{"id":21948,"date":"2022-07-29T04:57:00","date_gmt":"2022-07-28T20:57:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21948"},"modified":"2022-07-29T06:28:37","modified_gmt":"2022-07-28T22:28:37","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%9b%ba%e5%ae%9a%e5%89%82%e9%87%8f%e6%b2%99%e4%b8%81%e8%83%ba%e9%86%87-%e5%b8%83%e5%9c%b0%e5%a5%88%e5%be%b7%e8%81%94%e5%90%88%e5%90%b8%e5%85%a5","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21948","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u56fa\u5b9a\u5242\u91cf\u6c99\u4e01\u80fa\u9187-\u5e03\u5730\u5948\u5fb7\u8054\u5408\u5438\u5165\u5242\u633d\u6551\u6cbb\u7597\u54ee\u5598"},"content":{"rendered":"\n<p><a href=\"https:\/\/www.nejm.org\/medical-articles\/original-article\" class=\"\">ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n<h1 class=\"wp-block-heading\">Albuterol\u2013Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma<\/h1>\n\n\n\n<h3 class=\"wp-block-heading\">Alberto Papi, Bradley E. Chipps, Richard Beasley,\u00a0et al<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\">N Engl J Med 2022; 386:2071-2083<br \/>DOI: 10.1056\/NEJMoa2203163<\/h3>\n\n\n\n<h2 class=\"wp-block-heading\">Abstract<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">BACKGROUND<\/h2>\n\n\n\n<p>As asthma symptoms worsen, patients typically rely on short-acting \u03b2<sub>2<\/sub>-agonist (SABA) rescue therapy, but SABAs do not address worsening inflammation, which leaves patients at risk for severe asthma exacerbations. The use of a fixed-dose combination of albuterol and budesonide, as compared with albuterol alone, as rescue medication might reduce the risk of severe asthma exacerbation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">METHODS<\/h2>\n\n\n\n<p>We conducted a multinational, phase 3, double-blind, randomized, event-driven trial to evaluate the efficacy and safety of albuterol\u2013budesonide, as compared with albuterol alone, as rescue medication in patients with uncontrolled moderate-to-severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies, which were continued throughout the trial. Adults and adolescents (\u226512 years of age) were randomly assigned in a 1:1:1 ratio to one of three trial groups: a fixed-dose combination of 180 \u03bcg of albuterol and 160 \u03bcg of budesonide (with each dose consisting of two actuations of 90 \u03bcg and 80 \u03bcg, respectively [the higher-dose combination group]), a fixed-dose combination of 180 \u03bcg of albuterol and 80 \u03bcg of budesonide (with each dose consisting of two actuations of 90 \u03bcg and 40 \u03bcg, respectively [the lower-dose combination group]), or 180 \u03bcg of albuterol (with each dose consisting of two actuations of 90 \u03bcg [the albuterol-alone group]). Children 4 to 11 years of age were randomly assigned to only the lower-dose combination group or the albuterol-alone group. The primary efficacy end point was the first event of severe asthma exacerbation in a time-to-event analysis, which was performed in the intention-to-treat population.<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2203163?query=featured_home#\"><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">RESULTS<\/h2>\n\n\n\n<p>A total of 3132 patients underwent randomization, among whom 97% were 12 years of age or older. The risk of severe asthma exacerbation was significantly lower, by 26%, in the higher-dose combination group than in the albuterol-alone group (hazard ratio, 0.74; 95% confidence interval [CI], 0.62 to 0.89; P=0.001). The hazard ratio in the lower-dose combination group, as compared with the albuterol-alone group, was 0.84 (95% CI, 0.71 to 1.00; P=0.052). The incidence of adverse events was similar in the three trial groups.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.nejm.org\/na101\/home\/literatum\/publisher\/mms\/journals\/content\/nejm\/2022\/nejm_2022.386.issue-22\/nejmoa2203163\/20220531\/images\/img_xlarge\/nejmoa2203163_f0.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.nejm.org\/na101\/home\/literatum\/publisher\/mms\/journals\/content\/nejm\/2022\/nejm_2022.386.issue-22\/nejmoa2203163\/20220531\/images\/img_xlarge\/nejmoa2203163_f1.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.nejm.org\/na101\/home\/literatum\/publisher\/mms\/journals\/content\/nejm\/2022\/nejm_2022.386.issue-22\/nejmoa2203163\/20220531\/images\/img_xlarge\/nejmoa2203163_t1.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.nejm.org\/na101\/home\/literatum\/publisher\/mms\/journals\/content\/nejm\/2022\/nejm_2022.386.issue-22\/nejmoa2203163\/20220531\/images\/img_xlarge\/nejmoa2203163_f2.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.nejm.org\/na101\/home\/literatum\/publisher\/mms\/journals\/content\/nejm\/2022\/nejm_2022.386.issue-22\/nejmoa2203163\/20220531\/images\/img_xlarge\/nejmoa2203163_t2.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.nejm.org\/na101\/home\/literatum\/publisher\/mms\/journals\/content\/nejm\/2022\/nejm_2022.386.issue-22\/nejmoa2203163\/20220531\/images\/img_xlarge\/nejmoa2203163_t3.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">CONCLUSIONS<\/h2>\n\n\n\n<p>The risk of severe asthma exacerbation was significantly lower with as-needed use of a fixed-dose combination of 180 \u03bcg of albuterol and 160 \u03bcg of budesonide than with as-needed use of albuterol alone among patients with uncontrolled moderate-to-severe asthma who were receiving a wide range of inhaled glucocorticoid-containing maintenance therapies. (Funded by Avillion; MANDALA ClinicalTrials.gov number,&nbsp;<a href=\"http:\/\/clinicaltrials.gov\/show\/NCT03769090\" target=\"_blank\" rel=\"noreferrer noopener\">NCT03769090. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ORIGINAL ARTICLE Albuterol\u2013Budesonide Fixed-Dose Combin [&hellip;]<\/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\/21948"}],"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=21948"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21948\/revisions"}],"predecessor-version":[{"id":21949,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21948\/revisions\/21949"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21948"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21948"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}