{"id":873,"date":"2023-04-07T11:47:53","date_gmt":"2023-04-07T03:47:53","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=873"},"modified":"2023-04-07T11:47:53","modified_gmt":"2023-04-07T03:47:53","slug":"%e8%ae%b0%e4%bd%8f%e6%89%80%e6%9c%89fda%e7%94%9f%e7%89%a9%e8%8d%af-%e9%9d%b6%e5%90%91cd20-ocrevusocrelizumab-%e5%a4%9a%e5%8f%91%e6%80%a7%e7%a1%ac%e5%8c%96ms","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=873","title":{"rendered":"\u8bb0\u4f4f\u6240\u6709FDA\u751f\u7269\u836f | \u9776\u5411CD20 | Ocrevus\u00aeOcrelizumab | \u591a\u53d1\u6027\u786c\u5316MS"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\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 class=\"wp-block-paragraph\">Ocrelizumab\u662f\u4e00\u79cd\u4eba\u6e90\u5316\u9488\u5bf9CD20\u6297\u539f\u7684\u5355\u514b\u9686\u6297\u4f53\uff0c\u7531\u745e\u58eb\u7f57\u6c0f\uff08Roche\uff09\u516c\u53f8\u5f00\u53d1\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u836f2017\u5e74\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\uff08Ocrevus<sup>\u00ae<\/sup>Ocrelizumab\uff09\uff0c\u7528\u4e8e\u6cbb\u7597\u591a\u53d1\u6027\u786c\u5316\u75c7\uff08MS\uff09\u3002\u662f\u76ee\u524d\u552f\u4e00\u4e00\u4e2a\u6279\u51c6\u6cbb\u7597\u539f\u53d1\u8fdb\u5c55\u578bMS\uff08PPMS\uff09\u7684\u836f\u7269\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2022\u5e74Ocrelizumab\u51fb\u8d25\u7f57\u6c0f\u4e00\u4f17\u6297\u80bf\u7624\u4ea7\u54c1\uff0c\u6210\u4e3a\u7f57\u6c0f\u9500\u91cfTop1\u7684\u91cd\u78c5\u70b8\u5f39\u7ea7\u836f\u7269\uff0860\u4ebf\u745e\u58eb\u6cd5\u90ce\uff0c\u7ea6\u5408455\u4ebf\u4eba\u6c11\u5e01\uff09\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u76ee\u524dOcrelizumab\u5728\u4e2d\u56fd\u672a\u4e0a\u5e02\uff0c\u4e2d\u6587\u540d\u6682\u97f3\u8bd1\u4e3a\u5965\u5229\u73e0\u5355\u6297\uff08\u65e0\u51fa\u5904\uff09\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u51e0\u79cdCD20\u5355\u6297\u7ed3\u6784<\/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\/04\/image-8-1024x549.png\" alt=\"\" class=\"wp-image-879\" width=\"650\" height=\"348\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-8-1024x549.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-8-300x161.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-8-768x412.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-8-1218x653.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-8-880x472.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-8.png 1534w\" sizes=\"auto, (max-width: 650px) 100vw, 650px\" \/><figcaption class=\"wp-element-caption\"><em>Biomedicines . 2019 Mar 14;7(1):20.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Ocrelizumab\u4e0e\u5229\u59a5\u6614\u5355\u6297\uff0c\u4ee5\u53ca\u4e0b\u6b21\u4f1a\u8bb2\u5230\u7684\u5965\u6cd5\u59a5\u6728\u5355\u6297\uff0c\u5747\u4e3a\u6297B\u7ec6\u80de\u8868\u9762CD20\u6297\u539f\u7684\u5355\u6297\uff0c\u533a\u522b\u5728\u4e8e\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5229\u59a5\u6614\u5355\u6297\u4e3a\u4eba\u9f20\u5d4c\u5408\u6297\u4f53\uff0cFab\u6bb5\u53ef\u53d8\u533