{"id":3792,"date":"2008-07-22T09:00:26","date_gmt":"2008-07-22T01:00:26","guid":{"rendered":"http:\/\/localhost:9966\/?p=3792"},"modified":"2026-06-23T15:47:04","modified_gmt":"2026-06-23T07:47:04","slug":"%e8%8d%af%e5%93%81%e4%b8%8d%e8%89%af%e5%8f%8d%e5%ba%94%e4%bf%a1%e6%81%af%e9%80%9a%e6%8a%a5%ef%bc%88%e7%ac%ac15%e6%9c%9f%ef%bc%89","status":"publish","type":"post","link":"https:\/\/www.blpa.com.cn\/?p=3792","title":{"rendered":"\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\uff08\u7b2c15\u671f\uff09"},"content":{"rendered":"

\n\t\u4f7f\u7528\u91cd\u7ec4\u4eba\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\u5e94\u63a7\u5236\u8840\u7ea2\u86cb\u767d\u6d53\u5ea6\u3001<\/span><\/span><\/span>\n<\/p>\n

\n\t\u8b66\u60d5\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u751f\u6b96\u6bd2\u6027\u3001<\/span><\/span><\/span>\n<\/p>\n

\n\t\u8b66\u60d5\u6297\u6291\u90c1\u836f\u6cbb\u7597\u8fc7\u7a0b\u4e2d\u7684\u81ea\u6740\u98ce\u9669<\/span><\/span><\/span>\n<\/p>\n

\n\t\u53d1\u5e03\u65e5\u671f\uff1a<\/span>2008-07-10<\/span><\/span><\/b>\n<\/p>\n

\n\t\u7f16\u8005\u6309\uff1a<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u5236\u5ea6\u662f\u6211\u56fd\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u4e3a\u4fdd\u969c\u516c\u4f17\u7528\u836f\u5b89\u5168\u800c\u5efa\u7acb\u7684\u4e00\u9879\u5236\u5ea6\u3002\u300a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u300b\u9762\u5411\u793e\u4f1a\u516c\u5f00\u53d1\u5e03\uff0c\u5bf9\u63a8\u52a8\u6211\u56fd\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u5de5\u4f5c\uff0c\u4fdd\u969c\u5e7f\u5927\u4eba\u6c11\u7fa4\u4f17\u7528\u836f\u5b89\u5168\u8d77\u5230\u4e86\u79ef\u6781\u4f5c\u7528\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u968f\u7740\u836f\u54c1\u5e02\u573a\u7684\u5168\u7403\u5316\uff0c\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e5f\u8d8b\u4e8e\u56fd\u9645\u5316\uff0c\u5176\u4ed6\u56fd\u5bb6\u7684\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4fe1\u606f\u5bf9\u4fdd\u969c\u6211\u56fd\u516c\u4f17\u7528\u836f\u5b89\u5168\u5177\u6709\u975e\u5e38\u91cd\u8981\u7684\u4f5c\u7528\uff0c\u4e5f\u662f\u6211\u56fd\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u5de5\u4f5c\u7684\u91cd\u8981\u5185\u5bb9\u4e4b\u4e00\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u300a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u300b\u56fd\u5916\u4fe1\u606f\u7248\u5c06\u4ecb\u7ecd\u56fd\u5916\u5176\u4ed6\u76d1\u7ba1\u90e8\u95e8\u53d1\u5e03\u7684\u6700\u65b0\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u5206\u6790\u5b89\u5168\u6027\u4fe1\u606f\u53d1\u5e03\u7684\u80cc\u666f\u53ca\u76f8\u5173\u6280\u672f\u8d44\u6599\uff0c\u540c\u65f6\u53c2\u8003\u901a\u62a5\u54c1\u79cd\u5728\u6211\u56fd\u4e34\u5e8a\u4f7f\u7528\u60c5\u51b5\uff0c\u8bc4\u4f30\u5176\u5728\u6211\u56fd\u7684\u6548\u76ca<\/span>\/\u98ce\u9669\u3002\u53d1\u5e03\u300a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u300b\u56fd\u5916\u4fe1\u606f\u7248\u65e8\u5728\u8ba9\u5e7f\u5927\u4eba\u6c11\u7fa4\u4f17\uff0c\u5c24\u5176\u662f\u533b\u52a1\u5de5\u4f5c\u8005\uff0c\u5168\u9762\u4e86\u89e3\u548c\u638c\u63e1\u6700\u65b0\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4fe1\u606f\uff0c\u964d\u4f4e\u6216\u5c3d\u91cf\u907f\u514d\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u7684\u91cd\u590d\u53d1\u751f\uff0c\u4ece\u800c\u4e3a\u4fdd\u969c\u516c\u4f17\u7528\u836f\u5b89\u5168\u7b51\u8d77\u4e00\u9053\u6709\u6548\u5c4f\u969c\u3002<\/span>
\n<\/span>          <\/span><\/span>\u4f7f\u7528\u91cd\u7ec4\u4eba\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\u5e94\u63a7\u5236\u8840\u7ea2\u86cb\u767d\u6d53\u5ea6<\/span><\/span><\/b><\/span>\n<\/p>\n

\n\t  \u4e00\u3001\u80cc\u666f<\/span><\/span>
\n<\/span>  <\/span>2006\u5e7411\u670816\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5c31\u53d1\u8868\u5728\u300a\u65b0\u82f1\u683c\u5170\u6742\u5fd7\u300b\u4e0a\u7684\u4e00\u9879\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\u53d1\u5e03\u5b89\u5168\u6027\u516c\u544a\u3002\u516c\u544a\u79f0\uff0c\u4e00\u9879\u540d\u4e3a\u201cCHOIR\u201d\u7684\u7814\u7a76\u53d1\u73b0\uff1a\u672a\u63a5\u53d7\u900f\u6790\u6cbb\u7597\u7684\u6162\u6027\u80be\u75c5\u60a3\u8005\u4f7f\u7528\u963f\u6cd5\u4f9d\u6cca\u6c40\uff08epoetin  alfa\uff0c\u91cd\u7ec4\u4eba\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\uff09\u4ee5\u671f\u5c06\u8840\u7ea2\u86cb\u767d\uff08Hb\uff09\u6d53\u5ea6\u63d0\u9ad8\u5230\u8bf4\u660e\u4e66\u63a8\u8350\u7684\u6d53\u5ea6\uff0812 g\/dL\uff09\u4ee5\u4e0a\uff0c\u7ed3\u679c\u51fa\u73b0\u6b7b\u4ea1\u3001\u5fc3\u808c\u6897\u6b7b\uff0c\u6216\u56e0\u5fc3\u8870\u548c\u8111\u5352\u4e2d\u4f4f\u9662\u7684\u98ce\u9669\u5347\u9ad8[1]\u3002<\/span>
\n<\/span>  <\/span>2007\u5e741\u670826\u65e5\uff0c\u7f8e\u56fdFDA\u548cAmgen\u516c\u53f8\u5171\u540c\u53d1\u5e03\u4e86\u4e00\u9879\u5927\u578b\u3001\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u5b89\u6170\u5242\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u3002\u8bd5\u9a8c\u53d1\u73b0\uff0c\u80bf\u7624\u60a3\u8005\u4f7f\u7528\u8fbe\u4f9d\u6cca\u6c40\uff08darbepoetin  alfa\uff0c\u957f\u6548\u91cd\u7ec4\u4eba\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\uff09\u6cbb\u7597\u80bf\u7624\u672c\u8eab\u5f15\u8d77\u7684\u8d2b\u8840\uff0c\u60a3\u8005\u7684\u8f93\u8840\u9700\u6c42\u6ca1\u6709\u51cf\u5c11\uff0c\u4e14\u6b7b\u4ea1\u7387\u589e\u9ad8\u3002<\/span>
\n<\/span>\u6b64\u540e\uff0c\u7f8e\u56fd\u3001\u6b27\u76df\u7b49\u7684\u836f\u54c1\u7ba1\u7406\u90e8\u95e8\u66fe\u591a\u6b21\u53d1\u5e03\u5173\u4e8e\u91cd\u7ec4\u4eba\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\uff08<\/span>rHuEPO\uff09\u7684\u5b89\u5168\u6027\u516c\u544a\uff0c\u8b66\u793a\u8be5\u7c7b\u836f\u54c1\u53ef\u80fd\u5bfc\u81f4\u6b7b\u4ea1\u7387\u589e\u52a0\u3001\u53d1\u751f\u4e25\u91cd\u5fc3\u8840\u7ba1\u548c\u8840\u6813\u4e8b\u4ef6\u53ca\u4fc3\u8fdb\u80bf\u7624\u589e\u957f\u7684\u98ce\u9669\u3002FDA\u5df2\u4e8e2007\u5e74\u5bf9\u91cd\u7ec4\u4eba\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\u7684\u8bf4\u660e\u4e66\u8fdb\u884c\u4e86\u4fee\u6539\u3002<\/span>
\n<\/span>  \u81ea<\/span>2006\u5e74\u62a5\u9053rHuEPO\u7684\u98ce\u9669\u4ee5\u6765\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u4e00\u76f4\u5bf9\u8be5\u7c7b\u836f\u54c1\u4fdd\u6301\u9ad8\u5ea6\u5173\u6ce8\uff0c\u53ca\u65f6\u8ddf\u8e2a\u56fd\u5916\u6700\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u5e76\u5728\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7f51\u7ad9\uff08<\/span>www.nmpa.gov.cn<\/span><\/u><\/a>\uff09\u3001\u4e2d\u5fc3\u7f51\u7ad9\uff08<\/span>www.cdr.gov.cn\uff09\u7b49\u8f7d\u4f53\u62a5\u9053\u4e86\u76f8\u5173\u4fe1\u606f\uff0c\u540c\u65f6\u5bc6\u5207\u5173\u6ce8\u6211\u56fdrHuEPO\u7684\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u60c5\u51b5\u3002\u867d\u7136\u6211\u56fd\u76ee\u524d\u5c1a\u672a\u53d1\u73b0rHuEPO\u4e0a\u8ff0\u98ce\u9669\u76f8\u5173\u7684\u7814\u7a76\u548c\u62a5\u544a\uff0c\u4f46\u662f\u4e3a\u4f7f\u5e7f\u5927\u533b\u62a4\u4eba\u5458\u548c\u60a3\u8005\u53ca\u65f6\u4e86\u89e3rHuEPO\u53ef\u80fd\u8bf1\u53d1\u7684\u98ce\u9669\uff0c\u4fdd\u969c\u4e34\u5e8a\u7528\u836f\u5b89\u5168\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u7279\u901a\u62a5\u6b64\u5b89\u5168\u6027\u4fe1\u606f\u3002<\/span><\/span>\n<\/p>\n

