{"id":20096,"date":"2021-03-29T05:05:00","date_gmt":"2021-03-28T21:05:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=20096"},"modified":"2021-04-02T08:28:51","modified_gmt":"2021-04-02T00:28:51","slug":"jama%e5%9c%a8%e7%ba%bf%e5%8f%91%e8%a1%a8%ef%bc%9a%e4%b8%ad%e7%ad%89%e5%89%82%e9%87%8f%e4%b8%8e%e6%a0%87%e5%87%86%e5%89%82%e9%87%8f%e9%a2%84%e9%98%b2%e6%80%a7%e6%8a%97%e5%87%9d%e5%af%b9%e6%96%b0","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=20096","title":{"rendered":"[JAMA\u5728\u7ebf\u53d1\u8868]\uff1a\u4e2d\u7b49\u5242\u91cf\u4e0e\u6807\u51c6\u5242\u91cf\u9884\u9632\u6027\u6297\u51dd\u5bf9\u65b0\u51a0\u80ba\u708eICU\u60a3\u8005\u8840\u6813\u4e8b\u4ef6\u3001ECMO\u6cbb\u7597\u6216\u75c5\u6b7b\u7387\u7684\u5f71\u54cd"},"content":{"rendered":"\n

Original Investigation March 18, 2021<\/p>\n\n\n\n

Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial<\/h1>\n\n\n\n

INSPIRATION Investigators<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>Published online March 18, 2021. doi:10.1001\/jama.2021.4152<\/h3>\n\n\n\n

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

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

Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis.<\/p>\n\n\n\n

\u65b0\u51a0\u80ba\u708e\u5371\u91cd\u60a3\u8005\u5e38\u5e38\u53d1\u751f\u8840\u6813\u4e8b\u4ef6\u3002\u6709\u5173\u6307\u5bfc\u6297\u6813\u9884\u9632\u5f3a\u5ea6\u65b9\u9762\u4ec5\u6709\u6709\u9650\u7684\u8d44\u6599\u3002<\/p>\n\n\n\n

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

To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU).<\/p>\n\n\n\n

\u8bc4\u4f30\u6536\u5165ICU\u7684\u65b0\u51a0\u80ba\u708e\u60a3\u8005\u63a5\u53d7\u4e2d\u7b49\u5242\u91cf\u4e0e\u6807\u51c6\u5242\u91cf\u9884\u9632\u6027\u6297\u51dd\u7684\u6548\u679c\u3002<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong> \u8bbe\u8ba1\uff0c\u573a\u666f\u53ca\u7814\u7a76\u5bf9\u8c61<\/h3>\n\n\n\n

Multicenter randomized trial with a 2\u2009\u00d7\u20092 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020.<\/p>\n\n\n\n

\u5728\u4f0a\u671710\u4e2a\u533b\u5b66\u4e2d\u5fc3\u8fdb\u884c\u7684\u591a\u4e2d\u5fc32x2\u6790\u56e0\u8bbe\u8ba1\u3001\u968f\u673a\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5728\u6536\u5165ICU\u7684\u65b0\u51a0\u80ba\u708e\u60a3\u8005\u6bd4\u8f83\u4e2d\u7b49\u5242\u91cf\u4e0e\u6807\u51c6\u5242\u91cf\u9884\u9632\u6027\u6297\u51dd\uff08\u7b2c\u4e00\u5047\u8bbe\uff09\u4ee5\u53ca\u4ed6\u6c40\u6cbb\u7597\u4e0e\u5b89\u6170\u5242\uff08\u7b2c\u4e8c\u5047\u8bbe\uff0c\u672c\u6587\u672a\u4e88\u62a5\u544a\uff09\u30022020\u5e747\u670829\u65e5\u81f311\u670819\u65e5\u95f4\u5165\u9009\u60a3\u8005\u300230\u5929\u4e3b\u8981\u7ed3\u5c40\u6307\u6807\u7684\u6700\u540e\u968f\u8bbf\u65e5\u671f\u4e3a2020\u5e7412\u670819\u65e5\u3002<\/p>\n\n\n\n

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

Intermediate-dose (enoxaparin, 1 mg\/kg daily) (n\u2009=\u2009276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n\u2009=\u2009286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up.<\/p>\n\n\n\n

\u4e2d\u7b49\u5242\u91cf\uff08\u4f9d\u8bfa\u809d\u7d20enoxaparin, 1 mg\/kg\/\u65e5) (n\u2009=\u2009276) \u4e0e\u6807\u51c6\u9884\u9632\u6297\u51dd (\u4f9d\u8bfa\u809d\u7d20enoxaparin, 40 mg\/\u65e5) (n\u2009=\u2009286)\uff0c\u836f\u7269\u5242\u91cf\u6839\u636e\u4f53\u91cd\u53ca\u808c\u9150\u6e05\u9664\u7387\u8fdb\u884c\u8c03\u6574\u3002\u5206\u914d\u7684\u6cbb\u7597\u8ba1\u5212\u6301\u7eed\u5230\u5b8c\u621030\u5929\u968f\u8bbf\u3002<\/p>\n\n\n\n

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

The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count <20 \u00d7103<\/sup>\/\u00b5L). All outcomes were blindly adjudicated.<\/p>\n\n\n\n

