{"id":508,"date":"2023-10-25T18:21:14","date_gmt":"2023-10-25T10:21:14","guid":{"rendered":"http:\/\/www.yaozhiyou.com\/?p=508"},"modified":"2023-10-25T18:21:14","modified_gmt":"2023-10-25T10:21:14","slug":"%e5%8e%84%e8%be%be%e6%9b%bf%e5%b0%bc%ef%bc%88erdafitinib%ef%bc%89%c2%b7%e5%b0%bf%e8%b7%af%e4%b8%8a%e7%9a%ae%e7%99%8c%ef%bc%88%e8%86%80%e8%83%b1%e7%99%8c%ef%bc%89%e7%9a%84%e5%85%8b%e6%98%9f","status":"publish","type":"post","link":"https:\/\/www.yaozhiyou.com\/?p=508","title":{"rendered":"\u5384\u8fbe\u66ff\u5c3c\uff08Erdafitinib\uff09\u00b7\u5c3f\u8def\u4e0a\u76ae\u764c\uff08\u8180\u80f1\u764c\uff09\u7684\u514b\u661f"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-509\" src=\"https:\/\/www.yaozhiyou.com\/wp-content\/uploads\/2023\/10\/\u5384\u8fbe\u66ff\u5c3c.png\" alt=\"\u5384\u8fbe\u66ff\u5c3c\" width=\"450\" height=\"528\" \/><\/p>\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>0<\/strong><strong title=\"\" data-original-title=\"\">1<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u4ec0\u4e48\u662f\u8180\u80f1\u764c\uff08\u5c3f\u8def\u4e0a\u76ae\u764c\uff09\uff1f<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section data-role=\"paragraph\">\u5728\u8180\u80f1\u764c\uff08\u5c3f\u8def\u4e0a\u76ae\u764c\uff09\u4e2d\uff0c\u7ec6\u80de\u5728\u8180\u80f1\u4e2d\u5f02\u5e38\u751f\u957f\u5f62\u6210\u80bf\u7624\u3002\u5927\u591a\u6570\u8180\u80f1\u764c\u59cb\u4e8e\u8180\u80f1\u5185\u5c42\uff0c\u79f0\u4e3a\u5c3f\u8def\u4e0a\u76ae\u3002\u5982\u679c\u80bf\u7624\u6269\u6563\u5230\u8180\u80f1\u5916\uff0c\u5219\u88ab\u8ba4\u4e3a\u662f\u665a\u671f\u8180\u80f1\u764c\u3002<\/p>\n<\/section>\n<section data-role=\"paragraph\">\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>0<\/strong><strong title=\"\" data-original-title=\"\" data-num=\"2\">2<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u8180\u80f1\u764c\u4e3a\u4ec0\u4e48\u4f1a\u643a\u5e26FGFR\u7a81\u53d8\uff1f<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section data-role=\"paragraph\">FGFR\u00a0\u4ee3\u8868\u6210\u7ea4\u7ef4\u7ec6\u80de\u751f\u957f\u56e0\u5b50\u53d7\u4f53\u3002FGFR\u00a0\u5e2e\u52a9\u7ec6\u80de\u751f\u957f\u3001\u5b58\u6d3b\u548c\u7e41\u6b96\u3002\u5728\u67d0\u4e9b\u7c7b\u578b\u7684\u764c\u75c7\u4e2d\uff0c\u4f8b\u5982\u5728\u67d0\u4e9b\u8180\u80f1\u764c\u75c5\u4f8b\u4e2d\uff0c\u63a7\u5236\u00a0FGFR\u00a0\u7684\u57fa\u56e0\u53ef\u80fd\u4f1a\u53d1\u751f\u7a81\u53d8\uff08\u79f0\u4e3a\u00a0FGFR\u00a0\u6539\u53d8\uff09\u3002FGFR\u00a0\u7684\u7a81\u53d8\u4f1a\u5bfc\u81f4\u764c\u7ec6\u80de\u53d1\u5c55\uff0c\u5bfc\u81f4\u751f\u957f\u548c\u6269\u6563\u3002<\/p>\n<\/section>\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>0<\/strong><strong