a\u5747\u4e3a\u9f20\u6e90\u7ed3\u6784\uff0c\u4eba\u6e90\u5316\u7a0b\u5ea6\u53ea\u670965%\u5de6\u53f3\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ocrelizumab\u9664\u4fdd\u7559Fab\u4e0a\u4e92\u8865\u51b3\u5b9a\u533a\uff08CDRs\uff09\u7684\u90e8\u5206\u9f20\u6e90\u7ed3\u6784\u5916\uff0c\u5176\u4ed6\u90e8\u5206\u5747\u4e3a\u4eba\u6e90\u6210\u5206\uff0c\u662f\u4e00\u79cd\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\uff0c\u4eba\u6e90\u5316\u7a0b\u5ea6\u5927\u4e8e90%\u3002<br><br>\u4e0b\u6b21\u4f1a\u8bb2\u5230\u7684\u5965\u6cd5\u59a5\u6728\u5355\u6297\uff0c\u662f\u5168\u4eba\u6e90\u6297\u4f53\uff0c\u4eba\u6e90\u5316\u7a0b\u5ea6100%\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u591a\u53d1\u6027\u786c\u5316\u662f\u4e00\u79cd\u8131\u9ad3\u9798\u75be\u75c5<\/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\/04\/image-5-1024x390.png\" alt=\"\" class=\"wp-image-875\" width=\"560\" height=\"212\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-5-1024x390.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-5-300x114.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-5-768x292.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-5-1536x585.png 1536w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-5-1218x464.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-5-880x335.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-5.png 1600w\" sizes=\"auto, (max-width: 560px) 100vw, 560px\" \/><figcaption class=\"wp-element-caption\"><em>\u9ed8\u6c99\u4e1c\u8bca\u7597\u624b\u518c\uff1a\u8131\u810a\u9798\u75be\u75c5\u6982\u8ff0<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">\u795e\u7ecf\u7ea4\u7ef4\uff0c\u7531\u8102\u86cb\u767d\u7ec4\u7ec7\u5305\u88f9\uff0c\u5f62\u6210\u9ad3\u9798\u3002\u5c31\u50cf\u7535\u7ebf\u5468\u56f4\u7684\u7edd\u7f18\u4e00\u6837\uff0c\u9ad3\u9798\u4f7f\u795e\u7ecf\u4fe1\u53f7\u80fd\u591f\u5feb\u901f\u51c6\u786e\u5730\u6cbf\u7740\u795e\u7ecf\u7ea4\u7ef4\u4f20\u5bfc\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9ad3\u9798\u53d7\u635f\u65f6\uff0c\u795e\u7ecf\u7ea4\u7ef4\u4fbf\u4e0d\u80fd\u6b63\u5e38\u4f20\u5bfc\u7535\u51b2\u52a8\u3002\u5bfc\u81f4\u591a\u53d1\u6027\u786c\u5316\uff0c\u89c6\u795e\u7ecf\u810a\u9ad3\u708e\u7b49\u8131\u9ad3\u9798\u75be\u75c5\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u591a\u53d1\u6027\u786c\u5316\u7684\u5206\u7c7b\uff1a<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u591a\u53d1\u6027\u786c\u5316\u53ef\u4ee5\u5206\u4e3a\u4ee5\u4e0b1+3\u7c7b\uff1a<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1\u3001\u4e34\u5e8a\u5b64\u7acb\u7efc\u5408\u5f81\uff08Clinically isolated syndrome\uff0cCIS\uff09\uff1a<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6307\u60a3\u8005\u9996\u6b21\u51fa\u73b0\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff08central nervous system\uff0cCNS\uff09\u708e\u6027\u8131\u9ad3\u9798\u4e8b\u4ef6\uff0c\u5f15\u8d77\u7684\u76f8\u5173\u75c7\u72b6\u548c\u5ba2\u89c2\u4f53\u5f81\u81f3\u5c11\u6301\u7eed24 h\uff0c\u4e14\u4e3a\u5355\u76f8\u4e34\u5e8a\u75c5\u7a0b\uff0c\u7c7b\u4f3c\u4e8e\u591a\u53d1\u6027\u786c\u5316\uff08multiple