{"id":67444,"date":"2018-11-27T01:00:00","date_gmt":"2018-12-07T04:14:57","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/3eeae3a3c9\/"},"modified":"2018-12-07T12:15:04","modified_gmt":"2018-12-07T04:15:04","slug":"3eeae3a3c9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/67444\/","title":{"rendered":"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09"},"content":{"rendered":"
\n

\u7279\u7ea6\u64b0\u7a3f\u4eba\uff1a\u9b4f\u5229\u519b<\/span><\/p>\n

\n

\u622a\u6b622018\u5e7411\u670826\u65e5\uff0cFDA\u5df2\u7ecf\u6279\u51c6\u4e8653\u4e2a\u65b0\u836f\uff0c\u867d\u7136\u5df2\u7ecf\u63a5\u8fd1\u5e74\u5e95\uff0c\u4f46\u4ecd<\/span>\u6709<\/span>\u591a\u4e2a\u65b0\u836f\u7684PDUFA\u622a\u6b62\u65e5\u671f\u843d\u57282018\u5e7412\u6708\u62162019\u5e741\u5b63\u5ea6\uff0c\u56e0\u6b64\u5c1a\u65e0\u6cd5\u51c6\u786e\u9884\u6d4bFDA\u57282018\u5e74\u4f1a\u6279\u51c6\u591a\u5c11\u4e2a\u65b0\u836f\u4e0a\u5e02\u3002\u5c3d\u7ba1\u5982\u6b64\uff0c2018\u5e74\u83b7\u6279\u65b0\u836f\u7684\u6570\u91cf\u5df2\u7ecf\u662f\u8fd120\u5e74\u6765\u7684\u65b0\u9ad8\u3002\u9664\u4e86\u6570\u91cf\u591a\uff0c\u8d28\u91cf\u4e5f\u662f\u5f88\u9ad8\uff0c\u5f88\u591a\u65b0\u836f\u90fd\u662f\u7a81\u7834\u6027\u7684\uff0c\u5982\u5927\u9ebb\u4e8c\u915a\u3001CGRP\u6291\u5236\u5242\u3001\u5b50\u5bab\u5185\u819c\u5f02\u4f4d\u75c7\u53e3\u670d\u7597\u6cd5\u7b49\u7b49\uff0c\u5b83\u4eec\u7684\u4e0a\u5e02\u5c06\u6781\u5927\u5730\u6ee1\u8db3\u4e34\u5e8a\u9700\u6c42\uff0c\u4e0e\u6b64\u540c\u65f6\uff0c\u5f88\u591a\u4ea7\u54c1\u4e5f\u5c06\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u3002\u5728\u672c\u6587\u91cc\uff0c\u6211\u4eec\u5c06\u5bf9FDA\u6279\u51c6\u7684\u5168\u90e8\u65b0\u836f\u9010\u4e2a\u70b9\u8bc4\uff0c\u56e0\u4e3a\u7bc7\u5e45\u592a\u957f\uff0c\u6240\u4ee5\u6211\u4eec\u5c06\u5206\u4e24\u6b21\u63a8\u9001\u3002<\/span>
<\/p>\n

1. Lutathera\uff08<\/span>Lutetium Dotatate Lu-177\uff09<\/span><\/span><\/strong><\/span><\/p>\n

1\u670826\u65e5\uff0cFDA\u6279\u51c6\u4e86Advanced Accelerator Applications\u516c\u53f8\u7684Lutathera\uff0c\u7528\u4e8e\u751f\u957f\u6291\u7d20\u53d7\u4f53\u9633\u6027\u7684\u80c3\u80a0\u80f0\u795e\u7ecf\u5185\u5206\u6ccc\u7624\uff08GEP-NET\uff09\u6cbb\u7597\u3002Lutathera\u662f\u4e00\u79cd\u653e\u5c04\u6027\u9565\uff08Lu-177\uff09\u6807\u8bb0\u7684\u751f\u957f\u6291\u7d20\u7c7b\u4f3c\u7269\uff0c\u53ef\u4e0e\u751f\u957f\u6291\u7d20\u53d7\u4f53\u7ed3\u5408\uff0c\u5c24\u5176\u662f\u5bf9\u4e9a\u578b2\u53d7\u4f53\u5177\u6709\u5f88\u9ad8\u7684\u4eb2\u548c\u529b\u3002\u836f\u7269\u4e0e\u8be5\u9776\u70b9\u9633\u6027\u7684\u80bf\u7624\u7ec6\u80de\u7ed3\u5408\u540e\uff0c\u9565\u91ca\u653e\u51fa\u03b2\u5c04\u7ebf\uff0c\u8fdb\u800c\u7834\u574f\u80bf\u7624\u7ec6\u80de\u3002\u7597\u6548\u65b9\u9762\uff0c\u4e00\u9879\u6709229\u4f8b\u665a\u671f\u751f\u957f\u6291\u7d20\u53d7\u4f53\u9633\u6027GEP-NET\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08NETTER-1\uff09\u6570\u636e\u663e\u793a\uff0c\u4f7f\u7528\u672c\u54c1\u8054\u5408\u957f\u6548\u5965\u66f2\u80bd\u6cbb\u7597\u7ec4\u76f8\u6bd4\u957f\u6548\u5965\u66f2\u80bd\u5355\u72ec\u6cbb\u7597\u7ec4\uff0c\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\u663e\u8457\u5ef6\u957f\uff0c\u5206\u522b\u4e3aNR (31.0, NE) <\/span>vs<\/em> <\/span>27.4 (22.2, NE)\uff0c\u98ce\u9669\u6bd4\u4e3a0.52[1]\u3002\u795e\u7ecf\u5185\u5206\u6ccc\u80bf\u7624\u662f\u4e00\u7c7b\u80da\u80ce\u7684\u795e\u7ecf\u5185\u5206\u6ccc\u7ec6\u80de\u3001\u5177\u6709\u795e\u7ecf\u5185\u5206\u6ccc\u7269\u548c\u53ef\u4ee5\u4ea7\u751f\u591a\u80bd\u6fc0\u7d20\u7684\u80bf\u7624[2]\uff0c\u6bcf\u5e74\u53d1\u75c5\u7387\u4e3a1\/2.7\u4e07[3]\uff0c\u9664\u4e86\u795e\u7ecf\u5185\u5206\u6ccc\u7624\uff0c\u672c\u54c1\u8fd8\u5728\u5f00\u53d1\u55dc\u94ec\u7ec6\u80de\u7624\uff08phase\u2161\uff09\u3001\u5c0f\u7ec6\u80de\u80ba\u764c\uff08phase\u2160\/\u2161\uff09\u7b49\u9002\u5e94\u75c7\uff0c\u90e8\u5206\u5206\u6790\u5e08\u8ba4\u4e3a\u672c\u54c1\u6709\u9500\u552e\u989d\u5cf0\u503c\u8d85\u8fc710\u4ebf\u7f8e\u5143\u7684\u6f5c\u529b\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Lutetium Dotatate Lu-177<\/span><\/p>\n

2. Biktarvy\uff08<\/span>Bictegravir\/\u6069\u66f2\u4ed6\u6ee8\/\u66ff\u8bfa\u798f\u97e6\u827e\u62c9\u915a\u80fa\uff09<\/span><\/strong><\/span><\/p>\n

2\u67087\u65e5\uff0cFDA\u6279\u51c6\u5409\u5229\u5fb7\u7684Biktarvy\u7528\u4e8e1\u578b\u4eba\u7c7b\u514d\u75ab\u7f3a\u9677\u75c5\u6bd2\uff08HIV\uff09\u611f\u67d3\u6cbb\u7597\u3002Biktarvy\u662f\u4e00\u79cd\u4e09\u8054\u7597\u6cd5\uff0c\u542b\u65b0\u4e00\u4ee3\u6574\u5408\u9176\u6291\u5236\u5242Bictegravir\u3001\u6838\u82f7\u7c7b\u9006\u8f6c\u5f55\u9176\u6291\u5236\u5242\u6069\u66f2\u4ed6\u6ee8\u548c\u66ff\u8bfa\u798f\u97e6\u827e\u62c9\u915a\u80fa[4]\u3002\u76f8\u6bd4\u5409\u5229\u5fb7\u524d\u4e00\u4ee3\u9e21\u5c3e\u9152\uff0c\u65b0\u578b\u6574\u5408\u9176\u6291\u5236\u5242Bictegravir\u65e0\u9700\u518d\u4f7f\u7528\u809d\u836f\u9176\u6291\u5236\u5242Cobicistat\u6765\u5ef6\u957f\u4f5c\u7528\u65f6\u95f4\uff0c\u800c\u4e14\u76f8\u6bd4\u66ff\u8bfa\u798f\u97e6\u4e8c\u5421\u544b\u916f\uff0c\u66ff\u8bfa\u798f\u97e6\u827e\u62c9\u915a\u80fa\u80be\u6bd2\u6027\u548c\u9aa8\u9abc\u6bd2\u6027\u5927\u5e45\u4e0b\u964d\u3002\u7597\u6548\u65b9\u9762\uff0c\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u5c06Biktarvy\uff08BIC\/FTC\/TAF\uff09\u4e0e\u2002Dolutegravir+\u6069\u66f2\u4ed6\u6ee8+\u66ff\u8bfa\u798f\u97e6\uff08DTG\/FTC\/TAF\uff09\u7ec4\u5408\u7597\u6cd5\u8fdb\u884c\u4e86\u6297\u75c5\u6bd2\u7597\u6548\u5bf9\u6bd4\uff0c\u7ecf\u8fc748\u5468\u6cbb\u7597\uff0cBIC\/FTC\/TAF\u6cbb\u7597\u7ec4\u75c5\u6bd2\u8f7d\u91cf\u4f4e\u4e8e50\u62f7\u8d1d\u7684\u60a3\u8005\u6bd4\u4f8b\u4e3a92.4%\uff08290\/314\uff09\uff0c\u800cDTG\/FTC\/TAF\u7ec4\u4e3a93.0%\uff08293\/315\uff09\uff0c\u8fbe\u5230\u7edf\u8ba1\u5b66\u610f\u4e49\u4e0a\u7684\u975e\u52a3\u6027\u3002\u4e0e\u836f\u7269\u76f8\u5173\u7684\u6574\u4f53\u4e0d\u826f\u53cd\u5e94\u65b9\u9762\uff0cBIC\/FTC\/TAF\u660e\u663e\u4f4e\u4e8eDTG\/FTC\/TAF\uff0826%\u2002vs<\/em>\u200240%\uff09\uff0c\u5176\u4e2d\u5455\u5410\u53d1\u751f\u7387\u5206\u522b\u4e3a\uff085%\u2002vs<\/em>\u200217%\uff09[5]\u3002\u56e0\u4e3a\u6297HIV\u9e21\u5c3e\u9152\u9700\u8981\u957f\u671f\u7528\u836f\uff0c\u6240\u4ee5\u9664\u4e86\u7597\u6548\u548c\u8010\u836f\u6027\u5916\uff0c\u4e0d\u826f\u53cd\u5e94\u548c\u4fbf\u6377\u6027\u4e5f\u662f\u5f71\u54cd\u4ea7\u54c1\u6210\u8d25\u7684\u4e3b\u8981\u56e0\u7d20\uff0c\u672c\u54c1\u8fd9\u4e24\u65b9\u9762\u7684\u4f18\u52bf\uff0c\u6ce8\u5b9a\u8ba9\u5b83\u6210\u4e3a\u827e\u6ecb\u75c5\u6cbb\u7597\u5e02\u573a\u7684\u9886\u5934\u7f8a\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u5219\u6709\u671b\u8fbe\u523066.7\u4ebf\u7f8e\u5143\uff0c\u662f2018\u5e74\u6700\u503c\u5f97\u5173\u6ce8\u7684\u836f\u7269\u4e4b\u4e00\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Bictegravir<\/span><\/p>\n

3.  Symdeko\uff08Tezacaftor\/Ivacaftor\uff09<\/span><\/strong><\/span><\/p>\n

2\u670812\u65e5\uff0cFDA\u6279\u51c6\u4e86Vertex\u516c\u53f8\u7684Symdeko\uff0c\u7528\u4e8eF508del\u57fa\u56e0\u7a81\u53d8\u7684\u7eaf\u5408\u5b50\uff0c\u6216\u56ca\u6027\u7ea4\u7ef4\u5316\u8de8\u819c\u4f20\u5bfc\u8c03\u8282\u56e0\u5b50\uff08CFTR\uff09\u57fa\u56e0\u5b58\u5728\u81f3\u5c11\u4e00\u5904\u7a81\u53d8\u3001\u4e14\u6709\u4f53\u5916\/\u4e34\u5e8a\u8bc1\u636e\u663e\u793a\u5bf9\u672c\u54c1\u654f\u611f\u7684\u56ca\u6027\u7ea4\u7ef4\u5316\u6cbb\u7597\u3002\u4e00\u9879\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u663e\u793a\uff0c504\u540dF508del\u57fa\u56e0\u7a81\u53d8\u7684\u7eaf\u5408\u5b50\u60a3\u8005\u63a5\u53d7\u672c\u54c1\u6216\u5b89\u6170\u5242\u6cbb\u759724\u5468\uff0c\u6cbb\u7597\u7ec4\u60a3\u8005\u7b2c1\u79d2\u7528\u529b\u547c\u6c14\u5bb9\u79ef\u5360\u9884\u8ba1\u503c\u767e\u5206\u6bd4\uff08pp FEV1\uff09\u76f8\u6bd4\u57fa\u7ebf\u4e0a\u53474%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u5219\u4e0b\u964d1%\uff0c\u8fbe\u5230\u4e3b\u8981\u6cbb\u7597\u7ec8\u70b9\u3002\u9664\u6b64\u4ee5\u5916\uff0c\u53e6\u6709\u4e34\u5e8a\u8bd5\u9a8c\u8bc1\u660eSymdeko\u76f8\u6bd4tezacaftor\u5355\u72ec\u6cbb\u7597\u66f4\u6709\u6548[6]\u3002CF\u662fCFTR\u57fa\u56e0\u7a81\u53d8\u6240\u5f15\u8d77\u7684\u75be\u75c5\uff0c\u4e34\u5e8a\u8868\u73b0\u4e3a\u6162\u6027\u963b\u585e\u6027\u80ba\u75be\u75c5\u3001\u80f0\u817a\u529f\u80fd\u4e0d\u5168\u53ca\u6c57\u817a\u53d7\u7d2f\u6240\u81f4\u7684\u6c57\u6db2\u94a0\u3001\u6c2f\u5f02\u5e38\u5347\u9ad8\u3002CF\u662f\u4e00\u79cd\u5728\u767d\u79cd\u4eba\u4e2d\u5e38\u89c1\u7684\u81f4\u547d\u9057\u4f20\u75be\u75c5\uff0c\u53d1\u75c5\u7387\u8fbe1\/2000\uff0c\u4e9a\u6d32\u4eba\u548c\u975e\u6d32\u9ed1\u4eba\u8f83\u4e3a\u5c11\u89c1[7]\u3002CF\u6cbb\u7597\u65b9\u6848\u8f83\u4e3a\u7f3a\u4e4f\uff0c\u672c\u54c1\u76f8\u8f83Orkambi(lumacaftor\/ivacaftor)\uff0c\u6548\u679c\u6709\u6240\u63d0\u5347\uff08pp FEV1\uff1a4% vs 2.4%\uff09[8]\uff0c\u83b7\u5f97\u4e86FDA\u7a81\u7834\u6027\u7597\u6cd5\uff0c\u5b64\u513f\u836f\u548c\u4f18\u5148\u5ba1\u8bc4\u7b49\u4e09\u9879\u8d44\u683c\u8ba4\u5b9a\uff0c\u540c\u65f6\u4e5f\u662f\u6709\u671b\u6210\u4e3a\u4e00\u4e2a\u91cd\u78c5\u70b8\u5f39\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u5219\u6709\u671b\u8fbe\u523019.90\u4ebf\u7f8e\u5143<\/span>\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Tezacaftor<\/span><\/p>\n

