{"id":24796,"date":"2025-11-21T21:10:31","date_gmt":"2025-11-21T13:10:31","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=24796"},"modified":"2025-12-01T12:10:34","modified_gmt":"2025-12-01T04:10:34","slug":"%e4%ba%94%e5%b9%b4%e6%80%bb%e7%94%9f%e5%ad%98%e7%8e%87%e8%be%be93%ef%bc%8c%e5%88%9b%e6%96%b0%e5%8d%95%e6%8a%97%e5%86%8d%e8%8e%b7fda%e6%89%b9%e5%87%86%ef%bc%8c%e8%82%bf%e7%98%a4%e5%ae%8c%e5%85%a8","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/%e4%ba%94%e5%b9%b4%e6%80%bb%e7%94%9f%e5%ad%98%e7%8e%87%e8%be%be93%ef%bc%8c%e5%88%9b%e6%96%b0%e5%8d%95%e6%8a%97%e5%86%8d%e8%8e%b7fda%e6%89%b9%e5%87%86%ef%bc%8c%e8%82%bf%e7%98%a4%e5%ae%8c%e5%85%a8\/","title":{"rendered":"\u4e94\u5e74\u603b\u751f\u5b58\u7387\u8fbe93%\uff0c\u521b\u65b0\u5355\u6297\u518d\u83b7FDA\u6279\u51c6\uff0c\u80bf\u7624\u5b8c\u5168\u6d88\u5931\u6301\u7eed\u8d852\u5e74"},"content":{"rendered":"\n

\u9ad8\u5371\u578b\u5192\u70df\u578b\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff08HR-SMM\uff09\u662f\u4e00\u79cd\u65e0\u75c7\u72b6\u6076\u6027\u80bf\u7624\uff0c\u5176\u57fa\u56e0\u7ec4\u4e0e\u6d3b\u52a8\u6027\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u76f8\u540c\uff0c\u4e14\u53ef\u5728\u9aa8\u9ad3\u4e2d\u68c0\u6d4b\u5230\u8fd9\u4e9b\u5f02\u5e38\u7ec6\u80de\u3002\u636e\u4f30\u8ba1\uff0c\u7ea650%\u7684HR-SMM\u60a3\u8005\u53ef\u80fd\u5728\u786e\u8bca\u540e\u4e24\u5e74\u5185\u8fdb\u5c55\u4e3a\u6d3b\u52a8\u6027\u75be\u75c5\u3002<\/p>\n\n\n\n

\u5728\u6cbb\u7597\u63a2\u7d22\u4e2d\uff0c\u517c\u5177\u7597\u6548\u3001\u4fbf\u6377\u6027\u4e0e\u5b89\u5168\u6027\u7684\u836f\u7269\u59cb\u7ec8\u662f\u4e34\u5e8a\u5173\u6ce8\u7684\u6838\u5fc3\u65b9\u5411\u3002\u8fbe\u96f7\u59a5\u5c24\u5355\u6297(daratumumab)\u4e0e\u900f\u660e\u8d28\u9178\u9176 – fihj(hyaluronidase-fihj)\u521b\u65b0\u6027\u5730\u5c06\u6838\u5fc3\u6cbb\u7597\u6210\u5206\u4e0e\u5438\u6536\u589e\u5f3a\u6280\u672f\u76f8\u7ed3\u5408\uff0c\u4ee5\u76ae\u4e0b\u6ce8\u5c04\u7684\u7ed9\u836f\u65b9\u5f0f\u6253\u7834\u4e86\u4f20\u7edf\u9759\u8109\u8f93\u6ce8\u7684\u5c40\u9650\uff0c\u5728\u4fdd\u969c\u6cbb\u7597\u6548\u679c\u7684\u540c\u65f6\u5927\u5e45\u7b80\u5316\u4e86\u6cbb\u7597\u6d41\u7a0b\uff0c\u4e3a\u60a3\u8005\u5e26\u6765\u4e86\u66f4\u8d34\u5408\u5b9e\u9645\u6cbb\u7597\u9700\u6c42\u7684\u65b0\u9009\u62e9\u3002<\/p>\n\n\n\n