\n\t\u4e8c\u3001\u4ea7\u54c1\u57fa\u672c\u60c5\u51b5<\/span><\/span>
\n<\/span>  <\/span>rHuEPO\u662f\u7ecf\u91cd\u7ec4DNA\u6280\u672f\u4ea7\u751f\u7684\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\uff0c\u4e3a165\u4e2a\u6c28\u57fa\u9178\u7ec4\u6210\u7684\u7cd6\u86cb\u767d\u3002\u5176\u4e0e\u7ea2\u7cfb\u7956\u7ec6\u80de\u7684\u8868\u9762\u53d7\u4f53\u7ed3\u5408\uff0c\u523a\u6fc0\u7ea2\u7cfb\u7956\u7ec6\u80de\u7684\u5206\u5316\uff0crHuEPO\u4ea6\u53ef\u4fc3\u4f7f\u7ea2\u7ec6\u80de\u81ea\u9aa8\u9ad3\u5411\u8840\u6db2\u4e2d\u91ca\u653e\uff0c\u8fdb\u800c\u8f6c\u5316\u4e3a\u6210\u719f\u7ea2\u7ec6\u80de\u3002\u53e6\u5916\uff0crHuEPO\u6709\u7a33\u5b9a\u7ea2\u7ec6\u80de\u819c\uff0c\u63d0\u9ad8\u7ea2\u7ec6\u80de\u819c\u6297\u6c27\u5316\u9176\u7684\u529f\u80fd\u3002<\/span>
\n<\/span>  <\/span>rHuEPO\u4e3b\u8981\u7528\u4e8e\u6cbb\u7597\u80be\u529f\u80fd\u4e0d\u5168\u6240\u81f4\u7684\u8d2b\u8840\uff0c\u4e34\u5e8a\u4e0a\u8fd8\u7528\u4e8e\u80bf\u7624\u76f8\u5173\u8d2b\u8840\u548c\u5916\u79d1\u56f4\u624b\u672f\u671f\u7684\u7ea2\u7ec6\u80de\u52a8\u5458\u7b49\u3002\u56fd\u5185\u4e0d\u540c\u4f01\u4e1a\u8be5\u7c7b\u836f\u54c1\u7684\u9002\u5e94\u75c7\u4e0d\u5b8c\u5168\u76f8\u540c\u3002rHuEPO\u7684\u5546\u54c1\u540d\u6709\u7f57\u53ef\u66fc\u3001\u5f18\u80fd\u3001\u5b81\u7ea2\u6b23\u3001\u96ea\u8fbe\u5347\u3001\u4f73\u6797\u8c6a\u3001\u6021\u666e\u5229\u3001\u4f9d\u666e\u5b9a\u3001\u6021\u5b9d\u3001\u5229\u8840\u5b9d\u3001\u76ca\u6bd4\u5965\u3001\u4f9d\u500d\u3001\u6d4e\u8109\u6b23\u3001\u73af\u5c14\u535a\u3001\u8d5b\u535a\u5c14\u3001\u8bfa\u4e4b\u7d20\u7b49\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e09\u3001<\/span>rHuEPO\u7684\u5b89\u5168\u6027\u98ce\u9669<\/span>
\n<\/span>  \u7f8e\u56fd<\/span>FDA\u7b49\u836f\u653f\u90e8\u95e8\u53d1\u5e03\u7684\u5173\u4e8erHuEPO\u7684\u5b89\u5168\u6027\u4fe1\u606f\u53ca\u7814\u7a76\u8d44\u6599\u6d89\u53ca\u7684\u591a\u9879\u4e34\u5e8a\u7814\u7a76\u663e\u793a\uff0c\u4f7f\u7528\u8be5\u7c7b\u836f\u54c1\u4f7f\u5f97Hb\u6d53\u5ea6\u7ef4\u6301\u5728\u8bf4\u660e\u4e66\u63a8\u8350\u6d53\u5ea6\uff0812g\/dL\uff09\u4ee5\u4e0a\u7684\u75c5\u4eba\u5b58\u5728\u6b7b\u4ea1\u7387\u589e\u52a0\u3001\u53d1\u751f\u4e25\u91cd\u5fc3\u8840\u7ba1\u548c\u8840\u6813\u4e8b\u4ef6\u53ca\u4fc3\u8fdb\u80bf\u7624\u589e\u957f\u7684\u98ce\u9669\u3002<\/span><\/span>\n<\/p>\n

\n\t  \uff08\u4e00\uff09\u80be\u75c5\u60a3\u8005<\/span><\/span>
\n<\/span>  \u7814\u7a76<\/span>1[1]\uff1a1432\u540d\u672a\u900f\u6790\u7684\u80be\u529f\u80fd\u8870\u7aed\u8d2b\u8840\u60a3\u8005\u88ab\u5206\u914d\u5230\u4e24\u4e2a\u6cbb\u7597\u7ec4\uff0c\u4e24\u7ec4\u60a3\u8005\u5747\u7528\u963f\u6cd5\u4f9d\u4f2f\u6c40\u6cbb\u7597\u8d2b\u8840\uff0cHb\u7ef4\u6301\u6d53\u5ea6\u5747\u6570\u5206\u522b\u4e3a13.5g\/dL\u548c11.3g\/dL\u3002\u7814\u7a76\u663e\u793a\uff0c\u9ad8Hb\u6d53\u5ea6\u7ec4\u60a3\u8005\u53d1\u751f\u4e25\u91cd\u5fc3\u8840\u7ba1\u4e8b\u4ef6\uff08\u6b7b\u4ea1\u3001\u5fc3\u808c\u6897\u6b7b\u3001\u8111\u5352\u4e2d\u3001\u5145\u8840\u6027\u5fc3\u529b\u8870\u7aed\uff09\u7684\u53d1\u751f\u7387\u4e3a17.5%\uff08125\/715\uff09\uff0c\u4f4eHb\u6d53\u5ea6\u7ec4\u53d1\u751f\u7387\u4e3a13.5%\uff0897\/717\uff09\uff0c\u9ad8\u6d53\u5ea6\u7ec4\u66f4\u6613\u53d1\u751f\u4e25\u91cd\u5fc3\u8840\u7ba1\u4e8b\u4ef6\uff08HR=1.3\uff0c95%CI:1.0\uff5e1.7\uff0cp\uff1d0.03\uff09\u3002<\/span>
\n<\/span>  \u7814\u7a76<\/span>2[2]\uff1a1265\u540d\u900f\u6790\u7684\u80be\u529f\u80fd\u8870\u7aed\u8d2b\u8840\u60a3\u8005\u88ab\u5206\u914d\u5230\u4e24\u4e2a\u6cbb\u7597\u7ec4\uff0c\u4e24\u7ec4\u60a3\u8005\u5747\u7528\u963f\u6cd5\u4f9d\u4f2f\u6c40\u6cbb\u7597\u8d2b\u8840\uff0c\u7ea2\u7ec6\u80de\u6bd4\u5bb9\u5747\u6570\u5206\u522b\u4e3a42\u00b13%\u548c30\u00b13%\u3002\u7814\u7a76\u663e\u793a\uff0c\u9ad8Hb\u6d53\u5ea6\u7ec4\u60a3\u8005\u6b7b\u4ea1\u7387\u4e3a35%\uff08221\/634\uff09\uff0c\u4f4e\u6d53\u5ea6\u7ec4\u6b7b\u4ea1\u7387\u4e3a29%\uff08185\/631\uff09\uff0c\u9ad8\u6d53\u5ea6\u7ec4\u6b7b\u4ea1\u7387\u589e\u9ad8\u7684\u539f\u56e0\u5c1a\u4e0d\u6e05\u695a\u3002\u975e\u81f4\u6b7b\u6027\u5fc3\u808c\u6897\u6b7b\uff083.1% vs 2.3%\uff09\u3001\u900f\u6790\u8840\u7ba1\u901a\u8def\u6813\u585e\uff0839% vs 29%\uff09\u53ca\u5176\u4ed6\u8840\u6813\u4e8b\u4ef6\uff0822% vs 18%\uff09\u5728\u9ad8\u6d53\u5ea6\u7ec4\u4e2d\u4e5f\u6709\u8f83\u9ad8\u7684\u53d1\u751f\u7387\u3002<\/span><\/span>\n<\/p>\n

\n\t  \uff08\u4e8c\uff09\u80bf\u7624\u60a3\u8005<\/span><\/span>
\n<\/span>  \u4e73\u817a\u764c\u3001\u5934\u9888\u764c\u3001\u5b50\u5bab\u9888\u764c\u3001\u6dcb\u5df4\u7624\u548c\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u7684\u60a3\u8005\u4f7f\u7528<\/span>rHuEPO\u4f7f\u5f97Hb\u6d53\u5ea6\u7ef4\u6301\u572812 g\/dL\u4ee5\u4e0a\u65f6\uff0c\u75c5\u4eba\u7684\u80bf\u7624\u589e\u957f\u901f\u5ea6\u52a0\u5feb\u548c\/\u6216\u751f\u5b58\u7387\u964d\u4f4e\uff08\u8be6\u89c1\u88681\uff09\uff1b\u5bf9\u4e8e\u4f7f\u7528rHuEPO\u4f7f\u5f97Hb\u6d53\u5ea6\u7ef4\u6301\u572812 g\/dL\u4ee5\u4e0b\u7684\u75c5\u4eba\uff0c\u8fd8\u6ca1\u6709\u6392\u9664\u80bf\u7624\u589e\u957f\u901f\u5ea6\u52a0\u5feb\u3001\u6b7b\u4ea1\u7387\u5347\u9ad8\u7684\u98ce\u9669\u3002\u4e34\u5e8a\u5bf9\u7167\u8bd5\u9a8c\u5e76\u6ca1\u6709\u8868\u660e\u80bf\u7624\u75c5\u4eba\u4f7f\u7528rHuEPO\u80fd\u591f\u6539\u5584\u8d2b\u8840\u75c7\u72b6\u3001\u751f\u5b58\u8d28\u91cf\u548c\u5065\u5eb7\u72b6\u51b5\u3002<\/span><\/span>\n<\/p>\n

\n\t  \uff08\u4e09\uff09\u827e\u6ecb\u75c5\u60a3\u8005<\/span><\/span>
\n<\/span>  \u4e34\u5e8a\u5bf9\u7167\u8bd5\u9a8c\u5e76\u6ca1\u6709\u8868\u660e\u4f7f\u7528\u9f50\u591a\u592b\u5b9a\u7684\u827e\u6ecb\u75c5\u60a3\u8005\u4f7f\u7528<\/span>rHuEPO\u80fd\u591f\u6539\u5584\u8d2b\u8840\u75c7\u72b6\u3001\u751f\u5b58\u8d28\u91cf\u548c\u5065\u5eb7\u72b6\u51b5\u3002<\/span><\/span>\n<\/p>\n