4.  Erleada\uff08Apalutamide\uff09<\/span><\/strong><\/span><\/p>\n

2\u670814\u65e5\uff0cFDA\u6279\u51c6\u4e86\u5f3a\u751f\u7684Erleada\uff0c\u7528\u4e8e\u975e\u8f6c\u79fb\u6027\u53bb\u52bf\u62b5\u6297\u7684\u524d\u5217\u817a\u764c\uff08NM-CRPC\uff09\u6cbb\u7597\u3002Apalutamide\u662f\u4e00\u79cd\u96c4\u6027\u6fc0\u7d20\u53d7\u4f53\u6291\u5236\u5242\uff0cSPARTAN\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u663e\u793a\uff0c1207\u540dNM-CRPC\u5728\u777e\u4e38\u5207\u9664\u6216\u4fc3\u6027\u817a\u6fc0\u7d20\u91ca\u653e\u6fc0\u7d20\uff08GnRH\uff09\u7c7b\u4f3c\u7269\u6cbb\u7597\u7684\u57fa\u7840\u4e0a\uff0c\u63a5\u53d7\u672c\u54c1\u6216\u5b89\u6170\u5242\u6cbb\u7597\uff0c\u672c\u54c1\u6cbb\u7597\u7ec4\u60a3\u8005\u65e0\u8f6c\u79fb\u751f\u5b58\u671f\u4e2d\u4f4d\u503c\u8fbe40.5\u4e2a\u6708\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4e3a16.2\u4e2a\u6708\u3002\u524d\u5217\u817a\u764c\u662f\u4e00\u79cd\u9ad8\u53d1\u764c\u75c7\uff0c2017\u5e74\u7ea6\u670916.12\u4e07\u7f8e\u56fd\u4eba\u88ab\u8bca\u65ad\u4e3a\u524d\u5217\u817a\u764c\uff0c\u81f4\u6b7b\u75c5\u4f8b\u9ad8\u8fbe2.67\u4e07[9]\u3002\u672c\u54c1\u7597\u6548\u51fa\u8272\uff0c\u7528\u836f\u5468\u671f\u8f83\u957f\uff0c\u800c\u4e14\u6709\u671b\u83b7\u6279\u7528\u4e8e\u8f6c\u79fb\u6027\u53bb\u52bf\u62b5\u6297\u7684\u524d\u5217\u817a\u764c\uff0c\u5e02\u573a\u524d\u666f\u975e\u5e38\u5149\u660e\uff0c\u662f2018\u5e74\u6700\u503c\u5f97\u5173\u6ce8\u7684\u65b0\u836f\u4e4b\u4e00\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282022\u5e74\u7684\u9500\u552e\u989d\u5219\u6709\u671b\u8fbe\u523015.70\u4ebf\u7f8e\u5143<\/span>\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Apalutamide<\/span><\/p>\n

5.  Trogarzo\uff08Ibalizumab\uff09<\/span><\/strong><\/span><\/p>\n

3\u67086\u65e5\uff0cFDA\u6279\u51c6\u4e86Taimed\u516c\u53f8\u7684Trogarzo\u4e0e\u5176\u4ed6\u6297\u9006\u8f6c\u5f55\u836f\u5408\u7528\uff0c\u6cbb\u7597\u9ad8\u5ea6\u8010\u836f\u7684HIV-1\u611f\u67d3\u3002Ibalizumab\u662f\u4e00\u79cd\u4eba\u6e90\u5316\u7684IgG4\u5355\u6297\uff0c\u53ef\u975e\u7ade\u4e89\u6027\u7ed3\u5408CD4\u7ec6\u80de\uff0c\u4ee5\u963b\u788dHIV-1\u75c5\u6bd2\u8fdb\u5165\u7ec6\u80de\u5185\u3002\u5728\u4e00\u9879\u5355\u7ec4\u8bbe\u8ba1\uff0c\u5f00\u653e\u6807\u7b7e\u7684\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c40\u540d\u591a\u79cd\u6297\u9006\u8f6c\u5f55\u836f\u7269\u6cbb\u7597\u5931\u8d25\u7684\u4e25\u91cd\u8010\u836fHIV-1\u611f\u67d3\u8005\uff0c\u5728\u4f18\u5316\u6297\u75c5\u6bd2\u6cbb\u7597\u65b9\u6848\u7684\u80cc\u666f\u6cbb\u7597\u4e0b\u6dfb\u52a0\u672c\u54c1\u6cbb\u7597\uff0c\u7ed3\u679c\u663e\u793a\uff0c33\u540d\u60a3\u8005\uff0883%\uff09\u75c5\u6bd2\u8f7d\u91cf\u76f8\u6bd4\u57fa\u7ebf\uff084.5log10\u62f7\u8d1d\/\u6beb\u5347\uff09\u81f3\u5c11\u51cf\u5c110.5 log10\u62f7\u8d1d\/\u6beb\u5347\uff0c\u5e73\u5747\u75c5\u6bd2\u8f7d\u91cf\u51cf\u5c11\u4e3a1.1log10\u62f7\u8d1d\/\u6beb\u5347\u3002\u5728\u7b2c25\u5468\u65f6\uff0c43%\u7684\u60a3\u8005\u7684\u75c5\u6bd2\u8f7d\u91cf\u5c0f\u4e8e50\u62f7\u8d1d\/\u6beb\u5347\uff0c50%\u7684\u75c5\u6bd2\u8f7d\u91cf\u5c0f\u4e8e200\u62f7\u8d1d\/\u6beb\u5347[10]\u3002\u867d\u7136\u5927\u90e8\u5206HIV-1\u611f\u67d3\u8005\u5728\u591a\u79cd\u6297\u9006\u8f6c\u5f55\u836f\u7269\u7684\u6cbb\u7597\u4e0b\uff0c\u75c5\u6bd2\u8f7d\u91cf\u5f97\u4ee5\u5f88\u597d\u7684\u63a7\u5236\uff0c\u4f46\u90e8\u5206\u60a3\u8005\u5728\u7ecf\u8fc7\u591a\u79cd\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u6cbb\u7597\u540e\u51fa\u73b0\u9ad8\u5ea6\u8010\u836f\uff0c\u533b\u751f\u675f\u624b\u65e0\u7b56\uff0c\u6b7b\u4ea1\u98ce\u9669\u8f83\u9ad8\uff0c\u672c\u54c1\u867d\u7136\u6f5c\u5728\u7528\u836f\u4eba\u7fa4\u4e0d\u5927\uff0c\u4f46\u4e3a\u533b\u751f\u63d0\u4f9b\u4e86\u4e00\u79cd\u65b0\u7684\u6cbb\u7597\u9009\u62e9[11]\u3002\u5e02\u573a\u65b9\u9762\uff0c\u672c\u54c1\u53ef\u80fd\u8981\u8d70\u9ad8\u4ef7\u7b56\u7565\uff0c\u4f46\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u7684\u53ef\u80fd\u6027\u5f88\u5c0f\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u4e3a2.93\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

6.  Ilumya\uff08Tildrakizumab\uff09<\/span><\/strong><\/span><\/p>\n

3\u670820\u65e5\uff0cFDA\u6279\u51c6\u4e86\u592a\u9633\u5236\u836f\u7684Ilumya\uff0c\u7528\u4e8e\u9002\u5408\u63a5\u53d7\u5149\u7167\u6216\u6fc0\u5149\u6cbb\u7597\u7684\u4e2d\u91cd\u5ea6\u6591\u5757\u94f6\u5c51\u75c5\u6cbb\u7597\u3002Tildrakizumab\u662f\u4e00\u79cd\u4eba\u6e90\u5316\u7684IgG1\u5355\u6297\uff0c\u9776\u70b9\u4e3aIL-23p19\uff0cFDA\u6279\u51c6Tildrakizumab\u4e0a\u5e02\uff0c\u662f\u57fa\u4e8e\u4e24\u9879\u591a\u4e2d\u5fc3\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c926\u540d\u60a3\u8005\u5206\u522b\u63a5\u53d7100mg\u672c\u54c1\u6216\u5b89\u6170\u5242\u6cbb\u7597\uff0c12\u5468\u540e\uff0cTildrakizumab\u6cbb\u7597\u7ec4\u94f6\u5c51\u75c5\u76ae\u80a4\u9762\u79ef\u4e0e\u4e25\u91cd\u6027\u6307\u6570\uff08PASI\uff09\u81f3\u5c11\u4e0b\u964d75%\u7684\u60a3\u8005\u6bd4\u4f8b\uff08PASI 75\uff09\u5206\u522b\u4e3a64%\u548c61%\uff0c\u5b89\u6170\u5242\u7ec4\u4ec5\u5206\u522b\u4e3a6%\u548c6%\uff1b\u6cbb\u7597\u7ec4\u6574\u4f53\u8bc4\u4ef7\u6cd5\uff08PGA\uff09\u8bc4\u5206\u4e3a0\u5206\u62161\u5206\u548c\u81f3\u5c11\u63d0\u9ad82\u5206\u7684\u60a3\u8005\u6bd4\u4f8b\u5206\u522b\u4e3a58%\u548c55%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u5206\u522b\u4e3a7%\u548c4%[12]\u3002\u867d\u7136\u94f6\u5c51\u75c5\u662f\u4e00\u4e2a\u975e\u5e38\u5e9e\u5927\u7684\u6cbb\u7597\u5e02\u573a\uff0c\u4f46\u7ade\u4e89\u5df2\u7ecf\u975e\u5e38\u6fc0\u70c8\uff0c\u5728\u5f3a\u751f\u7684Tremfya\uff08IL-23\u6297\u4f53\uff09\u3001\u793c\u6765\u7684Taltz\uff08IL-17A\u6297\u4f53\uff09\u548c\u8bfa\u534eCosentyx\uff08IL-17A\u6297\u4f53\uff09\u7b49\u7ade\u4e89\u5bf9\u624b\u9762\u524d\uff0c\u672c\u54c1\u5728\u7597\u6548\u4e0a\u5904\u4e8e\u52a3\u52bf\uff0c\u751a\u81f3\u4e0e\u963f\u8fbe\u6728\u5355\u6297\u548c\u963f\u666e\u65af\u7279\u76f8\u6bd4\uff0c\u592a\u9633\u5236\u836f\u90fd\u6ca1\u6709\u8db3\u591f\u7684\u628a\u63e1\uff0c\u56e0\u6b64\u672c\u54c1\u7684\u9500\u552e\u989d\u57285\u5e74\u5185\u7a81\u783410\u4ebf\u7f8e\u5143\u7684\u53ef\u80fd\u6027\u4e0d\u5927\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282022\u5e74\u7684\u9500\u552e\u989d\u4e3a1.2\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

7.  Crysvita\uff08Burosumab\uff09<\/span><\/strong><\/span><\/p>\n

4\u670817\u65e5\uff0cFDA\u6279\u51c6Ultragenyx\u516c\u53f8\u7684Crysvita\u4e0a\u5e02\uff0c\u7528\u4e8e1\u5c81\u53ca\u4ee5\u4e0a\u6210\u4eba\u548c\u513f\u7ae5X\u8fde\u9501\u4f4e\u78f7\u8840\u75c7\uff08XLH\uff09\u6cbb\u7597\u3002Burosumab\u662f\u4e00\u79cd\u6210\u7ea4\u7ef4\u7ec6\u80de\u751f\u957f\u56e0\u5b50\uff08FGF\uff0923\u6291\u5236\u5242\uff0c\u672c\u54c1\u7684\u5b89\u5168\u6709\u6548\u6027\u5df2\u7ecf\u5728\u56db\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5f97\u5230\u4e86\u786e\u8ba4\u3002\u5728\u8fd9\u4e9b\u8bd5\u9a8c\u4e2d\uff0c94%\u7684\u6210\u4eba\u60a3\u8005\u6bcf\u6708\u4e00\u6b21\u63a5\u53d7\u672c\u54c1\u6cbb\u7597\u540e\u8840\u78f7\u503c\u8fbe\u5230\u6b63\u5e38\u6c34\u5e73\uff0c\u800c\u63a5\u53d7\u5b89\u6170\u5242\u6cbb\u7597\u7684\u60a3\u8005\u53ea\u67098%\u8fbe\u6b63\u5e38\u6c34\u5e73\u3002\u5728\u513f\u7ae5\u60a3\u8005\u4e2d\uff0c\u9ad8\u8fbe94%-100%\u7684\u60a3\u8005\u7ecf\u8fc7\u672c\u54c1\u6bcf\u4e24\u5468\u4e00\u6b21\u7684\u6cbb\u7597\u540e\uff0c\u8840\u78f7\u503c\u8fbe\u5230\u6b63\u5e38\u6c34\u5e73\u3002XLH\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u7f55\u89c1\u75be\u75c5\uff0c\u5728\u7f8e\u56fd\u5927\u7ea6\u67093\u5343\u513f\u7ae5\u548c1.2\u4e07\u6210\u4eba\u7f79\u60a3\u6b64\u75c5\u3002XLH\u4e0d\u540c\u4e8e\u5176\u4ed6\u5f62\u5f0f\u7684\u4f5d\u507b\u75c5\uff0c\u7ef4\u751f\u7d20D\u6cbb\u7597\u65e0\u6548\uff0cBurosumab\u662f\u8be5\u6cbb\u7597\u9886\u57df\u7684\u9996\u836f\uff0c\u5c3d\u7ba1\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u7684\u6f5c\u529b\u4e0d\u5927\uff0c\u4f46\u4e5f\u662f\u7a81\u7834\u6027\u7684[13]\u3002<\/span><\/p>\n

8.  Tavalisse\uff08Fostamatinib disodium\uff09<\/span><\/strong><\/span><\/p>\n

\u540c\u57284\u670817\u65e5\uff0cFDA\u8fd8\u6279\u51c6\u4e86Rigel\u516c\u53f8\u7684\u813e\u916a\u6c28\u9178\uff08Syk\uff09\u6fc0\u9176\u6291\u5236\u5242Fostamatinib\uff0c\u7528\u4e8e\u6162\u6027\u514d\u75ab\u6027\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u8f85\u52a9\u6cbb\u7597\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e24\u9879\u5b89\u6170\u5242\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08FIT-1\u548cFIT-2\uff09\u548c\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08FIT-3\uff09\uff0c\u5728FIT1\u548cFIT2\u8bd5\u9a8c\u4e2d\uff0c47\u540d\u5148\u524d\u63a5\u53d7\u8fc7\u4fc3\u8840\u5c0f\u677f\u751f\u6210\u7d20\u53d7\u4f53\u6fc0\u52a8\u5242\uff08TPO-RA\uff09\u6cbb\u7597\u7684\u60a3\u8005\uff0c\u67098\u540d\uff0817%\uff09\u5bf9\u672c\u54c1\u6709\u7a33\u5b9a\u7684\u5e94\u7b54 [14]\u3002\u56e0\u4e3aFostamatinib\u6f5c\u5728\u6cbb\u7597\u5bf9\u8c61\u4e0d\u591a\uff0c\u800c\u4e14\u53ea\u670917%\u7684\u4eba\u6709\u7a33\u5b9a\u7684\u5e94\u7b54\uff0c\u56e0\u6b64\u672c\u54c1\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u7684\u6f5c\u529b\u4e0d\u5927\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u4e3a4.23\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Fostamatinib disodium<\/span><\/p>\n

