{"id":643,"date":"2022-11-28T19:29:35","date_gmt":"2022-11-28T11:29:35","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=643"},"modified":"2022-11-28T19:29:35","modified_gmt":"2022-11-28T11:29:35","slug":"%e5%a6%82%e4%bd%95%e8%ae%b0%e4%bd%8f%e6%89%80%e6%9c%89fda%e6%89%b9%e5%87%86%e7%94%9f%e7%89%a9%e8%8d%af%ef%bc%9f-palivizumab%e5%b8%95%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97%e3%80%81nirsevimab%e5%b0%bc","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=643","title":{"rendered":"\u5982\u4f55\u8bb0\u4f4f\u6240\u6709FDA\u6279\u51c6\u751f\u7269\u836f\uff1f| Palivizumab\u5e15\u5229\u73e0\u5355\u6297\u3001Nirsevimab\u5c3c\u585e\u97e6\u5355\u6297 | \u9884\u9632\u4e0b\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2RSV\u611f\u67d3"},"content":{"rendered":"\n

\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

Palivizumab\u7531MedImmune\u516c\u53f8\u7814\u53d1\uff0c\u540e\u88ab\u963f\u65af\u5229\u5eb7\u516c\u53f8\u6536\u8d2d\uff0c1998\u5e74\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02\uff08SYNAGIS\u00ae<\/sup> palivizumab\uff09\uff0c\u7528\u4e8e\u9884\u9632\u4e0b\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2\uff08RSV\uff09\u611f\u67d3\uff0c2019\u5e74SOBI\u516c\u53f8\u83b7\u5f97\u5176\u5728\u7f8e\u56fd\u7684\u6743\u76ca\u3002\u8be5\u836f\u672a\u5728\u56fd\u5185\u6279\u51c6\u4e0a\u5e02\uff0cCDE\u7533\u62a5\u4fe1\u606f\u91cc\uff08JXSL1100025\uff09\u4e2d\u6587\u540d\u4e3a\u5e15\u5229\u73e0\u5355\u6297\u3002<\/p>\n\n\n\n

Nirsevimab\u4e3a\u963f\u65af\u5229\u5eb7\u516c\u53f8\u548c\u8d5b\u8bfa\u83f2\u516c\u53f8\u8054\u5408\u5f00\u53d1\u7684\u957f\u6548\u9884\u9632RSV\u836f\u7269\uff0c\u76ee\u524d\u521a\u521a\u5728\u6b27\u76df\u4e0a\u5e02\uff08Beyfortus\u00ae<\/sup>\u00a0Nirsevimab \uff09\u3002\u56fd\u5185\u6682\u672a\u4e0a\u5e02\uff0c\u4e00\u4e9b\u6587\u732e\u4e2d\u4e2d\u6587\u540d\u4e3a\u5c3c\u585e\u97e6\u5355\u6297\u3002<\/p>\n\n\n\n

1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n

RSV\u901a\u8fc7\u76f4\u63a5\u63a5\u89e6\u548c\u98de\u6cab\u4f20\u64ad\uff0c\u662f\u5f15\u8d775\u5c81\u4ee5\u4e0b\u513f\u7ae5\u6025\u6027\u4e0b\u547c\u5438\u9053\u611f\u67d3\u7684\u9996\u8981\u75c5\u539f\u4f53\u3002<\/p>\n\n\n\n

RSV\u75c5\u6bd2\u7ed3\u6784<\/strong><\/p>\n\n\n

\n
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Immunity . 2019 Sep 17;51(3):429-442.<\/em>RSV<\/figcaption><\/figure>\n<\/div>\n\n\n

RSV\u662f\u4e00\u79cd\u5355\u80a1\u8d1f\u94feRNA\u75c5\u6bd2\uff0c\u5305\u542b10\u4e2a\u57fa\u56e0\uff0c\u7f16\u780111\u79cd\u86cb\u767d\u8d28\u3002\u5176\u4e2d\u878d\u5408\u86cb\u767dF<\/strong>\u5e8f\u5217\u9ad8\u5ea6\u4fdd\u5b88\uff0c\u53ef\u4ee5\u7528\u6765\u8bf1\u5bfc\u4ea7\u751f\u4e2d\u548c\u6297\u4f53\u6291\u5236RSV\u6d3b\u6027\u3002<\/p>\n\n\n\n