\u6458\u8981<\/strong><\/p>\n\n\n\n

2025\u5e7411\u67086\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\u76ae\u4e0b\u6ce8\u5c04\u578b<\u8fbe\u96f7\u59a5\u5c24\u5355\u6297(daratumumab)\u4e0e\u900f\u660e\u8d28\u9178\u9176 – fihj(hyaluronidase-fihj)>\uff0c\u7528\u4e8e\u6cbb\u7597\u9ad8\u5371\u578b\u5192\u70df\u578b\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff08High-Risk Smoldering Multiple Myeloma\uff0cHR-SMM\uff09\u6210\u5e74\u60a3\u8005\u3002<\/strong><\/strong><\/p>\n\n\n\n

\u6279\u51c6\u4f9d\u636e<\/strong><\/strong><\/p>\n\n\n\n

FDA\u7684\u6279\u51c6\u57fa\u4e8e<\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u4e0e\u900f\u660e\u8d28\u9178\u9176><\/strong>\u5728AQUILA\u8bd5\u9a8c\u4e2d\u7684\u663e\u8457\u7597\u6548\u3002<\/p>\n\n\n\n

\u57283\u671fAQUILA\uff0a\u7814\u7a76\u4e2d\uff0c\u8bc4\u4f30\u4e86<\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u4e0e\u900f\u660e\u8d28\u9178\u9176><\/strong>\u4e0e\u79ef\u6781\u76d1\u6d4b\u7684\u7597\u6548\u5bf9\u6bd4\u3002\u8fd9\u9879\u4e34\u5e8a\u8bd5\u9a8c\u5171\u7eb3\u5165390\u540d\u5e74\u9f84\u226518\u5c81\u3001\u786e\u8bca\u4e0d\u8d85\u8fc75\u5e74\u7684HR-SMM\u60a3\u8005\u3002<\/p>\n\n\n\n

\uff0aAQUILA\u8bd5\u9a8c\u662f\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u3001\u968f\u673a\u53163\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5171\u7eb3\u5165390\u540d\u5e74\u9f84\u4e0d\u4f4e\u4e8e18\u5c81\u4e14\u786e\u8bca\u65f6\u95f4\u4e0d\u8d85\u8fc75\u5e74\u7684\u9ad8\u5371\u578b\u5192\u70df\u578b\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\uff08HR-SMM\uff09\u3002\u60a3\u8005\u9700\u6ee1\u8db3\u9aa8\u9ad3\u514b\u9686\u6027\u6d46\u7ec6\u80de\u6bd4\u4f8b\u4e0d\u4f4e\u4e8e10%\uff0c\u5e76\u81f3\u5c11\u7b26\u5408\u4ee5\u4e0b\u4e00\u9879\u98ce\u9669\u7279\u5f81\uff1a\u8840\u6e05M\u86cb\u767d\u6c34\u5e73\u4e0d\u4f4e\u4e8e30\u514b\/\u5347\uff1bIgA\u578b\u75be\u75c5\uff1b\u514d\u75ab\u9ebb\u75f9\u4f34\u4e24\u79cd\u672a\u53d7\u7d2f\u514d\u75ab\u7403\u86cb\u767d\u540c\u79cd\u578b\u6c34\u5e73\u964d\u4f4e\uff1b\u8840\u6e05\u53d7\u7d2f\/\u672a\u53d7\u7d2f\u6e38\u79bb\u8f7b\u94fe\u6bd4\u503c\u57288\u81f3100\u4e4b\u95f4\uff1b\u6216\u9aa8\u9ad3\u514b\u9686\u6027\u6d46\u7ec6\u80de\u6bd4\u4f8b\u8d85\u8fc750%\u4f46\u4f4e\u4e8e60%\u3002\u60a3\u8005\u8fd8\u9700\u5177\u67090\u62161\u5206\u7684ECOG\u4f53\u80fd\u72b6\u6001\u8bc4\u5206\u3002<\/p>\n\n\n\n