9. Akynzeo\uff08Fosnetupitant\uff1bPalonosetron\uff09<\/span><\/strong><\/span><\/p>\n

4\u670819\u65e5\uff0cFDA\u6279\u51c6\u4e86Helsinn\u516c\u53f8\u7684Akynzeo\uff0c\u8054\u5408\u5730\u585e\u7c73\u677e\u7528\u4e8e\u9ad8\u81f4\u5410\u6027\u5316\u7597\u836f\u5f15\u8d77\u7684\u6025\u6027\u548c\u8fdf\u53d1\u6027\u6076\u5fc3\u5455\u5410\u9884\u9632\u3002\u672c\u54c1\u662f\u4e00\u79cd\u6ce8\u5c04\u5242\uff0c\u7531\u4e94\u7f9f\u8272\u80fa-3\uff085-HT3\uff09\u53d7\u4f53\u62ee\u6297\u5242\u5e15\u6d1b\u8bfa\u53f8\u743c\u548c\u795e\u7ecf\u6fc0\u80bd1 \uff08NK1\uff09\u53d7\u4f53\u6291\u5236\u5242fosnetupitant\u7ec4\u6210\u3002Fosnetupitant\u53ef\u4ee5\u89c6\u4e3a\u5948\u59a5\u5339\u5766\u7684\u524d\u836f\uff0c\u901a\u8fc7\u4f53\u5185\u6c34\u89e3\u540e\u4f1a\u8f6c\u5316\u4e3a\u5948\u59a5\u5339\u5766\uff0c\u4f46\u968f\u7740\u78f7\u9178\u57fa\u56e2\u7684\u5f15\u5165\uff0c\u6c34\u6eb6\u6027\u5927\u5e45\u589e\u5f3a\uff0c\u4e3a\u5236\u5907\u6ce8\u5c04\u5242\u63d0\u4f9b\u4e86\u5fc5\u8981\u7684\u6761\u4ef6\u3002\u56e0\u4e3a\u5948\u59a5\u5339\u5766\u548c\u5e15\u6d1b\u8bfa\u53f8\u743c\u7ec4\u5408\u7597\u6cd5\u5df2\u7ecf\u65e9\u57282014\u5e74\u5c31\u83b7\u5f97FDA\u6279\u51c6\uff0c\u591a\u9879\u4e34\u5e8a\u8bd5\u9a8c\u5df2\u7ecf\u8bc1\u660e\u4e86\u5948\u59a5\u5339\u5766\u548c\u5e15\u6d1b\u8bfa\u53f8\u743c\u7ec4\u5408\u7597\u6cd5\u7684\u6709\u6548\u6027\uff0c\u6240\u4ee5FDA\u5e76\u6ca1\u6709\u8981\u6c42Helsinn\u5f00\u5c55\u66f4\u591a\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6765\u8bc1\u660efosnetupitant\u7684\u6709\u6548\u6027[15]\u3002\u5bf9\u4e8e\u5316\u7597\u5f15\u8d77\u7684\u5267\u70c8\u6076\u5fc3\u5455\u5410\uff0c\u6ce8\u5c04\u6216\u8bb8\u662f\u6bd4\u53e3\u670d\u66f4\u597d\u7684\u9009\u62e9\uff0c\u867d\u7136FDA\u6b64\u524d\u5df2\u7ecf\u6279\u51c6\u4e86Heron\u516c\u53f8\u7684\u963f\u745e\u5339\u5766\u9759\u8109\u6ce8\u5c04\u4e73\u5242\uff0c\u4f46\u914d\u65b9\u4e2d\u542b\u6709\u5927\u91cf\u8102\u8d28\uff0c\u53d7\u4f17\u9762\u5c06\u8fdc\u4e0d\u53caAkynzeo\u6ce8\u5c04\u6db2\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Fosnetupitant<\/span><\/p>\n

10.  Lucemyra\uff08Lofexidine\uff09<\/span><\/strong><\/span><\/p>\n

5\u670816\u65e5\uff0cFDA\u6279\u51c6\u4e86US Worldmeds\u516c\u53f8\u7684Lucemyra\uff0c\u7528\u4e8e\u51cf\u8f7b\u6216\u89e3\u9664\u963f\u7247\u7c7b\u836f\u7269\u7684\u6212\u65ad\u7efc\u5408\u75c7\u3002Lofexidine\u662f\u4e00\u79cd\u80be\u4e0a\u817a\u7d20\u03b12\u53d7\u4f53\u6fc0\u52a8\u5242\uff0c\u662f\u9996\u4e2a\u88abFDA\u6279\u51c6\u7528\u4e8e\u963f\u7247\u6212\u65ad\u7efc\u5408\u5f81\u6cbb\u7597\u7684\u975e\u963f\u7247\u7c7b\u836f\u7269[16]\u3002Lofexidine\uff08\u6d1b\u975e\u897f\u5b9a\uff09\u662f\u8fd1\u5e74\u6765\u8001\u836f\u65b0\u6279\u7684\u5178\u578b\u6848\u4f8b\uff0c\u6d1b\u975e\u897f\u5b9a\u4e8e1990\u5e74\u5c31\u5df2\u7ecf\u5728\u82f1\u56fd\u4e0a\u5e02[17]\uff0c\u4f46\u7f8e\u56fd\u4e00\u76f4\u6ca1\u6709\u6279\u51c6\u672c\u54c1\u3002\u8fd1\u5e74\u6765\uff0c\u7f8e\u56fd\u7684\u963f\u7247\u836f\u7269\u5371\u673a\u6108\u6f14\u6108\u70c8\uff0c\u963f\u7247\u836f\u7269\u6212\u65ad\u6cbb\u7597\u5df2\u7ecf\u6e10\u6e10\u5730\u6f14\u53d8\u6210\u4e00\u4e2a\u5de8\u5927\u7684\u5e02\u573a\uff0cUS Worldmeds\u7ecf\u8fc7\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u8bc1\u660e\u4e86\u672c\u54c1\u7684\u6709\u6548\u6027\uff0c\u4e3a\u7f8e\u56fd\u963f\u7247\u836f\u7269\u6212\u65ad\u6cbb\u7597\u5e26\u6765\u5168\u65b0\u7684\u6cbb\u7597\u9009\u62e9\u3002\u5c3d\u7ba1\u5982\u6b64\uff0c\u8be5\u6cbb\u7597\u9886\u57df\u5c1a\u672a\u51fa\u73b0\u91cd\u78c5\u70b8\u5f39\u7ea7\u836f\u7269\uff0c\u56e0\u6b64\u672c\u54c1\u5728\u7f8e\u56fd\u4e0a\u5e02\u540e\u4e94\u5e74\u5185\u9500\u552e\u989d\u7a81\u783410\u4ebf\u7f8e\u5143\u7684\u53ef\u80fd\u6027\u4e5f\u4e0d\u5927\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Lofexidine<\/span><\/p>\n

11.  Aimovig\uff08Erenumab\uff09<\/span><\/strong><\/span><\/p>\n

5\u670817\u65e5\uff0cFDA\u6279\u51c6\u4e86\u5b89\u8fdb\u548c\u8bfa\u534e\u8054\u5408\u5f00\u53d1\u7684Aimovig\uff0c\u7528\u4e8e\u504f\u5934\u75db\u6cbb\u7597\u3002Erenumab\u662f\u7b2c\u4e00\u4e2a\u83b7\u6279\u4e0a\u5e02\u7684\u964d\u9499\u7d20\u57fa\u56e0\u76f8\u5173\u80bd\uff08CGRP\uff09\u53d7\u4f53\u6291\u5236\u5242\uff0cFDA\u6279\u51c6\u8be5\u4ea7\u54c1\u4e0a\u5e02\u662f\u57fa\u4e8e\u4e09\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ed3\u679c\u3002\u5728\u7b2c\u4e00\u9879\u8bd5\u9a8c\uff08NCT 02456740\uff09\u4e2d\uff0c955\u540d\u9635\u53d1\u6027\u504f\u5934\u75db\u60a3\u8005\u5206\u522b\u63a5\u53d7\u672c\u54c170mg\u6bcf\u6708\u4e00\u6b21\u3001140mg\u6bcf\u6708\u4e00\u6b21\u6216\u5b89\u6170\u5242\u6cbb\u7597\uff0c6\u4e2a\u6708\u540e\uff0c70mg\u6bcf\u6708\u4e00\u6b21\u6cbb\u7597\u7ec4\u60a3\u8005\u6bcf\u6708\u504f\u5934\u75db\u5e73\u5747\u53d1\u4f5c\u5929\u6570\u76f8\u6bd4\u57fa\u7ebf\u4e0b\u964d3.2\u5929\uff0c140mg\u6bcf\u6708\u4e00\u6b21\u7ec4\u4e0b\u964d3.7\u5929\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4e0b\u964d1.8\u5929[18]\u3002\u8bd5\u9a8c\u4e8c\uff08NCT 02483585\uff09\u662f\u4e00\u9879\u6709577\u540d\u9635\u53d1\u6027\u504f\u5934\u75db\u60a3\u8005\u53c2\u4e0e\u7684\u53cc\u81c2\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7ecf\u8fc7\u4e09\u4e2a\u6708\u7684\u6cbb\u7597\uff0c70mg\u6bcf\u6708\u4e00\u6b21\u7ec4\u60a3\u8005\u6bcf\u6708\u504f\u5934\u75db\u53d1\u4f5c\u5929\u6570\u76f8\u6bd4\u57fa\u7ebf\u4e0b\u964d2.9\u5929\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a1.8\u5929\u3002\u8bd5\u9a8c\u4e09\uff08NCT 02066415\uff09\u662f\u4e00\u9879\u5171\u6709667\u540d\u6162\u6027\u504f\u5934\u75db\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7ecf\u8fc7\u4e09\u4e2a\u6708\u6cbb\u7597\uff0c70mg\u6bcf\u6708\u4e00\u6b21\u7ec4\u60a3\u8005\u6bcf\u6708\u504f\u5934\u75db\u53d1\u4f5c\u5929\u6570\u76f8\u6bd4\u57fa\u7ebf\u4e0b\u964d6.6\u5929\uff0c140mg\u6bcf\u6708\u4e00\u6b21\u7ec4\u4e0b\u964d6.6\u5929\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4e0b\u964d4.2\u5929[19]\u3002\u504f\u5934\u75db\u662f\u4e00\u79cd\u5e38\u89c1\u7684\u6162\u6027\u5934\u75db\uff0c\u5168\u7403\u7ea6\u670915%\u7684\u4eba\u9996\u8fd9\u79cd\u75be\u75c5\u6298\u78e8\uff0c\u672a\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\u5de8\u5927[20]\u3002\u867d\u7136\u5904\u5728\u4e34\u5e8a\u672b\u671f\u7684CGRP\u6291\u5236\u5242\u8f83\u591a\uff0c\u4f46\u4e0e\u672c\u54c1\u76f8\u6bd4\uff0c\u4e34\u5e8a\u7597\u6548\u5e76\u6ca1\u6709\u8d28\u7684\u63d0\u5347\uff0c\u76f8\u53cd\uff0cAimovig\u56e0\u9996\u53d1\u7684\u4f18\u52bf\u800c\u6709\u671b\u8fbe\u5230\u91cd\u78c5\u70b8\u5f39\u7ea7\u522b\uff0c\u79d1\u777f\u552f\u5b89\u5bf9\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u9884\u6d4b\u503c\u4e3a12.45\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

12.Lokelma\uff08Sodium Zirconium Cyclosilicate\uff09<\/span><\/strong><\/span><\/p>\n

5\u670818\u65e5\uff0cFDA\u6279\u51c6\u4e86\u963f\u65af\u5229\u5eb7\u7684Lokelma\uff0c\u7528\u4e8e\u9ad8\u94be\u8840\u75c7\u6cbb\u7597\u3002Sodium Zirconium Cyclosilicate\uff08\u73af\u7845\u9178\u9506\u94a0\uff09\u662f\u4e00\u79cd\u4e0d\u5438\u6536\u7684\u7845\u9178\u9506\uff0c\u5bf9\u94be\u79bb\u5b50\u6709\u975e\u5e38\u9ad8\u7684\u4eb2\u548c\u529b\uff0c\u53ef\u4f18\u5148\u6355\u83b7\u94be\u4ee5\u4ea4\u6362\u94a0\u6216\u6c22\u3002\u672c\u54c1\u901a\u8fc7\u589e\u52a0\u94be\u7684\u7caa\u4fbf\u6392\u51fa\uff0c\u4ee5\u8d77\u5230\u964d\u4f4e\u8840\u94be\u7684\u4f5c\u7528[21]\u3002\u672c\u54c1\u7684\u5b89\u5168\u6709\u6548\u6027\u5728\u4e09\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5f97\u5230\u4e86\u786e\u8ba4\uff0c\u9664\u4e86\u94be\u8840\u75c7\uff0c\u672c\u54c1\u5f00\u53d1\u7684\u9002\u5e94\u75c7\u8fd8\u6709\u9ad8\u6c28\u8840\u75c7\uff0c\u76ee\u524d\u5df2\u7ecf\u5904\u5728\u6ce8\u518c\u9636\u6bb5\u3002\u5728\u4f17\u591a\u9ad8\u94be\u8840\u75c7\u7528\u836f\u4e2d\uff0c\u672c\u54c1\u7684\u7597\u6548\u8f83\u4e3a\u51fa\u8272\uff0c\u662f\u9500\u552e\u989d\u5cf0\u503c\u6709\u671b\u8fbe\u523010\u4ebf\u7f8e\u5143\u7684\u6f5c\u529b\u80a1\u4e4b\u4e00\u3002<\/span><\/p>\n