\u878d\u5408\u86cb\u767dF<\/strong>\u4ee5\u4e09\u805a\u4f53\u5f62\u5f0f\u5b58\u5728\uff0c\u5305\u542b\u878d\u5408\u524d\uff08Pre-F\uff09\u548c\u878d\u5408\u540e\uff08Post-F\uff09\u4e24\u79cd\u6784\u8c61\u3002Pre-F\u662f\u4e00\u79cd\u4e9a\u7a33\u5b9a\u7ed3\u6784\uff0c\u5f53\u75c5\u6bd2\u4e0e\u7ec6\u80de\u53d1\u751f\u878d\u5408\u540e\uff0c\u53ef\u4ee5\u5411\u7a33\u5b9a\u7684Post-F\u8f6c\u53d8\u3002<\/p>\n\n\n\n

\u878d\u5408\u86cb\u767dF\u7684\u6297\u539f\u8868\u4f4d<\/strong><\/p>\n\n\n

\n
\"\"
Immunity . 2019 Sep 17;51(3):429-442.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n

\u76ee\u524d\u5df2\u7ecf\u9274\u5b9a\u76846\u79cd\u6297\u539f\u8868\u4f4d\uff08site \u2160\u3001\u2161\u3001\u2162\u3001\u2163\u3001\u2164\u548c\u00d8\uff09\u5747\u5b58\u5728\u4e8ePre-F\u86cb\u767d\u4e2d\u3002Post-F\u542b\u67094\u79cd\u6297\u539f\u8868\u4f4d\uff08site\u2160\u3001\u2161\u3001\u2162\u548c\u2163\uff09\u3002<\/p>\n\n\n\n

\u5404\u6297\u539f\u8868\u4f4d\u7684\u6297\u4f53\u4e2d\u548c\u6548\u529b\u5982\u56fe\u3002<\/p>\n\n\n\n

\u9884\u9632RSV\u7684\u6297\u4f53<\/strong><\/p>\n\n\n

\n
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Ann Allergy Asthma Immunol . 2020 Jul;125(1):36-46.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n

\u76ee\u524d\u4e0a\u5e02\u6216\u5728\u7814\u7684\u9884\u9632RSV\u6297\u4f53\u836f\u7269\u4e3b\u8981\u6709\uff1a<\/p>\n\n\n\n

1\u3001Palivizumab \u5e15\u5229\u73e0\u5355\u6297\uff0c\u963f\u65af\u5229\u5eb7\u516c\u53f8\u4ea7\u54c1\uff0c\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\u3002\u9776\u5411Pre-F\u878d\u5408\u86cb\u767d\u7684\u6297\u539f\u8868\u4f4dII\uff0c1998\u5e74\u83b7FDA\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n\n\n\n

2\u3001Nirsevimab \u5c3c\u585e\u97e6\u5355\u6297\uff0c\u963f\u65af\u5229\u5eb7\u548c\u8d5b\u8bfa\u83f2\u8054\u5408\u5f00\u53d1\uff0c\u5168\u4eba\u6e90\u5355\u514b\u9686\u6297\u4f53\uff0c\u9776\u5411Pre-F\u878d\u5408\u86cb\u767d\u6297\u4f53\u4e2d\u548c\u6548\u529b\u6700\u9ad8\u7684\u00d8\u8868\u4f4d\u30022022\u5e7411\u6708\u83b7\u6b27\u76df\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n\n\n\n

3\u3001\u9ed8\u6c99\u4e1c\u516c\u53f8\u7684Clesrovimab\uff0c\u9776\u5411Pre-F\u7684IV\u8868\u4f4d\uff0c\u76ee\u524d\u5904\u4e8eIII\u671f\u4e34\u5e8a\u9636\u6bb5\u3002<\/p>\n\n\n\n

4\u3001\u518d\u751f\u5143\u516c\u53f8\u7684Suptavumab\uff0cIII\u671f\u4e34\u5e8a\u5931\u8d25\uff0c\u76ee\u524d\u5df2\u7ecf\u505c\u6b62\u5f00\u53d1\u3002<\/p>\n\n\n\n

\u53e6\u5916\u8d5b\u8bfa\u83f2\u516c\u53f8\u7684\u7eb3\u7c73\u6297\u4f53\u5e73\u53f0\u4e5f\u5728\u8fdb\u884cRSV\u7eb3\u7c73\u6297\u4f53\u7684\u7814\u53d1\uff08ALX\u20110171\uff09\u3002<\/p>\n\n\n\n