\n\t<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
\n

\n\t\t\t\t\t\t\u539f\u60a3\u75be\u75c5\uff08<\/span>n<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u653e\u5316\u7597\u63aa\u65bd<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u6cbb\u7597\u836f\u7269<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u76ee\u6807<\/span>Hb<\/span>\uff08<\/span>g\/dl<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\tHb<\/span>\u8fbe\u5230\u6d53\u5ea6\uff08\u4e2d\u4f4d\u6570\uff0c<\/span>Q1<\/span>\uff0c<\/span>Q3<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u7ed3<\/span> <\/span>\u679c<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u7edf\u8ba1\u5b66\u53c2\u6570<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\uff08<\/span>HR<\/span>\uff0c<\/span>95%CI<\/span>\uff0c<\/span>P<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u4e73\u817a\u8f6c\u79fb\u764c\uff08<\/span>939<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u5316\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u963f\u6cd5\u4f9d\u4f2f\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12~14<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12.9<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t12.2<\/span>\uff0c<\/span>13.3<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12<\/span>\u4e2a\u6708\u751f\u5b58\u7387\u964d\u4f4e\uff08<\/span>70% vs. 76%<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.3<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t1.07~1.75<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t0.012 [3]<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u6dcb\u5df4\u7624\uff08<\/span>344<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u5316\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u8fbe\u4f9d\u6cca\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t13~15<\/span>\uff08\u7537\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t13~14<\/span>\uff08\u5973\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t11<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t9.8<\/span>\uff0c<\/span>12.1<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u603b\u4f53\u751f\u5b58\u7387\u964d\u4f4e<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.36<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t1.02 ~1.82<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u4e73\u817a\u764c\uff08<\/span>733<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u5316\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u8fbe\u4f9d\u6cca\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12.5~13<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t13.1<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t12.5<\/span>\uff0c<\/span>13.7<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u751f\u5b58\u7387\u964d\u4f4e\uff08<\/span>86% vs. 90%<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t3<\/span>\u5e74\u65e0\u8fdb\u5c55\u751f\u5b58\u7387\u964d\u4f4e\uff08<\/span>72% vs. 78%<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.42<\/span>\uff0c<\/span>0.93~2.18<\/span>\uff0c<\/span>– –<\/span>\uff1b<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t1.33<\/span>\uff0c<\/span>0.99 ~1.79<\/span>\uff0c<\/span>– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u5b50\u5bab\u9888\u764c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\uff08<\/span>114<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u5316\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\u653e\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u963f\u6cd5\u4f9d\u4f2f\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12~14<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12.7<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t12.1<\/span>\uff0c<\/span>13.3<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u751f\u5b58\u7387\u964d\u4f4e\uff08<\/span>61% vs. 71%<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t3<\/span>\u5e74\u65e0\u8fdb\u5c55\u751f\u5b58\u7387\u964d\u4f4e\uff08<\/span>59% vs. 62%<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\u5c40\u90e8\u63a7\u5236\u7387\u964d\u4f4e<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.28,0.68 ~ 2.42<\/span>\uff0c<\/span>– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t1.06,0.58~ 1.91<\/span>\uff0c<\/span>– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u5934\u9888\u764c\uff08<\/span>351<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u653e\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u963f\u6cd5\u4f9d\u4f2f\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u2265<\/span>14<\/span>\uff08\u5973\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\u2265<\/span>15<\/span>\uff08\u7537\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t5<\/span>\u5e74\u5c40\u90e8\u65e0\u8fdb\u5c55\u751f\u5b58\u7387\u964d\u4f4e<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\u603b\u4f53\u751f\u5b58\u7387\u964d\u4f4e<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.62<\/span>\uff0c<\/span>1.22~2.14<\/span>\uff0c<\/span>0.0008<\/span>\uff1b<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t1.39<\/span>\uff0c<\/span>1.05~1.84<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t0.02[4]<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u5934\u9888\u764c\uff08<\/span>522<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u653e\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u8fbe\u4f9d\u6cca\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t14~15.5<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t5<\/span>\u5e74\u5c40\u90e8\u63a7\u5236\u7387\u964d\u4f4e<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\u603b\u4f53\u751f\u5b58\u7387\u964d\u4f4e<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.44<\/span>\uff0c<\/span>1.06~1.96<\/span>\uff0c<\/span>0.02<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t1.28<\/span>\uff0c<\/span>0.98~1.68<\/span>\uff0c<\/span>0.08<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08<\/span>70<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u672a\u653e\u5316\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u963f\u6cd5\u4f9d\u4f2f\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12~14<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u603b\u4f53\u751f\u5b58\u7387\u964d\u4f4e<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t\uff08\u4e2d\u4f4d\u6570\uff1a<\/span>63<\/span>\u5929<\/span>vs.129<\/span>\u5929\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.84<\/span>\uff0c<\/span>– –<\/span>\uff0c<\/span>0.08<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u975e\u9aa8\u9ad3\u6076\u6027\u80bf\u7624\uff08<\/span>989<\/span>\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u672a\u653e\u5316\u7597<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u8fbe\u4f9d\u6cca\u6c40<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t12~13<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t10.6<\/span>\uff0c<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t9.4<\/span>\uff0c<\/span>11.8<\/span><\/span>\n\t\t\t\t\t<\/p>\n

\n\t\t\t\t\t\t <\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u603b\u4f53\u751f\u5b58\u7387\u964d\u4f4e\uff08\u4e2d\u4f4d\u6570\uff1a<\/span>8<\/span>\u4e2a\u6708<\/span>vs.10.8<\/span>\u4e2a\u6708\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.3<\/span>\uff0c<\/span>1.07~1.57<\/span>\uff0c<\/span>– –<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

  \uff08\u56db\uff09\u5916\u79d1\u624b\u672f\u75c5\u4eba<\/span><\/span>
\n<\/span>  \u5728\u6ca1\u6709\u4f7f\u7528\u6297\u51dd\u836f\u7269\u7684\u60c5\u51b5\u4e0b\u4f7f\u7528<\/span>rHuEPO\uff0c\u9759\u8109\u8840\u6813\u5f62\u6210\u7684\u51e0\u7387\u589e\u52a0\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u8868<\/span>1\uff1a\u9488\u5bf9\u80bf\u7624\u60a3\u8005\u5e94\u7528rHuEPO\u7684\u4e34\u5e8a\u5bf9\u7167\u7814\u7a76\u7ed3\u679c<\/span><\/span>\n<\/p>\n

\n\t
\n<\/span>  \u6ce8\uff1a<\/span>\u201c- -\u201d\u8868\u793a\u5185\u5bb9\u7f3a\u5931\u6216\u4e0d\u8be6\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u56db\u3001\u5173\u4e8e<\/span>rHuEPO\u7684\u4e0d\u826f\u53cd\u5e94\u60c5\u51b5<\/span>
\n<\/span>  \u68c0\u7d22\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u75c5\u4f8b\u62a5\u544a\u6570\u636e\u5e93\uff0c\u622a\u81f3<\/span>2008\u5e746\u670810\u65e5\uff0c\u68c0\u7d22\u5230rHuEPO\u76f8\u5173\u75c5\u4f8b141\u4f8b\uff0c\u5176\u4e2d\u4e25\u91cd\u75c5\u4f8b5\u4f8b\u3002\u4e0d\u826f\u53cd\u5e94\u4e3b\u8981\u8868\u73b0\u4e3a\uff1a\u9ad8\u8840\u538b\u3001\u76ae\u75b9\u3001\u5934\u75db\u3001\u7619\u75d2\u3001\u53d1\u70ed\u3001\u8d2b\u8840\u52a0\u91cd\u3001\u5fc3\u60b8\u3001\u6076\u5fc3\u3001\u5c40\u90e8\u75bc\u75db\u3001\u809d\u529f\u80fd\u5f02\u5e38\u3001\u51dd\u8840\u529f\u80fd\u4ea2\u8fdb\u3001\u8fc7\u654f\u6837\u53cd\u5e94\u3001\u5455\u5410\u3001\u808c\u75db\u3001\u5173\u8282\u75db\u3001\u4e4f\u529b\u3001\u80f8\u95f7\u3001\u5934\u6655\u3001\u8179\u6cfb\u3001\u8fc7\u654f\u6027\u4f11\u514b\u7b49\u3002\u6b7b\u4ea1\u75c5\u4f8b1\u4f8b\uff0c\u5176\u4e0d\u826f\u53cd\u5e94\u4e3a\u8fc7\u654f\u6027\u4f11\u514b\u3002\u672a\u68c0\u7d22\u5230\u4e25\u91cd\u5fc3\u8840\u7ba1\u548c\u8840\u6813\u4e8b\u4ef6\u53ca\u4fc3\u8fdb\u80bf\u7624\u589e\u957f\u76f8\u5173\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u75c5\u4f8b\u62a5\u544a\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e94\u3001\u5efa\u8bae<\/span><\/span>
\n<\/span>  \u9274\u4e8e\u4e0d\u5408\u7406\u4f7f\u7528<\/span>rHuEPO\u7684\u60a3\u8005\u53ef\u80fd\u5b58\u5728\u4e0a\u8ff0\u98ce\u9669\uff0c\u533b\u751f\u5904\u65b9rHuEPO\u65f6\uff0c\u5e94\u6743\u8861\u4f7f\u7528rHuEPO\u7684\u98ce\u9669\u4e0e\u6548\u76ca\uff1b\u5982\u9700\u7528\u836f\uff0c\u5e94\u4e25\u683c\u6309\u7167\u8bf4\u660e\u4e66\u9002\u5e94\u75c7\u4f7f\u7528\u8be5\u7c7b\u836f\u54c1\uff0c\u5e76\u76d1\u6d4b\u60a3\u8005\u7684Hb\u6d53\u5ea6\uff1b\u9488\u5bf9\u4e0d\u540c\u75be\u75c5\uff0c\u4e25\u683c\u6309\u7167\u8bf4\u660e\u4e66\u6216\u53c2\u8003\u76f8\u5173\u6743\u5a01\u533b\u7597\u6307\u5357\u63a7\u5236Hb\u6d53\u5ea6\uff1b\u76ee\u524d\u8d44\u6599\u663e\u793a\uff0c\u6b63\u786e\u5408\u7406\u4f7f\u7528rHuEPO\u7684\u6548\u76ca\u4ecd\u7136\u5927\u4e8e\u98ce\u9669\uff0c\u5bf9\u4e8e\u76ee\u524d\u6b63\u5728\u7528\u836f\u7684\u60a3\u8005\uff0c\u5728\u6ca1\u6709\u54a8\u8be2\u533b\u751f\u4e4b\u524d\u4e0d\u8981\u64c5\u81ea\u505c\u836f\uff0c\u5982\u60a3\u8005\u6216\u5176\u770b\u62a4\u8005\u53d1\u73b0\u4e0a\u8ff0\u98ce\u9669\u6216\u76f8\u5173\u75c7\u72b6\u5e94\u53ca\u65f6\u544a\u77e5\u533b\u751f\u3002<\/span><\/span>\n<\/p>\n

\n\t
\n<\/span>  \u53c2\u8003\u4fe1\u606f\uff1a<\/span><\/span>
\n<\/span>  <\/span>1\uff0eSingh AK, Szczech L, Tang KL, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease. N Engl j Med. 2006; 355:2085-98.<\/span>
\n<\/span>  <\/span>2\uff0eBesarab A, Bolton WK, Browne JK, et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. NEJM.1998;339:584-90.<\/span>
\n<\/span>  <\/span>3\uff0eLeyland-Jones B, Semiglazov V, Pawlicki M, et al. Maintaining Normal Hemoglobin Levels with Epoetin Alfa in Mainly Nonanemic Patients with Metastatic Breast Cancer Receiving First-Line Chemotherapy: A Survival Study. JCO. 2005; 23(25): 1-13.<\/span>
\n<\/span>  <\/span>4\uff0eHenke M, Laszig R, R\u00fcbe C, et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomized, double-blind, placebo-controlled trial. The Lancet.2003; 362:1255-1260.<\/span><\/span>\n<\/p>\n