13.  Doptelet\uff08Avatrombopag\uff09<\/span><\/strong><\/span><\/p>\n

5\u670821\u65e5\uff0cFDA\u6279\u51c6Akarx\u516c\u53f8\u7684\u4fc3\u8840\u5c0f\u677f\u751f\u6210\u7d20\u53d7\u4f53\u6fc0\u52a8\u5242Avatrombopag\uff0c\u7528\u4e8e\u6162\u6027\u809d\u75c5\u5bfc\u81f4\u7684\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u6cbb\u7597\u3002\u672c\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5728ADAPT-1\u548cADAPT-2\u4e24\u9879\u8bd5\u9a8c\u4e2d\u8fdb\u884c\u4e86\u7814\u7a76\uff0c\u6d89\u53ca435\u540d\u60a3\u6709\u6162\u6027\u809d\u75c5\u548c\u4e25\u91cd\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u7684\u60a3\u8005\u3002\u8bd5\u9a8c\u4e2d\uff0c\u53d7\u8bd5\u8005\u5206\u522b\u63a5\u53d740mg\u548c60mg\u4e24\u79cd\u5242\u91cf\u7684Avatrombopag\u6216\u5b89\u6170\u5242\u6cbb\u7597\uff0c5\u5929\u540e\uff0c\u60a3\u8005\u7684\u8840\u5c0f\u677f\u8ba1\u6570\u76f8\u6bd4\u57fa\u7ebf\u663e\u8457\u589e\u52a0\uff0c\u800c\u4e14\u4e0e\u5b89\u6170\u5242\u5b58\u5728\u663e\u8457\u6027\u5dee\u5f02[22]<\/span>\u3002\u5c3d\u7ba1\u672c\u54c1\u83b7\u5f97\u4e86FDA\u5b64\u513f\u836f\u548c\u4f18\u5148\u5ba1\u8bc4\u4e24\u9879\u7279\u6b8a\u901a\u9053\u7684\u8d44\u683c\uff0c\u4f46\u6f5c\u5728\u53d7\u4f17\u5e76\u4e0d\u5927\uff0c\u800c\u4e14\u540c\u9776\u70b9\u7684\u836f\u7269\u8fd8\u6709\u8bfa\u534e\u7684Eltrombopag\u548c\u76d0\u91ce\u4e49\u7684Lusutrombopag\uff0c\u56e0\u6b64\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u7684\u6f5c\u529b\u4e0d\u5927\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u4e3a3.88\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n


<\/p>\n

14.  Palynziq\uff08Pegvaliase\uff09<\/span><\/strong><\/span><\/p>\n

5\u670824\u65e5\uff0cFDA\u6279\u51c6\u4e86Biomarin\u516c\u53f8\u7684Palynziq\uff0c\u7528\u4e8e\u8840\u6db2\u4e2d\u82ef\u4e19\u6c28\u9178\u6d53\u5ea6\u5927\u4e8e600\u03bcmol\/L\u7684\u82ef\u4e19\u916e\u5c3f\u75c7\u6cbb\u7597\u3002Pegvaliase\u662f\u4e00\u79cd\u91cd\u7ec4\u82ef\u4e19\u6c28\u9178\u6c28\u88c2\u89e3\u9176\u7684\u805a\u4e59\u4e8c\u9187\u4fee\u9970\u7269\uff0c\u53ef\u5c06\u82ef\u4e19\u6c28\u9178\u8f6c\u5316\u4e3a\u6c28\u548c\u53cd\u5f0f\u8089\u6842\u9178\uff0c\u56e0\u6b64\u53ef\u4f5c\u4e3a\u82ef\u4e19\u6c28\u9178\u7f9f\u5316\u9176\u7684\u66ff\u4ee3\u7597\u6cd5\u3002\u7ecf\u8fc7\u805a\u4e59\u4e8c\u9187\u4fee\u9970\u4ee5\u540e\uff0c\u534a\u8870\u671f\u5ef6\u957f\uff0c\u4f7f\u7528\u66f4\u52a0\u65b9\u4fbf[23]\u3002\u82ef\u4e19\u916e\u5c3f\u75c7\u662f\u4e00\u79cd\u6c28\u57fa\u9178\u4ee3\u8c22\u5f02\u5e38\u7684\u5e38\u67d3\u8272\u4f53\u9057\u4f20\u75be\u75c5\uff0c98%-99%\u7684\u60a3\u8005\u662f\u7531\u82ef\u4e19\u6c28\u9178\u7f9f\u5316\u9176\u7f3a\u4e4f\u6240\u81f4[24]\uff0c\u5728\u7f8e\u56fd\u7684\u60a3\u75c5\u7387\u4e3a1\/15000\u81f31\/10000[25]\uff0c\u7ea6\u6709\u4e09\u4e07\u540d\u60a3\u8005\uff0c\u662f\u60a3\u8005\u57fa\u6570\u975e\u5e38\u7406\u60f3\u7684\u7f55\u89c1\u75c5\u3002\u5c3d\u7ba1\u6709\u5927\u91cf\u60a3\u8005\u5df2\u7ecf\u4f7f\u7528Kuvan\uff08\u76d0\u9178\u6c99\u4e19\u8776\u5464\uff09\u6cbb\u7597\uff0c\u4f46\u672c\u54c1\u7684\u5e74\u6cbb\u7597\u6210\u672c\u9ad8\u8fbe20\u4e07\u7f8e\u5143\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u51762024\u5e74\u7684\u9500\u552e\u989d\u6709\u671b\u8fbe\u52305.92\u4ebf\u7f8e\u5143\uff0c\u6210\u4e3a\u5b64\u513f\u836f\u4e2d\u7684\u91cd\u78c5\u4ea7\u54c1\u3002<\/span><\/p>\n

15.  Olumiant\uff08Baricitinib\uff09<\/span><\/strong><\/span><\/p>\n

5\u670831\u65e5\uff0cFDA\u6279\u51c6\u4e86\u793c\u6765\u7684JAK1\/2\u6291\u5236\u5242Baricitinib\uff0c\u7528\u4e8e\u80bf\u7624\u574f\u6b7b\u56e0\u5b50\uff08TNF\uff09\u6291\u5236\u5242\u54cd\u5e94\u4e0d\u8db3\u7684\u4e2d\u91cd\u5ea6\u7c7b\u98ce\u6e7f\u6027\u5173\u8282\u708e\u6cbb\u7597\u3002\u56e0\u4e3a\u4e4b\u524d\u88abFDA\u62d2\u7edd\u8fc7\u4e00\u6b21[26]\uff0c\u56e0\u6b64\u672c\u54c1\u57282017\u5e74\u7387\u5148\u83b7\u5f97\u4e86EMA\u7684\u6279\u51c6\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e4\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5176\u4e2d\u4e24\u9879\uff08NCT01185353\u548cNCT01469013 \uff09\u662f\u5242\u91cf\u76f8\u5173\u6027\u8bd5\u9a8c\uff0c\u7ed3\u679c\u663e\u793a\uff0cACR20\u54cd\u5e94\u7387\u968f\u5242\u91cf\u7684\u589e\u52a0\u800c\u63d0\u9ad8\u3002\u53e6\u5916\u4e24\u9879\uff08 NCT01721057 \u548cNCT01721044\uff09\u662f\u4e3a\u671f24\u5468\u7684\u7597\u6548\u786e\u8ba4\u8bd5\u9a8c\uff0c\u5728\u4f20\u7edf\u7f13\u89e3\u75be\u75c5\u7684\u6297\u98ce\u6e7f\u6027\u836f\u7269\uff08cDMARDs\uff09\u7684\u80cc\u666f\u6cbb\u7597\u4e0b\uff0c\u4f7f\u7528\u6bcf\u65e5\u4e00\u6b212mg Baricitinib\u6216\u5b89\u6170\u5242\u6cbb\u7597\uff0c24\u5468\u540e\uff0c\u6cbb\u7597\u7ec4\u7684ACR20\u5206\u522b\u4e3a61%\u548c45%\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a42%\u548c27%\uff1bACR50\u5206\u522b\u4e3a41%\u548c23%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u5206\u522b\u4e3a21%\u548c13%\uff1bACR70\u5206\u522b\u4e3a25%\u548c13%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u5206\u522b\u4e3a8%\u548c3%[27]\u3002\u56e0\u4e3aFDA\u6ca1\u6709\u6279\u51c64mg\u89c4\u683c\u4e0a\u5e02\uff0c\u672c\u54c1\u7684\u7597\u6548\u5927\u6253\u6298\u6263\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u4e3a12.02\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Baricitinib<\/span><\/p>\n

16.  Moxidectin\uff08Moxidectin\uff09<\/span><\/strong><\/span><\/p>\n

6\u670813\u65e5\uff0cFDA\u6279\u51c6Medicines Development for Global Health \u7684Moxidectin\uff08\u83ab\u897f\u83cc\u7d20\uff09\uff0c\u7528\u4e8e\u76d8\u5c3e\u4e1d\u866b\u75c5\u6cbb\u7597\u3002\u83ab\u897f\u83cc\u7d20\u662f\u4e00\u79cd\u5927\u73af\u5185\u916f\u7c7b\u9a71\u866b\u6297\u751f\u7d20\uff0c\u65e9\u572860\u5e74\u4ee3\u5c31\u5df2\u7ecf\u95ee\u4e16\uff0c\u4f46\u7f8e\u56fd\u4e00\u76f4\u672a\u6279\u51c6\u672c\u54c1\u4eba\u7528\uff0c\u56e0\u6b64\u83ab\u897f\u83cc\u7d20\u4e5f\u662f\u5178\u578b\u7684\u8001\u836f\u65b0\u6279\u7684\u54c1\u79cd\u3002\u76d8\u5c3e\u4e1d\u866b\u5bc4\u751f\u4e8e\u773c\u90e8\u6216\u76ae\u4e0b\u7ec4\u7ec7\uff0c\u4e3b\u8981\u4e34\u5e8a\u7279\u5f81\u4e3a\u773c\u90e8\u635f\u5bb3\uff0c\u53ef\u81f4\u5931\u660e\uff0c\u6545\u53c8\u79f0\u6cb3\u76f2\u75c7\u3002\u5728\u4e00\u9879\u67091472\u540d\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08NCT 00790998\uff09\u4e2d\uff0c977\u540d\u60a3\u8005\u670d\u7528\u83ab\u897f\u83cc\u7d20\uff0c475\u540d\u60a3\u8005\u670d\u7528\u4f0a\u7ef4\u83cc\u7d20\uff0c\u7ecf\u8fc71\u4e2a\u6708\u7684\u6cbb\u7597\uff0c\u83ab\u897f\u83cc\u7d20\u6cbb\u7597\u7ec4\u5fae\u4e1d\u86b4\u5e73\u5747\u5bc6\u5ea6\u4e3a0.1\uff0c\u800c\u4f0a\u7ef4\u83cc\u7d20\u6cbb\u7597\u7ec4\u4e3a2.3[28]\u300212\u4e2a\u6708\u540e\uff0c\u83ab\u897f\u83cc\u7d20\u6cbb\u7597\u7ec4\u5fae\u4e1d\u86b4\u5e73\u5747\u5bc6\u5ea6\u4e3a1.79\uff0c\u800c\u4f0a\u7ef4\u83cc\u7d20\u6cbb\u7597\u7ec4\u4e3a9.83\u3002\u6cb3\u76f2\u75c7\u5728\u53d1\u8fbe\u56fd\u5bb6\u5df2\u7ecf\u5f88\u5c11\u89c1\uff0c\u4f46\u5728\u975e\u6d32\u5374\u975e\u5e38\u5e38\u89c1\uff0c\u672c\u54c1\u7684\u83b7\u6279\u65e0\u7591\u662f\u975e\u6d32\u4eba\u6c11\u7684\u798f\u97f3\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Moxidectin<\/span><\/p>\n

17.  Zemdri\uff08Plazomicin\uff09<\/span><\/strong><\/span><\/p>\n

6\u670825\u65e5\uff0cFDA\u6279\u51c6Achaogen\u516c\u53f8\u7684\u65b0\u4e00\u4ee3\u6c28\u57fa\u7cd6\u82f7\u7c7b\u6297\u751f\u7d20Plazomicin\uff0c\u7528\u4e8e\u5c3f\u8def\u611f\u67d3\u6cbb\u7597\u3002\u5728\u4e00\u9879\u6709609\u540d\u6210\u4eba\u60a3\u8005\u53c2\u4e0e\u7684\u975e\u52a3\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff08NCT02486627\uff09\u4e2d\uff0c\u672c\u54c1\u6cbb\u7597\u7ec4\u76845\u5929\u590d\u5408\u6cbb\u6108\uff08\u4e34\u5e8a\u610f\u4e49\u4e0a\u7684\u6cbb\u6108\u6216\u6539\u5584\u3001\u5fae\u751f\u7269\u6839\u9664\uff09\u7387\u4e3a88%\uff0c\u800c\u7f8e\u7f57\u57f9\u5357\u6cbb\u7597\u7ec4\u4e3a91.4%\uff0c\u8fbe\u5230\u7edf\u8ba1\u5b66\u610f\u4e49\u4e0a\u7684\u975e\u52a3\u6548\uff0c\u6cbb\u6108\u68c0\u9a8c\u8bbf\u89c6\uff08test-of-cure visit\uff0cTOC<\/span>\uff09\u590d\u5408\u6cbb\u6108\uff08\u4e34\u5e8a\u610f\u4e49\u4e0a\u7684\u6cbb\u6108\u3001\u5fae\u751f\u7269\u6839\u9664\uff09\u7387<\/span>\u5206\u522b\u4e3a81.7%\u548c70.1%\uff0c\u8fbe\u5230\u7edf\u8ba1\u5b66\u610f\u4e49\u4e0a\u7684\u4f18\u6548[29]\u3002\u81ea80\u5e74\u4ee3\u4ee5\u6765\uff0c\u4eba\u7c7b\u7684\u611f\u67d3\u75be\u75c5\u5f97\u5230\u975e\u5e38\u597d\u7684\u63a7\u5236\uff0c\u867d\u7136\u6709\u90e8\u5206\u65b0\u578b\u6297\u751f\u7d20\u88ab\u7814\u53d1\u51fa\u6765\uff0c\u4f46\u5f80\u5f80\u88ab\u9650\u5236\u4f7f\u7528\uff0c\u56e0\u6b64\u5728\u8fc7\u53bb\u4e09\u5341\u5e74\u91cc\uff0c\u5236\u836f\u5de8\u5934\u5bf9\u6297\u751f\u7d20\u7684\u7814\u53d1\u5e76\u4e0d\u611f\u5174\u8da3\u3002\u968f\u7740\u8fd1\u5e74\u6765\u8d85\u7ea7\u83cc\u7684\u51fa\u73b0\uff0c\u65b0\u578b\u6297\u751f\u7d20\u7684\u7814\u53d1\u518d\u6b21\u6210\u4e3a\u4e86\u521b\u65b0\u836f\u7684\u70ed\u95e8\uff0c\u56e0\u4e3a\u672c\u54c1\u5bf9\u591a\u91cd\u8010\u836f\u6027\u7684\u683c\u5170\u9634\u6027\u83cc\u6709\u6548\uff0c\u57282017\u5e745\u6708\u83b7\u5f97\u4e86FDA\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u4e3a0.78\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Plazomicin<\/span><\/p>\n

