\u7f57\u6c99\u53f8\u4ed6\u662f\u6b27\u6d32\u9996\u4e2a\u7528\u4e8e\u6162\u6027\u80be\u810f\u75c5\u76f8\u5173\u7684\u8d2b\u8840\u6210\u4eba\u60a3\u8005\u7684\u53e3\u670d\u4f4e\u6c27\u8bf1\u5bfc\u56e0\u5b50 (HIF) \u812f\u6c28\u9170\u7f9f\u5316\u9176 (PH) \u6291\u5236\u5242\u3002<\/span><\/p>\n \u4e1c\u4eac2021\u5e748\u670820\u65e5 \/\u7f8e\u901a\u793e\/ — \u5b89\u65af\u6cf0\u6765\u5236\u836f\u96c6\u56e2\uff08\u4e1c\u4eac\u8bc1\u5238\u4ea4\u6613\u6240\u80a1\u7968\u4ee3\u7801\uff1a4503\uff0c\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98\uff1a\u5b89\u5ddd\u5065\u53f8\u535a\u58eb\uff0c\u201c\u5b89\u65af\u6cf0\u6765\u201d\uff09\u548c\u7f8e\u56fd\u73d0\u535a\u8fdb\u516c\u53f8\uff08\u7eb3\u65af\u8fbe\u514b\u4ee3\u7801\uff1aFGEN\uff0c\u9996\u5e2d\u6267\u884c\u5b98\uff1aEnrique Conterno\uff0c\u201c\u73d0\u535a\u8fdb\u201d) \u4e8e2021\u5e748\u670819\u65e5<\/span>\u5ba3\u5e03\uff0c\u6b27\u76df\u59d4\u5458\u4f1a (EC) \u5df2\u6279\u51c6 EVRENZO TM<\/sup> (\u7f57\u6c99\u53f8\u4ed6) \u7528\u4e8e\u6cbb\u7597\u4e0e\u6162\u6027\u80be\u75c5 (CKD) \u76f8\u5173\u7684\u75c7\u72b6\u6027\u8d2b\u8840\u6210\u4eba\u60a3\u8005\u3002<\/p>\n \u201c\u6211\u4eec\u5f88\u9ad8\u5174 EVRENZO \u5df2\u83b7\u6279\u6210\u4e3a\u6b27\u76df\u7b2c\u4e00\u4e2a\u53e3\u670d <\/span>HIF-PH \u6291\u5236\u5242\uff0c\u7528\u4e8e\u6cbb\u7597\u4e0e CKD \u76f8\u5173\u7684\u75c7\u72b6\u6027\u8d2b\u8840\u6210\u4eba\u60a3\u8005\uff0c\u201d\u5b89\u65af\u6cf0\u6765\u5f00\u53d1\u603b\u88c1\u3001\u5065\u5eb7\u79d1\u5b66\u7855\u58eb\u3001\u533b\u5b66\u535a\u58ebSteven Benner\u8bf4\u3002 \u201c\u4eca\u5929\u7684\u6279\u51c6\uff0c\u4e3a\u900f\u6790\u6216\u975e\u900f\u6790\u7684CKD\u8d2b\u8840\u60a3\u8005\u5e26\u6765\u4e86\u5177\u6709\u5168\u65b0\u4f5c\u7528\u673a\u5236\u7684\u6cbb\u7597\u9009\u62e9\uff0c\u89e3\u51b3\u8fd9\u79cd\u75be\u75c5\u591a\u65b9\u9762\u7684\u95ee\u9898\u3002<\/span>\u6211\u4eec\u671f\u5f85\u7740\u5c06\u7f57\u6c99\u53f8\u4ed6\u5e26\u7ed9\u6b27\u76df\u5404\u56fd\u7684 CKD \u8d2b\u8840\u6210\u4eba\u60a3\u8005 \u3002\u201d<\/p>\n \u5168\u7403\u8303\u56f4\u5185\u6bcf10\u4eba\u4e2d\u5c31\u67091\u4eba\u53d7CKD\u5f71\u54cd\uff0c\u5176\u4e2d\u6bcf5\u4eba\u4e2d\u5c31\u67091\u4eba\u53d7\u8d2b\u8840\u5f71\u54cd\u3002[1, 2]<\/sup> CKD\u8d2b\u8840\u901a\u5e38\u672a\u5f97\u5230\u6cbb\u7597\u6216\u672a\u8fbe\u5230\u6cbb\u7597\u76ee\u6807\uff0c\u5e76\u4e0e\u751f\u6d3b\u8d28\u91cf\u663e\u8457\u4e0b\u964d\u3001\u5fc3\u8840\u7ba1\u548c\u80be\u810f\u75c5\u60c5\u6301\u7eed\u8fdb\u5c55\u81f3\u4e0d\u826f\u7ed3\u5c40\u76f8\u5173\u3002[3-5]<\/sup><\/p>\n \u201c\u8d2b\u8840\u662f CKD \u7684\u4e00\u79cd\u663e\u8457\u4e14\u65e9\u671f\u7684\u5e76\u53d1\u75c7\uff0c\u5e76\u968f\u7740 CKD \u6076\u5316\uff0c\u5176\u53d1\u751f\u7684\u9891\u7387\u548c\u5f71\u54cd\u52a0\u5927\uff0c\u5f71\u54cd\u60a3\u8005\u7684\u65e5\u5e38\u751f\u6d3b\u3001\u81ea\u7406\u548c\u884c\u52a8\u80fd\u529b\uff0c\u201d\u82f1\u56fd\u7687\u5bb6\u5185\u79d1\u533b\u5b66\u9662\u9662\u58eb\u3001\u82f1\u56fd\u83b1\u65af\u7279\u5927\u5b66\u80be\u79d1\u533b\u5b66Mayer\u6559\u6388\u53ca\u987e\u95ee\u80be\u75c5\u5b66\u5bb6Jonathan Barratt \u533b\u5b66\u535a\u58eb\u8bf4\uff0c \u201c\u8fd9\u9879\u6279\u51c6\u610f\u5473\u7740\uff0c\u5728\u4e3a\u60a3\u8005\u7ba1\u7406\u8d2b\u8840\u75c7\u72b6\u548c\u7ef4\u6301\u76ee\u6807\u8840\u7ea2\u86cb\u767d\u6c34\u5e73\u63d0\u4f9b\u4e00\u79cd\u6709\u6548\u3001\u7b80\u5355\u6cbb\u7597\u65b9\u6848\uff0c\u4ee5\u6700\u5927\u7a0b\u5ea6\u51cf\u8f7b\u5bf9\u60a3\u8005\u751f\u6d3b\u8d28\u91cf\u7684\u5f71\u54cd\u65b9\u9762\uff0c\u5411\u524d\u8fc8\u51fa\u4e86\u91cd\u8981\u7684\u4e00\u6b65\u3002\u201d<\/p>\n \u7f57\u6c99\u53f8\u4ed6\u662f\u6b27\u76df\u9996\u4e2a\u53e3\u670d<\/span>\u4f4e\u6c27\u8bf1\u5bfc\u56e0\u5b50\uff08HIF\uff09\u812f\u6c28\u9170\u7f9f\u5316\u9176\uff08PH\uff09\u6291\u5236\u5242\u3002\u6bd4\u8d77\u901a\u5e38\u4e0e\u9759\u8109\u94c1\u5242\u5171\u540c\u7ed9\u836f\u7684\u53ef\u6ce8\u5c04\u7ea2\u7ec6\u80de\u751f\u6210\u523a\u6fc0\u5242\uff08ESA\uff09\uff0c\u7f57\u6c99\u53f8\u4ed6\u901a\u8fc7\u4e0d\u540c\u7684\u4f5c\u7528\u673a\u5236\u63d0\u9ad8\u8840\u7ea2\u86cb\u767d\uff08Hb\uff09\u6c34\u5e73\u3002\u4f5c\u4e3a HIF-PH \u6291\u5236\u5242\uff0c\u7f57\u6c99\u53f8\u4ed6\u901a\u8fc7\u6fc0\u6d3b\u8eab\u4f53\u5bf9\u8840\u6db2\u4e2d\u6c27\u542b\u91cf\u964d\u4f4e\u7684\u81ea\u7136\u53cd\u5e94\uff0c\u6b64\u53cd\u5e94\u6d89\u53ca\u591a\u4e2a\u76f8\u4e92\u534f\u540c\u7684\u8fc7\u7a0b\u7684\u8c03\u8282\uff0c\u4ece\u800c\u5728\u51cf\u5c11\u9759\u8109\u94c1\u5242\u4f7f\u7528\u7684\u60c5\u51b5\u4e0b\u7ba1\u7406\u8d2b\u8840\u3002<\/p>\n \u201cHIF-PH \u6291\u5236\u5242\u4ee3\u8868\u4e86CKD \u8d2b\u8840\u6cbb\u7597\u7684\u91cd\u5927\u8fdb\u5c55\uff0c\u201d\u73d0\u535a\u8fdb\u9996\u5e2d\u533b\u5b66\u5b98\u3001\u533b\u5b66\u535a\u58eb\u3001\u516c\u5171\u536b\u751f\u7855\u58eb Mark Eisner \u8bf4\u3002 \u201c\u7f57\u6c99\u53f8\u4ed6\u4e3a\u60a3\u6709\u8fd9\u79cd\u75be\u75c5\u7684\u60a3\u8005\u63d0\u4f9b\u4e86\u5168\u65b0\u7a81\u7834\u3002\u201d<\/p>\n \u8fd9\u9879\u6279\u51c6\u662f\u9075\u5faa\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08CHMP\uff09 \u4e8e 6 \u6708 \u57fa\u4e8e\u4e00\u4e2a\u5305\u542b8\u9879\u591a\u4e2d\u5fc3\u968f\u673a\u8bd5\u9a8c\u3001\u8986\u76d6\u5168\u7403\u8303\u56f4\u51859,600\u540d\u60a3\u8005\u7684\u7efc\u5408\u6027\u5173\u952e\u4e09\u671f\u9879\u76ee\u7ed3\u679c\u6388\u4e88\u7f57\u6c99\u53f8\u4ed6\u7684\u79ef\u6781\u610f\u89c1\u505a\u51fa\u7684\u3002[7-12]<\/sup>\u8be5\u9879\u76ee\u7684\u7ed3\u679c\u8868\u660e\uff0c\u65e0\u8bba\u60a3\u8005\u662f\u5426\u63a5\u53d7\u900f\u6790\uff0c\u6216\u662f\u5426\u66fe\u63a5\u53d7 ESA \u6cbb\u7597\uff0c\u7f57\u6c99\u53f8\u4ed6\u90fd\u80fd\u6709\u6548\u5730\u8fbe\u5230\u5e76\u7ef4\u6301 CKD \u75c7\u72b6\u6027\u8d2b\u8840\u60a3\u8005\u7684\u76ee\u6807 Hb \u6c34\u5e73 (10-12g\/dL) \u3002[7-11]<\/sup> \u7f57\u6c99\u53f8\u4ed6\u4e34\u5e8a\u5f00\u53d1\u9879\u76ee\u4e2d\u89c2\u5bdf\u5230\u7684\u5b89\u5168\u6027\u7279\u5f81\uff0c\u53cd\u6620\u4e86\u7814\u7a76\u7684CKD\u4eba\u7fa4\u7279\u5f81\uff0c\u5e76\u4e0eESA\u76f8\u5f53\u3002[7-12]<\/sup><\/p>\n EC \u6709\u6743\u4e3a\u6b27\u76df\u6210\u5458\u56fd\u4ee5\u53ca\u6b27\u6d32\u7ecf\u6d4e\u533a (EEA) \u56fd\u5bb6\u51b0\u5c9b\u3001\u632a\u5a01\u3001\u5217\u652f\u6566\u58eb\u767b\u6279\u51c6\u836f\u54c1\u3002[13]<\/sup><\/p>\n \u7f57\u6c99\u53f8\u4ed6\u83b7\u5f97EC\u7684\u6279\u51c6\uff0c\u4e3a\u73d0\u535a\u8fdb\u5e26\u6765\u4e86\u5b89\u65af\u6cf0\u6765\u652f\u4ed8\u76841.2 \u4ebf\u7f8e\u5143\u7684\u91cc\u7a0b\u7891\u4ed8\u6b3e\uff0c\u73d0\u535a\u8fdb\u8fd8\u5c06\u6839\u636e\u6b27\u6d32\u51c0\u9500\u552e\u989d\u83b7\u5f97\u7279\u8bb8\u6743\u4f7f\u7528\u8d39\u3002<\/p>\n \u5173\u4e8e\u6162\u6027\u80be\u810f\u75c5\u53ca\u5176\u8d2b\u8840<\/b><\/p>\n \u6162\u6027\u80be\u810f\u75c5\uff08CKD\uff09\u662f\u4e00\u79cd\u8fdb\u884c\u6027\u75be\u75c5\uff0c\u7279\u5f81\u4e3a\u80be\u529f\u80fd\u9010\u6e10\u4e27\u5931\uff0c\u6700\u7ec8\u53ef\u80fd\u5bfc\u81f4\u80be\u8870\u7aed\u6216\u7ec8\u672b\u671f\u80be\u75c5\uff0c\u9700\u8981\u8fdb\u884c\u900f\u6790\u6216\u80be\u79fb\u690d\u3002[14]<\/sup>\u8bb8\u591aCKD\u60a3\u8005\u5728\u8fdb\u5c55\u5230\u80be\u8870\u7aed\u524d\u6b7b\u4e8e\u5fc3\u8840\u7ba1\u5e76\u53d1\u75c7\uff0c\u56e0\u6b64\u65e9\u671f\u80be\u810f\u75c5\u7684\u60a3\u75c5\u7387\u9ad8\u4e8e\u7ec8\u672b\u671f\u75be\u75c5\u3002[14, 15]<\/sup>\u5168\u4e16\u754c\u6bcf10\u4eba\u4e2d\u5c31\u67091\u4eba\u53d7CKD\u5f71\u54cd\u3002\u9884\u8ba1\u52302040\u5e74\uff0cCKD\u5c06\u6210\u4e3a\u5168\u7403\u7b2c\u4e94\u5927\u8fc7\u65e9\u6b7b\u4ea1\u7684\u56e0\u7d20\u3002[1,16]<\/sup><\/p>\n \u8d2b\u8840\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u533b\u5b66\u72b6\u51b5\uff0c\u4f53\u73b0\u5728\u60a3\u8005\u7ea2\u7ec6\u80de\u4e0d\u8db3\u548c\u8840\u7ea2\u86cb\u767d\u6c34\u5e73\u4f4e\uff0c\u662fCKD\u5e38\u89c1\u7684\u65e9\u671f\u5e76\u53d1\u75c7\uff0c\u5f71\u54cd\u7ea620%\u7684CKD\u60a3\u8005\u3002[2, 17]<\/sup>CKD\u8d2b\u8840\u4e0e\u4f4f\u9662\u3001\u5fc3\u8840\u7ba1\u5e76\u53d1\u75c7\u548c\u6b7b\u4ea1\u98ce\u9669\u7684\u589e\u52a0\u6709\u5173\uff0c\u4e5f\u53ef\u5f15\u8d77\u4e25\u91cd\u7684\u75b2\u4e4f\u3001\u8ba4\u77e5\u529f\u80fd\u969c\u788d\u53ca\u751f\u6d3b\u8d28\u91cf\u4e0b\u964d\u3002[4, 18]<\/sup>\u8f93\u8840\u88ab\u7528\u4e8e\u6cbb\u7597\u91cd\u5ea6\u8d2b\u8840\uff0c\u7136\u800c\uff0c\u8f93\u8840\u53ef\u80fd\u51cf\u5c11\u60a3\u8005\u8fdb\u884c\u80be\u79fb\u690d\u7684\u53ef\u80fd\u6027\u5e76\u53ef\u80fd\u589e\u52a0\u611f\u67d3\u548c\/\u6216\u5e76\u53d1\u75c7\uff08\u5982\u5fc3\u810f\u8870\u7aed\u548c\u8fc7\u654f\u53cd\u5e94\uff09\u7684\u98ce\u9669\u3002[19, 20]<\/sup><\/p>\n \u5173\u4e8e\u7f57\u6c99\u53f8\u4ed6<\/b><\/p>\n \u53e3\u670d\u4f4e\u6c27\u8bf1\u5bfc\u56e0\u5b50\u812f\u6c28\u9170\u7f9f\u5316\u9176\uff08HIF-PH\uff09\u6291\u5236\u5242\u7f57\u6c99\u53f8\u4ed6\u662f\u4e00\u79cd\u9996\u521b\u65b0\u836f\uff0c\u901a\u8fc7\u589e\u52a0\u5185\u6e90\u6027\u4fc3\u7ea2\u7ec6\u80de\u751f\u6210\u7d20\u751f\u6210\uff0c\u6539\u5584\u94c1\u7684\u5438\u6536\u548c\u8c03\u52a8\uff0c\u964d\u4f4e\u94c1\u8c03\u7d20\uff0c\u4fc3\u8fdb\u7ea2\u7ec6\u80de\u751f\u6210\u3002\u7f57\u6c99\u53f8\u4ed6\u540c\u65f6\u6b63\u5728\u8fdb\u884c\u7528\u4e8e\u6cbb\u7597\u9aa8\u9ad3\u589e\u751f\u5f02\u5e38\u7efc\u5408\u5f81\uff08MDS\uff09\u76f8\u5173\u8d2b\u8840\u7684\u4e09\u671f\u4e34\u5e8a\u5f00\u53d1\u548c\u5316\u7597\u8bf1\u5bfc\u6027\u8d2b\u8840\uff08CIA\uff09\u7684\u4e8c\u671f\u4e34\u5e8a\u5f00\u53d1\u3002<\/p>\n \u7f57\u6c99\u53f8\u4ed6\u5df2\u5728\u6b27\u76df\u6210\u5458\u56fd\uff0c\u5305\u62ec\u6b27\u6d32\u7ecf\u6d4e\u533a\u56fd\u5bb6\uff0c\u4ee5\u53ca\u65e5\u672c\u3001\u4e2d\u56fd\u3001\u667a\u5229\u548c\u97e9\u56fd\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u900f\u6790\uff08DD\uff09\u53ca\u975e\u900f\u6790\uff08NDD\uff09\u6210\u4eba\u60a3\u8005\u7684CKD\u8d2b\u8840\u3002\u5b89\u65af\u6cf0\u6765\u548c\u963f\u65af\u5229\u5eb7\u5df2\u5728\u5168\u7403\u8303\u56f4\u5185\u5411\u76d1\u7ba1\u673a\u6784\u63d0\u4ea4\u4e86\u7f57\u6c99\u53f8\u4ed6\u7684\u5176\u4ed6\u51e0\u9879\u8bb8\u53ef\u7533\u8bf7\uff0c\u76ee\u524d\u6b63\u5728\u5ba1\u6279\u4e2d\u3002<\/p>\n \u5b89\u65af\u6cf0\u6765\u548c\u73d0\u535a\u8fdb\u6b63\u5728\u5408\u4f5c\u4e8e\u65e5\u672c\u3001\u6b27\u6d32\u3001\u571f\u8033\u5176\u3001\u4fc4\u7f57\u65af\u548c\u72ec\u7acb\u56fd\u5bb6\u8054\u5408\u4f53\u3001\u4e2d\u4e1c\u548c\u5357\u975e\u5730\u533a\u8fdb\u884c\u7f57\u6c99\u53f8\u4ed6\u7528\u4e8eCKD\u8d2b\u8840\u6f5c\u5728\u6cbb\u7597\u7684\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u3002\u73d0\u535a\u8fdb\u548c\u963f\u65af\u5229\u5eb7\u6b63\u5728\u5408\u4f5c\u4e8e\u7f8e\u56fd\u3001\u4e2d\u56fd\u3001\u5176\u4ed6\u7f8e\u6d32\u5e02\u573a\u3001\u6fb3\u5927\u5229\u4e9a\/\u65b0\u897f\u5170\u548c\u4e1c\u5357\u4e9a\u5730\u533a\u8fdb\u884c\u7f57\u6c99\u53f8\u4ed6\u7528\u4e8eCKD\u8d2b\u8840\u6f5c\u5728\u6cbb\u7597\u7684\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u3002<\/p>\n \u91cd\u8981\u5b89\u5168\u4fe1\u606f<\/b><\/p>\n \u7f57\u6c99\u53f8\u4ed6\u5b8c\u6574\u7684\u6b27\u6d32\u4ea7\u54c1\u7279\u6027\u6458\u8981 (SPC\/SmPC) \u53ef\u4ece\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u83b7\u5f97\uff0c\u7f51\u5740\u4e3a http:\/\/www.ema.europa.eu\/<\/a> [21] <\/sup><\/p>\n \u5173\u4e8e\u5b89\u65af\u6cf0\u6765<\/b><\/p>\n \u5b89\u65af\u6cf0\u6765\u5236\u836f\u96c6\u56e2\u662f\u4e00\u5bb6\u5236\u836f\u4f01\u4e1a\uff0c\u4e1a\u52a1\u904d\u53ca\u5168\u740370\u591a\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\u3002\u76ee\u524d\uff0c\u6211\u4eec\u6b63\u5728\u63a8\u8fdb\u201c\u7126\u70b9\u9886\u57df\u7684\u7814\u7a76\u7b56\u7565\uff08Focus Area Approach\uff09\u201d\uff0c\u65e8\u5728\u901a\u8fc7\u805a\u7126\u751f\u7406\u673a\u5236\u548c\u6cbb\u7597\u624b\u6bb5\uff0c\u786e\u5b9a\u6301\u7eed\u7814\u53d1\u65b0\u836f\u7684\u673a\u4f1a\uff0c\u89e3\u51b3\u5c1a\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002\u4e0e\u6b64\u540c\u65f6\uff0c\u6211\u4eec\u6b63\u5728\u5c06\u76ee\u5149\u6295\u5411\u5904\u65b9\u836f\u4ee5\u5916\u7684\u4e1a\u52a1\u9886\u57df\uff0c\u5c06\u6211\u4eec\u7684\u4e13\u4e1a\u6280\u80fd\u548c\u77e5\u8bc6\u4e0e\u4e0d\u540c\u9886\u57df\u5916\u90e8\u5408\u4f5c\u4f19\u4f34\u7684\u5c16\u7aef\u6280\u672f\u76f8\u7ed3\u5408\uff0c\u6253\u9020Rx+®<\/sup>\u533b\u7597\u89e3\u51b3\u65b9\u6848\u3002\u901a\u8fc7\u8fd9\u4e9b\u52aa\u529b\uff0c\u5b89\u65af\u6cf0\u6765\u7acb\u5fd7\u5904\u4e8e\u4e0d\u65ad\u53d8\u5316\u7684\u533b\u7597\u884c\u4e1a\u7684\u6700\u524d\u6cbf\uff0c\u5c06\u79d1\u5b66\u7684\u8fdb\u6b65\u8f6c\u53d8\u4e3a\u60a3\u8005\u7684\u4ef7\u503c\u3002\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee\u6211\u4eec\u7684\u7f51\u7ad9https:\/\/www.astellas.com\/en<\/a><\/u>\u3002 <\/p>\n \u5173\u4e8e\u73d0\u535a\u8fdb<\/b><\/p>\n 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10-K\u5e74\u62a5\u548c\u622a\u81f32021\u5e746\u670830\u65e5\u7684Form 10-Q\u5b63\u62a5\u4e2d\u6240\u9610\u8ff0\u7684\u5176\u4ed6\u4e8b\u9879\uff0c\u5305\u62ec\u5176\u4e2d\u7684\u98ce\u9669\u56e0\u7d20\u3002\u6211\u4eec\u5728\u6b64\u63d0\u9192\u6295\u8d44\u8005\u4e0d\u8981\u8fc7\u5ea6\u4f9d\u8d56\u8fd9\u4e9b\u524d\u77bb\u6027\u58f0\u660e\uff0c\u8fd9\u4e9b\u58f0\u660e\u4ec5\u5728\u672c\u65b0\u95fb\u7a3f\u53d1\u5e03\u4e4b\u65e5\u6709\u6548\u3002\u9664\u975e\u6cd5\u5f8b\u8981\u6c42\uff0c\u5426\u5219\u6211\u4eec\u6ca1\u6709\u4e49\u52a1\u66f4\u65b0\u672c\u65b0\u95fb\u7a3f\u4e2d\u7684\u4efb\u4f55\u524d\u77bb\u6027\u58f0\u660e\u3002<\/p>\n \u53c2\u8003\u6587\u732e<\/b><\/p>\n[1]. Nephrology ISo. Chronic kidney disease. Global kidney health atlas 2019 [Accessed August 2021<\/span>]. Available from: https:\/\/www.theisn.org\/wp-content\/uploads\/2021\/05\/GKHAtlas_2019_WebFIle-1.pdf<\/a>. \u76f8\u5173\u94fe\u63a5 :<\/p>\n http:\/\/www.fibrogen.com<\/p>\n","protected":false},"excerpt":{"rendered":" \u7f57\u6c99\u53f8\u4ed6\u662f\u6b27\u6d32\u9996\u4e2a\u7528\u4e8e\u6162\u6027\u80be\u810f\u75c5\u76f8\u5173\u7684\u8d2b\u8840\u6210\u4eba\u60a3\u8005\u7684\u53e3\u670d\u4f4e\u6c27\u8bf1\u5bfc\u56e0\u5b50 (HIF) \u812f\u6c28\u9170\u7f9f\u5316\u9176 (PH) \u6291\u5236\u5242\u3002 \u4e1c\u4eac2021\u5e748\u670820\u65e5 \/\u7f8e\u901a\u793e\/ — \u5b89\u65af\u6cf0\u6765\u5236\u836f\u96c6\u56e2\uff08\u4e1c\u4eac\u8bc1\u5238\u4ea4\u6613\u6240\u80a1\u7968\u4ee3\u7801\uff1a4503\uff0c\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98\uff1a\u5b89\u5ddd\u5065\u53f8\u535a\u58eb\uff0c\u201c\u5b89\u65af\u6cf0\u6765\u201d\uff09\u548c\u7f8e\u56fd\u73d0\u535a\u8fdb\u516c\u53f8\uff08\u7eb3\u65af\u8fbe\u514b\u4ee3\u7801\uff1aFGEN\uff0c\u9996\u5e2d\u6267\u884c\u5b98\uff1aEnrique Conterno\uff0c\u201c\u73d0\u535a\u8fdb\u201d) \u4e8e2021\u5e748\u670819\u65e5\u5ba3\u5e03\uff0c\u6b27\u76df\u59d4\u5458\u4f1a (EC) \u5df2\u6279\u51c6 EVRENZO TM (\u7f57\u6c99\u53f8\u4ed6) \u7528\u4e8e\u6cbb\u7597\u4e0e\u6162\u6027\u80be\u75c5 (CKD) \u76f8\u5173\u7684\u75c7\u72b6\u6027\u8d2b\u8840\u6210\u4eba\u60a3\u8005\u3002 \u201c\u6211\u4eec\u5f88\u9ad8\u5174 EVRENZO \u5df2\u83b7\u6279\u6210\u4e3a\u6b27\u76df\u7b2c\u4e00\u4e2a\u53e3\u670d HIF-PH \u6291\u5236\u5242\uff0c\u7528\u4e8e\u6cbb\u7597\u4e0e CKD \u76f8\u5173\u7684\u75c7\u72b6\u6027\u8d2b\u8840\u6210\u4eba\u60a3\u8005\uff0c\u201d\u5b89\u65af\u6cf0\u6765\u5f00\u53d1\u603b\u88c1\u3001\u5065\u5eb7\u79d1\u5b66\u7855\u58eb\u3001\u533b\u5b66\u535a\u58ebSteven Benner\u8bf4\u3002 \u201c\u4eca\u5929\u7684\u6279\u51c6\uff0c\u4e3a\u900f\u6790\u6216\u975e\u900f\u6790\u7684CKD\u8d2b\u8840\u60a3\u8005\u5e26\u6765\u4e86\u5177\u6709\u5168\u65b0\u4f5c\u7528\u673a\u5236\u7684\u6cbb\u7597\u9009\u62e9\uff0c\u89e3\u51b3\u8fd9\u79cd\u75be\u75c5\u591a\u65b9\u9762\u7684\u95ee\u9898\u3002\u6211\u4eec\u671f\u5f85\u7740\u5c06\u7f57\u6c99\u53f8\u4ed6\u5e26\u7ed9\u6b27\u76df\u5404\u56fd\u7684 CKD \u8d2b\u8840\u6210\u4eba\u60a3\u8005 \u3002\u201d \u5168\u7403\u8303\u56f4\u5185\u6bcf10\u4eba\u4e2d\u5c31\u67091\u4eba\u53d7CKD\u5f71\u54cd\uff0c\u5176\u4e2d\u6bcf5\u4eba\u4e2d\u5c31\u67091\u4eba\u53d7\u8d2b\u8840\u5f71\u54cd\u3002[1, 2] CKD\u8d2b\u8840\u901a\u5e38\u672a\u5f97\u5230\u6cbb\u7597\u6216\u672a\u8fbe\u5230\u6cbb\u7597\u76ee\u6807\uff0c\u5e76\u4e0e\u751f\u6d3b\u8d28\u91cf\u663e\u8457\u4e0b\u964d\u3001\u5fc3\u8840\u7ba1\u548c\u80be\u810f\u75c5\u60c5\u6301\u7eed\u8fdb\u5c55\u81f3\u4e0d\u826f\u7ed3\u5c40\u76f8\u5173\u3002[3-5] \u201c\u8d2b\u8840\u662f CKD \u7684\u4e00\u79cd\u663e\u8457\u4e14\u65e9\u671f\u7684\u5e76\u53d1\u75c7\uff0c\u5e76\u968f\u7740 CKD \u6076\u5316\uff0c\u5176\u53d1\u751f\u7684\u9891\u7387\u548c\u5f71\u54cd\u52a0\u5927\uff0c\u5f71\u54cd\u60a3\u8005\u7684\u65e5\u5e38\u751f\u6d3b\u3001\u81ea\u7406\u548c\u884c\u52a8\u80fd\u529b\uff0c\u201d\u82f1\u56fd\u7687\u5bb6\u5185\u79d1\u533b\u5b66\u9662\u9662\u58eb\u3001\u82f1\u56fd\u83b1\u65af\u7279\u5927\u5b66\u80be\u79d1\u533b\u5b66Mayer\u6559\u6388\u53ca\u987e\u95ee\u80be\u75c5\u5b66\u5bb6Jonathan Barratt \u533b\u5b66\u535a\u58eb\u8bf4\uff0c \u201c\u8fd9\u9879\u6279\u51c6\u610f\u5473\u7740\uff0c\u5728\u4e3a\u60a3\u8005\u7ba1\u7406\u8d2b\u8840\u75c7\u72b6\u548c\u7ef4\u6301\u76ee\u6807\u8840\u7ea2\u86cb\u767d\u6c34\u5e73\u63d0\u4f9b\u4e00\u79cd\u6709\u6548\u3001\u7b80\u5355\u6cbb\u7597\u65b9\u6848\uff0c\u4ee5\u6700\u5927\u7a0b\u5ea6\u51cf\u8f7b\u5bf9\u60a3\u8005\u751f\u6d3b\u8d28\u91cf\u7684\u5f71\u54cd\u65b9\u9762\uff0c\u5411\u524d\u8fc8\u51fa\u4e86\u91cd\u8981\u7684\u4e00\u6b65\u3002\u201d \u7f57\u6c99\u53f8\u4ed6\u662f\u6b27\u76df\u9996\u4e2a\u53e3\u670d\u4f4e\u6c27\u8bf1\u5bfc\u56e0\u5b50\uff08HIF\uff09\u812f\u6c28\u9170\u7f9f\u5316\u9176\uff08PH\uff09\u6291\u5236\u5242\u3002\u6bd4\u8d77\u901a\u5e38\u4e0e\u9759\u8109\u94c1\u5242\u5171\u540c\u7ed9\u836f\u7684\u53ef\u6ce8\u5c04\u7ea2\u7ec6\u80de\u751f\u6210\u523a\u6fc0\u5242\uff08ESA\uff09\uff0c\u7f57\u6c99\u53f8\u4ed6\u901a\u8fc7\u4e0d\u540c\u7684\u4f5c\u7528\u673a\u5236\u63d0\u9ad8\u8840\u7ea2\u86cb\u767d\uff08Hb\uff09\u6c34\u5e73\u3002\u4f5c\u4e3a HIF-PH \u6291\u5236\u5242\uff0c\u7f57\u6c99\u53f8\u4ed6\u901a\u8fc7\u6fc0\u6d3b\u8eab\u4f53\u5bf9\u8840\u6db2\u4e2d\u6c27\u542b\u91cf\u964d\u4f4e\u7684\u81ea\u7136\u53cd\u5e94\uff0c\u6b64\u53cd\u5e94\u6d89\u53ca\u591a\u4e2a\u76f8\u4e92\u534f\u540c\u7684\u8fc7\u7a0b\u7684\u8c03\u8282\uff0c\u4ece\u800c\u5728\u51cf\u5c11\u9759\u8109\u94c1\u5242\u4f7f\u7528\u7684\u60c5\u51b5\u4e0b\u7ba1\u7406\u8d2b\u8840\u3002 \u201cHIF-PH \u6291\u5236\u5242\u4ee3\u8868\u4e86CKD \u8d2b\u8840\u6cbb\u7597\u7684\u91cd\u5927\u8fdb\u5c55\uff0c\u201d\u73d0\u535a\u8fdb\u9996\u5e2d\u533b\u5b66\u5b98\u3001\u533b\u5b66\u535a\u58eb\u3001\u516c\u5171\u536b\u751f\u7855\u58eb Mark Eisner \u8bf4\u3002 \u201c\u7f57\u6c99\u53f8\u4ed6\u4e3a\u60a3\u6709\u8fd9\u79cd\u75be\u75c5\u7684\u60a3\u8005\u63d0\u4f9b\u4e86\u5168\u65b0\u7a81\u7834\u3002\u201d \u8fd9\u9879\u6279\u51c6\u662f\u9075\u5faa\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08CHMP\uff09 \u4e8e 6 \u6708 \u57fa\u4e8e\u4e00\u4e2a\u5305\u542b8\u9879\u591a\u4e2d\u5fc3\u968f\u673a\u8bd5\u9a8c\u3001\u8986\u76d6\u5168\u7403\u8303\u56f4\u51859,600\u540d\u60a3\u8005\u7684\u7efc\u5408\u6027\u5173\u952e\u4e09\u671f\u9879\u76ee\u7ed3\u679c\u6388\u4e88\u7f57\u6c99\u53f8\u4ed6\u7684\u79ef\u6781\u610f\u89c1\u505a\u51fa\u7684\u3002[7-12]\u8be5\u9879\u76ee\u7684\u7ed3\u679c\u8868\u660e\uff0c\u65e0\u8bba\u60a3\u8005\u662f\u5426\u63a5\u53d7\u900f\u6790\uff0c\u6216\u662f\u5426\u66fe\u63a5\u53d7 ESA \u6cbb\u7597\uff0c\u7f57\u6c99\u53f8\u4ed6\u90fd\u80fd\u6709\u6548\u5730\u8fbe\u5230\u5e76\u7ef4\u6301 CKD \u75c7\u72b6\u6027\u8d2b\u8840\u60a3\u8005\u7684\u76ee\u6807 Hb \u6c34\u5e73 (10-12g\/dL) \u3002[7-11] \u7f57\u6c99\u53f8\u4ed6\u4e34\u5e8a\u5f00\u53d1\u9879\u76ee\u4e2d\u89c2\u5bdf\u5230\u7684\u5b89\u5168\u6027\u7279\u5f81\uff0c\u53cd\u6620\u4e86\u7814\u7a76\u7684CKD\u4eba\u7fa4\u7279\u5f81\uff0c\u5e76\u4e0eESA\u76f8\u5f53\u3002[7-12] EC \u6709\u6743\u4e3a\u6b27\u76df\u6210\u5458\u56fd\u4ee5\u53ca\u6b27\u6d32\u7ecf\u6d4e\u533a (EEA) \u56fd\u5bb6\u51b0\u5c9b\u3001\u632a\u5a01\u3001\u5217\u652f\u6566\u58eb\u767b\u6279\u51c6\u836f\u54c1\u3002[13] \u7f57\u6c99\u53f8\u4ed6\u83b7\u5f97EC\u7684\u6279\u51c6\uff0c\u4e3a\u73d0\u535a\u8fdb\u5e26\u6765\u4e86\u5b89\u65af\u6cf0\u6765\u652f\u4ed8\u76841.2 \u4ebf\u7f8e\u5143\u7684\u91cc\u7a0b\u7891\u4ed8\u6b3e\uff0c\u73d0\u535a\u8fdb\u8fd8\u5c06\u6839\u636e\u6b27\u6d32\u51c0\u9500\u552e\u989d\u83b7\u5f97\u7279\u8bb8\u6743\u4f7f\u7528\u8d39\u3002 \u5173\u4e8e\u6162\u6027\u80be\u810f\u75c5\u53ca\u5176\u8d2b\u8840 \u6162\u6027\u80be\u810f\u75c5\uff08CKD\uff09\u662f\u4e00\u79cd\u8fdb\u884c\u6027\u75be\u75c5\uff0c\u7279\u5f81\u4e3a\u80be\u529f\u80fd\u9010\u6e10\u4e27\u5931\uff0c\u6700\u7ec8\u53ef\u80fd\u5bfc\u81f4\u80be\u8870\u7aed\u6216\u7ec8\u672b\u671f\u80be\u75c5\uff0c\u9700\u8981\u8fdb\u884c\u900f\u6790\u6216\u80be\u79fb\u690d\u3002[14]\u8bb8\u591aCKD\u60a3\u8005\u5728\u8fdb\u5c55\u5230\u80be\u8870\u7aed\u524d\u6b7b\u4e8e\u5fc3\u8840\u7ba1\u5e76\u53d1\u75c7\uff0c\u56e0\u6b64\u65e9\u671f\u80be\u810f\u75c5\u7684\u60a3\u75c5\u7387\u9ad8\u4e8e\u7ec8\u672b\u671f\u75be\u75c5\u3002[14, 15]\u5168\u4e16\u754c\u6bcf10\u4eba\u4e2d\u5c31\u67091\u4eba\u53d7CKD\u5f71\u54cd\u3002\u9884\u8ba1\u52302040\u5e74\uff0cCKD\u5c06\u6210\u4e3a\u5168\u7403\u7b2c\u4e94\u5927\u8fc7\u65e9\u6b7b\u4ea1\u7684\u56e0\u7d20\u3002[1,16] \u8d2b\u8840\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u533b\u5b66\u72b6\u51b5\uff0c\u4f53\u73b0\u5728\u60a3\u8005\u7ea2\u7ec6\u80de\u4e0d\u8db3\u548c\u8840\u7ea2\u86cb\u767d\u6c34\u5e73\u4f4e\uff0c\u662fCKD\u5e38\u89c1\u7684\u65e9\u671f\u5e76\u53d1\u75c7\uff0c\u5f71\u54cd\u7ea620%\u7684CKD\u60a3\u8005\u3002[2, 17]CKD\u8d2b\u8840\u4e0e\u4f4f\u9662\u3001\u5fc3\u8840\u7ba1\u5e76\u53d1\u75c7\u548c\u6b7b\u4ea1\u98ce\u9669\u7684\u589e\u52a0\u6709\u5173\uff0c\u4e5f\u53ef\u5f15\u8d77\u4e25\u91cd\u7684\u75b2\u4e4f\u3001\u8ba4\u77e5\u529f\u80fd\u969c\u788d\u53ca\u751f\u6d3b\u8d28\u91cf\u4e0b\u964d\u3002[4, 18]\u8f93\u8840\u88ab\u7528\u4e8e\u6cbb\u7597\u91cd\u5ea6\u8d2b\u8840\uff0c\u7136\u800c\uff0c\u8f93\u8840\u53ef\u80fd\u51cf\u5c11\u60a3\u8005\u8fdb\u884c\u80be\u79fb\u690d\u7684\u53ef\u80fd\u6027\u5e76\u53ef\u80fd\u589e\u52a0\u611f\u67d3\u548c\/\u6216\u5e76\u53d1\u75c7\uff08\u5982\u5fc3\u810f\u8870\u7aed\u548c\u8fc7\u654f\u53cd\u5e94\uff09\u7684\u98ce\u9669\u3002[19, 20] \u5173\u4e8e\u7f57\u6c99\u53f8\u4ed6… Read More<\/a><\/p>\n","protected":false},"author":556,"featured_media":8278,"comment_status":"close","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1965],"tags":[],"class_list":["post-41501","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-partnerships"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/41501","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/users\/556"}],"replies":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/comments?post=41501"}],"version-history":[{"count":1,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/41501\/revisions"}],"predecessor-version":[{"id":41502,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/41501\/revisions\/41502"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media\/8278"}],"wp:attachment":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media?parent=41501"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/categories?post=41501"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/tags?post=41501"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
