{"id":48996,"date":"2018-09-25T01:00:00","date_gmt":"2018-09-26T01:53:56","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/26\/%e9%80%9f%e9%80%92-%e9%99%8d%e4%bd%8e%e5%a4%8d%e5%8f%91%e9%a3%8e%e9%99%a995%ef%bc%8c-%e8%a1%a5%e4%bd%93%e6%8a%91%e5%88%b6%e6%96%b0%e8%8d%af3%e6%9c%9f%e7%bb%93%e6%9e%9c%e4%bc%98%e5%bc%82\/"},"modified":"2018-09-26T09:53:58","modified_gmt":"2018-09-26T01:53:58","slug":"%e9%80%9f%e9%80%92-%e9%99%8d%e4%bd%8e%e5%a4%8d%e5%8f%91%e9%a3%8e%e9%99%a995%ef%bc%8c-%e8%a1%a5%e4%bd%93%e6%8a%91%e5%88%b6%e6%96%b0%e8%8d%af3%e6%9c%9f%e7%bb%93%e6%9e%9c%e4%bc%98%e5%bc%82","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/48996\/","title":{"rendered":"\u901f\u9012 | \u964d\u4f4e\u590d\u53d1\u98ce\u966995%\uff0c \u8865\u4f53\u6291\u5236\u65b0\u836f3\u671f\u7ed3\u679c\u4f18\u5f02"},"content":{"rendered":"
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\u258e\u836f\u660e<\/span><\/strong>\u5eb7\u5fb7\/\u62a5\u9053<\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/h1>\n

\u4eca\u65e5\uff0cAlexion\u5ba3\u5e03\u4e86\u5176Soliris(eculizumab)\uff0c\u7528\u4e8e\u6cbb\u7597\u81ea\u4f53\u6297\u6c34\u901a\u9053\u86cb\u767d-4\uff08AQP4\uff09\u6297\u4f53\u9633\u6027\u7684\u89c6\u795e\u7ecf\u810a\u9ad3\u708e\u8c31\u7cfb\u75be\u75c5\uff08NMOSD\uff09\u76843\u671f\u8bd5\u9a8c\u79ef\u6781\u9876\u7ebf\u7ed3\u679c\u3002<\/span><\/p>\n