18.  Epidiolex\uff08Cannabidiol\uff09<\/span><\/strong><\/span><\/p>\n

\u5728Plazomicin\u83b7\u6279\u7684\u540c\u4e00\u5929\uff0cFDA\u8fd8\u6279\u51c6\u4e86GW\u516c\u53f8\u7684Cannabidiol\uff08\u5927\u9ebb\u4e8c\u915a\uff09\uff0c\u7528\u4e8eLennox-Gastaut\u7efc\u5408\u5f81\u548cDravet\u7efc\u5408\u5f81\u6cbb\u7597\u3002\u5927\u9ebb\u4e8c\u915a\u662f\u4ece\u5927\u9ebb\u4e2d\u63d0\u53d6\u5206\u79bb\u51fa\u7684\u5355\u4f53\uff0c\u662fFDA\u6279\u51c6\u7684\u7b2c\u4e00\u4e2a\u5927\u9ebb\u7c7b\u836f\u7269[30]\u3002\u4e00\u9879\u6709225\u540dLennox-Gastaut\u7efc\u5408\u5f81\u60a3\u8005\u53c2\u4e0e\u7684\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\uff08NCT02224560\uff09\u6570\u636e\u663e\u793a\uff0c\u5927\u9ebb\u4e8c\u915a\u6cbb\u7597\u7ec4\u60a3\u8005\u7684\u766b\u75eb\u53d1\u4f5c\u9891\u7387\u76f8\u6bd4\u5b89\u6170\u5242\u7ec4\u5927\u5e45\u4e0b\u964d\uff0c\u5176\u4e2d\u5b89\u6170\u5242\u7ec4\u4e0b\u964d17.2%\uff0c10mg\/kg\u6cbb\u7597\u7ec4\u4e0b\u964d37.2%\uff0c20mg\/kg\u6cbb\u7597\u7ec4\u4e0b\u964d41.9%[31]\u3002\u53e6\u4e00\u9879\u56fd\u9645\u591a\u4e2d\u5fc3\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08NCT02224690\uff09\u4e5f\u5f97\u5230\u4e86\u76f8\u4f3c\u7684\u7ed3\u679c\uff0c86\u4f8bLennox-Gastaut\u7efc\u5408\u5f81\u60a3\u8005\u4f7f\u752820mg\/kg\u7684\u5927\u9ebb\u4e8c\u915a\u6cbb\u7597\uff0c\u766b\u75eb\u53d1\u4f5c\u9891\u7387\u76f8\u6bd4\u5b89\u6170\u5242\u4e0b\u964d43.9%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4e3a17.2%[32]\u3002Dravet\u7efc\u5408\u5f81\u65b9\u9762\uff0c61\u4f8b\u4f7f\u7528\u5927\u9ebb\u4e8c\u915a\u6cbb\u7597\u7684Dravet\u7efc\u5408\u5f81\u60a3\u8005\uff0c\u6bcf\u6708\u766b\u75eb\u53d1\u4f5c\u6b21\u6570\u4ece12.4\u6b21\u4e0b\u964d\u52305.9\u6b21\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4ece14.9\u6b21\u4e0b\u964d\u523014.1\u6b21[33]\u3002Lennox-Gastaut\u7efc\u5408\u5f81\u548cDravet\u7efc\u5408\u5f81\u90fd\u662f\u7f55\u89c1\u7684\u766b\u75eb\u7efc\u5408\u5f81\uff0c\u6cbb\u7597\u65b9\u6848\u7f3a\u4e4f\uff0c\u672c\u54c1\u7597\u6548\u51fa\u8272\uff0c\u800c\u4e14\u662f\u957f\u671f\u7528\u836f\uff0c\u5982\u679c\u5b9a\u4ef7\u5408\u7406\uff0c\u672c\u54c1\u6709\u6f5c\u529b\u6210\u4e3a\u4e00\u4e2a\u91cd\u78c5\u70b8\u5f39\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c12022\u5e74\u7684\u9500\u552e\u989d\u53ef\u8fbe11.91\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Cannabidiol<\/span><\/p>\n

19.  Braftovi\uff08Encorafenib\uff09<\/span><\/strong><\/span><\/p>\n

6\u670827\u65e5\uff0cFDA\u6279\u51c6Array\u516c\u53f8\u7684encorafenib\uff0c\u4e0ebinimetinib\u8054\u5408\u6cbb\u7597 BRAFV600E\u6216V600K\u9633\u6027\u7684\u8f6c\u79fb\u6027\u9ed1\u8272\u7d20\u7624\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e00\u9879\u6d3b\u6027\u5bf9\u7167\u7684\u4e09\u81c2\u4e34\u5e8a\u8bd5\u9a8c\uff08NCT01909453\uff09\uff0c\u5171\u8ba1\u6709577\u540dBRAF V600E\u6216V600K\u9633\u6027\u7684\u8f6c\u79fb\u6027\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u53c2\u4e0e\u4e86\u7814\u7a76\u3002\u60a3\u8005\u88ab1:1:1\u5206\u6210\u4e09\u7ec4\uff0c\u5206\u522b\u63a5\u53d7encorafenib\u4e0ebinimetinib\u8054\u5408\u6cbb\u7597\u3001encorafenib\u5355\u836f\u6cbb\u7597\u6216vemurafenib\u5355\u836f\u6cbb\u7597\u3002\u7ed3\u679c\u663e\u793a\uff0cencorafenib\u4e0ebinimetinib\u8054\u5408\u6cbb\u7597\u7ec4\u60a3\u8005\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u8fbe14.9\u4e2a\u6708\uff0c\u800cvemurafenib\u5355\u836f\u6cbb\u7597\u7ec4\u4ec5\u4e3a7.3\u4e2a\u6708[34]\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n


<\/p>\n

20.  Mektovi\uff08Binimetinib\uff09<\/span><\/strong><\/span><\/p>\n

\u5728FDA\u6279\u51c6Array\u516c\u53f8\u7684Braftovi\u540c\u65f6\uff0c\u8fd8\u6279\u51c6\u4e86\u8be5\u516c\u53f8\u7684Mektovi\uff0c\u4e0eencorafenib\u8054\u5408\u6cbb\u7597 BRAF V600E\u6216V601K\u9633\u6027\u4e14\u65e0\u6cd5\u624b\u672f\u7684\u9ed1\u8272\u7d20\u7624\u3002Binimetinib\u662f\u4e00\u79cd\u6709\u4e1d\u5206\u88c2\u539f\u7ec6\u80de\u5916\u4fe1\u53f7\u8c03\u8282\u6fc0\u9176\uff08MEK\uff09\u6291\u5236\u5242\uff0c\u800cencorafenib\u662f\u4e00\u79cd\u4ee5BRAF V600E\u57fa\u56e0\u4e3a\u9776\u70b9\u7684\u6fc0\u9176\u6291\u5236\u5242\uff0cFDA\u6279\u51c6Binimetinib\u4e0a\u5e02\uff0c\u662f\u57fa\u4e8e\u4e8c\u8005\u7684\u4e00\u9879\u8054\u5408\u7528\u836f\u8bd5\u9a8c\uff08NCT01909453\uff09\u3002\u5728\u8fd9\u79cd\u7597\u6cd5\u4e4b\u524d\uff0cFDA\u5df2\u7ecf\u6279\u51c6\u8bfa\u534e\uff08GSK\uff09\u7684trametinib + dabrafenib\u548c\u7f57\u6c0f\u7684cobimetinib + vemurafenib\u7528\u4e8eBRAF V600E\u6216V600K\u9633\u6027\u7684\u8f6c\u79fb\u6027\u9ed1\u8272\u7d20\u7624\u6cbb\u7597\uff0c\u4ec5\u4ece\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u6570\u636e\u5bf9\u6bd4\u800c\u8a00\uff0cArray\u516c\u53f8\u7684Braftovi+Mektovi\u7565\u663e\u4f18\u52bf\uff0c\u4f46PFS\u7684\u5ef6\u957f\u5e76\u4e0d\u4e00\u5b9a\u662fOS\u7684\u5ef6\u957f<\/span><\/span>\u3002\u9274\u4e8eGSK\u548c\u7f57\u6c0f\u7684\u7ec4\u5408\u7597\u6cd5\u90fd\u672a\u8fbe\u5230\u91cd\u78c5\u70b8\u5f39\u7ea7\u522b\uff0cArray<\/span>\u5728\u6ca1\u6709\u538b\u5012\u6027\u4f18\u52bf\u7684\u524d\u63d0\u4e0b\uff0c\u5176\u7ec4\u5408\u7597\u6cd5\u8981\u60f3\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\uff0c\u4f9d\u7136\u96be\u5ea6\u91cd\u91cd\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282023\u5e74\u7684\u9500\u552e\u989d\u4e3a5.55\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

 \u4e09\u79cd\u7597\u6cd5\u5bf9BRAF V600E\u6216V600K\u9633\u6027\u7684\u8f6c\u79fb\u6027\u9ed1\u8272\u7d20\u7624\u7684\u7597\u6548\u5bf9\u6bd4<\/span><\/span><\/strong><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

7\u670813\u65e5\uff0cFDA\u6279\u51c6\u4e86Siga\u516c\u53f8\u7684Tecovirimat\uff0c\u7528\u4f5c\u5929\u82b1\u6cbb\u7597\u3002Tecovirimat\u5929\u82b1\u75c5\u6bd2p37\u86cb\u767d\u6291\u5236\u5242\uff0cFDA\u6279\u51c6\u672c\u54c1\u4e0a\u5e02\u4ec5\u57fa\u4e8e\u4e00\u9879\u5b89\u5168\u6027\u8bd5\u9a8c\u548c\u52a8\u7269\u8bd5\u9a8c\u7684\u7ed3\u679c\u3002\u56e0\u4e3a\u5929\u82b1\u75c5\u51e0\u4e4e\u5df2\u7ecf\u7edd\u8ff9\uff0c\u4e3a\u8bd5\u836f\u800c\u5728\u4eba\u8eab\u4e0a\u63a5\u79cd\u5929\u82b1\u75c5\u6bd2\u4e0d\u7b26\u5408\u4f26\u7406\uff0c\u56e0\u6b64Tecovirimat\u5e76\u6ca1\u6709\u5f00\u5c55\u6709\u6548\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u800c\u662f\u83b7\u51c6\u7528\u65b0\u897f\u5170\u5154\u66ff\u4ee3\uff0c\u6700\u7ec8\u8bd5\u9a8c\u8bc1\u5b9e\uff0cTecovirimat\u6cbb\u7597\u7ec4\u76f8\u6bd4\u5b89\u6170\u5242\u7ec4\u751f\u5b58\u7387\u663e\u8457\u6027\u63d0\u9ad8[37]\u3002\u8fd9\u662f\u7b2c\u4e00\u79cd\u83b7\u6279\u7528\u4e8e\u5bf9\u6297\u5929\u82b1\u7684\u836f\u7269\uff0c\u5c3d\u7ba1\u4e16\u536b\u7ec4\u7ec7\u66fe\u5bf9\u5916\u5ba3\u5e03\uff0c\u5929\u82b1\u65e9\u572880\u5e74\u4ee3\u5c31\u5df2\u7ecf\u88ab\u6839\u9664\uff0c\u4f46\u957f\u671f\u4ee5\u6765\u4eba\u4eec\u4e00\u76f4\u62c5\u5fc3\u5929\u82b1\u88ab\u505a\u6210\u751f\u5316\u6b66\u5668\u3002FDA\u5728\u516c\u544a\u4e2d\u5df2\u7ecf\u8bf4\u660e\uff0c\u6279\u51c6\u672c\u54c1\u662f\u4e3a\u4e86\u5e94\u5bf9\u751f\u7269\u6050\u6016\u4e3b\u4e49\u7684\u5a01\u80c1[38]\u3002\u56e0\u4e3aTecovirimat\uff0cSiga\u516c\u53f8\u83b7\u5f97\u4e86\u4e00\u5f20\u4f18\u5148\u5ba1\u8bc4\u5238\uff0c11\u67081\u65e5\uff0cSiga\u516c\u53f8\u5bf9\u5916\u5ba3\u5e03\u4ee58000\u4e07\u7f8e\u5143\u7684\u4ef7\u683c\u5411\u793c\u6765\u8f6c\u8ba9\u5176\u4f18\u5148\u5ba1\u8bc4\u5238[39]\uff0c\u56e0\u6b64Siga\u516c\u53f8\u53ef\u80fd\u201c\u9189\u7fc1\u4e4b\u610f\u4e0d\u5728\u9152\u201d\uff0c\u800c\u5728\u4e8e\u4f18\u5148\u5ba1\u8bc4\u5238\uff0c\u8fd9\u79cd\u521b\u65b0\u836f\u5f00\u53d1\u7b56\u7565\u503c\u5f97\u5e7f\u5927\u4e2d\u5c0f\u578b\u4f01\u4e1a\u53bb\u5b66\u4e60\u548c\u6548\u4eff\u3002<\/span><\/p>\n

21.  Tpoxx\uff08Tecovirimat\uff09<\/span><\/strong>
<\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Tecovirimat<\/span><\/p>\n

22.  Krintafel\uff08Tafenoquine\uff09<\/span><\/strong><\/span><\/p>\n

7\u670820\u65e5\uff0cFDA\u6279\u51c6\u4e86GSK\u7684Tafenoquine\uff0c\u7528\u4e8e16\u5c81\u53ca\u4ee5\u4e0a\u60a3\u8005\u7684\u95f4\u65e5\u759f\u6839\u6cbb\uff08\u6216\u590d\u53d1\u9884\u9632\uff09\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6570\u636e\uff0c\u8bd5\u9a8c\u4e00\uff08NCT01376167\uff09\u5171\u6709399\u540d\u60a3\u8005\u5165\u7ec4\uff0c\u5176\u4e2d260\u540d\u60a3\u8005\u63a5\u53d7\u672c\u54c1\u8054\u5408\u6c2f\u55b9\u6cbb\u7597\uff0c139\u540d\u60a3\u8005\u63a5\u53d7\u6c2f\u55b9\u52a0\u5b89\u6170\u5242\u6cbb\u7597\u3002\u7ecf\u8fc76\u4e2a\u6708\u7684\u6cbb\u7597\uff0cTafenoquine\u52a0\u6c2f\u55b9\u6cbb\u7597\u7ec4\u76f8\u6bd4\u5b89\u6170\u5242\u52a0\u6c2f\u55b9\u6cbb\u7597\u7ec4\u7684\u590d\u53d1\u7387\u4e0b\u964d76%\u3002\u53e6\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff08(NCT01376167\uff09\u662f\u4e00\u9879\u5242\u91cf\u76f8\u5173\u6027\u8bd5\u9a8c\uff0c\u8bd5\u9a8c\u7ed3\u679c\u4e0e\u8bd5\u9a8c\u4e00\u7c7b\u4f3c\u3002\u7ecf\u8fc76\u4e2a\u6708\u7684\u6cbb\u7597\uff0cTafenoquine\u52a0\u6c2f\u55b9\u6cbb\u7597\u7ec484%\u7684\u60a3\u8005\u65e0\u590d\u53d1\uff0c\u800c\u5b89\u6170\u5242\u52a0\u6c2f\u55b9\u6cbb\u7597\u7ec4\u4ec5\u4e3a39%[40]\u3002\u759f\u75be\u662f\u4e00\u79cd\u5bc4\u751f\u866b\u611f\u67d3\u75be\u75c5\uff0c\u5728\u53d1\u8fbe\u56fd\u5bb6\u51e0\u4e4e\u5df2\u7ecf\u7edd\u8ff9\uff0c\u56e0\u6b64\u672c\u54c1\u5bf9GSK\u800c\u8a00\uff0c\u53ef\u80fd\u5b66\u672f\u4ef7\u503c\u8fdc\u5927\u4e8e\u7ecf\u6d4e\u4ef7\u503c\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/span><\/p>\n

