{"id":24015,"date":"2023-06-15T04:51:00","date_gmt":"2023-06-14T20:51:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=24015"},"modified":"2023-06-15T05:53:32","modified_gmt":"2023-06-14T21:53:32","slug":"jama%e5%8f%91%e7%97%85%e8%ae%ba%e6%96%87%ef%bc%9a%e9%a2%84%e9%98%b2%e6%80%a7%e6%8a%97%e7%94%9f%e7%b4%a0%e5%af%b9%e9%85%92%e7%b2%be%e7%9b%b8%e5%85%b3%e9%87%8d%e7%97%87%e8%82%9d%e7%82%8e%e7%97%85","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=24015","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u9884\u9632\u6027\u6297\u751f\u7d20\u5bf9\u9152\u7cbe\u76f8\u5173\u91cd\u75c7\u809d\u708e\u75c5\u6b7b\u7387\u7684\u5f71\u54cd"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

May 9, 2023<\/p>\n\n\n\n

Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis: A Randomized Clinical Trial<\/h1>\n\n\n\n

Alexandre Louvet, Julien Labreuche, Thong Dao, et al<\/h3>\n\n\n\n

JAMA. <\/em>2023;329(18):1558-1566. doi:10.1001\/jama.2023.4902<\/h3>\n\n\n\n

Key Points<\/p>\n\n\n\n

Question<\/strong>  Among patients with severe alcohol-related hepatitis, does the combination of amoxicillin-clavulanate with prednisolone, compared with placebo with prednisolone, reduce mortality?<\/p>\n\n\n\n

Findings<\/strong>  In this randomized clinical trial that included 284 patients, mortality at 60 days was 17.3% in the amoxicillin-clavulanate group compared with 21.3% in the placebo group, a nonsignificant difference (hazard ratio, 0.77; 95% CI, 0.45-1.31).<\/p>\n\n\n\n

Meaning<\/strong>  Among patients with severe alcohol-related hepatitis receiving prednisolone, amoxicillin-clavulanate did not improve survival at 60-day follow-up compared with placebo.<\/a><\/p>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  The benefits of prophylactic antibiotics for hospitalized patients with severe alcohol-related hepatitis are unclear.<\/p>\n\n\n\n

Objective<\/strong>  To determine the efficacy of amoxicillin-clavulanate, compared with placebo, on mortality in patients hospitalized with severe alcohol-related hepatitis and treated with prednisolone.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  Multicenter, randomized, double-blind clinical trial among patients with biopsy-proven severe alcohol-related hepatitis (Maddrey function score \u226532 and Model for End-stage Liver Disease [MELD] score \u226521) from June 13, 2015, to May 24, 2019, in 25 centers in France and Belgium. All patients were followed up for 180 days. Final follow-up occurred on November 19, 2019.<\/p>\n\n\n\n

Intervention<\/strong>  Patients were randomly assigned (1:1 allocation) to receive prednisolone combined with amoxicillin-clavulanate (n\u2009=\u2009145) or prednisolone combined with placebo (n\u2009=\u2009147).<\/p>\n\n\n\n

Main Outcome and Measures<\/strong>  The primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days; incidence of infection, incidence of hepatorenal syndrome, and proportion of participants with a MELD score less than 17 at 60 days; and proportion of patients with a Lille score less than 0.45 at 7 days.<\/p>\n\n\n\n

Results<\/strong>  Among 292 randomized patients (mean age, 52.8 [SD, 9.2] years; 80 [27.4%] women) 284 (97%) were analyzed. There was no significant difference in 60-day mortality between participants randomized to amoxicillin-clavulanate and those randomized to placebo (17.3% in the amoxicillin-clavulanate group and 21.3% in the placebo group [P<\/em>\u2009=\u2009.33]; between-group difference, \u22124.7% [95% CI, \u221214.0% to 4.7%]; hazard ratio, 0.77 [95% CI, 0.45-1.31]). Infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group (29.7% vs 41.5%; mean difference, \u221211.8% [95% CI, \u221223.0% to \u22120.7%]; subhazard ratio, 0.62; [95% CI, 0.41-0.91]; P<\/em>\u2009=\u2009.02). There were no significant differences in any of the remaining 3 secondary outcomes. The most common serious adverse events were related to liver failure (25 in the amoxicillin-clavulanate group and 20 in the placebo group), infections (23 in the amoxicillin-clavulanate group and 46 in the placebo group), and gastrointestinal disorders (15 in the amoxicillin-clavulanate group and 21 in the placebo group).<\/p>\n\n\n\n

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Conclusion and Relevance<\/strong>  In patients hospitalized with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone. These results do not support prophylactic antibiotics to improve survival in patients hospitalized with severe alcohol-related hepatitis.<\/p>\n\n\n\n

Trial Registration<\/strong>  ClinicalTrials.gov Identifier: NCT02281929<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  May 9, 2023 Effe […]<\/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\/24015"}],"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=24015"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24015\/revisions"}],"predecessor-version":[{"id":24232,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24015\/revisions\/24232"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}