\n\t\u8b66\u60d5\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u751f\u6b96\u6bd2\u6027<\/span><\/span><\/b><\/span>\n<\/p>\n

\n\t  \u4e00\u3001\u80cc\u666f<\/span><\/span>
\n<\/span>  <\/span>2007\u5e7410\u6708\uff0c\u7f57\u6c0f\u516c\u53f8\u5206\u522b\u4e0e\u7f8e\u56fd\u3001\u82f1\u56fd\u836f\u54c1\u7ba1\u7406\u90e8\u95e8\u5171\u540c\u53d1\u5e03\u4fe1\u606f\uff0c\u8b66\u544a\u598a\u5a20\u671f\u95f4\u4f7f\u7528\u5417\u66ff\u9ea6\u8003\u915a\u916f\uff08\u5546\u54c1\u540d\uff1a\u9a81\u6089\uff09\u53ef\u80fd\u589e\u52a0\u6d41\u4ea7\u548c\u5148\u5929\u7578\u5f62\u7684\u98ce\u9669\uff0c\u5f3a\u8c03\u80b2\u9f84\u5973\u6027\u60a3\u8005\u5fc5\u987b\u91c7\u53d6\u6709\u6548\u63aa\u65bd\u907f\u5b55\u3002\u7f8e\u56fd\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u598a\u5a20\u671f\u7528\u836f\u5206\u7c7b\u4e5f\u56e0\u6b64\u4eceC\u7c7b\uff08\u4e0d\u80fd\u6392\u9664\u5bf9\u80ce\u513f\u4ea7\u751f\u4f24\u5bb3\u7684\u98ce\u9669\uff09\u6539\u53d8\u4e3aD\u7c7b\uff08\u5b58\u5728\u5bf9\u80ce\u513f\u4ea7\u751f\u98ce\u9669\u7684\u8bc1\u636e\uff09\u3002<\/span>
\n<\/span>  \u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u4e00\u76f4\u5bf9\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u5b89\u5168\u6027\u95ee\u9898\u4fdd\u6301\u5173\u6ce8\uff0c\u53ca\u65f6\u8ddf\u8e2a\u56fd\u5916\u6700\u65b0\u7814\u7a76\u548c\u62a5\u9053\uff0c\u5e76\u5728\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7f51\u7ad9<\/span>www.nmpa.gov.c>\uff09\u3001\u4e2d\u5fc3\u7f51\u7ad9\uff08www.cdr.gov.cn>\uff09\u7b49\u8f7d\u4f53\u4e0a\u62a5\u9053\u4e86\u76f8\u5173\u4fe1\u606f\uff0c\u540c\u65f6\u5bc6\u5207\u5173\u6ce8\u6211\u56fd\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u7684\u53d1\u751f\u60c5\u51b5\u3002\u867d\u7136\u6211\u56fd\u76ee\u524d\u5c1a\u672a\u6536\u5230\u4e0e\u5417\u66ff\u9ea6\u8003\u915a\u916f\u76f8\u5173\u7684\u751f\u6b96\u6bd2\u6027\u62a5\u544a\uff0c\u4f46\u4e3a\u4f7f\u5e7f\u5927\u533b\u52a1\u4eba\u5458\u548c\u60a3\u8005\u53ca\u65f6\u4e86\u89e3\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u4f7f\u7528\u98ce\u9669\uff0c\u4fdd\u969c\u4e34\u5e8a\u7528\u836f\u5b89\u5168\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u7279\u901a\u62a5\u6b64\u5b89\u5168\u6027\u4fe1\u606f\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e8c\u3001\u4ea7\u54c1\u57fa\u672c\u60c5\u51b5<\/span><\/span>
\n<\/span>  \u5417\u66ff\u9ea6\u8003\u915a\u916f\uff08\u53c8\u540d\u9709\u915a\u9178\u916f\uff09\u662f\u4e00\u79cd\u514d\u75ab\u6291\u5236\u5242<\/span>,1997\u5e74\u5728\u6211\u56fd\u83b7\u51c6\u4e0a\u5e02\uff0c\u6709\u7247\u5242\u3001\u80f6\u56ca\u5242\u548c\u6ce8\u5c04\u5242\u3002\u4e3b\u8981\u7528\u4e8e\u63a5\u53d7\u540c\u79cd\u5f02\u4f53\u80be\u810f\u6216\u809d\u810f\u79fb\u690d\u7684\u60a3\u8005\u9884\u9632\u5668\u5b98\u7684\u6392\u65a5\u53cd\u5e94\uff0c\u5e38\u4e0e\u5176\u4ed6\u514d\u75ab\u6291\u5236\u5242\uff0c\u5982\u73af\u5b62\u7d20A\u3001\u4ed6\u514b\u83ab\u53f8\u3001\u76ae\u8d28\u7c7b\u56fa\u9187\u7b49\u540c\u65f6\u4f7f\u7528\u3002<\/span>
\n<\/span>\u5417\u66ff\u9ea6\u8003\u915a\u916f\u53e3\u670d\u6216\u9759\u8109\u7ed9\u836f\u540e\u5438\u6536\u8fc5\u901f\uff0c\u5728\u4f53\u5185\u8131\u916f\u5316\u540e\u5f62\u6210\u5177\u6709\u514d\u75ab\u6291\u5236\u6d3b\u6027\u7684\u4ee3\u8c22\u4ea7\u7269\u9ea6\u8003\u915a\u9178\u3002\u9ea6\u8003\u915a\u9178\u901a\u8fc7\u6291\u5236\u6b21\u9ec4\u560c\u5464\u5355\u6838\u82f7\u9178\u8131\u6c22\u9176\u963b\u6b62\u9e1f\u560c\u5464\u7684\u5408\u6210<\/span>,\u5e76\u53ef\u9009\u62e9\u6027\u963b\u65adT\u6dcb\u5df4\u7ec6\u80de\u548cB\u6dcb\u5df4\u7ec6\u80de\u7684\u589e\u6b96,\u53d1\u6325\u514d\u75ab\u6291\u5236\u4f5c\u7528\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e09\u3001\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u751f\u6b96\u6bd2\u6027<\/span><\/span>
\n<\/span>  \u7f57\u6c0f\u516c\u53f8\u79f0\uff0c\u6839\u636e\u7f8e\u56fd\u5168\u56fd\u79fb\u690d\u540e\u598a\u5a20\u767b\u8bb0\u5904\uff08<\/span>NTPR\uff09\u7684\u6570\u636e\u548c\u7f57\u6c0f\u516c\u53f8\u904d\u5e03\u5168\u7403\u7684\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u7cfb\u7edf\u6536\u96c6\u7684\u6570\u636e\uff0c\u5728\u598a\u5a20\u671f\u95f4\u4f7f\u7528\u5417\u66ff\u9ea6\u8003\u915a\u916f\u53ef\u80fd\u4f1a\u589e\u52a0\u598a\u5a20\u59343\u4e2a\u6708\u53d1\u751f\u6d41\u4ea7\u548c\u5148\u5929\u7578\u5f62\u7684\u98ce\u9669\uff0c\u7279\u522b\u662f\u5916\u8033\u548c\u9762\u90e8\u7578\u5f62\uff08\u5305\u62ec\u5154\u5507\u3001\u816d\u88c2\uff09\uff0c\u4ee5\u53ca\u80a2\u7aef\u3001\u5fc3\u810f\u3001\u98df\u9053\u548c\u80be\u810f\u7578\u5f62\u3002<\/span><\/span>\n<\/p>\n

\n\t  \uff08\u4e00\uff09<\/span>NTPR\u6570\u636e<\/span>
\n<\/span>  <\/span>2006\u5e7412\u6708\uff0cNTPR\u516c\u5e03\u4e86\u524d\u77bb\u6027\u7814\u7a76\u6570\u636e\uff0c24\u540d\u5973\u6027\u79fb\u690d\u60a3\u8005\u5728\u63a5\u53d7\u5417\u66ff\u9ea6\u8003\u915a\u916f\u6cbb\u7597\u671f\u95f4\u5171\u62a5\u544a\u4e8633\u6b21\u598a\u5a20\uff0c\u5176\u4e2d15\u6b21\u81ea\u7136\u6d41\u4ea7\uff0845%\uff09\uff0c\u5176\u4f5918\u6b21\u4ea7\u4e0b\u6d3b\u5a74\u3002\u5728\u8fd918\u4e2a\u5a74\u513f\u4e2d\uff0c\u67094\u4e2a\u51fa\u73b0\u4e86\u7ed3\u6784\u7578\u5f62\uff0822%\uff09\u3002<\/span><\/span>\n<\/p>\n

\n\t  \uff08\u4e8c\uff09\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u6570\u636e<\/span><\/span>
\n<\/span>  \u7f57\u6c0f\u516c\u53f8\u56de\u987e\u4e86<\/span>1995\u5e74\u81f32007\u5e74\u836f\u54c1\u4e0a\u5e02\u540e\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u6570\u636e\uff0c\u572877\u540d\u598a\u5a20\u671f\u95f4\u66b4\u9732\u4e8e\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u5987\u5973\u4e2d\uff0c25\u540d\u53d1\u751f\u81ea\u7136\u6d41\u4ea7\uff0c14\u540d\u7684\u5a74\u513f\u6216\u80ce\u513f\u51fa\u73b0\u7578\u5f62\uff0c\u5176\u4e2d\u67096\u4e2a\u8033\u90e8\u7578\u5f62\u3002<\/span><\/span>\n<\/p>\n

\n\t  \uff08\u4e09\uff09\u4e34\u5e8a\u524d\u52a8\u7269\u8bd5\u9a8c\u6570\u636e<\/span><\/span>
\n<\/span>  \u5728\u4e34\u5e8a\u524d\u52a8\u7269\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u4e2d\u4e5f\u66fe\u89c2\u5bdf\u5230\u7c7b\u4f3c\u7684\u7ed3\u6784\u7578\u5f62\u3002\u7f57\u6c0f\u516c\u53f8\u5728\u5f00\u53d1\u5417\u66ff\u9ea6\u8003\u915a\u916f\u8fc7\u7a0b\u4e2d\u8fdb\u884c\u7684\u52a8\u7269\u751f\u6b96\u6bd2\u6027\u7814\u7a76\u8868\u660e\uff0c\u5373\u4f7f\u672a\u53d1\u751f\u6bcd\u4f53\u6bd2\u6027\uff0c\u80da\u80ce\u5438\u6536\u548c\u7578\u5f62\u7684\u53d1\u751f\u7387\u4e5f\u6709\u6240\u589e\u52a0\u3002\u6839\u636e\u4f53\u8868\u9762\u79ef\u8fdb\u884c\u6362\u7b97\uff0c\u96cc\u6027\u5927\u9f20\u548c\u5bb6\u5154\u63a5\u53d7\u7684\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u5242\u91cf\u5206\u522b\u76f8\u5f53\u4e8e\u4eba\u7c7b\u80be\u810f\u548c\u5fc3\u810f\u79fb\u690d\u60a3\u8005\u5efa\u8bae\u5242\u91cf\u7684<\/span>0.02\u81f30.9\u500d\u3002\u5728\u5b50\u4ee3\u5927\u9f20\u4e2d\uff0c\u53d1\u751f\u7684\u7578\u5f62\u5305\u62ec\u65e0\u773c\u3001\u65e0\u4e0b\u988c\u548c\u8111\u79ef\u6c34\u3002\u5728\u5b50\u4ee3\u5bb6\u5154\u4e2d\uff0c\u53d1\u751f\u7684\u7578\u5f62\u5305\u62ec\u5fc3\u810f\u5f02\u4f4d\u3001\u80be\u5f02\u4f4d\u3001\u8188\u759d\u548c\u8110\u759d\u3002<\/span><\/span>\n<\/p>\n