Tafenoquine<\/span><\/p>\n

23.  Tibsovo\uff08Ivosidenib\uff09<\/span><\/strong><\/span><\/p>\n

\u5728Krintafel \u83b7\u6279\u7684\u540c\u4e00\u5929\uff0cAgios\u516c\u53f8\u4e5f\u8fce\u6765\u4e86\u81ea\u5df1\u7684\u65b0\u836f\u2014\u2014Ivosidenib\u83b7FDA\u6279\u51c6\u7528\u4e8e\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u9176-1(IDH1)\u57fa\u56e0\u7a81\u53d8\u7684\u590d\u53d1\u6216\u96be\u6cbb\u6027\u6025\u6027\u7c92\u7ec6\u80de\u767d\u8840\u75c5\uff08AML\uff09\u6cbb\u7597\u3002Tibsovo\u662f\u4e00\u79cd\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u9176-1\u6291\u5236\u5242\uff0cFDA\u6279\u51c6\u672c\u54c1\u662f\u6839\u636e\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u7684\u5355\u81c2\u4e34\u5e8a\u8bd5\u9a8c\uff08NCT02074839\uff09\u7684\u7ed3\u679c\uff0c174\u540dIDH1\u7a81\u53d8\u7684\u590d\u53d1\u6216\u96be\u6cbb\u6027AML\u60a3\u8005\u53c2\u4e0e\u4e86\u8bd5\u9a8c\uff0c\u4e2d\u4f4d\u968f\u8bbf\u65f6\u95f4\u4e3a8.3\u4e2a\u6708\uff0c32.8%\u7684\u60a3\u8005\u83b7\u5f97\u5b8c\u5168\u7f13\u89e3\uff08\u65e0\u75be\u75c5\u8ff9\u8c61\u4e14\u8840\u7ec6\u80de\u8ba1\u6570\u5b8c\u5168\u6062\u590d\uff09\u6216\u90e8\u5206\u8840\u6db2\u6062\u590d\u7684\u5b8c\u5168\u7f13\u89e3\uff08\u65e0\u75be\u75c5\u8ff9\u8c61\u4e14\u8840\u7ec6\u80de\u8ba1\u6570\u90e8\u5206\u6062\u590d\uff09\uff0c\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u4e3a8.2\u4e2a\u6708\u3002AML\u662f\u4e00\u79cd\u8fdb\u5c55\u5feb\u901f\u7684\u8840\u6db2\u7624\uff0c\u636e\u7f8e\u56fd\u56fd\u5bb6\u764c\u75c7\u7814\u7a76\u6240\u4f30\u8ba1\uff0c2018\u5e74\u5c06\u670919520\u4eba\u88ab\u8bca\u65ad\u4e3aAML\uff0c\u5176\u4e2d10670\u4eba\u5c06\u6b7b\u4e8e\u8be5\u75c5[41]\u3002\u8003\u8651\u5230\u53d7\u4f17\u60a3\u8005\u4eba\u7fa4\u5e76\u4e0d\u591a\uff0c\u800c\u4e14\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027AML\u5df2\u7ecf\u6709\u591a\u4e2a\u7597\u6cd5\u83b7\u6279\u4e0a\u5e02\uff0c\u672c\u54c1\u5355\u9760AML\u9002\u5e94\u75c7\u51e0\u4e4e\u4e0d\u53ef\u80fd\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u4e3a6.21\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Ivosidenib<\/span><\/p>\n

24.  Orilissa\uff08Elagolix sodium\uff09<\/span><\/strong><\/span><\/p>\n

7\u670823\u65e5\uff0cFDA\u6279\u51c6\u827e\u4f2f\u7ef4\u7684\u4fc3\u9ec4\u4f53\u6fc0\u7d20\u91ca\u653e\u6fc0\u7d20\u53d7\u4f53\u6291\u5236\u5242Elagolix\uff0c\u7528\u4e8e\u5b50\u5bab\u5185\u819c\u5f02\u4f4d\u75c7\u6cbb\u7597[42]\u3002Elagolix\u5b89\u5168\u6709\u6548\u6027\u5df2\u7ecf\u5728\u4e24\u9879\u5171\u67091686\u540d\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08EM-I \u548c EM-II\uff09\u4e2d\u8fdb\u884c\u4e86\u8bc4\u4f30\uff0c\u8fd9\u4e24\u9879\u8bd5\u9a8c\u8bbe\u8ba1\u51e0\u4e4e\u76f8\u540c\uff0c\u60a3\u8005\u88ab\u5206\u4e3a\u4e09\u4e2a\u7ec4\uff0c\u5206\u522b\u6bcf\u65e5\u4e00\u6b21\u53e3\u670d\u672c\u54c1150mg\uff0c\u6bcf\u65e5\u4e8c\u6b21\u670d\u7528\u672c\u54c1200mg\u6216\u5b89\u6170\u5242\u3002\u8bd5\u9a8c\u901a\u8fc7\u5b50\u5bab\u5185\u819c\u5f02\u4f4d\u75c7\u6bcf\u65e5\u75bc\u75db\u5f71\u54cd\u91cf\u8868<\/span>\uff08DPIS\uff0cEndometriosis Daily Pain Impact Scale<\/span>\uff09\u6765\u8bc4\u4f30\u836f\u7269\u7684\u75bc\u75db\u53d8\u5316\uff0c\u5728EM-I\u8bd5\u9a8c\u4e2d\uff0c\u7ecf\u671f\u75bc\u75db\u8bc4\u5206\u76f8\u6bd4\u57fa\u7ebf\u4e0b\u964d\u8d85\u8fc70.81\u5206\u6216\u975e\u7ecf\u671f\u76c6\u8154\u75bc\u75db\u8bc4\u5206\u76f8\u6bd4\u57fa\u7ebf\u4e0b\u964d\u8d85\u8fc70.36\u5206\uff0c\u89c6\u4e3a\u60a3\u8005\u5bf9\u836f\u7269\u5e94\u7b54\u3002\u7ecf\u8fc7\u4e09\u4e2a\u6708\u7684\u6cbb\u7597\uff0c150mg\u6cbb\u7597\u7ec4\u7684\u75db\u7ecf\u60a3\u8005\u5e94\u7b54\u7387\u4e3a46%\uff0c\u975e\u7ecf\u671f\u76c6\u8154\u75bc\u75db\u60a3\u8005\u7684\u5e94\u7b54\u7387\u4e3a50%\uff0c200mg\u6cbb\u7597\u7ec4\u5206\u522b\u4e3a76%\u548c55%\uff0c\u5b89\u6170\u5242\u7ec4\u5219\u4e3a20%\u548c26%\u3002\u5728EM-II\u4e2d\uff0c\u60a3\u8005\u7684\u5e94\u7b54\u6807\u51c6\u6709\u6240\u63d0\u9ad8\uff0c\u7ecf\u671f\u75bc\u75db\u548c\u975e\u7ecf\u671f\u76c6\u8154\u75bc\u75db\u8bc4\u5206\u5206\u522b\u76f8\u8f83\u57fa\u7ebf\u4e0b\u964d\u8d85\u8fc70.85\u5206\u548c0.43\u5206\uff0c\u89c6\u4e3a\u5e94\u7b54\u3002\u4e09\u4e2a\u6708\u65f6\uff0c150mg\u6cbb\u7597\u7ec4\u7684\u75db\u7ecf\u60a3\u8005\u5e94\u7b54\u7387\u4e3a43%\uff0c\u975e\u7ecf\u671f\u76c6\u8154\u75bc\u75db\u60a3\u8005\u7684\u5e94\u7b54\u7387\u4e3a50%\uff0c200mg\u6cbb\u7597\u7ec4\u5206\u522b\u4e3a72%\u548c58%\uff0c\u5b89\u6170\u5242\u7ec4\u5219\u4e3a23%\u548c37%[43]\u3002\u5b50\u5bab\u5185\u819c\u5f02\u4f4d\u75c7\u662f\u5973\u6027\u5e38\u89c1\u7684\u75be\u75c5\uff0c\u5f71\u54cd\u4e8610%\u7684\u751f\u80b2\u5e74\u9f84\u6bb5\u5973\u6027\uff0c<\/span>\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u5747\u8bf4\u660eElagolix\u5242\u91cf\u4f9d\u8d56\u6027\u5730\u964d\u4f4e\u4e86\u5b50\u5bab\u5185\u819c\u5f02\u4f4d\u75c7\u60a3\u8005\u7684\u75db\u7ecf\u6216\u975e\u7ecf\u671f\u76c6\u8154\u75bc\u75db\uff0c\u56e0\u4e3a\u672c\u54c1\u5bf9\u9aa8\u5bc6\u5ea6\u5f71\u54cd\u8f83\u5c0f\uff0c\u52a0\u4e4b\u53e3\u670d\u7684\u4f18\u52bf\uff0c\u672c\u54c1\u5f88\u6709\u671b\u6210\u4e3a\u4e00\u5927\u91cd\u78c5\u70b8\u5f39\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u9500\u552e\u989d\u5c06\u57282024\u5e74\u8fbe\u523020.00\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Elagolix sodium<\/span><\/p>\n

25. Omegaven\uff08Fish Oil Triglycerides\uff09<\/span><\/strong><\/span><\/p>\n

7\u670824\u65e5\uff0cFDA\u6279\u51c6\u8d39\u68ee\u5c24\u65af\u5361\u6bd4\u516c\u53f8\u7684\u9c7c\u6cb9\u7518\u6cb9\u4e09\u916f\u4e73\u5242\uff0c\u8fd9\u662f\u4e00\u79cd\u542b\u591a\u79cd\u7518\u6cb9\u4e09\u916f\u7684\u9759\u8109\u6ce8\u5c04\u4e73\u5242\uff0c\u4ee5\u66ff\u4ee3\u666e\u901a\u7684\u80a0\u5916\u8425\u517b\u4e3a\u60a3\u80a0\u5916\u8425\u517b\u76f8\u5173\u7684\u80c6\u6c41\u6de4\u79ef\u75c7\u7684\u513f\u7ae5\uff0c\u63d0\u4f9b\u80fd\u91cf\u548c\u8102\u80aa\u9178\u3002Omegaven\u662f\u4e00\u79cd\u5168\u65b0\u7684\u80a0\u5916\u8425\u517b\uff0c\u542b\u6709\u4e8c\u5341\u78b3\u4e94\u70ef\u9178\uff08EPA\uff09\u3001\u4e8c\u5341\u4e8c\u78b3\u516d\u70ef\u9178\uff08DHA\uff09\u3001\u68d5\u6988\u9178\u3001\u6cb9\u9178\u3001\u68d5\u6988\u70ef\u9178\u3001\u4e9a\u6cb9\u9178\u3001\u8c46\u853b\u9178\u3001\u82b1\u751f\u56db\u70ef\u9178\u548c\u03b1-\u4e9a\u9ebb\u9178\u7b49\u591a\u79cd\u5fc5\u987b\u8102\u80aa\u9178\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e24\u9879\u5f00\u653e\u6807\u7b7e\u7684\u5355\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4e24\u9879\u8bd5\u9a8c\u5408\u8ba1\u6709123\u540d\u60a3\u8005\u7eb3\u5165\u7edf\u8ba1\uff0c\u5176\u4e2d80\u540d\u60a3\u8005\u63a5\u53d7Omegaven\u6cbb\u7597\uff0c\u800c41\u540d\u60a3\u8005\u91c7\u7528\u75c5\u4f8b\u5bf9\u7167\uff08\u63a5\u53d7\u5927\u8c46\u6cb9\u4e73\u5242\u6cbb\u7597\uff09\uff0c\u7ed3\u679c\u663e\u793a\uff0c\u63a5\u53d7Omegaven\u6cbb\u7597\u7684\u513f\u7ae5\uff0c\u4f53\u91cd\u589e\u957f\u60c5\u51b5\u4e0e\u5927\u8c46\u6cb9\u4e73\u5242\u7597\u6cd5\u76f8\u4f3c\uff0c\u76f4\u63a5\u6216\u7ed3\u5408\u80c6\u7ea2\u7d20\uff08DBil\uff09\u6c34\u5e73\u4ece\u5f00\u59cb\u6cbb\u7597\u65f6\u76842.0 mg\/dL\uff0c\u4e0b\u964d\u52300.60 mg\/dL[44]\u3002\u65e9\u4ea7\u513f\u5f80\u5f80\u9700\u8981\u901a\u8fc7\u80a0\u5916\u8425\u517b\u9014\u5f84\u6765\u83b7\u53d6\u80fd\u91cf\uff0c\u4f46\u957f\u671f\u4f7f\u7528\u80a0\u5916\u8425\u517b\u53ef\u80fd\u4f1a\u5bfc\u81f4\u809d\u810f\u5185\u53d1\u751f\u80c6\u6c41\u6de4\u79ef\uff0c\u56e0\u4e3a\u60a3\u8005\u57fa\u6570\u6709\u9650\uff0c\u56e0\u6b64\u83b7\u5f97\u4e86<\/span>FDA\u7684\u5b64\u513f\u836f\u8ba4\u5b9a\u3002<\/span><\/p>\n

26. Mulpleta\uff08Lusutrombopag\uff09<\/span><\/strong><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Lusutrombopag<\/span><\/p>\n

7\u670831\u65e5\uff0cFDA\u6279\u51c6\u4e86\u76d0\u91ce\u4e49\u516c\u53f8\u7684Lusutrombopag\uff0c\u7528\u4e8e\u6162\u6027\u809d\u75c5\u5bfc\u81f4\u7684\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u6cbb\u7597\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8eL-PLUS 1\uff08n=97\uff09\u548cL-PLUS 2\uff08n=215\uff09\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6570\u636e\uff0c\u4e24\u9879\u8bd5\u9a8c\u8bbe\u8ba1\u51e0\u4e4e\u76f8\u540c\uff0c\u60a3\u8005\u5206\u522b\u63a5\u53d7Lusutrombopag\u6216\u5b89\u6170\u5242\u6cbb\u75977\u5929\uff0c\u8840\u5c0f\u677f\u8ba1\u6570\u8d85\u8fc750 \u00d7 109\/L\u4e14\u8840\u5c0f\u677f\u589e\u91cf\u8d85\u8fc720 \u00d7 109\/L\u7684\u60a3\u8005\u6bd4\u4f8b\u5206\u522b\u4e3a76% vs 6%\uff08L-PLUS 1\uff09\u548c65% <\/span>vs <\/span><\/em>13%\uff08L-PLUS 2\uff09\u3002\u5c3d\u7ba1\u4fc3\u8840\u5c0f\u677f\u751f\u6210\u7d20\u53d7\u4f53\u6291\u5236\u5242\u53ef\u4ee5\u5927\u5e45\u51cf\u5c11\u60a3\u8005\u5bf9\u8840\u5c0f\u677f\u8f93\u6db2\u7684\u4f9d\u8d56\uff0c\u4f46\u622a\u6b62\u76ee\u524d\uff0cFDA\u5df2\u7ecf\u6279\u51c6Eltrombopag[45]\u3001Avatrombopag\u548cLusutrombopag[46]\u4e09\u4e2a\u540c\u7c7b\u4ea7\u54c1\u4e0a\u5e02\uff0c\u800c\u4e14\u6a2a\u5411\u6bd4\u8f83\u8fd9\u4e09\u4e2a\u4ea7\u54c1\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff0c\u5e76\u4e0d\u5b58\u5728\u8d28\u7684\u5dee\u5f02\u3002Eltrombopag\u5df2\u7ecf\u4e0a\u5e02\u8d85\u8fc75\u5e74\uff0c\u76ee\u524d\u9500\u552e\u989d\u4ecd\u4e0d\u8db310\u4ebf\u7f8e\u5143\uff0c\u56e0\u6b64\u672c\u54c1\u5e74\u9500\u552e\u989d\u8981\u8d85\u8fc710\u4ebf\u7f8e\u5143\u7684\u96be\u5ea6\u5de8\u5927\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282023\u5e74\u7684\u9500\u552e\u989d\u4e3a1.13\u4ebf\u7f8e\u5143<\/span>\u3002<\/span><\/p>\n

