{"id":110305,"date":"2019-05-10T00:00:50","date_gmt":"2019-05-17T09:38:35","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/110305\/"},"modified":"2019-05-17T17:38:37","modified_gmt":"2019-05-17T09:38:37","slug":"8a926203d4","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/110305\/","title":{"rendered":"\u513f\u7ae5\u808c\u65e0\u529b\u836fFDA\u9996\u5ea6\u83b7\u6279\u4e0a\u5e02 \u6211\u56fd\u52a0\u5feb\u5f15\u8fdb\u5b64\u513f\u836f"},"content":{"rendered":"
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\"\u513f\u7ae5\u808c\u65e0\u529b\u836fFDA\u9996\u5ea6\u83b7\u6279\u4e0a\u5e02<\/a><\/strong><\/p>\n

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\u8fd1\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08Food&Drug Administration\uff0c\u4ee5\u4e0b\u7b80\u79f0FDA\uff09\u6279\u51c6Jacobus\u5236\u836f\u516c\u53f8\u7684\u836f\u7269Ruzurgi\uff08amifampridine\uff09\u4e0a\u5e02\uff0c\u7528\u4e8e6\u5c81\u81f317\u5c81\u60a3\u8005Lambert-Eaton\u808c\u65e0\u529b\u7efc\u5408\u5f81\uff08\u4ee5\u4e0b\u7b80\u79f0LEMS\uff09\u7684\u6cbb\u7597\u3002<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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 \u5168\u65871501\u5b57\uff0c\u7528\u65f63\u5206\u949f<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

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FDA\u57282018\u5e74\u6765\u52a0\u901f\u6279\u51c6\u4e86\u51e0\u5341\u79cd\u5b64\u513f\u836f\u4e0a\u5e02\u3002\u4e0e\u4e4b\u76f8\u5bf9\u7684\u662f\uff0c\u6211\u56fd\u5bf9\u5b64\u513f\u836f\u7684\u653f\u7b56\u4e5f\u9010\u6e10\u653e\u5f00\uff0c\u5ba1\u6279\u901f\u5ea6\u4e0d\u65ad\u52a0\u5feb\uff0c\u5229\u597d\u653f\u7b56\u9891\u51fa\u3002\u5317\u4eac\u9f0e\u81e3\u7ba1\u7406\u54a8\u8be2\u6709\u9650\u516c\u53f8\u521b\u59cb\u4eba\u53f2\u7acb\u81e3\u5bf9\u8bb0\u8005\u8868\u793a\uff0c\u56e0\u4e3a\u6709\u5ba1\u6279\u7eff\u8272\u901a\u9053\uff0c\u73b0\u5728\u7f55\u89c1\u75c5\u836f\u7269\u7684\u5ba1\u6279\u901f\u5ea6\u660e\u663e\u52a0\u5feb\uff0c\u5f15\u8fdb\u56fd\u5916\u7f55\u89c1\u75c5\u836f\u7269\u5230\u56fd\u5185\u4e0a\u5e02\u7684\u901f\u5ea6\u8fdb\u4e00\u6b65\u52a0\u5feb\u3002\u53ea\u8981\u7b26\u5408\u4e0a\u5e02\u6761\u4ef6\uff0c\u73b0\u5728\u53ea\u9700\u4e00\u5e74\u5de6\u53f3\uff0c\u751a\u81f3\u51e0\u4e2a\u6708\u5c31\u53ef\u4ee5\u5b9e\u73b0\u4e0a\u5e02\u3002<\/span><\/p>\n

\n

\u4e16\u754c\u4e0a\u9996\u4e2a\u513f\u7ae5\u808c\u65e0\u529b\u836f\u7269\u83b7\u6279<\/strong><\/p>\n<\/section>\n

5\u67087\u65e5\uff0c\u5b64\u513f\u836fRuzurgi\u88abFDA\u6279\u51c6\u4e0a\u5e02\u7684\u6d88\u606f\u4f20\u6765\uff0c\u8be5\u836f\u7269\u7684\u9002\u5e94\u75c7\u662f\u513f\u7ae5\u808c\u65e0\u529b\u7efc\u5408\u5f81\uff086\uff5e17\u5c81LEMS\uff09\u3002\u5b64\u513f\u836f\u662f\u6307\u6cbb\u7597\u7f55\u89c1\u75c5\u7684\u836f\u7269\u3002<\/span><\/p>\n