\n\t\u56db\u3001\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6570\u636e\u5e93\u4fe1\u606f<\/span><\/span>
\n<\/span>  \u622a\u81f3<\/span>2008\u5e746\u670810\u65e5\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u75c5\u4f8b\u62a5\u544a\u6570\u636e\u5e93\u4e2d\uff0c\u6709\u5173\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u75c5\u4f8b\u62a5\u544a\u5171365\u4f8b\u3002\u4e3b\u8981\u4e0d\u826f\u53cd\u5e94\u8868\u73b0\u4e3a\uff1a\u8179\u6cfb\u3001\u8179\u75db\u3001\u6076\u5fc3\u3001\u5455\u5410\u3001\u809d\u529f\u80fd\u5f02\u5e38\u7b49\u6d88\u5316\u7cfb\u7edf\u53cd\u5e94\uff1b\u767d\u7ec6\u80de\u51cf\u5c11\u3001\u8840\u5c0f\u677f\u51cf\u5c11\u3001\u9aa8\u9ad3\u6291\u5236\u7b49\u8840\u6db2\u7cfb\u7edf\u53cd\u5e94\u4ee5\u53ca\u80ba\u708e\u7b49\u611f\u67d3\u6027\u75be\u75c5\u3002\u65e0\u6d41\u4ea7\u3001\u80ce\u513f\u6216\u65b0\u751f\u513f\u7578\u5f62\u75c5\u4f8b\u3002<\/span>
\n<\/span>  <\/span>1995\u5e74\u81f32008\u5e743\u6708\uff0c\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6570\u636e\u5e93\u4e2d\uff0c\u6709\u5173\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u4e0d\u826f\u53cd\u5e94\u62a5\u544a2613\u4f8b\uff0c\u6d89\u53ca\u4e0d\u826f\u53cd\u5e947597\u4f8b\u6b21\u3002\u4e0d\u826f\u53cd\u5e94\u8868\u73b0\u4e3a\u80ce\u513f\u5f02\u5e38\u7684\u670945\u4f8b\u6b21\uff0c\u5176\u4e2d\u6b7b\u80ce\uff08\u5305\u62ec\u6d41\u4ea7\uff0923\u4f8b\u6b21\u3001\u7578\u5f6215\u4f8b\u6b21\uff08\u6d89\u53ca\u591a\u4e2a\u5668\u5b98\u7cfb\u7edf\uff09\uff0c\u5176\u4ed6\u5f02\u5e387\u4f8b\u6b21\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e94\u3001\u5efa\u8bae<\/span><\/span>
\n<\/span>  \u9274\u4e8e\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u751f\u6b96\u6bd2\u6027\uff0c\u5efa\u8bae\u533b\u751f\u5728\u4e3a\u80b2\u9f84\u5973\u6027\u60a3\u8005\u5904\u65b9\u5417\u66ff\u9ea6\u8003\u915a\u916f\u524d\uff0c\u4e00\u5b9a\u8981\u6392\u9664\u60a3\u8005\u598a\u5a20\u7684\u53ef\u80fd\u3002\u5e94\u544a\u77e5\u60a3\u8005\u4e0e\u5417\u66ff\u9ea6\u8003\u915a\u916f\u76f8\u5173\u7684\u6d41\u4ea7\u548c\u81f4\u7578\u98ce\u9669\uff0c\u8981\u6c42\u60a3\u8005\u5728\u5f00\u59cb\u5417\u66ff\u9ea6\u8003\u915a\u916f\u6cbb\u7597\u4e4b\u524d\u3001\u6cbb\u7597\u671f\u95f4\u4ee5\u53ca\u4e2d\u6b62\u6cbb\u7597\u540e<\/span>6\u5468\u5185\u90fd\u5fc5\u987b\u91c7\u53d6\u6709\u6548\u7684\u907f\u5b55\u63aa\u65bd\u3002\u533b\u751f\u5e94\u4e0e\u60a3\u8005\u5546\u8ba8\u907f\u5b55\u65b9\u6cd5\uff0c\u544a\u77e5\u60a3\u8005\u5417\u66ff\u9ea6\u8003\u915a\u916f\u53ef\u80fd\u964d\u4f4e\u53e3\u670d\u907f\u5b55\u836f\u4e2d\u6fc0\u7d20\u7684\u8840\u836f\u6d53\u5ea6\uff0c\u7406\u8bba\u4e0a\u53ef\u80fd\u964d\u4f4e\u907f\u5b55\u836f\u7684\u6709\u6548\u6027\uff0c\u56e0\u6b64\u6700\u597d\u540c\u65f6\u91c7\u53d6\u4e24\u79cd\u907f\u5b55\u63aa\u65bd\u3002<\/span>
\n<\/span>  \u60a3\u8005\u5e94\u79ef\u6781\u914d\u5408\u533b\u751f\u63d0\u51fa\u7684\u5b55\u68c0\u8981\u6c42\uff0c\u8ba4\u771f\u9605\u8bfb\u8bf4\u660e\u4e66\u4e2d\u6709\u5173\u4ea7\u54c1\u98ce\u9669\u7684\u63d0\u793a\u4fe1\u606f\u3002\u8ba1\u5212\u6000\u5b55\u7684\u5987\u5973\uff0c\u5e94\u5c31\u4f7f\u7528\u5417\u66ff\u9ea6\u8003\u915a\u916f\u7684\u5229\u5f0a\u95ee\u9898\u54a8\u8be2\u533b\u751f\u3002<\/span><\/span>
\n<\/span>  \u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u5e94\u52a0\u5f3a\u836f\u54c1\u4e0a\u5e02\u540e\u7684\u76d1\u6d4b\u5de5\u4f5c\uff0c\u53ca\u65f6\u62a5\u9001\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\uff0c\u5e76\u5c06\u836f\u54c1\u7684\u98ce\u9669\u4fe1\u606f\u6709\u6548\u5730\u4f20\u9012\u7ed9\u533b\u62a4\u4eba\u5458\u548c\u60a3\u8005\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u53c2\u8003\u4fe1\u606f\uff1a<\/span>http:\/\/www.fda.gov\/medwatch\/safety\/2007\/CellCept_dearhcpoct07.pdf<\/span><\/span>\n<\/p>\n

\n\t
\n<\/span>            <\/span> <\/span>\u8b66\u60d5\u6297\u766b\u75eb\u836f\u53ef\u80fd\u5b58\u5728\u7684\u81ea\u6740\u98ce\u9669<\/span><\/span><\/b><\/span>\n<\/p>\n