 \u4e09\u79cd\u8840\u5c0f\u677f\u53d7\u4f53\u6fc0\u52a8\u5242\u5e94\u7b54\u7387\u5bf9\u6bd4<\/span><\/strong><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

 27. Poteligeo\uff08Mogamulizumab\uff09<\/span><\/strong>
<\/p>\n

8\u67088\u65e5\uff0cFDA\u6279\u51c6\u65e5\u672c\u9e92\u9e9f\u534f\u548c\u53d1\u9175\u7684Mogamulizumab\uff0c\u7528\u4f5c\u590d\u53d1\u6027\u8548\u6837\u771f\u83cc\u75c5\uff08MF\uff09\u6216\u585e\u624e\u91cc\u7efc\u5408\u5f81\uff08SS\uff09\u4e8c\u7ebf\u6cbb\u7597\u3002MF\u662f\u4e00\u79cdT\u7ec6\u80de\u60f0\u6027\u6dcb\u5df4\u7624\uff0c\u591a\u53d1\u4e8e\u76ae\u80a4\uff0c\u5178\u578b\u7279\u5f81\u662f\u591a\u79cd\u591a\u6837\u7684\u7ea2\u6591\uff0cMF\u6bd4\u8f83\u5c11\u89c1\uff0c\u4ec5\u5360\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u76842%-3%[47]\u3002SS\u662f\u4e00\u79cd\u5168\u8eab\u6027\u6210\u719fT\u7ec6\u80de\u6dcb\u5df4\u7624\uff0c\u4ee5\u7ea2\u76ae\u75c5\u3001\u6dcb\u5df4\u7ed3\u80bf\u5927\u548c\u5916\u5468\u8840\u4e2dsezary\u7ec6\u80de\u4e3a\u7279\u5f81[48]\u3002MF\u548cSS\u90fd\u662f\u7f55\u89c1\u800c\u53c8\u96be\u6cbb\u7684\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u7c7b\u578b\uff0c\u672c\u54c1\u7684\u83b7\u6279\u5c06\u4e3a\u60a3\u8005\u5e26\u6765\u5168\u65b0\u7684\u6cbb\u7597\u9009\u62e9\u3002Mogamulizumab\u662f\u4e00\u79cdCC\u8d8b\u5316\u56e0\u5b50\u53d7\u4f534\uff08CCR4\uff09\u5355\u6297\uff0c\u672c\u54c1\u7684\u83b7\u6279\u662f\u57fa\u4e8e\u4e00\u9879\u5171\u6709372\u4f8bMF\u548cSS\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08NCT01728805\uff09\uff0c\u60a3\u8005\u88ab1:1\u5206\u7ec4\uff0c\u5206\u522b\u88ab\u7ed9\u4e88\u672c\u54c1\u6216\u4f0f\u7acb\u8bfa\u4ed6\u6cbb\u7597\uff0c\u7ed3\u679c\u663e\u793a\uff0c\u672c\u54c1\u6cbb\u7597\u7ec4\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u4e2d\u4f4d\u503c\u4e3a7.6\u4e2a\u6708\uff0c\u800c\u4f0f\u7acb\u8bfa\u4ed6\u6cbb\u7597\u7ec4\u4ec5\u4e3a3.1\u4e2a\u6708[49]\u3002\u56e0\u4e3a\u8fd9\u79cd\u75c5\u6bd4\u8f83\u7f55\u89c1\uff0cMogamulizumab\u4ec5\u9760MF\u6216SS\uff0c\u96be\u4ee5\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u3002<\/span><\/span><\/span><\/p>\n

28. Galafold\uff08Migalastat\uff09<\/span><\/strong><\/span><\/p>\n

8\u670810\u65e5\uff0cFDA\u6279\u51c6\u4e86Amicus\u516c\u53f8\u7684migalastat\uff0c\u7528\u4e8e\u6cd5\u5e03\u91cc\u75c5\u6cbb\u7597\u3002\u6cd5\u5e03\u91cc\u75c5\u662f\u4e00\u79cdX\u67d3\u8272\u4f53\u4e0a\u7684\u03b1-\u534a\u4e73\u7cd6\u82f7\u9176A\uff08GLA\uff09\u57fa\u56e0\u7684\u7a81\u53d8\uff0c\u6eb6\u9176\u4f53\u5185\u9170\u57fa\u9798\u978d\u9187\u4e09\u5df1\u7cd6\u5806\u79ef\u5f15\u53d1\u7684\u5fc3\u810f\u3001\u80be\u810f\u3001\u8111\u8840\u7ba1\u53ca\u795e\u7ecf\u75c5\u53d8\u3002\u6cd5\u5e03\u91cc\u75c5\u662f\u4e00\u79cd\u975e\u5e38\u7f55\u89c1\u7684\u9057\u4f20\u75c5\uff0c\u7537\u6027\u60a3\u75c5\u7387\u4e3a\u56db\u4e07\u5206\u4e4b\u4e00\uff0c\u665a\u53d1\u578b\u6cd5\u5e03\u91cc\u75c5\u8f83\u4e3a\u5e38\u89c1\uff0c\u5728\u67d0\u4e9b\u4eba\u7fa4\u4e2d\uff0c\u60a3\u75c5\u7387\u53ef\u8fbe1\/4000\u52301\/1500\u3002\u5728\u672c\u54c1\u83b7\u6279\u4ee5\u524d\uff0c\u6cd5\u5e03\u91cc\u75c5\u4e3b\u8981\u662f\u03b1-\u534a\u4e73\u7cd6\u82f7\u9176A\u66ff\u4ee3\u6cbb\u7597\uff0c\u800c\u672c\u54c1\u662f\u4e00\u79cd\u03b1-\u534a\u4e73\u7cd6\u82f7\u9176\u4fc3\u8fdb\u5242\uff0c\u53ef\u589e\u52a0\u8fd9\u79cd\u9176\u7684\u6d3b\u6027\uff0c\u8fdb\u800c\u53d1\u6325\u6cbb\u7597\u4f5c\u7528\u3002\u672c\u54c1\u7684\u6709\u6548\u6027\u5728\u4e00\u9879\u670945\u540d\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5f97\u5230\u8bc1\u5b9e\uff0c\u4e0e\u5b89\u6170\u5242\u7ec4\u76f8\u6bd4\uff0c\u672c\u54c1\u6cbb\u7597\u7ec4\u60a3\u8005\u80be\u810f\u8840\u7ba1\u4e2d\u7684\u9170\u57fa\u9798\u978d\u9187\u4e09\u5df1\u7cd6\u542b\u91cf\u5927\u5e45\u4e0b\u964d [50] \u3002\u5e02\u573a\u65b9\u9762\uff0c\u672c\u54c1\u5df2\u7ecf\u5728\u6b27\u6d32\u4e0a\u5e02\uff0c\u4ece\u9500\u552e\u989d\u6765\u770b\uff0c\u4e5f\u662f\u5b64\u513f\u836f\u4e2d\u7684\u4f7c\u4f7c\u8005\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u5176\u57282023\u5e74\u7684\u9500\u552e\u989d\u53ef\u8fbe6.76\u4ebf\u7f8e\u5143\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Migalastat<\/span><\/p>\n

29.Annovera\uff08Segesterone ; Ethinyl Estradiol\uff09<\/span><\/strong><\/span><\/p>\n

8\u670810\u65e5\uff0cFDA\u6279\u51c6\u4e86\u65b0\u578b\u907f\u5b55\u836fAnnovera\uff0c\u8fd9\u662f\u4e00\u79cd\u542bsegesterone\u548c\u7094\u96cc\u9187\u7684\u9634\u9053\u73af\uff0c\u8be5\u73af\u4e0d\u53ef\u964d\u89e3\uff0c\u53ef\u5728\u9634\u9053\u4e2d\u653e\u7f6e\u4e09\u5468\uff0c\u7136\u540e\u53d6\u51fa\u653e\u7f6e\u4e00\u5468\uff0c\u6bcf\u56db\u5468\u4e00\u5faa\u73af\uff0c\u53ef\u91cd\u590d\u4f7f\u752813\u6b21\uff08\u4e00\u5e74\uff09\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e00\u9879\u67092265\u540d\u60a3\u8005\u53c2\u4e0e\u7684\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5408\u5e76\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6570\u636e\u7edf\u8ba1\uff0c2111\u540d\u5973\u6027\u5728\u4e00\u5e74\u5185\u5b8c\u6210\u4e8617427\u6b21\u5faa\u73af\uff0c\u73c0\u5c14\u6307\u6570(Pearl Index)\u7edf\u8ba1\u663e\u793a\uff0c\u6c47\u603b\u6000\u5b55\u7387\u4e3a2.98%\/\u5e74[51]\u3002\u907f\u5b55\u836f\u5e02\u573a\u5e9e\u5927\uff0c\u4f46\u5bf9\u4ea7\u54c1\u8981\u6c42\u8f83\u9ad8\uff0c\u4e0d\u826f\u53cd\u5e94\u3001\u907f\u5b55\u6548\u7387\u3001\u4f7f\u7528\u4fbf\u6377\u6027\u90fd\u662f\u5f71\u54cd\u6210\u8d25\u7684\u5173\u952e\u6027\u56e0\u7d20\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Segesterone<\/span><\/p>\n

30. Onpattro\uff08Patisiran\uff09<\/span><\/strong><\/span><\/p>\n

8\u67081\u65e5\uff0cFDA\u6279\u51c6\u4e86Alnylam\u516c\u53f8\u7684Patisiran\uff0c\u7528\u4e8e\u5bb6\u65cf\u6027\u8f6c\u7532\u72b6\u817a\u7d20\u86cb\u767d\u6dc0\u7c89\u6837\u53d8\uff08hATTR\uff09<\/span>\u76f8\u5173\u7684\u591a\u53d1\u6027\u795e\u7ecf\u75c5\u6cbb\u7597\u3002\u8fd9\u662f\u4e00\u79cd\u8102\u8d28\u5305\u88f9\u7684\u53cc\u94fe\u5c0f\u5e72\u6270\u6838\u7cd6\u6838\u9178\uff08RNAi\uff09\uff0c\u53ef\u4f5c\u7528\u4e8e\u91ce\u751f\u6216\u7a81\u53d8\u578b\u8f6c\u7532\u72b6\u817a\u7d20\u86cb\u767d\uff08TTR\uff09\u4fe1\u4f7fRNA\uff0c\u4ece\u800c\u5bfc\u81f4TTR\u86cb\u767d\u5f62\u6210\u548c\u6c89\u79ef\u51cf\u5c11\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e00\u9879\u540d\u4e3aAPOLLO\u7684\u2162\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u5bb6\u65cf\u6027\u6dc0\u7c89\u6837\u591a\u53d1\u6027\u795e\u7ecf\u75c5\u60a3\u8005\uff08\u5305\u62ec\u5fc3\u808c\u53d8\u6027\u60a3\u8005\uff09\u63a5\u53d7patisiran\u6216\u5b89\u6170\u5242\u6cbb\u7597\uff0c\u795e\u7ecf\u635f\u4f24\u7a0b\u5ea6\u5f97\u5230\u663e\u8457\u6539\u5584\uff0c\u6cbb\u759718\u4e2a\u6708\u7684NIS+7\u8bc4\u5206\uff08\u4e00\u79cd\u795e\u7ecf\u635f\u4f24\u7684\u7efc\u5408\u8bc4\u5206\uff09\u4e3a-6.0\u5206\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4e3a28.0\u5206\uff0c\u76f8\u5dee34.0\u5206[52]\u3002\u5728\u5168\u7403\u8303\u56f4\u5185\uff0c\u7ea6\u67095\u4e07\u4eba\u7f79\u60a3\u6b64\u75c5\uff0cPatisiran\u662f\u622a\u6b62\u76ee\u524d\u8be5\u9886\u57df\u6700\u597d\u7684\u836f\u7269\uff0c\u83b7\u5f97\u4e86FDA\u5b64\u513f\u836f\u3001\u4f18\u5148\u5ba1\u8bc4\u548c\u7a81\u7834\u6027\u7597\u6cd5\u4e09\u9879\u8ba4\u5b9a[53]\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u53ef\u8fbe10.75\u4ebf\u7f8e\u5143\uff0c\u662f2018\u5e74\u6700\u503c\u5f97\u5173\u6ce8\u7684\u836f\u7269\u4e4b\u4e00\u3002<\/span><\/p>\n

31. Diacomit\uff08Stiripentol\uff09<\/span><\/strong><\/span><\/p>\n

8\u670820\u65e5\uff0cFDA\u6279\u51c6\u4e86Biocodex\u7684Stiripentol\uff0c\u4e0e\u6c2f\u5df4\u5360\u8054\u5408\u7528\u4e8eDravet\u7efc\u5408\u5f81\u6cbb\u7597\uff0c\u8fd9\u662fFDA\u57282018\u5e74\u6279\u51c6\u7684\u7b2c\u4e8c\u4e2aDravet\u7efc\u5408\u5f81\u7528\u836f\u3002\u672c\u54c1\u7684\u4f5c\u7528\u673a\u5236\u5c1a\u672a\u5b8c\u5168\u6e05\u695a\uff0cFDA\u6279\u51c6\u672c\u54c1\u4e0a\u5e02\u662f\u57fa\u4e8e\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ed3\u679c\u3002\u4e24\u9879\u8bd5\u9a8c\u5171\u670964\u540d\u60a3\u8005\u53c2\u52a0\uff0c\u60a3\u8005\u5728\u63a5\u53d7\u6c2f\u5df4\u5360\u6216\u6258\u5421\u916f\u6cbb\u7597\u7684\u57fa\u7840\u4e0a\uff0c\u6dfb\u52a050 mg\/kg\/day\u7684\u672c\u54c1\u6216\u5b89\u6170\u5242\u6cbb\u75972\u4e2a\u6708\uff0c\u5728\u8bd5\u9a8c\u4e00\u4e2d\uff0c\u672c\u54c1\u6cbb\u7597\u7ec4\u670915\u540d\uff0871%\uff09\u60a3\u8005\u5f3a\u76f4-\u9635\u631b\u6027\u6216\u9635\u631b\u6027\u766b\u75eb\u53d1\u4f5c\u9891\u7387\u4e0b\u964d50%\u4ee5\u4e0a\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u67091\u4eba\uff085%\uff09\uff0c\u8bd5\u9a8c\u4e8c\u7ed3\u679c\u4e0e\u8bd5\u9a8c\u4e00\u7c7b\u4f3c\uff0c\u5176\u4e2d\u6cbb\u7597\u7ec4\u4e3a8\u4eba\uff0867%\uff09\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a1\u4eba\uff089.1%\uff09\u3002\u53e6\u5916\uff0c\u5728\u8bd5\u9a8c\u671f\u95f4\uff0c\u5206\u522b\u670943%\u548c25%\u7684\u60a3\u8005\u6ca1\u6709\u51fa\u73b0\u5168\u8eab\u6027\u9635\u631b\u6027\u6216\u5f3a\u76f4-\u9635\u631b\u6027\u766b\u75eb\u53d1\u4f5c[54]\u3002Stiripentol\u65e9\u572880\u5e74\u4ee3\u5c31\u5df2\u7ecf\u88ab\u53d1\u73b0\uff0c\u5e76\u4e8e2007\u5e74\u83b7\u5f97\u4e86EMA\u7684\u6279\u51c6\uff0c\u4ece\u76ee\u524d\u7684\u5e02\u573a\u8868\u73b0\u6765\u770b\uff0c\u672c\u54c1\u56e0\u4e3a\u65b0\u83b7FDA\u7684\u6279\u51c6\u800c\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u7684\u53ef\u80fd\u6027\u4e0d\u5927\u3002<\/span><\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Stiripentol<\/span><\/p>\n