title=\"\" data-original-title=\"\" data-num=\"3\">3<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u6709\u591a\u5c11\u665a\u671f\u8180\u80f1\u764c\u60a3\u8005\u643a\u5e26FGFR\u7a81\u53d8\uff1f<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section data-role=\"paragraph\">\u5927\u7ea6\u670920%\u7684\u8180\u80f1\u764c\u60a3\u8005\u643a\u5e26\u6709FGFR\u7a81\u53d8\u3002<\/p>\n<section data-role=\"paragraph\">\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>04<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u5384\u8fbe\u66ff\u5c3c\u9002\u5e94\u75c7<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p>\u5384\u8fbe\u66ff\u5c3c\u662f\u4e00\u79cd\u6fc0\u9176\u6291\u5236\u5242\uff0c\u7528\u4e8e\u6cbb\u7597\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u7684\u6210\u4eba\u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u9700\u6ee1\u8db3\u4ee5\u4e0b\u6761\u4ef6\uff1a<\/p>\n<p>\uff081\uff09\u6709FGFR3\u6216FGFR2\u57fa\u56e0\u7a81\u53d8\u3002<\/p>\n<p>\uff082\uff09\u5728\u81f3\u5c11\u4e00\u79cd\u5148\u524d\u7684\u94c2\u7c7b\u5316\u7597\u65b9\u6848\u8fdb\u884c\u4e2d\u6216\u5316\u7597\u540e\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\uff0c\u5305\u62ec\u65b0\u8f85\u52a9\u6216\u8f85\u52a9\u94c2\u7c7b\u5316\u7597\u65b9\u6848\u6cbb\u7597\u768412\u4e2a\u6708\u5185\u3002<\/p>\n<\/section>\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>05<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u5384\u8fbe\u66ff\u5c3c\u63a8\u8350\u5242\u91cf<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section data-role=\"paragraph\">\uff081\uff09\u5728\u63a5\u53d7\u5384\u8fbe\u66ff\u5c3c\u6cbb\u7597\u4e4b\u524d\uff0c\u5148\u786e\u8ba4\u80bf\u7624\u6807\u672c\u6709FGFR\u57fa\u56e0\u7a81\u53d8\u3002<\/p>\n<p>\uff082\uff09\u63a8\u8350\u521d\u59cb\u8ba1\u91cf\uff1a\u4e3a\u6bcf\u5929\u4e00\u6b21\uff0c8mg\/\u6b21\/\u5929\uff0c\u82e5\u8fbe\u5230\u6807\u51c6\u5219\u589e\u52a0\u81f39mg\/\u6b21\/\u5929\u3002\u5728\u521d\u59cb\u5242\u91cf\u6cbb\u7597\u540e\u7684\u7b2c14\u81f321\u5929\u8bc4\u4f30\u8840\u78f7\u6c34\u5e73\uff0c\u82e5\u8840\u78f7\u6c34\u5e73\uff1c5.5mg\/dL\u4e14\u6ca1\u6709\u773c\u79d1\u75be\u75c5\u62162\u7ea7\u53ca\u4ee5\u4e0a\u7ea7\u522b\u4e0d\u826f\u53cd\u5e94\uff0c\u5219\u589e\u52a0\u5242\u91cf\u81f39mg\/\u6b21\/\u5929\u3002<\/p>\n<p>\uff083\uff09\u53ef\u4e0e\u98df\u7269\u6216\u4e0d\u4e0e\u98df\u7269\u6574\u7247\u541e\u670d\u3002<\/p>\n<\/section>\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>06<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u5384\u8fbe\u66ff\u5c3c\u7684\u8ba1\u91cf\u8c03\u6574<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section