{"id":943,"date":"2023-05-03T15:40:35","date_gmt":"2023-05-03T07:40:35","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=943"},"modified":"2023-05-03T15:40:35","modified_gmt":"2023-05-03T07:40:35","slug":"%e8%ae%b0%e4%bd%8f%e6%89%80%e6%9c%89fda%e7%94%9f%e7%89%a9%e8%8d%af-%e4%b8%a4%e6%ac%becd38%e7%94%9f%e7%89%a9%e5%88%b6%e5%89%82-%e8%be%be%e9%9b%b7%e5%a6%a5%e5%b0%a4%e5%8d%95%e6%8a%97%e3%80%81isatuxi","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=943","title":{"rendered":"\u8bb0\u4f4f\u6240\u6709FDA\u751f\u7269\u836f | \u4e24\u6b3eCD38\u751f\u7269\u5236\u5242 | \u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u3001Isatuximab\u827e\u6c99\u59a5\u6614\u5355\u6297 | \u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7b49"},"content":{"rendered":"\n<p>\u7528\u56fe\u50cf\u8bb0\u5fc6\u7684\u65b9\u6cd5\uff0c\u4e00\u4e2a\u836f\u4e00\u5f20\u56fe\uff0c\u8bb0\u4f4f\u6240\u6709FDA\u6279\u51c6\u4e0a\u5e02\u751f\u7269\u5236\u5242\u7684\u540d\u79f0\uff0c\u9776\u70b9\uff0c\u9002\u5e94\u75c7\u7b49\u4fe1\u606f\u3002<\/p>\n\n\n\n<p>\u76ee\u524dFDA\u83b7\u6279\u4e0a\u5e02\u9776\u70b9CD38\u751f\u7269\u5236\u5242\u6709\u4e24\u6b3e\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u200b\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u7531\u7f8e\u56fd\u5f3a\u751f\u516c\u53f8\u5f00\u53d1\uff0c\u662f\u9996\u4e2a\u9488\u5bf9CD38\u5206\u5b50\u7684\u5355\u514b\u9686\u6297\u4f53\u3002\u836f\u72692015\u5e74\u83b7\u5f97FDA\u7684\u6279\u51c6\u4e0a\u5e02\uff08DARZALEX<sup>\u00ae<\/sup>&nbsp;Daratumumab\uff09\uff0c\u5df2\u83b7\u5f97\u591a\u9879\u9002\u5e94\u75c7\uff0c\u76ee\u524d\u5df2\u4ece\u56db\u7ebf\u7597\u6cd5\u6269\u5c55\u5230\u4e00\u7ebf\u3002<\/li>\n<\/ul>\n\n\n\n<p>2019\u5e74\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u5728\u4e2d\u56fd\u83b7\u6279\u4e0a\u5e02\uff1a\u5546\u54c1\u540d\u5146\u73c2\u00ae\u4e3a\u9759\u8109\u6ce8\u5c04\u5242\u578b\uff0c\u9002\u5e94\u75c7\u4e3a\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff1b\u5546\u54c1\u540d\u5146\u73c2\u901f\u00ae\u4e3a\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\uff0c\u9002\u5e94\u75c7\u4e3a\u539f\u53d1\u6027\u8f7b\u94fe\u578b\u6dc0\u7c89\u6837\u53d8\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sarclisa<sup>\u00ae<\/sup>&nbsp;Isatuximab \u4e5f\u662f\u4e00\u6b3e\u9776\u70b9CD38\u751f\u7269\u5236\u5242\u3002\u7531\u6cd5\u56fd\u8d5b\u8bfa\u83f2\uff08Sanofi\uff09\u516c\u53f8\u5f00\u53d1\uff0c\u540c\u6837\u7528\u4e8e\u6cbb\u7597\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u3002\u836f\u7269\u4e8e2020\u5e74\u83b7FDA\u6279\u51c6\u4e0a\u5e02\u3002\u76ee\u524d\u4e2d\u56fd\u5c1a\u672a\u83b7\u6279\uff0c\u4e2d\u6587\u540d\u97f3\u8bd1\u4e3a\u827e\u6c99\u59a5\u6614\u5355\u6297\uff08\u65e0\u51fa\u5904\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n<p>\u591a\u53d1\u6027\u9aa8\u9ad3\u7624(multiple myeloma\uff0cMM)\u662f\u4e00\u79cd\u8d77\u6e90\u4e8e\u60a3\u8005\u9aa8\u9ad3\u3001\u4e0d\u53ef\u6cbb\u6108\u7684\u6d46\u7ec6\u80de\u6076\u6027\u80bf\u7624\u3002<\/p>\n\n\n\n<p><strong>B\u7ec6\u80de\u5206\u5316\u8fc7\u7a0b<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1024x454.png\" alt=\"\" class=\"wp-image-944\" width=\"724\" height=\"321\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1024x454.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-300x133.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-768x341.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1218x540.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-880x390.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image.png 1281w\" sizes=\"auto, (max-width: 724px) 100vw, 724px\" \/><figcaption class=\"wp-element-caption\"><em>J Neurol . 