\"\u901f\u9012<\/p>\n

NMOSD\u662f\u4e00\u79cd\u6781\u5177\u7834\u574f\u6027\u7684\uff0c\u8865\u4f53\u4ecb\u5bfc\u7684\u7f55\u89c1\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff08CNS\uff09\u75be\u75c5\u3002\u60a3\u8005\u7ecf\u5386\u4e0d\u53ef\u9884\u6d4b\u7684\u590d\u53d1\u548c\u6076\u5316\u75c5\u7a0b\uff0c\u800c\u4e14\u6bcf\u6b21\u590d\u53d1\u90fd\u4f1a\u589e\u52a0\u6b8b\u75be\u7a0b\u5ea6\uff0c\u5e76\u53ef\u80fd\u5bfc\u81f4\u8fc7\u65e9\u6b7b\u4ea1\u3002\u89c6\u795e\u7ecf\u708e\u53ef\u5f15\u8d77\u773c\u75db\u548c\u5931\u660e\uff0c\u800c\u6a2a\u8d2f\u6027\u810a\u9ad3\u708e\u53ef\u5bfc\u81f4\u4e25\u91cd\u7684\u865a\u5f31\uff0c\u6d3b\u52a8\u529f\u80fd\u53d7\u635f\uff0c\u611f\u89c9\u548c\u8fd0\u52a8\u969c\u788d\uff0c\u80a0\u548c\u8180\u80f1\u529f\u80fd\u4e27\u5931\uff0c\u762b\u75ea\u548c\u547c\u5438\u8870\u7aed\u3002\u5927\u90e8\u5206\u60a3\u8005\u4f1a\u51fa\u73b0\u6c38\u4e45\u6027\u4e25\u91cd\u6b8b\u75be\uff0c\u5305\u62ec\u5931\u660e\u548c\u762b\u75ea\uff0c\u6216\u5728\u75be\u75c5\u53d1\u4f5c\u516d\u5e74\u5185\u6b7b\u4ea1\u3002\u6709\u6c38\u4e45\u6027\u8fd0\u52a8\u969c\u788d\uff0c\u8f6e\u6905\u4f9d\u8d56\uff0c\u6c38\u4e45\u6027\u89c6\u529b\u6b8b\u75be\u7684NMOSD\u60a3\u8005\u6bd4\u4f8b\u5206\u522b\u4e3a34%\uff0c23%\u548c18%\uff0c\u5176\u6b7b\u4ea1\u7387\u4e3a9%\u3002NMOSD\u4e3b\u8981\u5f71\u54cd\u5973\u6027\uff0c\u5176\u4e2d\u7ea6\u6709\u56db\u5206\u4e4b\u4e09\u60a3\u8005\u4e3a\u81ea\u4f53\u6297AQP4\u6297\u4f53\u9633\u6027\u3002AQP4\u662f\u4e00\u79cd\u5b58\u5728\u4e8e\u5927\u8111\u548c\u810a\u9ad3\u67d0\u4e9b\u7ec6\u80de\u4e2d\u7684\u86cb\u767d\uff0c\u5bf9\u795e\u7ecf\u7ec6\u80de\u7684\u5b58\u6d3b\u81f3\u5173\u91cd\u8981\u3002\u81ea\u4f53\u6297AQP4\u6297\u4f53\u4e0e\u5176\u6297\u539f\u7684\u7ed3\u5408\u80fd\u6fc0\u6d3b\u8865\u4f53\u7ea7\u8054\u53cd\u5e94\uff0c\u7834\u574fCNS\uff08\u4e3b\u8981\u5728\u810a\u9ad3\u548c\u89c6\u795e\u7ecf\uff09\u4e2d\u7684\u91cd\u8981\u7ec6\u80de\uff0c\u9020\u6210\u8131\u9ad3\u9798\u548c\u795e\u7ecf\u5143\u7ec6\u80de\u7684\u6b7b\u4ea1\uff0c\u6700\u7ec8\u5bfc\u81f4\u5931\u660e\u3001\u9ebb\u75f9\u3001\u751a\u81f3\u6b7b\u4ea1\u3002\u76ee\u524d\u5c1a\u65e0\u9488\u5bf9NMOSD\u7684\u6279\u51c6\u7597\u6cd5\u3002<\/span><\/p>\n

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\u4eba\u6e90\u5316\u7684\u6297\u8865\u4f53C5\u5355\u514b\u9686\u6297\u4f53Soliris\uff0c\u662f\u4e00\u4e2a\u201cfirst-in-class\u201d\u8865\u4f53\u6291\u5236\u5242\uff0c\u80fd\u901a\u8fc7\u6291\u5236\u7ec8\u7aef\u8865\u4f53\u6765\u6291\u5236\u514d\u75ab\u7cfb\u7edf\u7684\u5931\u63a7\u6027\u6fc0\u6d3b\u3002<\/span><\/strong>Soliris\u80fd\u963b\u6b62\u8865\u4f53C5\u88c2\u89e3\u6210C5b\u548cC5a\u3002\u5176\u4e2dC5b\u53ef\u5f62\u6210\u819c\u653b\u51fb\u590d\u5408\u7269C5b-9\u6740\u4f24\u661f\u5f62\u80f6\u8d28\u7ec6\u80de\uff1b\u800cC5a\u4f5c\u4e3a\u4e00\u79cd\u91cd\u8981\u7684\u8d8b\u5316\u56e0\u5b50\uff0c\u53ef\u8d8b\u5316\u5de8\u566c\u7ec6\u80de\u3001\u4e2d\u6027\u7c92\u7ec6\u80de\u3001\u55dc\u9178\u6027\u7c92\u7ec6\u80de\u7b49\u8fdb\u5165\u708e\u75c7\u5c40\u90e8\uff0c\u51cf\u5c11C5a\u7684\u751f\u6210\u53ef\u4ee5\u51cf\u8f7b\u75c5\u7076\u533a\u57df\u7684\u514d\u75ab\u708e\u6027\u635f\u4f24\u3002\u56e0\u6b64\u6291\u5236\u8865\u4f53\u6fc0\u6d3b\uff0c\u53ef\u51cf\u8f7b\u81ea\u4f53\u6297AQP4\u6297\u4f53\u9633\u6027\u7684NMOSD\u60a3\u8005\u7684CNS\u635f\u5bb3\uff0c\u4e5f\u662f\u7814\u53d1NMOSD\u6cbb\u7597\u836f\u7269\u7684\u91cd\u8981\u7b56\u7565\u3002\u6b64\u524d\uff0cSoliris\u4f5c\u4e3a\u5b64\u513f\u836f\u7269\u5df2\u7ecf\u83b7\u6279\uff0c\u6cbb\u7597\u9635\u53d1\u6027\u591c\u95f4\u8840\u7ea2\u86cb\u767d\u5c3f\uff08PNH\uff09\uff0c\u975e\u5178\u578b\u6eb6\u8840\u6027\u5c3f\u6bd2\u75c7\u7efc\u5408\u5f81\uff08aHUS\uff09\uff0c\u548c\u6297AchR\u6297\u4f53\u9633\u6027gMG\u7b49\u7f55\u89c1\u75c5\u3002<\/strong><\/span><\/p>\n