32. Oxervate\uff08Cenegermin\uff09<\/span><\/strong><\/span><\/p>\n

8\u670822\u65e5\uff0cFDA\u6279\u51c6Dompe\u516c\u53f8\u7684\u91cd\u7ec4\u795e\u7ecf\u751f\u957f\u56e0\u5b50\uff08NGF\uff09Oxervate\uff0c\u7528\u4f5c\u795e\u7ecf\u8425\u517b\u6027\u89d2\u819c\u708e\u6cbb\u7597\u3002Oxervate\u5df2\u7ecf\u57282017\u5e74\u83b7\u5f97EMA\u7684\u6279\u51c6\uff0cFDA\u6279\u51c6\u672c\u54c1\u4e0a\u5e02\u662f\u57fa\u4e8e\u4e24\u9879\u3001\u5171\u8ba1151\u4f8b\u795e\u7ecf\u8425\u517b\u6027\u89d2\u819c\u708e\u60a3\u8005\u53c2\u52a0\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u7ecf\u8fc7\u672c\u54c1\u76848\u5468\u6cbb\u7597\uff0c\u5728NGF0214\u8bd5\u9a8c\u4e2d\uff0c65.2%\u7684\u60a3\u8005\u8fbe\u5230\u89d2\u819c\u5b8c\u5168\u6108\u5408\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4e3a16.7%\u3002NGF0212\u5f97\u51fa\u7684\u8bd5\u9a8c\u7ed3\u679c\u4e5f\u51e0\u4e4e\u7c7b\u4f3c\uff0c72.0%\u7684Oxervate\u6cbb\u7597\u7ec4\u89d2\u819c\u5b8c\u5168\u6108\u5408\uff0c\u5b89\u6170\u5242\u7ec4\u4ec5\u4e3a33.3%[55]\u3002\u672c\u54c1\u7684\u4e3b\u8981\u4e0d\u826f\u53cd\u5e94\u662f\u773c\u75db\u548c\u773c\u90e8\u5145\u8840\u3002\u795e\u7ecf\u8425\u517b\u6027\u89d2\u819c\u708e\u662f\u4e00\u79cd\u7f55\u89c1\u75be\u75c5\uff0c\u53d1\u75c5\u7387\u4e0d\u8db3\u5341\u4e07\u5206\u4e4b\u4e94\uff0c\u56e0\u6b64\u672c\u54c1\u83b7\u5f97\u4e86FDA\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a[56]\u3002Oxervate\u5df2\u7ecf\u4e8e2017\u5e74\u83b7\u5f97EMA\u6279\u51c6\uff0c\u4f46Dompe\u516c\u53f8\u5e76\u6ca1\u6709\u516c\u5f00\u9500\u552e\u6570\u636e\uff0c\u8003\u8651\u5230\u60a3\u8005\u4e0d\u591a\uff0c\u800c\u4e14\u773c\u75db\u6bd4\u8f83\u660e\u663e\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u8131\u7ec4\u7387\u8f83\u9ad8\uff0c\u56e0\u6b64\u672c\u54c1\u6210\u4e3a\u91cd\u78c5\u70b8\u5f39\u7684\u6f5c\u529b\u4e0d\u5927\u3002<\/span><\/span><\/span><\/p>\n

33. Takhzyro\uff08Lanadelumab\uff09<\/span><\/strong><\/span><\/p>\n

8\u670823\u65e5\uff0cFDA\u6279\u51c6\u590f\u5c14\u516c\u53f8\u7684Lanadelumab\uff0c\u7528\u4f5c\u9057\u4f20\u8840\u7ba1\u7d27\u5f20\u6027\u6c34\u80bf\uff08HAE\uff09\u6cbb\u7597\u3002Takhzyro\u662f\u4e00\u79cd\u8840\u6d46\u6fc0\u80bd\u91ca\u653e\u9176\u6291\u5236\u5242\uff0c\u53ef\u901a\u8fc7\u6291\u5236\u8840\u6d46\u6fc0\u80bd\u91ca\u653e\u9176\u800c\u963b\u6b62\u7f13\u6fc0\u80bd\u7684\u751f\u6210\uff0c\u7528\u4e8e\u9632\u6b62\u80bf\u80c0\u53d1\u751f\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e00\u9879\u6709125\u540d\u2160\u578bHAE\u60a3\u8005\u53c2\u4e0e\u7684\u591a\u4e2d\u5fc3\u7684\u4e34\u5e8a\u8bd5\u9a8c(NCT02586805)[57]\u3002\u7ecf\u8fc7\u4e3a\u671f6\u4e2a\u6708\u7684\u6cbb\u7597\uff0c 150mg\u6bcf\u56db\u5468\u4e00\u6b21\u6cbb\u7597\u7ec4\u60a3\u8005HAE\u53d1\u751f\u7387\u76f8\u6bd4\u5b89\u6170\u5242\u4e0b\u964d76%\uff0c300mg\u6bcf\u56db\u5468\u4e00\u6b21\u6cbb\u7597\u7ec4\u4e0b\u964d73%\uff0c300mg\u6bcf\u4e24\u5468\u4e00\u6b21\u6cbb\u7597\u7ec4\u4e0b\u964d87%[58]\u3002HAE\u662f\u4e00\u79cd\u5e38\u67d3\u8272\u4f53\u663e\u6027\u9057\u4f20\u3001\u4ee5\u53cd\u590d\u53d1\u4f5c\u81ea\u9650\u6027\u7ec4\u7ec7\u6c34\u80bf\u4e3a\u7279\u5f81\u7684\u7f55\u89c1\u75c5\uff0c\u5c24\u5176\u5728\u906d\u53d7\u8f7b\u5fae\u521b\u4f24\u3001\u7cbe\u795e\u538b\u529b\u589e\u5927\u65f6\u66f4\u6613\u53d1\u751f\uff0c\u5927\u7ea6\u6bcf5\u4e07\u540d\u7537\u6027\u53ef\u80fd\u5c31\u6709\u4e00\u4eba\u7f79\u60a3\u6b64\u75c5\uff0c\u5176\u4e2d\u2160\u578b\u6700\u4e3a\u5e38\u89c1\uff0c\u7ea6\u5360\u60a3\u8005\u603b\u6570\u768485%[59]\u3002\u5c3d\u7ba1\u53d7\u4f17\u4eba\u7fa4\u5e76\u4e0d\u591a\uff0c\u4f46HAE\u6709\u5de8\u5927\u7684\u6cbb\u7597\u9700\u6c42\uff0c2017\u5e74\u5e02\u573a\u5df2\u7ecf\u89c4\u6a21\u8d85\u8fc77\u4ebf\u7f8e\u5143\u3002\u5728\u4f17\u591aHAE\u6cbb\u7597\u836f\u7269\u4e2d\uff0c\u672c\u54c1\u7684\u7597\u6548\u548c\u4e0d\u826f\u53cd\u5e94\u51e0\u4e4e\u90fd\u662f\u6700\u7406\u60f3\u7684\uff0c\u800c\u4e14\u662f\u76ae\u4e0b\u7ed9\u836f\uff0c\u56e0\u6b64\u5e02\u573a\u6f5c\u529b\u88ab\u5206\u6790\u5e08\u4eec\u4e00\u81f4\u770b\u597d\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282023\u5e74\u7684\u9500\u552e\u989d\u53ef\u8fbe 15.32\u4ebf\u7f8e\u5143\uff0c\u662f2018\u5e74\u6700\u503c\u5f97\u5173\u6ce8\u7684\u836f\u7269\u4e4b\u4e00\u3002<\/span><\/p>\n

34. Xerava\uff08Eravacycline\uff09<\/span><\/strong><\/span><\/p>\n

8\u670827\u65e5\uff0cFDA\u6279\u51c6\u4e86Tetraphase\u516c\u53f8\u7684Eravacycline\uff0c\u7528\u4e8e\u654f\u611f\u83cc\u6240\u81f4\u7684\u8179\u8154\u611f\u67d3\u6cbb\u7597\u3002Eravacycline\u662f\u4e00\u79cd\u65b0\u578b\u7684\u5168\u5408\u6210\u542b\u6c1f\u56db\u73af\u7d20\u7c7b\u6297\u751f\u7d20\uff0c\u6709\u5bf9\u6297\u591a\u79cd\u9769\u5170\u9634\u6027\u83cc\u7684\u6d3b\u6027\uff0c\u5305\u62ec\u5404\u79cd\u6746\u83cc\u3001\u5bf9\u78b3\u9752\u9709\u70ef\u7c7b\u3001\u5934\u5b62\u83cc\u7d20\u7c7b\u3001\u6c1f\u55b9\u8bfa\u916e\u7c7b\u548c\u03b2-\u5185\u9170\u80fa\u7c7b\u6297\u751f\u7d20\u4ea7\u751f\u8010\u836f\u7684\u591a\u79cd\u83cc\u682a[60]\u3002FDA\u6279\u51c6\u672c\u54c1\u662f\u57fa\u4e8e\u4e24\u9879\u5171\u67091041\u540d\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ed3\u679c\uff0c\u8bd5\u9a8c\u4e00\uff08NCT01844856\uff09\u4e2d\uff0cEravacycline\u6cbb\u7597\u7ec4\u670986.8%\u7684\u60a3\u8005\u8fbe\u5230\u4e34\u5e8a\u6cbb\u6108\uff0c\u800c\u5384\u4ed6\u57f9\u5357\u7ec4\u4e3a87.6%\uff0c\u8fbe\u5230\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u975e\u52a3\u6027\uff1b\u8bd5\u9a8c\u4e8c\uff08NCT02784704\uff09\u4e2d\uff0cEravacycline\u6cbb\u7597\u7ec4\u670990.8%\u7684\u60a3\u8005\u8fbe\u5230\u4e34\u5e8a\u6cbb\u6108\uff0c\u800c\u7f8e\u7f57\u57f9\u5357\u7ec4\u4e3a91.2%\uff0c\u540c\u6837\u8fbe\u5230\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u975e\u52a3\u6027[61]\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4bXerava\u57282024\u5e74\u7684\u9500\u552e\u989d\u53ef\u8fbe2.19\u4ebf\u7f8e\u5143<\/span>\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Eravacycline<\/span><\/p>\n

35. Pifeltro\uff08Doravirine\uff09<\/span><\/strong>
<\/p>\n

8\u670830\u65e5\uff0cFDA\u6279\u51c6\u4e86\u9ed8\u6c99\u4e1c\u7684Doravirine\uff0c\u4e0e\u5176\u4ed6\u6297\u9006\u8f6c\u5f55\u836f\u7269\u8054\u5408\u7528\u4e8e\u6cbb\u7597\u672a\u63a5\u53d7\u6297\u9006\u8f6c\u5f55\u836f\u7269\u6cbb\u7597HIV-1\u611f\u67d3\u3002\u672c\u54c1\u662f\u4e00\u79cd\u975e\u6838\u82f7\u7c7b\u9006\u8f6c\u5f55\u9176\u6291\u5236\u5242\uff0c\u5176\u5b89\u5168\u6709\u6548\u6027\u5df2\u7ecf\u5728\u4e24\u9879\u6d3b\u6027\u5bf9\u7167\u7684\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5f97\u5230\u786e\u8ba4\u3002\u5728\u4e00\u9879\u540d\u4e3aDRIVE-FORWARD\uff08NCT02275780\uff09\u7684\u8bd5\u9a8c\u4e2d\uff0c\u60a3\u8005\u5206\u522b\u63a5\u53d7Doravirine +\u6069\u66f2\u4ed6\u6ee8+\u66ff\u8bfa\u798f\u97e6\u6216darunavir + ritonavir+\u6069\u66f2\u4ed6\u6ee8+\u66ff\u8bfa\u798f\u97e6\u6cbb\u759748\u5468\uff0c\u7ed3\u679c\u663e\u793a\u672c\u54c1\u6cbb\u7597\u7ec4\u4e2d\uff0c84%\u7684\u60a3\u8005HIV-1\u75c5\u6bd2\u7684RNA\u5c0f\u4e8e50\u62f7\u8d1d\/\u6beb\u5347\uff0c\u800cdarunavir + ritonavir\u6cbb\u7597\u7ec4\u4e3a80%[62]\u3002DRIVE-AHEAD\uff08NCT02275780\uff09\u8bd5\u9a8c\u8bbe\u8ba1\u4e0eDRIVE-FORWARD\u7c7b\u4f3c\uff0c728\u4f8b\u60a3\u8005\u5206\u522b\u63a5\u53d7Doravirine+\u62c9\u7c73\u592b\u5b9a+\u66ff\u8bfa\u798f\u97e6\u6216\u4f9d\u6cd5\u97e6\u4ed1+\u6069\u66f2\u4ed6\u6ee8+\u66ff\u8bfa\u798f\u97e6\u6cbb\u759748\u5468\uff0c\u7ed3\u679c\u663e\u793aDoravirine\u6cbb\u7597\u7ec4\u4e2d\uff0c84%\u7684\u60a3\u8005HIV-1\u75c5\u6bd2\u7684RNA\u5c0f\u4e8e50\u62f7\u8d1d\/\u6beb\u5347\uff0c\u800c\u5bf9\u7167\u7ec4\u4ec5\u4e3a81%[63]\u3002\u672c\u54c1\u7ec4\u5408\u7597\u6cd5\u7684\u4f18\u52bf\u5728\u4e8e\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7387\u8f83\u4f4e\uff0c\u4e3b\u8981\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\u5934\u75db\uff086%\uff09\u3001\u4e4f\u529b\uff086%\uff09\u548c\u5455\u5410\uff087%\uff09\uff0c\u4f46\u6291\u5236\u75c5\u6bd2\u80fd\u529b\u5e76\u4e0d\u5982\u542b\u6574\u5408\u9176\u6291\u5236\u5242\u7684\u9e21\u5c3e\u9152\u3002\u9664\u6b64\u4ee5\u5916\uff0c\u9e21\u5c3e\u9152\u662fHIV\u6cbb\u7597\u5e02\u573a\u7684\u4e3b\u6d41\uff0c\u5355\u65b9\u4ea7\u54c1\u7684\u5904\u65b9\u5e76\u4e0d\u591a\uff0c\u79d1\u777f\u552f\u5b89\u9884\u6d4b\u672c\u54c1\u57282024\u5e74\u7684\u9500\u552e\u989d\u4ec5\u4e3a2.03\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n

\"2018\u5e74\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u9010\u4e2a\u8bc4\u8ff0\uff08\u4e00\uff09\"<\/p>\n

Doravirine<\/span><\/p>\n


<\/p>\n

\u6ce8\uff1a\u4e2d\u62ec\u53f7\u91cc\u7684\u6570\u5b57\u4e3a\u53c2\u8003\u6587\u732e\u5e8f\u53f7\uff0c\u56fe\u7247\u5747\u6765\u81eaFDA\u8bf4\u660e\u4e66<\/span>
<\/p>\n


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