sclerosis\uff0cMS\uff09\u7684\u4e00\u6b21\u5178\u578b\u4e34\u5e8a\u53d1\u4f5c\uff0c\u4f46\u5c1a\u4e0d\u80fd\u8bca\u65ad\u4e3aMS\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u60a3\u8005\u968f\u540e\u88ab\u8bca\u65ad\u4e3aMS\uff08\u7b26\u5408\u7a7a\u95f4\u548c\u65f6\u95f4\u591a\u53d1\u6027\uff0c\u5e76\u6392\u9664\u5176\u4ed6\u8bca\u65ad\uff09\uff0cCIS\u5c31\u662f\u8be5\u60a3\u8005\u7684\u7b2c\u4e00\u6b21\u53d1\u4f5c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2\u3001\u590d\u53d1\u7f13\u89e3\u578bMS\uff08relapsing remitting MS, RRMS\uff09\uff1a<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u578b\u75be\u75c5\u8868\u73b0\u4e3a\u660e\u663e\u7684\u590d\u53d1\u548c\u7f13\u89e3\u8fc7\u7a0b\uff0c\u6bcf\u6b21\u53d1\u4f5c\u540e\u5747\u57fa\u672c\u6062\u590d\uff0c\u4e0d\u7559\u6216\u4ec5\u7559\u4e0b\u8f7b\u5fae\u540e\u9057\u75c7\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MS \u60a3\u800580%~85%\u6700\u521d\u75c5\u7a0b\u4e2d\u8868\u73b0\u4e3a\u672c\u7c7b\u578b\u3002\u76ee\u524d\u6cbb\u7597\u836f\u7269\u8f83\u591a\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3\u3001\u7ee7\u53d1\u8fdb\u5c55\u578bMS\uff08secondary progressive MS, SPMS\uff09<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7ea650%\u7684RRMS \u60a3\u8005\u5728\u60a3\u75c510~15\u5e74\u540e\u75be\u75c5\u4e0d\u518d\u6709\u590d\u53d1\u7f13\u89e3\uff0c\u5448\u7f13\u6162\u8fdb\u884c\u6027\u52a0\u91cd\u8fc7\u7a0b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4\u3001\u539f\u53d1\u8fdb\u5c55\u578bMS\uff08primary progressive MS, PPMS\uff09<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u578b\u75c5\u7a0b\u5927\u4e8e1\u5e74\uff0c\u75be\u75c5\u5448\u7f13\u6162\u8fdb\u884c\u6027\u52a0\u91cd\uff0c\u65e0\u7f13\u89e3\u590d\u53d1\u8fc7\u7a0b\u3002\u7ea610%\u7684MS\u60a3\u8005\u8868\u73b0\u4e3a\u672c\u7c7b\u578b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ocrelizumab\u4e0a\u5e02\u524d\uff0cPPMS\u65e0FDA\u6279\u51c6\u7684\u836f\u7269\uff0c\u56e0\u6b64Ocrelizumab\u662f\u76ee\u524d\u552f\u4e00\u4e00\u4e2a\u83b7FDA\u6279\u51c6\u6cbb\u7597PPMS\u7684\u836f\u7269\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ocrelizumab\u4f5c\u7528\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\/04\/image-9-1024x711.png\" alt=\"\" class=\"wp-image-880\" width=\"626\" height=\"434\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-9-1024x711.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-9-300x208.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-9-768x534.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-9-1218x846.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-9-880x611.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-9.png 1268w\" sizes=\"auto, (max-width: 626px) 100vw, 626px\" \/><figcaption class=\"wp-element-caption\"><em>Brain Sci . 2020 Oct 20;10(10):758.