2022 Mar;269(3):1316-1334.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u6d46\u7ec6\u80de\uff08Plasma cell\uff09\u662f\u7531B\u6dcb\u5df4\u7ec6\u80de\u5206\u5316\u800c\u6765\u3002B\u7ec6\u80de\u6210\u719f\u540e\uff0c\u5f62\u6210\u6d46\u7ec6\u80de\uff0c\u6d46\u7ec6\u80de\u5408\u6210\u548c\u5206\u6ccc\u514d\u75ab\u7403\u86cb\u767d\uff08\u6297\u4f53\uff09\uff0c\u4ee5\u5e94\u5bf9\u611f\u67d3\u548c\u5916\u6765\u6297\u539f\u7684\u4fb5\u88ad\u3002<\/p>\n\n\n\n<p>CD38\u662f\u4e00\u79cd\u5355\u94fe\u8de8\u819c\u2161\u578b\u7cd6\u86cb\u767d\u3002\u5728\u5916\u5468\u8840\u6db2\u4e2d\uff0c\u5927\u7ea690%\u7684\u6b63\u5e38\u6d46\u7ec6\u80de\u300160%\u7684\u81ea\u7136\u6740\u4f24\u7ec6\u80de\u300160%\u7684\u5355\u6838\u7ec6\u80de\u4ee5\u53ca\u4e00\u4e9bT\u7ec6\u80de\u8868\u8fbeCD38\uff0c\u4f46B\u7ec6\u80de\u548c\u4e2d\u6027\u7c92\u7ec6\u80de\u5219\u4e0d\u8868\u8fbe\u3002<\/p>\n\n\n\n<p>\u5728\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u4e2d\uff0cCD38\u8868\u8fbe\u9633\u6027\u7387\u6781\u9ad8\uff0c\u662f\u4e00\u79cd\u6807\u5fd7\u6027\u6297\u539f\u3002\u8be5\u6297\u539f\u5728\u6d46\u7ec6\u80de\u7684\u6210\u719f\u548c\u589e\u6b96\u4e2d\u53d1\u6325\u7740\u91cd\u8981\u4f5c\u7528\uff0c\u5e76\u4e14\u4e0e\u75be\u75c5\u8fdb\u5c55\u548c\u9884\u540e\u5bc6\u5207\u76f8\u5173\u3002<\/p>\n\n\n\n<p><strong>CD38\u5355\u6297\u6297\u80bf\u7624\u673a\u5236<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1-1024x792.png\" alt=\"\" class=\"wp-image-945\" width=\"720\" height=\"556\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1-1024x792.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1-300x232.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1-768x594.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1-880x681.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-1.png 1198w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><figcaption class=\"wp-element-caption\"><em>Front Immunol . 2018 Nov 28;9:2722.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u6297CD38\u5355\u6297\u53ef\u4ee5\u901a\u8fc7\u591a\u79cd\u514d\u75ab\u76f8\u5173\u673a\u5236\u8bf1\u5bfc\u80bf\u7624\u7ec6\u80de\u51cb\u4ea1\uff0c\u5305\u62ec\u8865\u4f53\u4f9d\u8d56\u7684\u7ec6\u80de\u6bd2\u4f5c\u7528\uff08CDC\uff09\u3001\u6297\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u4ecb\u5bfc\u7684\u7ec6\u80de\u6bd2\u4f5c\u7528\uff08ADCC\uff09\u548c\u6297\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u541e\u566c\u4f5c\u7528\uff08ADCP\uff09\u3001\u76f4\u63a5\u7ec6\u80de\u51cb\u4ea1\u7b49\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u8fd8\u53ef\u4ee5\u901a\u8fc7\u514d\u75ab\u8c03\u8282\u4f5c\u7528\u589e\u52a0\u514d\u75ab\u7ec6\u80de\u7684\u6d3b\u6027\u5e76\u89e3\u9664\u80bf\u7624\u5fae\u73af\u5883\u5bf9\u514d\u75ab\u7ec6\u80de\u7684\u6291\u5236\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2\u3001\u4e24\u6b3eCD38\u5355\u6297\u5f02\u540c<\/h2>\n\n\n\n<p><strong>\u6297\u4f53\u7ed3\u6784\u5dee\u5f02<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-2-1024x668.png\" alt=\"\" class=\"wp-image-946\" width=\"616\" height=\"401\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-2-1024x668.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-2-300x196.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-2-768x501.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-2-880x574.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-2.png 1075w\" sizes=\"auto, (max-width: 616px) 100vw, 616px\" \/><figcaption class=\"wp-element-caption\"><em>Front Immunol . 2018 Nov 6;9:2559.