\u60a3\u8005\u63091\uff1a1\u968f\u673a\u5206\u7ec4\uff0c\u88ab\u5206\u5230\u6cbb\u7597\u7ec4\u7684\u60a3\u8005\u63a5\u53d7\u4e86<\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u4e0e\u900f\u660e\u8d28\u9178\u9176>\u76ae\u4e0b\u6ce8\u5c04<\/strong>\u3002\u7ed9\u836f\u9891\u7387\u662f\uff1a\u7b2c1\u81f38\u5468\u6bcf\u54681\u6b21\uff0c\u7b2c9\u81f324\u5468\u6bcf\u4e24\u54681\u6b21\uff0c\u4ece\u7b2c25\u5468\u8d77\u6bcf4\u54681\u6b21\uff0c\u76f4\u5230\u5b8c\u621039\u4e2a\u6cbb\u7597\u5468\u671f\u6216\u6301\u7eed36\u4e2a\u6708\uff0c\u6216\u76f4\u5230\u786e\u8bca\u4e3a\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u6216\u51fa\u73b0\u65e0\u6cd5\u8010\u53d7\u7684\u4e0d\u826f\u53cd\u5e94\u3002\u5bf9\u7167\u7ec4\uff08\u76d1\u6d4b\u7ec4\uff09\u63a5\u53d7\u79ef\u6781\u76d1\u6d4b\uff0c\u65e0\u7279\u5b9a\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u7814\u7a76\u4e3b\u8981\u8bc4\u4f30\u7684\u7597\u6548\u6307\u6807\u662f\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\uff0c\u4e5f\u5c31\u662f\u4ece\u6cbb\u7597\u5f00\u59cb\u5230\u75be\u75c5\u6076\u5316\u6216\u6b7b\u4ea1\u7684\u65f6\u95f4\u3002\u8fd9\u91cc\u7684\u201c\u75be\u75c5\u6076\u5316\u201d\u662f\u6307\u6309\u7167\u56fd\u9645\u9aa8\u9ad3\u7624\u5de5\u4f5c\u7ec4\uff08IMWG\uff09\u6807\u51c6\uff0c\u88ab\u786e\u8bca\u5df2\u7ecf\u4ece\u9690\u533f\u6027\u9636\u6bb5\u8fdb\u5c55\u4e3a\u771f\u6b63\u7684\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u6216\u6b7b\u4ea1\u3002\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u3001\u8f6c\u5316\u4e3a\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684\u4e00\u7ebf\u6cbb\u7597\u65f6\u95f4\u3001\u4e00\u7ebf\u6cbb\u7597\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u53ca\u603b\u751f\u5b58\u671f\uff08OS\uff09\u3002<\/p>\n\n\n\n

\u7814\u7a76\u7ed3\u679c<\/strong><\/strong><\/p>\n\n\n\n

1. <\/strong>\u6cbb\u7597\u7ec4\u7684\u5e73\u5747\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u672a\u8fbe\u5230<\/strong>\uff0c\u5373\u5927\u591a\u6570\u4eba\u75c5\u60c5\u90fd\u8fd8\u6ca1\u6076\u5316\uff0c\u6240\u4ee5\u65e0\u6cd5\u8ba1\u7b97\uff1b\u76d1\u6d4b\u7ec4\u4e3a41.5\u4e2a\u6708<\/strong>\uff0c\u5373\u4e00\u534a\u60a3\u8005\u572841.5\u4e2a\u6708\u540e\u75c5\u60c5\u51fa\u73b0\u8fdb\u5c55\u6216\u53bb\u4e16\u3002\u6cbb\u7597\u7ec4\u76f8\u6bd4\u76d1\u6d4b\u7ec4\uff0c\u663e\u8457\u5ef6\u957f\u4e86\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\uff0c\u610f\u5473\u7740\u6709\u6548\u5e2e\u52a9\u60a3\u8005\u63a7\u5236\u4e86\u75be\u75c5\u8fdb\u5c55\uff0c\u8ba9\u75c5\u60c5\u66f4\u4e45\u4e0d\u6076\u5316\u3002<\/strong><\/p>\n\n\n\n

2. <\/strong>\u6cbb\u7597\u7ec4\u8fd8\u89c2\u5bdf\u5230\u603b\u751f\u5b58\u671f\uff08OS\uff09\u6539\u5584\u3002<\/strong>2024\u5e74\u7f8e\u56fd\u8840\u6db2\u5b66\u4f1a\uff08ASH\uff09\u5e74\u4f1a\u4e0a\u516c\u5e03\u7684\u6570\u636e\u663e\u793a\uff0c\u6cbb\u7597\u7ec460\u4e2a\u6708\uff085\u5e74\uff09\u7684\u603b\u751f\u5b58\u7387\u4e3a93.0%\uff0c\u76d1\u6d4b\u7ec4\u4e3a86.9%\u3002<\/strong><\/p>\n\n\n\n

