{"id":27678,"date":"2025-01-27T04:02:00","date_gmt":"2025-01-26T20:02:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=27678"},"modified":"2025-01-27T06:09:18","modified_gmt":"2025-01-26T22:09:18","slug":"bmj%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e8%83%b8%e8%85%ba%e8%82%bd%ce%b11%e6%b2%bb%e7%96%97%e8%84%93%e6%af%92%e7%97%87%e7%9a%84%e7%96%97%e6%95%88%e4%b8%8e%e5%ae%89%e5%85%a8%e6%80%a7","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=27678","title":{"rendered":"[BMJ\u53d1\u8868\u8bba\u6587]\uff1a\u80f8\u817a\u80bd\u03b11\u6cbb\u7597\u8113\u6bd2\u75c7\u7684\u7597\u6548\u4e0e\u5b89\u5168\u6027"},"content":{"rendered":"\n

Research<\/strong><\/p>\n\n\n\n

The efficacy and safety of thymosin \u03b11 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial<\/h1>\n\n\n\n

Jianfeng Wu, Fei Pei, Lixin Zhou, et al<\/h3>\n\n\n\n

BMJ<\/em>\u00a02025;\u00a0388\u00a0doi:\u00a0https:\/\/doi.org\/10.1136\/bmj-2024-082583<\/a>\u00a0(Published 15 January 2025)Cite this as:\u00a0BMJ<\/em>\u00a02025;388:e082583<\/h3>\n\n\n\n

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

Objective<\/strong> To evaluate whether the immunomodulatory drug thymosin \u03b11 reduces mortality in adults with sepsis.<\/p>\n\n\n\n

Design<\/strong> Multicentre, double blinded, placebo controlled phase 3 trial.<\/p>\n\n\n\n

Setting<\/strong> 22 centres in China, September 2016 to December 2020.<\/p>\n\n\n\n

Participants<\/strong> 1106 adults aged 18-85 years with a diagnosis of sepsis according to sepsis-3 criteria and randomly assigned in a 1:1 ratio to receive thymosin \u03b11 (n=552) or placebo (n=554). A stratified block method was used for randomisation, and participants were stratified by age (<60 and \u226560 years) and centre.<\/p>\n\n\n\n

Interventions<\/strong> Subcutaneous injection of thymosin \u03b11 or placebo every 12 hours for seven days unless discontinued owing to discharge from the intensive care unit, death, or withdrawal of consent.<\/p>\n\n\n\n

Main outcome measure<\/strong> The primary outcome was 28 day all cause mortality after randomisation. All analyses were based on a modified intention-to-treat set, including participants who received at least one dose of study drug.<\/p>\n\n\n\n

Results<\/strong>\u00a0Of 1106 adults with sepsis enrolled in the study, 1089 were included in the modified intention-to-treat analyses (thymosin \u03b11 group n=542, placebo group n=547). 28 day all cause mortality occurred in 127 participants (23.4%) in the thymosin \u03b11 group and 132 (24.1%) in the placebo group (hazard ratio 0.99, 95% confidence interval 0.77 to 1.27; P=0.93 with log-rank test). No secondary or safety outcome differed statistically significantly between the two groups. The prespecified subgroup analysis showed a potential differential effect of thymosin \u03b11 on the primary outcome based on age (<60 years: hazard ratio 1.67, 1.04 to 2.67; \u226560 years: 0.81, 0.61 to 1.09; P for interaction=0.01) and diabetes (diabetes: 0.58, 0.35 to 0.99; no diabetes: 1.16, 0.87 to 1.53; P for interaction=0.04).<\/p>\n\n\n\n

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Conclusions<\/strong> This trial found no clear evidence to suggest that thymosin \u03b11 decreases 28 day all cause mortality in adults with sepsis.<\/p>\n\n\n\n

Trial registration<\/strong> ClinicalTrials.gov NCT02867267<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Research The efficacy and safety of thymosin \u03b11 for sep […]<\/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\/27678"}],"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=27678"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27678\/revisions"}],"predecessor-version":[{"id":27679,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27678\/revisions\/27679"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27678"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27678"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27678"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}