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\"\u901f\u9012<\/p>\n

\u25b2Soliris\u7684\u4f5c\u7528\u673a\u7406\uff08\u56fe\u7247\u6765\u6e90\uff1aSoliris\u5b98\u65b9\u7f51\u7ad9\uff09<\/span><\/strong>
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PREVENT\uff08Prevention of Relapses and Evaluation of Eculizumab in NMOSD Treatment\uff09\u8bd5\u9a8c\u662f\u4e00\u9879\u591a\u56fd\u3001\u53cc\u76f2\u3001\u5e73\u884c\u5bf9\u7167\u76843\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0cSoliris\u7528\u4e8e\u6cbb\u7597\u81ea\u4f53\u6297AQP4\u6297\u4f53\u9633\u6027\u7684NMOSD\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u8bd5\u9a8c\u5171\u9009\u53d6\u4e86\u5728\u8fc7\u53bb12\u4e2a\u6708\u5185\u6709\u81f3\u5c11\u4e24\u6b21\u590d\u53d1\u53f2\uff0c\u6216\u662f24\u4e2a\u6708\u5185\u6709\u4e09\u6b21\u590d\u53d1\u53f2\uff0c\u5e76\u5728\u7b5b\u67e5\u524d\u768412\u4e2a\u6708\u5185\u81f3\u5c11\u590d\u53d1\u4e00\u6b21\u7684143\u540d\u6210\u4eba\u60a3\u8005\uff0c\u4ee52\uff1a1\u7684\u6bd4\u4f8b\u968f\u673a\u5206\u914d\u5230Soliris\u7ec4\u6216\u5b89\u6170\u5242\u7ec4\u3002<\/span><\/p>\n