data-role=\"paragraph\"><strong>9\u00a0<\/strong><strong>\u6beb\u514b<\/strong><strong>\/<\/strong><strong>\u5929\u51cf\u5c11\u65f6\u95f4\u8868<\/strong><\/p>\n<p>\u7b2c\u4e00\uff1a8\u6beb\u514b\/\u5929<\/p>\n<p>\u7b2c\u4e8c\uff1a6\u6beb\u514b\/\u5929<\/p>\n<p>\u7b2c\u4e09\uff1a5\u6beb\u514b\/\u5929<\/p>\n<p>\u7b2c\u56db\uff1a4\u6beb\u514b\/\u5929<\/p>\n<p>\u7b2c\u4e94\uff1a\u9700\u8981\u7b2c\u4e94\u6b21\u51cf\u91cf\u5c31\u505c\u836f<\/p>\n<p><strong>8\u00a0<\/strong><strong>\u6beb\u514b<\/strong><strong>\/<\/strong><strong>\u5929\u51cf\u5c11\u65f6\u95f4\u8868<\/strong><\/p>\n<p>\u7b2c\u4e00\uff1a6\u6beb\u514b\/\u5929<\/p>\n<p>\u7b2c\u4e8c\uff1a5\u6beb\u514b\/\u5929<\/p>\n<p>\u7b2c\u4e09\uff1a4\u6beb\u514b\/\u5929<\/p>\n<p>\u7b2c\u56db\uff1a\u9700\u8981\u7b2c\u56db\u6b21\u51cf\u91cf\u5c31\u505c\u836f<\/p>\n<\/section>\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>07<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u51fa\u73b0\u526f\u4f5c\u7528\u65f6\u7684\u8ba1\u91cf\u8c03\u6574<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section data-role=\"paragraph\"><strong>\u9ad8\u78f7\u8840\u75c7<\/strong><\/p>\n<p>\uff081\uff09\u5728\u6240\u6709\u60a3\u8005\u4e2d\uff0c\u5c06\u78f7\u9178\u76d0\u6444\u5165\u91cf\u9650\u5236\u5728\u00a0600-800\u00a0\u6beb\u514b\/\u5929\uff1b\u5982\u679c\u8840\u6e05\u78f7\u9178\u76d0\u00a0&gt;7 mg\/dL\uff0c\u8003\u8651\u6dfb\u52a0\u53e3\u670d\u78f7\u9178\u76d0\u7ed3\u5408\u5242\uff0c\u76f4\u5230\u8840\u6e05\u78f7\u9178\u76d0\u6c34\u5e73\u6062\u590d\u5230\u00a0&lt;5.5 mg\/dL<\/p>\n<p>\uff082\uff09\u78f7\u9178\u76d0\u6c34\u5e73\u548c\u5242\u91cf<\/p>\n<ul class=\"list-paddingleft-1\">\n<li>5.6-6.9 mg\/dL (1.8-2.3 mmol\/L)\uff1a\u7ee7\u7eed\u4f7f\u7528\u5f53\u524d\u5242\u91cf<\/li>\n<li>7-9 mg\/dL (2.3-2.9 mmol\/L)\uff1a\u4fdd\u7559\uff1b\u6bcf\u5468\u91cd\u65b0\u8bc4\u4f30\u76f4\u5230\u78f7\u9178\u76d0 &lt;5.5 mg\/dL\uff08\u6216\u57fa\u7ebf\uff09\uff0c\u7136\u540e\u4ee5\u76f8\u540c\u7684\u5242\u91cf\u6c34\u5e73\u6062\u590d\uff1b\u5982\u679c\u9ad8\u78f7\u8840\u75c7\u6301\u7eed &gt;1 \u5468\uff0c\u5219\u51cf\u5c11\u5242\u91cf<\/li>\n<li>&gt;9 mg\/dL (&gt;2.9 mmol\/L)\uff1a\u4fdd\u7559\uff1b\u6bcf\u5468\u91cd\u65b0\u8bc4\u4f30\u76f4\u5230\u78f7\u9178\u76d0 &lt;5.5 mg\/dL\uff08\u6216\u57fa\u7ebf\uff09\uff0c\u7136\u540e\u4ee5\u4f4e 1 \u5242\u91cf\u6c34\u5e73\u91cd\u65b0\u5f00\u59cb<\/li>\n<li>&gt;10 mg\/dL (&gt;3.2 mmol\/L) \u6216\u57fa\u7ebf\u80be\u529f\u80fd\u663e\u7740\u6539\u53d8\u6216 3 \u7ea7\u9ad8\u9499\u8840\u75c7\uff1a\u4fdd\u7559\uff1b\u6bcf\u5468\u91cd\u65b0\u8bc4\u4f30\u76f4\u81f3\u78f7\u9178\u76d0 &lt;5.5 mg\/dL\uff08\u6216\u57fa\u7ebf\uff09\uff0c\u7136\u540e\u4ee5\u4f4e 2 \u5242\u91cf\u6c34\u5e73\u91cd\u65b0\u5f00\u59cb<\/li>\n<\/ul>\n<p><strong>\u4e2d\u5fc3\u6027\u6d46\u6db2\u6027\u89c6\u7f51\u819c\u75c5\u53d8\u6216\u89c6\u7f51\u819c\u8272\u7d20\u4e0a\u76ae\u8131\u79bb<\/strong><strong>\u00a0(CSR\/RPED)<\/strong><\/p>\n<p><strong>\uff08<\/strong><strong>1<\/strong><strong>\uff09<\/strong><strong>1<\/strong><strong>\u7ea7<\/strong><\/p>\n<ul