{"id":17899,"date":"2019-10-28T05:38:45","date_gmt":"2019-10-27T21:38:45","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=17899"},"modified":"2019-12-12T07:13:01","modified_gmt":"2019-12-11T23:13:01","slug":"jama%e5%9c%a8%e7%ba%bf%e5%8f%91%e8%a1%a8%ef%bc%9a%e5%bf%83%e8%84%8f%e5%a4%96%e7%a7%91%e6%9c%af%e5%90%8e%e4%bd%bf%e7%94%a8%e7%ba%a4%e7%bb%b4%e8%9b%8b%e7%99%bd%e5%8e%9f%e6%b5%93%e7%bc%a9%e7%89%a9","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=17899","title":{"rendered":"[JAMA\u5728\u7ebf\u53d1\u8868]\uff1a\u5fc3\u810f\u5916\u79d1\u672f\u540e\u4f7f\u7528\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269\u6216\u51b7\u6c89\u6dc0\u5bf9\u4e8e\u8f93\u6ce8\u8840\u6db2\u5236\u54c1\u7684\u5f71\u54cd"},"content":{"rendered":"\n

October 21, 2019<\/p>\n\n\n\n

Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial<\/h1>\n\n\n\n

J<\/a>eannie\u00a0Callum,\u00a0Michael E.\u00a0Farkouh,\u00a0Damon C.\u00a0Scales,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>Published online October 21, 2019. doi:10.1001\/jama.2019.17312<\/h3>\n\n\n\n

Abstract<\/h3>\n\n\n\n

Importance<\/strong>\u00a0\u80cc\u666f<\/h3>\n\n\n\n

Excessive bleeding is a common complication of cardiac surgery. An important cause of bleeding is acquired hypofibrinogenemia (fibrinogen level <1.5-2.0 g\/L), for which guidelines recommend fibrinogen replacement with cryoprecipitate or fibrinogen concentrate. The 2 products have important differences, but comparative clinical data are lacking.<\/p>\n\n\n\n

\u51fa\u8840\u8fc7\u591a\u662f\u5fc3\u810f\u624b\u672f\u7684\u5e38\u89c1\u5e76\u53d1\u75c7\u3002\u83b7\u5f97\u6027\u4f4e\u7ea4\u7ef4\u86cb\u767d\u539f\u8840\u75c7\uff08\u7ea4\u7ef4\u86cb\u767d\u539f\u6c34\u5e73<1.5-2.0 g\/L\uff09\u662f\u5bfc\u81f4\u51fa\u8840\u7684\u91cd\u8981\u539f\u56e0\uff0c\u6307\u5357\u63a8\u8350\u8f93\u6ce8\u51b7\u6c89\u6dc0\u6216\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269\u8865\u5145\u7ea4\u7ef4\u86cb\u767d\u539f\u3002\u8fd92\u79cd\u4ea7\u54c1\u5177\u6709\u91cd\u8981\u7684\u5dee\u522b\uff0c\u4f46\u662f\u5c1a\u7f3a\u4e4f\u4e34\u5e8a\u8d44\u6599\u8fdb\u884c\u6bd4\u8f83\u3002<\/p>\n\n\n\n

Objective<\/strong>\u00a0\u76ee\u7684<\/h3>\n\n\n\n

To determine if fibrinogen concentrate is noninferior to cryoprecipitate for treatment of bleeding related to hypofibrinogenemia after cardiac surgery.<\/p>\n\n\n\n

\u786e\u5b9a\u5fc3\u810f\u5916\u79d1\u624b\u672f\u540e\u6cbb\u7597\u4f4e\u7ea4\u7ef4\u86cb\u767d\u539f\u8840\u75c7\u76f8\u5173\u51fa\u8840\u65f6\uff0c\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269\u4e0d\u52a3\u4e8e\u51b7\u6c89\u6dc0\u3002<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>\u00a0\u8bbe\u8ba1\u3001\u573a\u666f\u548c\u7814\u7a76\u4eba\u7fa4<\/h3>\n\n\n\n

Randomized clinical trial at 11 Canadian hospitals enrolling adult patients experiencing clinically significant bleeding and hypofibrinogenemia after cardiac surgery (from February 10, 2017, to November 1, 2018). Final 28-day follow-up visit was completed on November 28, 2018.<\/p>\n\n\n\n