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\u8bd5\u9a8c\u7684\u4e3b\u8981\u7ec8\u70b9\u662f\u9996\u6b21\u590d\u53d1\u65f6\u95f4\uff0c\u8be5\u65f6\u95f4\u7531\u4e00\u4e2a\u72ec\u7acb\u7684\u59d4\u5458\u4f1a\u5224\u5b9a\uff0c\u8be5\u59d4\u5458\u4f1a\u7531\u4e09\u540d\u5bf9\u6cbb\u7597\u4e0d\u77e5\u60c5\u7684\u795e\u7ecf\u75c5\u5b66\/\u795e\u7ecf\u773c\u79d1\u4e13\u5bb6\u7ec4\u6210\u3002\u8be5\u5224\u5b9a\u662f\u57fa\u4e8e\u5224\u5b9a\u590d\u53d1\u7ae0\u7a0b\u4e2d\u63cf\u8ff0\u7684\u5ba2\u89c2\u548c\u4e00\u81f4\u7684\u4e34\u5e8a\u6807\u51c6\u505a\u51fa\u3002\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u5224\u5b9a\u7684\u5e74\u5ea6\u590d\u53d1\u7387\uff0c\u5bf9\u6b8b\u75be\u7a0b\u5ea6\u548c\u751f\u6d3b\u8d28\u91cf\u8bc4\u4f30\uff0c\u4ee5\u53ca\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u7b49\u5176\u5b83\u7ec8\u70b9\u3002\u9884\u5148\u6307\u5b9a\u7684\u654f\u611f\u6027\u5206\u6790\u5305\u62ec\u590d\u53d1\u65f6\u95f4\u548c\u6b21\u8981\u7ec8\u70b9\u7684\u5404\u79cd\u7c7b\u578b\u7684\u7edf\u8ba1\u5206\u6790\u3002<\/span><\/p>\n


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\u8be5\u7814\u7a76\u8fbe\u5230\u4e86\u4e3b\u8981\u7ec8\u70b9\uff0c\u8bc1\u660e\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0cSoliris\u6cbb\u7597\u4f7fNMOSD\u590d\u53d1\u7684\u98ce\u9669\u964d\u4f4e\u4e8694.2%\uff08p <0.0001\uff09\u3002<\/strong>\u572848\u5468\u65f6\uff0c\u63a5\u53d7Soliris\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u670997.9%\u6ca1\u6709\u590d\u53d1\uff0c\u800c\u63a5\u53d7\u5b89\u6170\u5242\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u8be5\u6bd4\u4f8b\u4e3a63.2%\u3002\u5728\u5173\u952e\u7684\u6b21\u8981\u7ec8\u70b9\u4e0a\uff0c\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0cSoliris\u6cbb\u7597\u5c06\u5224\u5b9a\u7684\u5e74\u5ea6\u590d\u53d1\u7387\u51cf\u5c11\u4e8695.5%\uff08p <0.0001\uff09\u3002Soliris\u603b\u4f53\u800c\u8a00\u5177\u6709\u826f\u597d\u7684\u8010\u53d7\u6027\uff0c\u5176\u5b89\u5168\u6027\u4e0e\u5148\u524d\u7684\u4e34\u5e8a\u7814\u7a76\u548c\u5176\u5728\u4e09\u79cd\u5df2\u7ecf\u88ab\u6279\u51c6\u7684\u9002\u5e94\u75c7\u4e2d\u7684\u8868\u73b0\u4e00\u81f4\u3002<\/span><\/p>\n


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Alexion\u516c\u53f8\u6267\u884c\u526f\u603b\u88c1\u517cR&D\u8d1f\u8d23\u4ebaJohn Orloff\u535a\u58eb\u8bf4\uff1a\u201cPREVENT\u7684\u7ed3\u679c\u8fdc\u8fdc\u8d85\u51fa\u4e86\u6211\u4eec\u7684\u9884\u671f\u3002NMOSD\u590d\u53d1\u98ce\u9669\u5982\u6b64\u4ee4\u4eba\u60ca\u53f9\u7684\u964d\u4f4e\uff0c\u8bc1\u660e\u4e86Soliris\u6291\u5236\u8865\u4f53\u7684\u72ec\u7279\u80fd\u529b\uff0c\u5e76\u5c55\u793a\u4e86\u4e00\u79cdNMOSD\u7684\u65b0\u7597\u6cd5\u3002\u9274\u4e8eNMOSD\u76ee\u524d\u5c1a\u65e0\u83b7\u6279\u7597\u6cd5\uff0cAlexion\u6b63\u5728\u8fc5\u901f\u884c\u52a8\uff0c\u4e0e\u76d1\u7ba1\u673a\u6784\u8ba8\u8bba\u8fd9\u4e9b\u7ed3\u679c\uff0c\u5e76\u5c06\u5728\u7f8e\u56fd\uff0c\u6b27\u76df\u548c\u65e5\u672c\u63d0\u4ea4\u7533\u8bf7\u3002\u201d<\/span><\/p>\n