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u4e24\u6b3e\u6297\u4f53\u7c7b\u578b\u4e0d\u540c\uff0c\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u662f\u5168\u4eba\u6e90\u7684\u5355\u514b\u9686\u6297\u4f53\uff0c\u800cIsatuximab\u662f\u4e00\u79cd\u4eba\u9f20\u5d4c\u5408\u7684\u5355\u514b\u9686\u6297\u4f53\u3002<br>\u56e0\u6b64\u4e24\u6b3e\u836f\u7269\u7684\u514d\u75ab\u539f\u6027\u6709\u6240\u5dee\u522b\u3002<\/p>\n\n\n\n<p><strong>\u6297\u4f53\u4e0eCD38\u7ed3\u5408\u8868\u4f4d\u4e0d\u540c<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-3.png\" alt=\"\" class=\"wp-image-947\" width=\"490\" height=\"417\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-3.png 836w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-3-300x255.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-3-768x653.png 768w\" sizes=\"auto, (max-width: 490px) 100vw, 490px\" \/><figcaption class=\"wp-element-caption\"><em>Cells . 2019 Nov 26;8(12):1522<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u548cIsatuximab\u5728\u4ebaCD38\u4e0a\u7684\u7ed3\u5408\u8868\u4f4d\u4e0d\u540c\u3002<\/p>\n\n\n\n<p>\u7070\u8272\u533a\u57df\u8868\u793a\u4ebaCD38\uff1b\u7ea2\u8272\u533a\u57df\u4e3a\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u7684CD38\u7ed3\u5408\u8868\u4f4d\uff1b\u84dd\u8272\u533a\u57df\u4e3aIsatuximab\u7684CD38\u7ed3\u5408\u8868\u4f4d\u3002<\/p>\n\n\n\n<p><strong>\u4f5c\u7528\u673a\u5236\u5dee\u5f02<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-4-1024x641.png\" alt=\"\" class=\"wp-image-948\" width=\"618\" height=\"386\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-4-1024x641.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-4-300x188.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-4-768x481.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-4-880x551.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-4.png 1136w\" sizes=\"auto, (max-width: 618px) 100vw, 618px\" \/><figcaption class=\"wp-element-caption\"><em>Blood . 2018 Jan 4;131(1):13-29.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u7531\u4e8e\u4e24\u6b3eCD38\u5355\u6297\u7684\u6297\u4f53\u7ed3\u6784\u548c\u4e0eCD38\u7ed3\u5408\u8868\u4f4d\u7684\u5dee\u5f02\uff0c\u5bfc\u81f4\u5176\u6297\u80bf\u7624\u4f5c\u7528\u673a\u5236\u4e5f\u5b58\u5728\u5dee\u522b\uff1a<\/p>\n\n\n\n<p>\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u7684CDC\uff08\u8865\u4f53\u4f9d\u8d56\u7684\u7ec6\u80de\u6bd2\u4f5c\u7528\uff09\u548cADCP\uff08\u6297\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u541e\u566c\u4f5c\u7528\uff09\u9ad8\u4e8eIsatuximab\u3002<\/p>\n\n\n\n<p>\u800cIsatuximab\u7684\u8bf1\u5bfc\u7ec6\u80de\u76f4\u63a5\u51cb\u4ea1\u548c\u8c03\u8282\u7ec6\u80de\u5916\u9176\u7684\u4f5c\u7528\u9ad8\u4e8e\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n<p><strong>\u4e24\u6b3eCD38\u5355\u6297FDA\u9002\u5e94\u75c7<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-5-1024x356.png\" alt=\"\" class=\"wp-image-949\" width=\"666\" height=\"232\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-5-1024x356.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-5-300x104.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-5-768x267.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-5-1218x424.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-5-880x306.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/05\/image-5.png 1239w\" sizes=\"auto, (max-width: 666px) 100vw, 666px\" \/><figcaption class=\"wp-element-caption\"><em><strong><mark style=\"background-color:rgba(0, 0, 0, 0);color:#49038c\" 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