\n\t  \u4e00\u3001\u80cc\u666f<\/span><\/span>
\n<\/span>  <\/span>2008\u5e741\u670831\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5411\u533b\u52a1\u4eba\u5458\u53d1\u5e03\u6709\u5173\u6297\u766b\u75eb\u836f\u7684\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u8b66\u793a\u670d\u7528\u6297\u766b\u75eb\u836f\u60a3\u8005\u53ef\u80fd\u5b58\u5728\u81ea\u6740\u89c2\u5ff5\u6216\u81ea\u6740\u884c\u4e3a\uff08\u5305\u62ec\u81ea\u6740\u4f01\u56fe\u548c\u81ea\u6740\u6b7b\u4ea1\uff09\u7684\u98ce\u9669\u3002<\/span>
\n<\/span>  <\/span>FDA\u5206\u6790\u4e8611\u79cd\u6297\u766b\u75eb\u836f\u7684\u5b89\u6170\u5242\u5bf9\u7167\u4e34\u5e8a\u7814\u7a76\u6570\u636e\uff0c\u6570\u636e\u663e\u793a\u670d\u7528\u8fd9\u4e9b\u836f\u7269\u7684\u60a3\u8005\uff0c\u81ea\u6740\u89c2\u5ff5\u548c\u81ea\u6740\u884c\u4e3a\u7684\u98ce\u9669\u7ea6\u4e3a\u670d\u7528\u5b89\u6170\u5242\u60a3\u8005\u76842\u500d\u3002\u9274\u4e8e\u6b64\uff0cFDA\u5c06\u4e0e\u5236\u836f\u4f01\u4e1a\u5171\u540c\u534f\u4f5c\u5728\u6297\u766b\u75eb\u836f\u4ea7\u54c1\u8bf4\u660e\u4e66\u4e0a\u8865\u5145\u76f8\u5173\u4fe1\u606f\u3002<\/span>
\n<\/span>  \u81ea\u62a5\u9053\u6297\u766b\u75eb\u836f\u7684\u98ce\u9669\u4ee5\u6765\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u4e00\u76f4\u5bf9\u8be5\u7c7b\u836f\u54c1\u4fdd\u6301\u9ad8\u5ea6\u5173\u6ce8\uff0c\u53ca\u65f6\u8ddf\u8e2a\u56fd\u5916\u6700\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u5e76\u5728\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7f51\u7ad9\uff08<\/span><\/span>www.nmpa.gov.cn<\/span><\/u><\/a>\uff09\u3001\u4e2d\u5fc3\u7f51\u7ad9\uff08<\/span>www.cdr.gov.cn<\uff09\u7b49\u8f7d\u4f53\u62a5\u9053\u4e86\u76f8\u5173\u4fe1\u606f\uff0c\u540c\u65f6\u5bc6\u5207\u5173\u6ce8\u6211\u56fd\u6297\u766b\u75eb\u836f\u7684\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u60c5\u51b5\u3002\u76ee\u524d\uff0c\u533b\u62a4\u4eba\u5458\u3001\u60a3\u8005\u53ca\u5bb6\u5c5e\u5bf9\u6297\u766b\u75eb\u836f\u53ef\u80fd\u5bfc\u81f4\u81ea\u6740\u89c2\u5ff5\u6216\u81ea\u6740\u884c\u4e3a\u7684\u98ce\u9669\u7684\u8ba4\u77e5\u5ea6\u4e0d\u9ad8\uff0c\u4e3a\u4f7f\u76f8\u5173\u4eba\u5458\u4e86\u89e3\u6297\u766b\u75eb\u836f\u53ef\u80fd\u8bf1\u53d1\u7684\u81ea\u6740\u98ce\u9669\uff0c\u4fdd\u969c\u4e34\u5e8a\u7528\u836f\u5b89\u5168\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u7279\u901a\u62a5\u6b64\u5b89\u5168\u6027\u4fe1\u606f\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e8c\u3001\u76f8\u5173\u6297\u766b\u75eb\u836f\u54c1\u79cd\u60c5\u51b5<\/span><\/span>
\n<\/span>  <\/span>FDA\u5206\u6790\u768411\u79cd\u6297\u766b\u75eb\u836f\u5305\u62ec\uff1a\u5361\u9a6c\u897f\u5e73\uff08carbamazepine\uff09\u3001\u975e\u5c14\u6c28\u916f\uff08felbamate\uff09\u3001\u52a0\u5df4\u55b7\u4e01\uff08gabapentin\uff09\u3001\u62c9\u83ab\u4e09\u55ea\uff08lamotrigine\uff09\u3001\u5de6\u4e59\u62c9\u897f\u5766\uff08levetiracetam\uff09\u3001\u5965\u5361\u897f\u5e73\uff08oxcarbazepine\uff09\u3001\u666e\u745e\u5df4\u6797\uff08pregabalin\uff09\u3001\u567b\u52a0\u5bbe\uff08tiagabine\uff09\u3001\u6258\u5421\u916f\uff08topiramate\uff09\u3001\u4e19\u620a\u9178\u76d0\uff08valproate\uff09\u3001\u5511\u5c3c\u6c99\u80fa\uff08zonisamide\uff09\u3002\u5176\u4e2d7\u4e2a\u54c1\u79cd\u5728\u6211\u56fd\u6709\u6279\u51c6\u6587\u53f7\uff0c\u5305\u62ec\uff1a\u5361\u9a6c\u897f\u5e73\u3001\u52a0\u5df4\u55b7\u4e01\u3001\u62c9\u83ab\u4e09\u55ea\u3001\u5de6\u4e59\u62c9\u897f\u5766\u3001\u5965\u5361\u897f\u5e73\u3001\u6258\u5421\u916f\u3001\u4e19\u620a\u9178\u76d0\u3002\u666e\u745e\u5df4\u6797\u5c1a\u672a\u5728\u6211\u56fd\u4e0a\u5e02\uff0c\u4f46\u5df2\u83b7\u51c6\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e09\u3001\u6297\u766b\u75eb\u836f\u4e0e\u81ea\u6740\u89c2\u5ff5\u6216\u81ea\u6740\u884c\u4e3a\u98ce\u9669<\/span><\/span>
\n<\/span>  <\/span>2005\u5e743\u6708\uff0c\u7f8e\u56fdFDA\u5bf9\u51e0\u79cd\u6297\u766b\u75eb\u836f\u8fdb\u884c\u521d\u6b65\u5206\u6790\u540e\uff0c\u53d1\u73b0\u8be5\u7c7b\u836f\u7269\u53ef\u80fd\u589e\u52a0\u81ea\u6740\u89c2\u5ff5\u53ca\u81ea\u6740\u884c\u4e3a\u7684\u98ce\u9669\uff0c\u56e0\u6b64\u8981\u6c42\u6297\u766b\u75eb\u836f\u7684\u5236\u836f\u4f01\u4e1a\u63d0\u4f9b\u76f8\u5173\u4fe1\u606f\uff0c\u4ee5\u4fbf\u5ba1\u6838\u8fd9\u4e9b\u836f\u7269\u4e0e\u81ea\u6740\u4e8b\u4ef6\u7684\u76f8\u5173\u6027\u3002<\/span>
\n<\/span>  <\/span>FDA\u5206\u6790\u4e8611\u79cd\u836f\u7269\u7684199\u4e2a\u5b89\u6170\u5242\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u3002\u7814\u7a76\u7684\u75be\u75c5\u5305\u62ec\u766b\u75eb\u3001\u90e8\u5206\u7cbe\u795e\u969c\u788d\u4ee5\u53ca\u5176\u4ed6\u75be\u75c5\uff08\u5305\u62ec\u504f\u5934\u75db\u548c\u795e\u7ecf\u6027\u75bc\u75db\uff09\u3002\u6570\u636e\u5206\u6790\u6d89\u53ca\u836f\u7269\u6cbb\u7597\u7ec427863\u4f4d\u60a3\u8005\uff0c\u5b89\u6170\u5242\u7ec416029\u4f4d\u60a3\u8005\uff0c\u7eb3\u5165\u5206\u6790\u7684\u60a3\u8005\u5747\u57285\u5c81\u4ee5\u4e0a\u3002\u5206\u6790\u7ed3\u679c\u663e\u793a\uff1a\u836f\u7269\u6cbb\u7597\u7ec4\u67094\u540d\u60a3\u8005\u81ea\u6740\uff0c\u5b89\u6170\u5242\u7ec4\u65e0\u60a3\u8005\u81ea\u6740\uff1b\u836f\u7269\u6cbb\u7597\u7ec4\u67090.43%\u7684\u60a3\u8005\u4ea7\u751f\u8fc7\u81ea\u6740\u89c2\u5ff5\u6216\u884c\u4e3a\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a0.22%\u3002<\/span>
\n<\/span>  \u7814\u7a76\u7ed3\u679c\u8fd8\u663e\u793a<\/span>(\u8be6\u89c1\u88681)\uff0c\u5728\u4e0d\u540c\u75be\u75c5\u7814\u7a76\u5bf9\u8c61\u4e2d\uff0c\u766b\u75eb\u60a3\u8005\u51fa\u73b0\u81ea\u6740\u89c2\u5ff5\u6216\u884c\u4e3a\u7684\u76f8\u5bf9\u98ce\u9669\u9ad8\u4e8e\u5176\u4ed6\u75be\u75c5\uff1b\u60a3\u8005\u5728\u5f00\u59cb\u670d\u836f\u7684\u7b2c1\u5468\u5c31\u89c2\u5bdf\u5230\u81ea\u6740\u89c2\u5ff5\u53ca\u81ea\u6740\u884c\u4e3a\u7684\u98ce\u9669\u589e\u9ad8\uff0c\u5e76\u81f3\u5c11\u6301\u7eed\u523024\u5468\uff1b\u4e0d\u540c\u836f\u7269\u548c\u4e0d\u540c\u4eba\u7fa4\u7684\u7814\u7a76\u7ed3\u679c\u5927\u4f53\u4e00\u81f4\uff0c\u4e14\u5404\u5e74\u9f84\u7ec4\u95f4\u6ca1\u6709\u663e\u8457\u5dee\u5f02\u3002<\/span>
\n<\/span>  \u8868<\/span>1\uff1a\u4e0d\u540c\u75be\u75c5\u60a3\u8005\u81ea\u6740\u89c2\u5ff5\u6216\u884c\u4e3a\u76f8\u5bf9\u98ce\u9669\u53ca\u5dee\u5f02<\/span><\/span>\n<\/p>\n

\n\t<\/p>\n\n\n\n\n\n\n\n
\n

\n\t\t\t\t\t\t\u75be\u75c5<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u836f\u7269\u7ec4\uff08\u2030\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u5b89\u6170\u5242\u7ec4\uff08\u2030\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u76f8\u5bf9\u98ce\u9669<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t\u98ce\u9669\u5dee\u5f02\uff08\u2030\uff09<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u766b\u75eb<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t3.5<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.0<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t3.5<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t2.5<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u7cbe\u795e\u969c\u788d<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t8.3<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t5.2<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.6<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t3.1<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u5176\u4ed6<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t2.0<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t0.8<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t2.5<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t1.2<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\t\u6c47\u603b<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t4.3<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t2.2<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t2.0<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\t2.1<\/span><\/span>\n\t\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