[2]. Dmitrieva O, de Lusignan S, Macdougall IC, Gallagher H, Tomson C, Harris K, et al. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. BMC Nephrol. 2013;14:24.
[3]. Wong MMY, Tu C, Li Y, Perlman RL, Pecoits-Filho R, Lopes AA, et al. Anemia and iron deficiency among chronic kidney disease Stages 3-5ND patients in the Chronic Kidney Disease Outcomes and Practice Patterns Study: often unmeasured, variably treated. Clin Kidney J<\/span>. 2020;13(4):613-24.
[4]. Schmidt RJ, Dalton CL. Treating anemia of chronic kidney disease in the primary care setting: cardiovascular outcomes and management recommendations. Osteopath Med Prim Care. 2007;1:14.
[5]. Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States<\/span>. PLoS One. 2014;9(1):e84943.
[6]. European Medicines Agency. Meeting highlights from the Commitee for Medicinal Products for Human Use (CHMP) June 2021 [Accessed August 2021<\/span>]. Available from: https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-june-2021<\/span><\/a>.
[7]. Clinicaltrials.Gov. Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (Pyrenees). NCT02278341. [Accessed August 2021<\/span>]. Available from: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02278341<\/a>.
[8.] Shutov E, Su\u0142owicz W, Esposito C, Tataradze A, Andric B, Reusch M, et al. Roxadustat for the treatment of anemia in chronic kidney disease patients not on dialysis: a phase 3, randomized, double-blind, placebo-controlled study (ALPS). Nephrol Dial Transplant. 2021; 1-11. doi: 10.1093\/ndt\/gfab057.
[9]. Coyne DW, Roger SD, Shin SK, Kim SG, Cadena AA, Moustafa MA, et al. Roxadustat for CKD-related Anemia in Non-dialysis Patients. Kidney Int Rep. 2021;6(3):624-35.
[10]. Provenzano R, Shutov E, Eremeeva L, Korneyeva S, Poole L, Saha G, et al. Roxadustat for anemia in patients with end-stage renal disease incident to dialysis. Nephrol Dial Transplant. 2021. doi: 10.1093\/ndt\/gfab051.
[11]. Fishbane S, El-Shahawy MA, Pecoits-Filho R, Van BP, Houser MT, Frison L, et al. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021;32(3):737-55.
[12]. Barratt J, Andric B, Tataradze A, Schömig M, Reusch M, Valluri U, et al. Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a phase 3, randomised, open-label, active-controlled study (DOLOMITES). Nephrol Dial Transplant. 2021. 1-13. doi: 10.1093\/ndt\/gfab191.
[13]. European Medicines Agency. Authorizations of Medicines [Accessed August 2021<\/span>]. Available from: https:\/\/www.ema.europa.eu\/about-us\/what-we-do\/authorisation-medicines<\/a>
[14]. Ojo A. Addressing the global burden of chronic kidney disease through clinical and translational research. Trans Am Clin Climatol Assoc. 2014;125:229-43; discussion 43-6.
[15]. Subbiah AK, Chhabra YK, Mahajan S. Cardiovascular disease in patients with chronic kidney disease: a neglected subgroup. Heart Asia<\/span>. 2016;8(2):56-61.
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[21]. Data on file. Northbrook, III. Astellas Pharma Inc. <\/p>\n