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\u7ea6\u7ff0\u970d\u666e\u91d1\u65af\u5927\u5b66\u526f\u6559\u6388Michael Levy\u535a\u58eb\u8bf4\uff1a\u201c\u6cbb\u7597NMOSD\u7684\u4e3b\u8981\u76ee\u6807\u662f\u9884\u9632\u590d\u53d1\uff0c\u56e0\u4e3a\u6bcf\u6b21\u590d\u53d1\u90fd\u4f1a\u8fdb\u4e00\u6b65\u52a0\u91cd\u6b8b\u75be\uff0c\u8fd9\u6b63\u662fNMOSD\u5177\u6709\u5982\u6b64\u7834\u574f\u6027\u7684\u539f\u56e0\u3002\u51e0\u5341\u5e74\u6765\uff0c\u6211\u4eec\u4e00\u76f4\u671f\u5f85\u7740\u627e\u5230\u80fd\u901a\u8fc7\u76f4\u51fb\u5176\u91cd\u8981\u7684\u75c5\u7406\u57fa\u7840\u4ee5\u9884\u9632\u590d\u53d1\u548c\u540e\u7eed\u6b8b\u75be\u79ef\u7d2f\u7684\u7597\u6cd5\u3002\u5728\u8fd9\u9879\u7a81\u7834\u6027\u7684\u968f\u673a\u5bf9\u7167\u5b9e\u9a8c\u4e2d\uff0cSoliris\u5c55\u793a\u51fa\u7684\u5bf9NMOSD\u7684\u5b9e\u8d28\u6027\u7597\u6548\uff0c\u53ef\u80fd\u4f1a\u6210\u4e3a\u88ab\u590d\u53d1\u7684\u6050\u60e7\u6240\u7b3c\u7f69\u7684\u60a3\u8005\u53ca\u5176\u5bb6\u5c5e\u7684\u4e00\u4e2a\u8f6c\u6298\u70b9\u3002\u201d<\/span><\/p>\n


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\u53c2\u8003\u8d44\u6599\uff1a<\/span><\/p>\n

[1]. Alexion Announces Successful Phase 3 PREVENT Study of Soliris\u00ae (Eculizumab) in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD). Retrieved September 24, 2018, from https:\/\/news.alexion.com\/press-release\/product-news\/alexion-announces-successful-phase-3-prevent-study-soliris-eculizumab-pat<\/span><\/p>\n

[2]. FDA\u6279\u51c6\u5168\u8eab\u578b\u91cd\u75c7\u808c\u65e0\u529b\u91cd\u78c5\u65b0\u836f. Retrieved September 24, 2018, from https:\/\/mp.weixin.qq.com\/s\/3p-gNY7O2d2SCMipMb2EMA<\/span><\/p>\n

[3]. Soliris\u00ae(eculizumab). Retrieved September 24, 2018, from www.solirisrems.com.<\/span><\/p>\n

[4]. Broadley, et al., (2012). Molecular Pathogenesis of Neuromyelitis Optica. Int. J. Mol. Sci., https:\/\/doi.org\/10.3390\/ijms131012970<\/span><\/p>\n


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\u672c\u6587\u6765\u81ea\u836f\u660e\u5eb7\u5fb7\u5fae\u4fe1\u56e2\u961f\uff0c\u6b22\u8fce\u8f6c\u53d1\u5230\u670b\u53cb\u5708\uff0c\u8c22\u7edd\u8f6c\u8f7d\u5230\u5176\u4ed6\u5e73\u53f0\uff1b\u5982\u6709\u5f00\u8bbe\u767d\u540d\u5355\u9700\u6c42\uff0c\u8bf7\u5728\u6587\u7ae0\u5e95\u90e8\u7559\u8a00\uff1b\u5982\u6709\u5176\u4ed6\u5408\u4f5c\u9700\u6c42\uff0c\u8bf7\u8054\u7cfbwuxi_media@wuxiapptec.com<\/span>
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