  \u4e94\u3001\u5efa\u8bae<\/span> \u56db\u3001\u56fd\u5185\u6297\u766b\u75eb\u836f\u5173\u4e8e\u81ea\u6740\u89c2\u5ff5\u6216\u884c\u4e3a\u7684\u4e0d\u826f\u53cd\u5e94\u60c5\u51b5<\/span><\/span>
\n<\/span>  \u68c0\u7d22\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u75c5\u4f8b\u62a5\u544a\u6570\u636e\u5e93\uff0c\u622a\u81f3<\/span>2008\u5e746\u670810\u65e5\uff0c\u672a\u68c0\u7d22\u5230\u5173\u4e8e\u5361\u9a6c\u897f\u5e73\u3001\u52a0\u5df4\u55b7\u4e01\u3001\u62c9\u83ab\u4e09\u55ea\u3001\u5de6\u4e59\u62c9\u897f\u5766\u3001\u6258\u5421\u916f\u3001\u4e19\u620a\u9178\u76d0\u5f15\u8d77\u81ea\u6740\u89c2\u5ff5\u53ca\u81ea\u6740\u884c\u4e3a\u7684\u75c5\u4f8b\u62a5\u544a\u3002\u68c0\u7d22\u5230\u5965\u5361\u897f\u5e73\u5f15\u8d77\u81ea\u6740\u89c2\u5ff5\u75c5\u4f8b\u62a5\u544a1\u4f8b\u3002<\/span>
\n<\/span>  \u4ee5\u7126\u8651\u3001\u6fc0\u52a8\u3001\u654c\u610f\u3001\u8e81\u72c2\u7b49\uff08\u7f8e\u56fd<\/span>FDA\u4fe1\u606f\u4e2d\u5217\u4e3a\u53ef\u80fd\u662f\u81ea\u6740\u884c\u4e3a\u7684\u524d\u5146\uff09\u4e3a\u5173\u952e\u8bcd\u68c0\u7d22\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u75c5\u4f8b\u62a5\u544a\u6570\u636e\u5e93\uff0c\u68c0\u7d22\u5230\u62c9\u83ab\u4e09\u55ea\u76f8\u5173\u75c5\u4f8b1\u4f8b\uff0c\u4e0d\u826f\u53cd\u5e94\u4e3a\u201c\u7126\u8651\u201d\uff1b\u6258\u5421\u916f\u76f8\u5173\u75c5\u4f8b6\u4f8b\uff0c\u4e0d\u826f\u53cd\u5e94\u540d\u79f0\u5206\u522b\u4e3a\u201c\u70e6\u8e81\u3001\u6613\u6012\u3001\u60c5\u7eea\u6fc0\u52a8\u201d\u3001\u201c\u7cbe\u795e\u604d\u60da\u201d\u3001\u201c\u7cbe\u795e\u5f02\u5e38\u201d\u3001\u201c\u6fc0\u52a8\u201d\u3001\u201c\u6291\u90c1\u201d\u548c\u201c\u7cbe\u795e\u5206\u88c2\u6837\u53cd\u5e94\u201d\uff1b\u5361\u9a6c\u897f\u5e73\u76f8\u5173\u75c5\u4f8b5\u4f8b\uff0c\u4e0d\u826f\u53cd\u5e94\u540d\u79f0\u5206\u522b\u4e3a\u201c\u7126\u8651\u201d\uff082\u4f8b\uff09\u3001\u201c\u7cbe\u795e\u5206\u88c2\u6837\u53cd\u5e94\u201d\u3001\u201c\u7cbe\u795e\u4e0d\u96c6\u4e2d\u201d\u3001\u201c\u6291\u90c1\u201d\uff1b\u4e19\u620a\u9178\u76d0\u76f8\u5173\u75c5\u4f8b4\u4f8b\uff0c\u4e0d\u826f\u53cd\u5e94\u540d\u79f0\u5206\u522b\u4e3a\u201c\u8e81\u72c2\u201d\uff083\u4f8b\uff09\u548c\u201c\u7cbe\u795e\u5f02\u5e38\u201d\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u9274\u4e8e\u56fd\u5916\u7814\u7a76\u663e\u793a\u670d\u7528\u6297\u766b\u75eb\u836f\u60a3\u8005\u53ef\u80fd\u5b58\u5728\u81ea\u6740\u89c2\u5ff5\u6216\u81ea\u6740\u884c\u4e3a\u7684\u98ce\u9669\uff0c\u5e76\u4e14\u6b64\u7c7b\u836f\u7269\u591a\u7531\u60a3\u8005\u5728\u5bb6\u4e2d\u81ea\u670d\u6216\u7531\u770b\u62a4\u8005\u76d1\u7763\u670d\u7528\uff0c\u5efa\u8bae\u533b\u751f\u5904\u65b9\u6297\u766b\u75eb\u836f\u65f6\uff0c\u544a\u77e5\u60a3\u8005\u3001\u60a3\u8005\u5bb6\u5c5e\u53ca\u770b\u62a4\u8005\u5173\u4e8e\u6297\u766b\u75eb\u836f\u53ef\u80fd\u589e\u52a0\u81ea\u6740\u89c2\u5ff5\u6216\u884c\u4e3a\u7684\u98ce\u9669\uff1b\u5bf9\u4e8e\u76ee\u524d\u6b63\u5728\u670d\u7528\u6297\u766b\u75eb\u836f\u7684\u60a3\u8005\uff0c\u5728\u6ca1\u6709\u54a8\u8be2\u533b\u751f\u4e4b\u524d\uff0c\u4e0d\u8981\u64c5\u81ea\u505c\u836f\u6216\u6539\u53d8\u6cbb\u7597\u65b9\u6848\uff1b\u5982\u53d1\u73b0\u60a3\u8005\u51fa\u73b0\u7126\u8651\u3001\u6fc0\u52a8\u3001\u654c\u610f\u3001\u8e81\u72c2\u3001\u6291\u90c1\u6216\u6291\u90c1\u52a0\u91cd\u7b49\u7cbe\u795e\u75c7\u72b6\uff0c\u6216\u6709\u4f24\u5bb3\u81ea\u5df1\u3001\u8fdc\u79bb\u5bb6\u4eba\u548c\u670b\u53cb\u7b49\u60f3\u6cd5\u6216\u884c\u4e3a\u65f6\uff0c\u60a3\u8005\u5bb6\u5c5e\u53ca\u770b\u62a4\u8005\u5e94\u53ca\u65f6\u544a\u77e5\u533b\u751f\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t
\n<\/span>  \u53c2\u8003\u4fe1\u606f\uff1a<\/span>www.fda.gov\/cder\/drug\/InfoSheets\/HCP\/ antiepilepticsHCP.htm.<\/span><\/span>\n<\/p>\n

\n\t
\n<\/span>            <\/span><\/span>\u8b66\u60d5\u6297\u6291\u90c1\u836f\u6cbb\u7597\u8fc7\u7a0b\u4e2d\u7684\u81ea\u6740\u98ce\u9669<\/span><\/span><\/b><\/span>\n<\/p>\n

\n\t  \u4e00\u3001\u80cc\u666f<\/span><\/span>
\n<\/span>  \u8fd1\u51e0\u5e74\uff0c\u6297\u6291\u90c1\u836f\u5bfc\u81f4\u81ea\u6740\u98ce\u9669\u589e\u9ad8\u7684\u95ee\u9898\u4e00\u76f4\u53d7\u5230\u56fd\u5185\u5916\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u7684\u5173\u6ce8\u3002\u81ea<\/span>2003\u5e74\u5f00\u59cb\uff0c\u7f8e\u56fd\u3001\u6b27\u76df\u7b49\u4e00\u4e9b\u56fd\u5bb6\u548c\u5730\u533a\u5f00\u5c55\u4e86\u6709\u5173\u513f\u7ae5\u3001\u9752\u5c11\u5e74\u548c\u6210\u5e74\u60a3\u8005\u4f7f\u7528\u6297\u6291\u90c1\u836f\u5f15\u8d77\u81ea\u6740\u98ce\u9669\u7684\u8bc4\u4f30\u5de5\u4f5c\u30022007\uff5e2008\u5e74\uff0c\u5728\u5bf9\u5927\u91cf\u4e34\u5e8a\u8d44\u6599\u8fdb\u884c\u6c47\u603b\u5206\u6790\u7684\u57fa\u7840\u4e0a\uff0c\u7f8e\u56fd\u548c\u6b27\u76df\u5206\u522b\u5b8c\u6210\u4e86\u6b64\u9879\u8bc4\u4f30\u5de5\u4f5c\uff0c\u5e76\u53d1\u5e03\u4fe1\u606f\uff0c\u8b66\u544a\u4f7f\u7528\u6297\u6291\u90c1\u836f\u53ef\u80fd\u5e26\u6765\u7684\u81ea\u6740\u98ce\u9669\uff0c\u8981\u6c42\u4f01\u4e1a\u4fee\u6539\u836f\u54c1\u8bf4\u660e\u4e66\uff0c\u52a0\u5165\u76f8\u5173\u8b66\u793a\u5185\u5bb9\u3002<\/span>
\n<\/span>  \u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u4e00\u76f4\u5bf9\u6297\u6291\u90c1\u836f\u7684\u5b89\u5168\u6027\u95ee\u9898\u4fdd\u6301\u5173\u6ce8\uff0c\u53ca\u65f6\u8ddf\u8e2a\u56fd\u5916\u6700\u65b0\u7814\u7a76\u548c\u62a5\u9053\uff0c\u5e76\u5728\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7f51\u7ad9\uff08<\/span><\/span>www.nmpa.gov.cn<\/span><\/u><\/a>\uff09\u3001\u4e2d\u5fc3\u7f51\u7ad9\uff08<\/span>www.cdr.gov.cn\uff09\u7b49\u8f7d\u4f53\u4e0a\u53d1\u5e03\u4e86\u76f8\u5173\u4fe1\u606f\uff0c\u540c\u65f6\u5bc6\u5207\u5173\u6ce8\u6211\u56fd\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u7684\u53d1\u751f\u60c5\u51b5\u3002\u867d\u7136\u6211\u56fd\u76ee\u524d\u6536\u5230\u7684\u4e0e\u6297\u6291\u90c1\u836f\u76f8\u5173\u7684\u81ea\u6740\u62a5\u544a\u8f83\u5c11\uff0c\u4f46\u4e3a\u4f7f\u5e7f\u5927\u533b\u52a1\u4eba\u5458\u548c\u60a3\u8005\u4e86\u89e3\u6297\u6291\u90c1\u836f\u7684\u4f7f\u7528\u98ce\u9669\uff0c\u4fdd\u969c\u4e34\u5e8a\u7528\u836f\u5b89\u5168\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u7279\u901a\u62a5\u6b64\u5b89\u5168\u6027\u4fe1\u606f\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e8c\u3001\u6291\u90c1\u75c7\u4e0e\u6297\u6291\u90c1\u836f<\/span><\/span>
\n<\/span>  \u6291\u90c1\u75c7\u662f\u4e00\u79cd\u5e38\u89c1\u7684\u60c5\u611f\u969c\u788d\uff0c\u53ef\u7531\u5404\u79cd\u539f\u56e0\u5f15\u8d77\uff0c\u4ee5\u60c5\u7eea\u4f4e\u843d\u3001\u601d\u7ef4\u8fdf\u949d\u548c\u8a00\u8bed\u52a8\u4f5c\u51cf\u5c11\u4e3a\u4e3b\u8981\u75c7\u72b6\uff0c\u60a3\u8005\u751a\u81f3\u51fa\u73b0\u81ea\u6740\u89c2\u5ff5\u548c<\/span>\/\u6216\u81ea\u6740\u884c\u4e3a\uff08\u5305\u62ec\u81ea\u6740\u4f01\u56fe\u548c\u81ea\u6740\u6b7b\u4ea1\uff09\u3002<\/span>
\n<\/span>  \u6291\u90c1\u75c7\u7684\u6cbb\u7597\u6709\u591a\u79cd\u65b9\u5f0f\uff0c\u4e3b\u8981\u4ee5\u7efc\u5408\u6cbb\u7597\u4e3a\u4e3b\uff0c\u5305\u62ec\u836f\u7269\u6cbb\u7597\u3001\u5fc3\u7406\u6cbb\u7597\u3001\u7269\u7406\u6cbb\u7597\u7b49\u3002\u6297\u6291\u90c1\u836f\u662f\u5f53\u524d\u6cbb\u7597\u5404\u79cd\u6291\u90c1\u75c7\u7684\u4e3b\u8981\u836f\u7269\uff0c\u80fd\u6709\u6548\u89e3\u9664\u6291\u90c1\u5fc3\u5883\uff0c\u540c\u65f6\u5bf9\u7126\u8651\u75c7\u3001\u5f3a\u8feb\u75c7\u3001\u60ca\u6050\u969c\u788d\u7b49\u7cbe\u795e\u969c\u788d\u4e5f\u6709\u7597\u6548\u3002\u6297\u6291\u90c1\u836f\u7684\u79cd\u7c7b\u8f83\u591a\uff0c\u5982\u9009\u62e9\u6027<\/span>5-\u7f9f\u8272\u80fa\u518d\u6444\u53d6\u6291\u5236\u5242\u7c7b\uff08SSRIs\uff09\u3001\u9009\u62e9\u60275-\u7f9f\u8272\u80fa\u53bb\u7532\u80be\u4e0a\u817a\u7d20\u518d\u6444\u53d6\u6291\u5236\u5242\u7c7b\uff08SNRIs\uff09\u3001\u4e09\u73af\u7c7b\uff08TCAs\uff09\u3001\u5355\u80fa\u6c27\u5316\u9176\u6291\u5236\u5242\u7c7b\uff08MAOIs\uff09\u7b49\u3002\u5176\u4e2dSSRIs\u591a\u6570\u4e0d\u7528\u4e8e\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u3002<\/span><\/span>\n<\/p>\n

