{"id":21516,"date":"2022-06-26T05:06:00","date_gmt":"2022-06-25T21:06:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21516"},"modified":"2022-06-26T06:15:25","modified_gmt":"2022-06-25T22:15:25","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%8d%95%e5%89%82%e8%84%82%e8%b4%a8%e4%bd%93%e4%b8%a4%e6%80%a7%e9%9c%89%e7%b4%a0b%e6%b2%bb%e7%96%97%e9%9a%90%e7%90%83%e8%8f%8c%e8%84%91%e8%86%9c","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21516","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u5355\u5242\u8102\u8d28\u4f53\u4e24\u6027\u9709\u7d20B\u6cbb\u7597\u9690\u7403\u83cc\u8111\u819c\u708e"},"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\">Single-Dose Liposomal Amphotericin B Treatment for Cryptococcal Meningitis<\/h1>\n\n\n\n<h3 class=\"wp-block-heading\">Joseph N. Jarvis, David S. Lawrence, David B. Meya,\u00a0et al<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\">N Engl J Med 2022; 386:1109-1120<br \/>DOI: 10.1056\/NEJMoa2111904<\/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>Cryptococcal meningitis is a leading cause of human immunodeficiency virus (HIV)\u2013related death in sub-Saharan Africa. Whether a treatment regimen that includes a single high dose of liposomal amphotericin B would be efficacious is not known.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">METHODS<\/h2>\n\n\n\n<p>In this phase 3 randomized, controlled, noninferiority trial conducted in five African countries, we assigned HIV-positive adults with cryptococcal meningitis in a 1:1 ratio to receive either a single high dose of liposomal amphotericin B (10 mg per kilogram of body weight) on day 1 plus 14 days of flucytosine (100 mg per kilogram per day) and fluconazole (1200 mg per day) or the current World Health Organization\u2013recommended treatment, which includes amphotericin B deoxycholate (1 mg per kilogram per day) plus flucytosine (100 mg per kilogram per day) for 7 days, followed by fluconazole (1200 mg per day) for 7 days (control). The primary end point was death from any cause at 10 weeks; the trial was powered to show noninferiority at a 10-percentage-point margin.<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2111904?query=featured_home#\"><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">RESULTS<\/h2>\n\n\n\n<p>A total of 844 participants underwent randomization; 814 were included in the intention-to-treat population. At 10 weeks, deaths were reported in 101 participants (24.8%; 95% confidence interval [CI], 20.7 to 29.3) in the liposomal amphotericin B group and 117 (28.7%; 95% CI, 24.4 to 33.4) in the control group (difference, \u22123.9 percentage points); the upper boundary of the one-sided 95% confidence interval was 1.2 percentage points (within the noninferiority margin; P&lt;0.001 for noninferiority). Fungal clearance from cerebrospinal fluid was \u22120.40 log<sub>10<\/sub>&nbsp;colony-forming units (CFU) per milliliter per day in the liposomal amphotericin B group and \u22120.42 log<sub>10<\/sub>&nbsp;CFU per milliliter per day in the control group. Fewer participants had grade 3 or 4 adverse events in the liposomal amphotericin B group than in the control group (50.0% vs. 62.3%).<\/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-12\/nejmoa2111904\/20220321\/images\/img_xlarge\/nejmoa2111904_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-12\/nejmoa2111904\/20220321\/images\/img_xlarge\/nejmoa2111904_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-12\/nejmoa2111904\/20220321\/images\/img_xlarge\/nejmoa2111904_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-12\/nejmoa2111904\/20220321\/images\/img_xlarge\/nejmoa2111904_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-12\/nejmoa2111904\/20220321\/images\/img_xlarge\/nejmoa2111904_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-12\/nejmoa2111904\/20220321\/images\/img_xlarge\/nejmoa2111904_t3.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">CONCLUSIONS<\/h2>\n\n\n\n<p>Single-dose liposomal amphotericin B combined with flucytosine and fluconazole was noninferior to the WHO-recommended treatment for HIV-associated cryptococcal meningitis and was associated with fewer adverse events. (Funded by the European and Developing Countries Clinical Trials Partnership and others; Ambition ISRCTN number,&nbsp;<a href=\"https:\/\/doi.org\/10.1186\/ISRCTN72509687\" target=\"_blank\" rel=\"noreferrer noopener\">ISRCTN72509687. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ORIGINAL ARTICLE Single-Dose Liposomal Amphotericin B T [&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\/21516"}],"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=21516"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21516\/revisions"}],"predecessor-version":[{"id":21517,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21516\/revisions\/21517"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21516"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21516"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21516"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}