\u8fd9\u9879\u968f\u673a\u4e34\u5e8a\u8bd5\u9a8c\u5728\u52a0\u62ff\u592711\u6240\u533b\u9662\u8fdb\u884c\uff0c\u7eb3\u5165\u5fc3\u810f\u5916\u79d1\u672f\u540e\u51fa\u73b0\u660e\u663e\u51fa\u8840\u53ca\u4f4e\u7ea4\u7ef4\u86cb\u767d\u539f\u8840\u75c7\u7684\u6210\u5e74\u60a3\u8005\uff08\u4ece2017\u5e742\u670810\u65e5\u81f32018\u5e7411\u67081\u65e5\uff09\u3002\u6700\u540e28\u5929\u968f\u8bbf\u4e8e2018\u5e7411\u670828\u65e5\u7ed3\u675f\u3002<\/p>\n\n\n\n

Interventions<\/strong>\u00a0\u5e72\u9884\u63aa\u65bd<\/h3>\n\n\n\n

Fibrinogen concentrate (4 g; n\u2009=\u2009415) or cryoprecipitate (10 units; n\u2009=\u2009412) for each ordered dose within 24 hours after cardiopulmonary bypass.<\/p>\n\n\n\n

\u5fc3\u80ba\u65c1\u8def\u624b\u672f\u540e24\u5c0f\u65f6\u5185\uff0c\u6bcf\u6b21\u533b\u5631\u7ed9\u4e88\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269 (4 g; n\u2009=\u2009415) \u6216\u51b7\u6c89\u6dc0 (10 \u4e2a\u5355\u4f4d; n\u2009=\u2009412)\u3002<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>\u00a0\u4e3b\u8981\u9884\u540e\u6307\u6807<\/h3>\n\n\n\n

Primary outcome was blood components (red blood cells, platelets, plasma) administered during 24 hours post bypass. A 2-sample, 1-sided test for the ratio of the mean number of units was conducted to evaluate noninferiority (threshold for noninferiority ratio, <1.2).<\/p>\n\n\n\n

\u4e3b\u8981\u9884\u540e\u7ec8\u70b9\u4e3a\u5fc3\u80ba\u65c1\u8def\u672f\u540e24\u5c0f\u65f6\u5185\u8f93\u6ce8\u7684\u8840\u6db2\u5236\u54c1\uff08\u7ea2\u7ec6\u80de\uff0c\u8840\u5c0f\u677f\u548c\u8840\u6d46\uff09\u3002\u5bf9\u8f93\u6ce8\u8840\u6db2\u5236\u54c1\u5e73\u5747\u5355\u4f4d\u6570\u7684\u6bd4\u503c\u8fdb\u884c2\u4e2a\u6837\u672c\u5355\u4fa7\u68c0\u9a8c\uff0c\u4ee5\u8bc4\u4ef7\u975e\u52a3\u6548\uff08\u975e\u52a3\u6548\u6bd4\u503c\u9608\u503c, <1.2\uff09\u3002<\/p>\n\n\n\n

Results<\/strong>\u00a0\u7ed3\u679c<\/h3>\n\n\n\n

Of 827 randomized patients, 735 (372 fibrinogen concentrate, 363 cryoprecipitate) were treated and included in the primary analysis (median age, 64 [interquartile range, 53-72] years; 30% women; 72% underwent complex operations; 95% moderate to severe bleeding; and pretreatment fibrinogen level, 1.6 [interquartile range, 1.3-1.9] g\/L). The trial met the a priori stopping criterion for noninferiority at the interim analysis after 827 of planned 1200 patients were randomized. Mean 24-hour postbypass allogeneic transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the fibrinogen concentrate group and 17.0 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group (ratio, 0.96 [1-sided 97.5% CI, \u2212\u221e to 1.09;\u00a0P<\/em>\u2009<\u2009.001 for noninferiority] [2-sided 95% CI, 0.84 to 1.09;\u00a0P<\/em>\u2009=\u2009.50 for superiority]). Thromboembolic events occurred in 26 patients (7.0%) in the fibrinogen concentrate group and 35 patients (9.6%) in the cryoprecipitate group.<\/p>\n\n\n\n