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">\u591a\u53d1\u6027\u786c\u5316\uff08Multiple Sclerosis\uff0cMS\uff09\u662f\u4e00\u79cd\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u5373\u514d\u75ab\u7cfb\u7edf\u9519\u8bef\u5730\u653b\u51fb\u4eba\u4f53\u81ea\u8eab\u7ec4\u7ec7\u3002<br>\u514d\u75ab\u7cfb\u7edf\u4e2d\u7684B\u6dcb\u5df4\u7ec6\u80de\u88ab\u6fc0\u6d3b\uff0c\u4ea7\u751f\u6297\u4f53\uff0c\u8fd9\u4e9b\u6297\u4f53\u9519\u8bef\u5730\u653b\u51fb\u9ad3\u9798\uff0c\u5373\u795e\u7ecf\u5143\u8f74\u7a81\u5468\u56f4\u7684\u4fdd\u62a4\u6027\u8102\u8d28\u5c42\uff0c\u5bfc\u81f4\u9ad3\u9798\u53d7\u635f\u6216\u7834\u574f\u3002\u9ad3\u9798\u7684\u53d7\u635f\u4f1a\u5bfc\u81f4\u795e\u7ecf\u4fe1\u53f7\u4f20\u8f93\u53d7\u963b\u6216\u4e2d\u65ad\uff0c\u4ece\u800c\u5f15\u53d1\u4e86\u591a\u53d1\u6027\u786c\u5316\u7684\u75c7\u72b6\uff0c\u5305\u62ec\u89c6\u529b\u6a21\u7cca\u3001\u80a2\u4f53\u65e0\u529b\u3001\u611f\u89c9\u5f02\u5e38\u7b49\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e34\u5e8a\u524d\u7814\u7a76\u8bc1\u5b9e\uff0cOcrelizumab\u53ef\u9009\u62e9\u6027\u5730\u7ed3\u5408\u8868\u8fbe\u4e8e\u7279\u5b9aB\u7ec6\u80de\u7684CD20\u6297\u539f\uff0c\u4f46\u4e0d\u7ed3\u5408\u5e72\u7ec6\u80de\u548c\u6d46\u7ec6\u80de\u8868\u9762\u7684CD20\uff0c\u56e0\u6b64\u80fd\u591f\u4fdd\u7559\u514d\u75ab\u7cfb\u7edf\u7684\u91cd\u8981\u529f\u80fd\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ocrelizumab\u6bcf\u5e74\u53ea\u9700\u8f93\u6ce82\u6b21\uff0c\u8fd9\u79cd\u6cbb\u7597\u4fbf\u5229\u6027\uff0c\u53ef\u663e\u8457\u63d0\u9ad8\u60a3\u8005\u7684\u6cbb\u7597\u4f9d\u4ece\u6027\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ocrelizumab FDA\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\/04\/image-7-1024x551.png\" alt=\"\" class=\"wp-image-877\" width=\"542\" height=\"291\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-7-1024x551.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-7-300x162.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-7-768x414.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-7-880x474.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-7.png 1027w\" sizes=\"auto, (max-width: 542px) 100vw, 542px\" \/><figcaption class=\"wp-element-caption\"><em>\u8be5\u836f\u7269\u76ee\u524d\u56fd\u5185\u6682\u672a\u6279\u51c6\u4e0a\u5e02<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Ocrelizumab\u662f\u76ee\u524d\u552f\u4e00\u4e00\u4e2a\u83b7\u5f97\u5168\u90e8\u56db\u79cd\u7c7b\u578bMS\u9002\u5e94\u75c7\u7684\u6cbb\u7597\u836f\u7269\u3002<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3\u3001\u56fe\u50cf\u8bb0\u5fc6<\/h2>\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\/04\/CD20-Ocr-web-1-gap.jpg\" data-gif=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/CD20-Ocr-web-1.gif\" alt=\"\" class=\"wp-image-881\" width=\"566\" height=\"388\"\/><figcaption class=\"wp-element-caption\">\u9f50\u5929\u5927\u5723\u53d8\u5316\u6210\u5965\u5229\u5965\uff0c\u6325\u821e\u91d1\u7b8d\u68d2\u6572\u6253B\u578b\u94c3\u94db\uff0c\u94c3\u94db\u91cc\u6389\u51fa\u7684\u5965\u5229\u5965\u997c\u5e72\u53d8\u6210\u4e86\u5965\u5229\u5965\u73e0\u5b50\u3002<\/figcaption><\/figure>\n<\/div>\n\n\n<p 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