\u5b89\u5168\u6027<\/strong><\/strong><\/p>\n\n\n\n

<\u8fbe\u96f7\u59a5\u5c24\u5355\u6297\u4e0e\u900f\u660e\u8d28\u9178\u9176><\/strong>\u7684\u526f\u4f5c\u7528\u5305\u62ec\uff1a\u8fc7\u654f\u53cd\u5e94\u3001\u6ce8\u5c04\u53cd\u5e94\u3001\u8f7b\u94fe\u6dc0\u7c89\u6837\u53d8\u60a3\u8005\u7684\u5fc3\u810f\u6bd2\u6027\u3001\u611f\u67d3\u3001\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3001\u8840\u5c0f\u677f\u51cf\u5c11\u3001\u5bf9\u80ce\u513f\u7684\u6bd2\u6027\u4ee5\u53ca\u5e72\u6270\u4ea4\u53c9\u914d\u8840\u4e0e\u7ea2\u7ec6\u80de\u6297\u4f53\u7b5b\u67e5\uff08\u5373\u53ef\u80fd\u5f71\u54cd\u8f93\u8840\u524d\u7684\u8840\u578b\u5339\u914d\u68c0\u6d4b\uff09\u3002<\/p>\n\n\n\n

2024\u5e74\u7f8e\u56fd\u8840\u6db2\u5b66\u4f1a\uff08ASH\uff09\u5e74\u4f1a\u4e0a\u516c\u5e03\u7684\u5b89\u5168\u6027\u6570\u636e\u663e\u793a\uff1a<\/p>\n\n\n\n

\u2022\u00a0<\/strong>\u6cbb\u7597\u7ec4\u4efb\u610f\u7ea7\u522b\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08TEAE\uff09\u7684\u53d1\u751f\u7387\u4e3a96.9%\uff0c\u76d1\u6d4b\u7ec4\u4e3a82.7%\u3002
\u2022\u00a0<\/strong>\u6cbb\u7597\u7ec4\u4e25\u91cd\u76843\/4\u7ea7\u4e0d\u826f\u4e8b\u4ef6\u7684\u53d1\u751f\u7387\u4e3a40.4%\uff0c\u76d1\u6d4b\u7ec4\u4e3a30.1%\u3002
\u2022\u00a0<\/strong>\u6cbb\u7597\u7ec45\u7ea7\uff08\u6b7b\u4ea1\uff09\u4e0d\u826f\u4e8b\u4ef6\u7684\u53d1\u751f\u7387\u4e3a1.0%\uff0c\u76d1\u6d4b\u7ec4\u4e3a2.0%\u3002
\u2022\u00a0<\/strong>\u6700\u5e38\u89c1\u76843\/4\u7ea7\u4e0d\u826f\u4e8b\u4ef6\u662f\u9ad8\u8840\u538b\uff08\u6cbb\u7597\u7ec45.7%\uff0c\u76d1\u6d4b\u7ec44.6%\uff09\u3002
\u2022\u00a0<\/strong>\u6cbb\u7597\u7ec4\u4e0d\u826f\u4e8b\u4ef6\u5bfc\u81f4\u505c\u836f\u7684\u6bd4\u4f8b\u4e3a5.7%\uff0c46.6%\u7684\u60a3\u8005\u56e0\u4e0d\u826f\u4e8b\u4ef6\u8c03\u6574\u5242\u91cf\u3002
\u2022\u00a0<\/strong>\u65b0\u51a0\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u5728\u6cbb\u7597\u7ec4\u7684\u53d1\u751f\u7387\u4e3a8.8%\uff0c\u76d1\u6d4b\u7ec4\u4e3a5.1%\uff1b\u4e24\u7ec4\u4e25\u91cd\u75c5\u4f8b\u5206\u522b\u4e3a2.6%\u548c0.5%\uff1b\u6cbb\u7597\u7ec4\u67091.0%\u7684\u60a3\u8005\u6b7b\u4e8e\u65b0\u51a0\u611f\u67d3\uff0c\u76d1\u6d4b\u7ec4\u65e0\u6b7b\u4ea1\u75c5\u4f8b\u3002<\/p>\n\n\n\n

\u8d44\u6599\u6765\u6e90\uff1a<\/p>\n\n\n\n

[1]https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma
[2]https:\/\/www.onclive.com\/view\/fda-approves-subcutaneous-daratumumab-for-high-risk-smoldering-multiple-myeloma<\/p>\n\n\n\n

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