\u4eceFDA\u5b98\u7f51\u83b7\u6089\uff0cFDA\u836f\u7269\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3\u795e\u7ecf\u75c5\u5b66\u4ea7\u54c1\u90e8\u4e3b\u4efbBilly Dunn\u535a\u58eb\u8868\u793a\uff0cFDA\u5c06\u7ee7\u7eed\u81f4\u529b\u4e8e\u4fc3\u8fdb\u7f55\u89c1\u75be\u75c5\u6cbb\u7597\u7684\u5f00\u53d1\u548c\u6279\u51c6\uff0c\u5c24\u5176\u662f\u513f\u7ae5\u7684\u6cbb\u7597\u3002\u4ed6\u8ba4\u4e3a\uff0c\u8fd9\u4e00\u51b3\u5b9a\u5c06\u4e3a\u60a3\u6709LEMS\u7684\u513f\u79d1\u60a3\u8005\u63d0\u4f9b\u6025\u9700\u7684\u6cbb\u7597\u9009\u62e9\u3002<\/span><\/p>\n

FDA\u5b98\u7f51\u663e\u793a\uff0cLEMS\u662f\u4e00\u79cd\u7f55\u89c1\u7684\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u4f1a\u5f71\u54cd\u60a3\u8005\u795e\u7ecf\u548c\u808c\u8089\u4e4b\u95f4\u7684\u8054\u7cfb\uff0c\u5e76\u5bfc\u81f4\u53d7\u5f71\u54cd\u60a3\u8005\u51fa\u73b0\u865a\u5f31\u548c\u5176\u4ed6\u75c7\u72b6\u3002\u60a3\u6709LEMS\u7684\u4eba\uff0c\u8eab\u4f53\u81ea\u8eab\u7684\u514d\u75ab\u7cfb\u7edf\u653b\u51fb\u795e\u7ecf\u808c\u8089\u63a5\u5934\uff08\u795e\u7ecf\u548c\u808c\u8089\u4e4b\u95f4\u7684\u8fde\u63a5\uff09\uff0c\u5e76\u7834\u574f\u795e\u7ecf\u7ec6\u80de\u5411\u808c\u8089\u7ec6\u80de\u53d1\u9001\u4fe1\u53f7\u7684\u80fd\u529b\u3002<\/span><\/p>\n

FDA\u5b98\u7f51\u5185\u5bb9\u6307\u51fa\uff0cLEMS\u53ef\u80fd\u4e0e\u60a3\u8005\u81ea\u8eab\u5176\u4ed6\u514d\u75ab\u6027\u75be\u75c5\u6709\u5173\uff0c\u4f46\u66f4\u5e38\u89c1\u4e8e\u60a3\u6709\u764c\u75c7\u7684\u60a3\u8005\uff0c\u4f8b\u5982\u5c0f\u7ec6\u80de\u80ba\u764c\u3002LEMS\u5728\u513f\u79d1\u60a3\u8005\u4e2d\u7684\u6d41\u884c\u7a0b\u5ea6\u5c1a\u4e0d\u6e05\u695a\uff0c\u4f30\u8ba1\u5176\u603b\u4f53\u60a3\u75c5\u7387\u4e3a\u767e\u4e07\u5206\u4e4b\u4e09\u3002\u800c\u5bf9LEMS\u6210\u4eba\u836f\u7269\u5145\u5206\u548c\u63a7\u5236\u826f\u597d\u7684\u7814\u7a76\u8bc1\u636e\u4e5f\u4e3aRuzurgi\u57286\uff5e17\u5c81\u60a3\u8005\u4eba\u7fa4\u4e2d\u7684\u5e94\u7528\u63d0\u4f9b\u4e86\u6709\u529b\u652f\u6491\u3002<\/span><\/p>\n

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\n

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\u6765\u6e90\uff1a\u6bcf\u7ecf\u7f51<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\"\u513f\u7ae5\u808c\u65e0\u529b\u836fFDA\u9996\u5ea6\u83b7\u6279\u4e0a\u5e02<\/p>\n

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