\u5171\u6709827\u540d\u60a3\u8005\u63a5\u53d7\u968f\u673a\u5206\u7ec4\uff0c\u5176\u4e2d 735 (372 \u540d\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269, 363 \u540d\u51b7\u6c89\u6dc0) \u63a5\u53d7\u6cbb\u7597\u5e76\u7eb3\u5165\u4e3b\u8981\u5206\u6790 (\u4e2d\u4f4d\u5e74\u9f84, 64 [\u56db\u5206\u4f4d\u533a\u95f4, 53-72] \u5c81; 30% \u5973\u6027; 72% \u63a5\u53d7\u590d\u6742\u624b\u672f; 95% \u4e2d\u91cd\u5ea6\u51fa\u8840; \u6cbb\u7597\u94b1\u7ea4\u7ef4\u86cb\u767d\u539f\u6c34\u5e73, 1.6 [\u56db\u5206\u4f4d\u533a\u95f4, 1.3-1.9] g\/L)\u3002\u8bd5\u9a8c\u9884\u8ba1\u6837\u672c\u91cf1200\u540d\u60a3\u8005\uff0c827\u540d\u60a3\u8005\u5165\u9009\u540e\u8fdb\u884c\u7684\u4e2d\u671f\u5206\u6790\u53d1\u73b0\uff0c\u8bd5\u9a8c\u7b26\u5408\u9884\u5148\u786e\u5b9a\u7684\u975e\u52a3\u6548\u7ec8\u6b62\u6807\u51c6\u3002\u5fc3\u80ba\u65c1\u8def\u540e24\u5c0f\u65f6\u5e73\u5747\u8f93\u8840\u91cf\uff0c\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269\u7ec4\u4e3a 16.3 (95% CI, 14.9 to 17.8) \u5355\u4f4d\uff0c\u51b7\u6c89\u6dc0\u7ec4 17.0 (95% CI, 15.6 to 18.6) \u5355\u4f4d (\u6bd4\u503c, 0.96 [\u5355\u4fa7 97.5% CI, \u2212\u221e to 1.09;\u00a0\u975e\u52a3\u6548P<\/em>\u2009<\u2009.001] [\u53cc\u4fa7 95% CI, 0.84 to 1.09;\u00a0\u975e\u52a3\u6548P<\/em>\u2009=\u2009.50])\u3002\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269\u7ec426\u540d (7.0%) \u60a3\u8005\u53ca\u51b7\u6c89\u6dc0\u7ec435\u540d (9.6%) \u60a3\u8005\u53d1\u751f\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u3002<\/p>\n\n\n\n

\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n

Conclusions and Relevance<\/strong>\u00a0\u7ed3\u8bba\u4e0e\u610f\u4e49<\/h3>\n\n\n\n

In patients undergoing cardiac surgery who develop clinically significant bleeding and hypofibrinogenemia after cardiopulmonary bypass, fibrinogen concentrate is noninferior to cryoprecipitate with regard to number of blood components transfused in a 24-hour period post bypass. Use of fibrinogen concentrate may be considered for management of bleeding in patients with acquired hypofibrinogenemia in cardiac surgery.<\/p>\n\n\n\n

\u5bf9\u4e8e\u5fc3\u80ba\u65c1\u8def\u540e\u53d1\u751f\u4e34\u5e8a\u660e\u663e\u51fa\u8840\u4e14\u5408\u5e76\u4f4e\u7ea4\u7ef4\u86cb\u767d\u539f\u8840\u75c7\u7684\u5fc3\u810f\u5916\u79d1\u672f\u540e\u60a3\u8005\uff0c\u8f93\u6ce8\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269\u5bf9\u4e8e\u5fc3\u80ba\u65c1\u8def\u540e24\u6d88\u5931\u8f93\u6ce8\u8840\u6db2\u5236\u54c1\u91cf\u4e0d\u52a3\u4e8e\u51b7\u6c89\u6dc0\u3002\u5bf9\u4e8e\u5fc3\u810f\u5916\u79d1\u672f\u540e\u83b7\u5f97\u6027\u4f4e\u7ea4\u7ef4\u86cb\u767d\u539f\u8840\u75c7\u60a3\u8005\uff0c\u53ef\u4ee5\u8003\u8651\u4f7f\u7528\u7ea4\u7ef4\u86cb\u767d\u539f\u6d53\u7f29\u7269\u6cbb\u7597\u51fa\u8840\u3002<\/p>\n\n\n\n

Trial Registration<\/strong>\u00a0\u8bd5\u9a8c\u6ce8\u518c<\/h3>\n\n\n\n

ClinicalTrials.gov Identifier:\u00a0NCT03037424<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

October 21, 2019 Effect of Fibrinogen Concent […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/17899"}],"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=17899"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/17899\/revisions"}],"predecessor-version":[{"id":17901,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/17899\/revisions\/17901"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17899"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17899"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17899"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}