\u5c3c\u585e\u97e6\u5355\u6297\u4e0e\u5e15\u5229\u73e0\u5355\u6297<\/strong><\/p>\n\n\n

\n
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https:\/\/www.sanofi.com\/dam\/jcr:2cf9283d-ada8-45ac-9d00-865206e8bd51\/2020_07_30_Nirsevimab_slides_website.pdf<\/em><\/em><\/figcaption><\/figure>\n<\/div>\n\n\n

\u76ee\u524d\u5df2\u7ecf\u4e0a\u5e02\u7684\u4e24\u79cd\u9884\u9632RSV\u6297\u4f53\u4e3a\u5c3c\u585e\u97e6\u5355\u6297\u548c\u5e15\u5229\u73e0\u5355\u6297\u3002<\/p>\n\n\n\n

\u5c3c\u585e\u97e6\u5355\u6297\u4e00\u4e2aRSV\u53d1\u75c5\u5b63\u4ec5\u9700\u4e00\u9488\uff0c\u5373\u53ef\u8fbe\u5230>70%\u7684\u9884\u9632\u6709\u6548\u7387\u3002\u800c\u5e15\u5229\u73e0\u5355\u6297\u4e00\u4e2aRSV\u53d1\u75c5\u5b63\u9700\u6bcf\u6708\u6ce8\u5c041\u9488\uff0c\u603b\u5171\u9700\u89815\u9488\uff0c\u8fbe\u523045-55%\u7684\u9884\u9632\u6709\u6548\u7387\u3002<\/p>\n\n\n\n

2\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n

\u9884\u9632RSV\u6297\u4f53\u836f\u7269\u9002\u5e94\u75c7<\/strong><\/p>\n\n\n

\n
\"\"
\u8be5\u836f\u7269\u76ee\u524d\u56fd\u5185\u6682\u672a\u6279\u51c6\u4e0a\u5e02<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n

Palivizumab \u5e15\u5229\u73e0\u5355\u6297\uff08FDA\uff09\uff1a<\/p>\n\n\n\n

\u9884\u9632\u513f\u7ae5\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2(RSV)\u5f15\u8d77\u7684\u4e25\u91cd\u4e0b\u547c\u5438\u9053\u611f\u67d3<\/p>\n\n\n\n

Nirsevimab \u5c3c\u585e\u97e6\u5355\u6297(EMA)\uff1a<\/p>\n\n\n\n

\u9884\u9632\u65b0\u751f\u513f\u548c\u5a74\u513f\u5728\u7b2c\u4e00\u4e2aRSV\u53d1\u75c5\u5b63\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2(RSV)\u5f15\u8d77\u7684\u4e0b\u547c\u5438\u9053\u611f\u67d3<\/p>\n\n\n\n

3\u3001\u56fe\u50cf\u8bb0\u5fc6<\/h2>\n\n\n
\n
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\u4e00\u4e2a\u722c\u7281\u4e0a\u5750\u7740\u4e00\u53ea\u732a\uff0c\u732a\u7684\u5c3e\u5df4\u585e\u5728\u6ce5\u571f\u91cc\uff0c\u5c0f\u732a\u6253\u5f00\u4e00\u4e2a\u8377\u5305\uff0c\u91ca\u653e\u51fa\u4e86\u75c5\u6bd2\u3002<\/figcaption><\/figure>\n<\/div>\n\n\n

\u722c\u7281\u548c\u732a\uff0c\u6ce5\u571f\u91cc\u585e\u7740\u5c3e\u5df4\uff0c\u4ee3\u8868\u4e24\u4e2aRSV\u836f\u7269\uff0c\u5e15\u5229\u73e0\u5355\u6297\u3001\u5c3c\u585e\u97e6\u5355\u6297\u3002<\/p>\n\n\n\n

\u8377\u5305\u91ca\u653e\u51fa\u75c5\u6bd2\uff0c\u4ee3\u8868\u836f\u7269\u4f5c\u7528\u4e3a\u9884\u9632\u5408\u80de\u75c5\u6bd2\u5f15\u8d77\u7684\u4e0b\u547c\u5438\u9053\u611f\u67d3\u3002<\/p>\n\n\n\n

\u4f60\u8bb0\u4f4f\u4e86\u4e48\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

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