\n\t\u4e09\u3001\u6297\u6291\u90c1\u836f\u4e0e\u81ea\u6740\u98ce\u9669<\/span><\/span>
\n<\/span>  \u6291\u90c1\u75c7\u548c\u5176\u4ed6\u4e00\u4e9b\u7cbe\u795e\u969c\u788d\u672c\u8eab\u5c31\u4e0e\u81ea\u6740\u98ce\u9669\u76f8\u5173\u3002\u65e0\u8bba\u662f\u5426\u670d\u7528\u6297\u6291\u90c1\u836f\uff0c\u60a3\u8005\u90fd\u53ef\u80fd\u51fa\u73b0\u6291\u90c1\u75c7\u72b6\u6076\u5316\u3001\u81ea\u6740\u89c2\u5ff5\u548c<\/span>\/\u6216\u81ea\u6740\u884c\u4e3a\u3002\u56fd\u5916\u7814\u7a76\u8868\u660e\uff0c\u6297\u6291\u90c1\u836f\u53ef\u80fd\u589e\u52a0\u513f\u7ae5\u3001\u9752\u5c11\u5e74\u53ca25\u5c81\u4ee5\u4e0b\u6210\u5e74\u4eba\u81ea\u6740\uff08\u5305\u62ec\u81ea\u6740\u89c2\u5ff5\u3001\u81ea\u6740\u884c\u4e3a\uff09\u7684\u98ce\u9669\uff0c\u5c24\u5176\u662f\u5728\u6cbb\u7597\u7684\u5934\u51e0\u4e2a\u6708\u3002<\/span>
\n<\/span>  \u7f8e\u56fd\u4e00\u9879\u7814\u7a76<\/span>[1]\u5bf9\u5728\u6291\u90c1\u75c7\uff08MDD\uff09\u3001\u5f3a\u8feb\u75c7\u548c\u5176\u4ed6\u7cbe\u795e\u969c\u788d\u7684\u513f\u7ae5\u548c\u9752\u5c11\u5e74\uff0818\u5c81\u4ee5\u4e0b\uff09\u4e2d\u8fdb\u884c\u768424\u9879\u77ed\u671f\uff08\u5c0f\u4e8e4\u4e2a\u6708\uff09\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c\u8fdb\u884c\u4e86\u6c47\u603b\u5206\u6790\u3002\u8fd9\u4e9b\u8bd5\u9a8c\u5171\u7eb3\u5165\u4e864681\u540d\u53d7\u8bd5\u8005\uff0c\u5305\u62ec9\u79cd\u6297\u6291\u90c1\u836f\u3002\u7ed3\u679c\u663e\u793a\uff0c\u53d7\u8bd5\u8005\u5728\u63a5\u53d7\u6297\u6291\u90c1\u836f\u6cbb\u7597\u7684\u6700\u521d\u51e0\u4e2a\u6708\u81ea\u6740\u98ce\u9669\u76f8\u5bf9\u5b89\u6170\u5242\u7ec4\u5347\u9ad8\u3002\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c402005\u5e74\u4e5f\u5b8c\u6210\u4e86\u5bf9\u4e24\u7c7b\u6297\u6291\u90c1\u836f\uff08SSRIs\u548cSNRIs\uff09\u7684\u8bc4\u4ef7\u5de5\u4f5c\uff0c\u53d1\u73b0\u670d\u7528\u8fd9\u4e24\u7c7b\u836f\u7269\u7684\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u81ea\u6740\u89c2\u5ff5\u3001\u81ea\u6740\u884c\u4e3a\u7684\u53d1\u751f\u98ce\u9669\u6bd4\u5b89\u6170\u5242\u7ec4\u9ad8\uff0c\u5efa\u8bae\u8fd9\u4e24\u7c7b\u6297\u6291\u90c1\u836f\u4e0d\u7528\u4e8e\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u3002<\/span>
\n<\/span>  <\/span>2007\u5e745\u6708\uff0c\u7f8e\u56fdFDA\u53d1\u5e03\u4e86\u6709\u5173\u6210\u5e74\u4eba\u4f7f\u7528\u6297\u6291\u90c1\u836f\u7684\u98ce\u9669\u8bc4\u4f30\u7ed3\u679c[2]\u3002\u8bc4\u4f30\u7eb3\u5165\u4e86295\u9879\u4f7f\u7528SSRIs\u548c\u5176\u4ed6\u6297\u6291\u90c1\u836f\u7684\u5b89\u6170\u5242\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5305\u62ec\u4e8677000\u4f59\u540d\u6291\u90c1\u75c7\uff08MDD\uff09\u548c\u5176\u4ed6\u7cbe\u795e\u969c\u788d\u7684\u6210\u5e74\u60a3\u8005\u3002\u7ed3\u679c\u8868\u660e\uff0c\u6297\u6291\u90c1\u836f\u5f15\u8d77\u7684\u81ea\u6740\u98ce\u9669\u5728\u4e0d\u540c\u5e74\u9f84\u6bb5\u5b58\u5728\u5dee\u5f02\uff1a18\uff5e24\u5c81\u4eba\u7fa4\u6297\u6291\u90c1\u836f\u7ec4\u81ea\u6740\u98ce\u9669\u9ad8\u4e8e\u5b89\u6170\u5242\u7ec4\uff0c24\u5c81\u4ee5\u4e0a\u4eba\u7fa4\u6297\u6291\u90c1\u836f\u7ec4\u81ea\u6740\u98ce\u9669\u4e0e\u5b89\u6170\u5242\u7ec4\u65e0\u663e\u8457\u5dee\u5f02\uff0c65\u5c81\u4ee5\u4e0a\u4eba\u7fa4\u6297\u6291\u90c1\u836f\u7ec4\u81ea\u6740\u98ce\u9669\u4f4e\u4e8e\u5b89\u6170\u5242\u7ec4\u3002\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u4e5f\u5f97\u51fa\u4e86\u7c7b\u4f3c\u7684\u8bc4\u4f30\u7ed3\u8bba\uff0c\u5373\u5e74\u8f7b\u6210\u5e74\u4eba\u5728\u4f7f\u7528\u6297\u6291\u90c1\u836f\u6cbb\u7597\u65f6\u53ef\u80fd\u5b58\u5728\u81ea\u6740\u884c\u4e3a\u589e\u52a0\u7684\u98ce\u9669\uff0c\u4e14\u4e0d\u540c\u6297\u6291\u90c1\u836f\u4e4b\u95f4\u7684\u98ce\u9669\u65e0\u5b9e\u8d28\u6027\u5dee\u5f02[3]\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u56db\u3001\u5efa\u8bae<\/span><\/span>
\n<\/span>  \u9274\u4e8e\u6297\u6291\u90c1\u836f\u4e0e\u81ea\u6740\u98ce\u9669\u53ef\u80fd\u7684\u76f8\u5173\u6027\uff0c\u5efa\u8bae\u5bf9\u6240\u6709\u4f7f\u7528\u6297\u6291\u90c1\u836f\u7684\u60a3\u8005\u8fdb\u884c\u5bc6\u5207\u76d1\u6d4b\uff0c\u89c2\u5bdf\u662f\u5426\u51fa\u73b0\u4e34\u5e8a\u75c7\u72b6\u6076\u5316\u3001\u884c\u4e3a\u5f02\u5e38\u6539\u53d8\uff08\u5305\u62ec\u51fa\u73b0\u65b0\u7684\u75c7\u72b6\uff09\u6216\u51fa\u73b0\u81ea\u6740\u89c2\u5ff5\u3001\u81ea\u6740\u4f01\u56fe\u3002\u5728\u836f\u7269\u6cbb\u7597\u7684\u5934\u51e0\u4e2a\u6708\uff0c\u6216\u8005\u5728\u6539\u53d8\u5242\u91cf\u3001\u6cbb\u7597\u65b9\u6848\u65f6\u5e94\u52a0\u5f3a\u76d1\u6d4b\u3002\u8fd9\u79cd\u76d1\u6d4b\u5e94\u4e00\u76f4\u6301\u7eed\u5230\u60a3\u8005\u4e34\u5e8a\u75c7\u72b6\u660e\u663e\u6539\u5584\u4e3a\u6b62\u3002<\/span><\/span>
\n<\/span>  \u6297\u6291\u90c1\u836f\u4e3a\u5904\u65b9\u836f\uff0c\u8bf7\u5728\u533b\u751f\u7684\u6307\u5bfc\u4e0b\u4f7f\u7528\u3002\u5982\u679c\u51fa\u73b0\u4e34\u5e8a\u75c7\u72b6\u6076\u5316\u3001\u884c\u4e3a\u5f02\u5e38\u6539\u53d8\u3001\u81ea\u6740\u89c2\u5ff5\u6216\u81ea\u6740\u4f01\u56fe\uff0c\u5e94\u53ca\u65f6\u54a8\u8be2\u533b\u751f\uff0c\u7531\u533b\u751f\u51b3\u5b9a\u662f\u5426\u6539\u53d8\u6cbb\u7597\u65b9\u6848\uff0c\u5305\u62ec\u4e2d\u65ad\u6cbb\u7597\u3002\u5982\u679c\u51b3\u5b9a\u505c\u6b62\u6cbb\u7597\uff0c\u836f\u7269\u5e94\u8be5\u9010\u6e10\u51cf\u91cf\uff0c\u9aa4\u7136\u505c\u836f\u53ef\u80fd\u5f15\u8d77\u4e00\u4e9b\u8eaf\u4f53\u548c\u7cbe\u795e\u75c7\u72b6\uff0c\u5982\u5934\u75db\u3001\u5934\u6655\u3001\u65e0\u529b\u3001\u9759\u5750\u4e0d\u80fd\u3001\u5931\u7720\u3001\u591a\u68a6\u3001\u7126\u8651\u3001\u70e6\u8e81\u7b49\u3002<\/span><\/span>
\n<\/span>  \u4e00\u4e9b\u6297\u6291\u90c1\u836f\u4e0d\u7528\u4e8e\u6cbb\u7597\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u7684\u6291\u90c1\u75c7\uff0c\u5e94\u4e25\u683c\u6309\u7167\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\u9002\u5e94\u75c7\u548c\u9002\u7528\u4eba\u7fa4\u7ed9\u836f\u3002\u533b\u7597\u673a\u6784\u548c\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u5e94\u52a0\u5f3a\u5bf9\u6297\u6291\u90c1\u836f\u4e0d\u826f\u53cd\u5e94\u7684\u76d1\u6d4b\u5de5\u4f5c\uff0c\u53ca\u65f6\u62a5\u544a\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4fe1\u606f\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t
\n<\/span>  \u53c2\u8003\u4fe1\u606f\uff1a<\/span><\/span>
\n<\/span>  <\/span>1\uff0eHammad TA, Laughren T, Racoosin J. Suicidality in pediatric subjects treated with antidepressant drugs. Arch General Psychiatry 2006 Mar;63(3):332-9.<\/span>
\n<\/span>  <\/span>2\uff0eFDA. Overview for December 13 Meeting of Psychopharmacologic Drugs Advisory Committee (PDAC).[2006-11-16]. http:\/\/www.fda.gov\/ohrms\/ dockets\/ac\/06\/briefing\/2006-4272b1-01-FDA.pdf.<\/span>
\n<\/span>  <\/span>3\uff0eMHRA. Implementation of warnings on suicidal thoughts and behaviors in antidepressants. [2008-2-4]. http:\/\/www.mhra.gov.uk\/NewsCentre\/ CON2033960.<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

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