\u4e3b\u8981\u9884\u540e\u6307\u6807\u4e3a\u590d\u5408\u6307\u6807\uff0c\u5bf9\u4e8e\u6ee1\u8db3\u5165\u9009\u6807\u51c6\u4e14\u63a5\u53d7\u81f3\u5c11\u4e00\u5242\u6cbb\u7597\u7684\u60a3\u8005\u8fdb\u884c\u8bc4\u4f30\uff0c\u5305\u62ec30\u5929\u5185\u9759\u8109\u6216\u52a8\u8109\u8840\u6813\u5f62\u6210\uff0c\u63a5\u53d7ECMO\u6cbb\u7597\u6216\u6b7b\u4ea1\u3002\u9884\u5148\u786e\u5b9a\u7684\u5b89\u5168\u6307\u6807\u5305\u62ec\u6839\u636e\u51fa\u8840\u5b66\u672f\u7814\u7a76\u4f1a\u5b9a\u4e49\u7684\u5927\u51fa\u8840\uff083\u578b\u62165\u578b\u5b9a\u4e49\uff09\uff08\u975e\u52a3\u6548\u8fb9\u754c\u6bd4\u6570\u6bd41.8\uff09\uff0c\u91cd\u5ea6\u8840\u5c0f\u677f\u7f3a\u4e4f\uff08\u8840\u5c0f\u677f\u8ba1\u6570<20 \u00d7103<\/sup>\/\u00b5L\uff09\u3002\u6240\u6709\u7ed3\u5c40\u6307\u6807\u7684\u8bc4\u4f30\u5747\u8bbe\u76f2\u3002<\/p>\n\n\n\n

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

Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI, \u22126.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48];\u00a0P<\/em>\u2009=\u2009.70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI, \u2212\u221e to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P<\/em>\u00a0for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%];\u00a0P<\/em>\u2009=\u2009.01).<\/p>\n\n\n\n

\u5171600\u540d\u60a3\u8005\u63a5\u53d7\u968f\u673a\u5206\u7ec4\uff0c562\u540d (93.7%) \u7eb3\u5165\u4e3b\u8981\u5206\u6790\uff08\u4e2d\u4f4d [\u56db\u5206\u4f4d\u533a\u95f4] \u5e74\u9f84, 62 [50-71] \u5c81; 237\u540d [42.2%] \u5973\u6027)\u3002\u4e2d\u7b49\u5242\u91cf\u7ec4126\u540d (45.7%) \u60a3\u8005\u4e0e\u6807\u51c6\u5242\u91cf\u7ec4126 \u540d (44.1%) \u60a3\u8005\u53d1\u751f\u4e3b\u8981\u7597\u6548\u7ed3\u5c40\u4e8b\u4ef6\uff08\u7edd\u5bf9\u98ce\u9669\u5dee\u5f02, 1.5% [95% CI, \u22126.6% to 9.8%]; \u6bd4\u6570\u6bd4, 1.06 [95% CI, 0.76-1.48];\u00a0P<\/em>\u2009=\u2009.70\uff09\u3002\u4e2d\u7b49\u5242\u91cf\u7ec47\u540d (2.5%) \u60a3\u8005\u53ca\u6807\u51c6\u5242\u91cf\u7ec44\u540d (1.4%) \u60a3\u8005\u53d1\u751f\u5927\u51fa\u8840\uff08\u98ce\u9669\u5dee\u5f02, 1.1% [1-sided 97.5% CI, \u2212\u221e to 3.4%]; \u6bd4\u6570\u6bd4, 1.83 [1-sided 97.5% CI, 0.00-5.93]\uff09\uff0c\u672a\u8fbe\u5230\u975e\u52a3\u6548\u6807\u51c6\uff08\u975e\u52a3\u6548P<\/em>\u503c\u00a0 >.99)\u3002\u4ec5\u4e2d\u7b49\u5242\u91cf\u7ec4\u60a3\u8005\u53d1\u751f\u91cd\u5ea6\u8840\u5c0f\u677f\u7f3a\u4e4f\uff086 vs 0 \u540d\u60a3\u8005; \u98ce\u9669\u5dee\u5f02, 2.2% [95% CI, 0.4%-3.8%];\u00a0P<\/em>\u2009=\u2009.01\uff09\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

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

Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19.<\/p>\n\n\n\n

\u5bf9\u4e8e\u6536\u5165ICU\u7684\u65b0\u51a0\u80ba\u708e\u60a3\u8005\uff0c\u4e0e\u6807\u51c6\u5242\u91cf\u9884\u9632\u6027\u6297\u51dd\u76f8\u6bd4\uff0c\u4e2d\u7b49\u5242\u91cf\u9884\u9632\u6027\u6297\u51dd\u5bf9\u5305\u62ec30\u5929\u5185\u9759\u8109\u6216\u52a8\u8109\u8840\u6813\u5f62\u6210\u3001ECMO\u6cbb\u7597\u6216\u6b7b\u4ea1\u5728\u5185\u7684\u590d\u5408\u9884\u540e\u6307\u6807\u6ca1\u6709\u663e\u8457\u5f71\u54cd\u3002\u8fd9\u4e9b\u7ed3\u679c\u4e0d\u652f\u6301\u5bf9\u4e8e\u6536\u5165ICU\u7684\u65b0\u51a0\u80ba\u708e\u60a3\u8005\u4e0d\u52a0\u9009\u62e9\u5730\u5e38\u89c4\u7ecf\u9a8c\u6027\u91c7\u7528\u4e2d\u7b49\u5242\u91cf\u9884\u9632\u6027\u6297\u51dd\u3002<\/p>\n\n\n\n

Trial Registration<\/strong><\/h3>\n\n\n\n

ClinicalTrials.gov Identifier:\u00a0NCT04486508<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation March 18, 2021 Ef […]<\/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\/20096"}],"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=20096"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/20096\/revisions"}],"predecessor-version":[{"id":20098,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/20096\/revisions\/20098"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20096"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20096"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20096"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}