04231968<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Ziresovir in Hospitalized Infants with […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26856"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=26856"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26856\/revisions"}],"predecessor-version":[{"id":26857,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26856\/revisions\/26857"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}