class=\"list-paddingleft-1\">\n<li>\u65e0\u75c7\u72b6\uff1b\u4ec5\u4e34\u5e8a\u6216\u8bca\u65ad\u89c2\u5bdf<\/li>\n<li>\u505c\u836f\u76f4\u5230\u89e3\u51b3<\/li>\n<li>\u5982\u679c\u5728 4 \u5468\u5185\u7f13\u89e3\uff0c\u5219\u5728\u4e0b\u4e00\u4e2a\u8f83\u4f4e\u5242\u91cf\u6c34\u5e73\u6062\u590d\uff1b\u7136\u540e\uff0c\u5982\u679c\u4e00\u4e2a\u6708\u6ca1\u6709\u590d\u53d1\uff0c\u8003\u8651\u91cd\u65b0\u5347\u7ea7<\/li>\n<li>\u5982\u679c\u8fde\u7eed 2 \u6b21\u773c\u79d1\u68c0\u67e5\u7a33\u5b9a\u4f46\u672a\u89e3\u51b3\uff0c\u5219\u5728\u4e0b\u4e00\u4e2a\u8f83\u4f4e\u5242\u91cf\u6c34\u5e73\u6062\u590d<\/li>\n<\/ul>\n<p><strong>\uff08<\/strong><strong>2<\/strong><strong>\uff09<\/strong><strong>2<\/strong><strong>\u7ea7<\/strong><\/p>\n<ul class=\"list-paddingleft-1\">\n<li>\u89c6\u529b 20\/40 \u6216\u66f4\u597d\uff0c\u6216\u89c6\u529b\u8f83\u57fa\u7ebf\u4e0b\u964d \u22643 \u884c<\/li>\n<li>\u4fdd\u7559\u76f4\u5230\u89e3\u51b3<\/li>\n<li>\u5982\u679c\u5728 4 \u5468\u5185\u89e3\u51b3\uff0c\u53ef\u4ee5\u5728\u4e0b\u4e00\u4e2a\u8f83\u4f4e\u5242\u91cf\u6c34\u5e73\u6062\u590d<\/li>\n<\/ul>\n<p><strong>\uff08<\/strong><strong>3<\/strong><strong>\uff09<\/strong><strong>3<\/strong><strong>\u7ea7<\/strong><\/p>\n<ul class=\"list-paddingleft-1\">\n<li>\u89c6\u529b\u4f4e\u4e8e 20\/40 \u6216\u89c6\u529b\u8f83\u57fa\u7ebf\u4e0b\u964d &gt;3 \u884c<\/li>\n<li>\u4fdd\u7559\u76f4\u5230\u89e3\u51b3<\/li>\n<li>\u5982\u679c\u5728 4 \u5468\u5185\u89e3\u51b3\uff0c\u53ef\u80fd\u4f1a\u6062\u590d\u8f83\u4f4e\u7684 2 \u4e2a\u5242\u91cf\u6c34\u5e73<\/li>\n<li>\u5982\u679c\u590d\u53d1\uff0c\u8003\u8651\u6c38\u4e45\u505c\u836f<\/li>\n<\/ul>\n<p><strong>\uff08<\/strong><strong>4<\/strong><strong>\uff09<\/strong><strong>4<\/strong><strong>\u7ea7<\/strong><\/p>\n<ul class=\"list-paddingleft-1\">\n<li>\u53d7\u5f71\u54cd\u773c\u775b\u7684\u89c6\u529b\u4e3a 20\/200 \u6216\u66f4\u5dee<\/li>\n<li>\u6c38\u4e45\u505c\u4ea7<\/li>\n<\/ul>\n<p><strong>\u5176\u4ed6\u4e0d\u826f\u53cd\u5e94<\/strong><\/p>\n<ul class=\"list-paddingleft-1\">\n<li>3 \u7ea7\uff1a\u505c\u836f\u76f4\u5230\u89e3\u51b3\u5230 1 \u7ea7\u6216\u57fa\u7ebf\uff0c\u7136\u540e\u53ef\u4ee5\u6062\u590d\u5242\u91cf 1 \u6c34\u5e73\u8f83\u4f4e<\/li>\n<li>4 \u7ea7\uff1a\u6c38\u4e45\u505c\u6b62<\/li>\n<\/ul>\n<p><strong>\u80be\u529f\u80fd\u4e0d\u5168<\/strong><\/p>\n<ul class=\"list-paddingleft-1\">\n<li>\u8f7b\u5ea6\u6216\u4e2d\u5ea6 (eGFR 30-89 mL\/min\/1.73 m 2 )\uff1a\u672a\u89c2\u5bdf\u5230\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u8d8b\u52bf\uff1b\u4e0d\u5efa\u8bae\u8c03\u6574\u5242\u91cf<\/li>\n<li>\u4e25\u91cd\u6216\u900f\u6790\uff1a\u672a\u77e5<\/li>\n<\/ul>\n<p><strong>\u809d\u529f\u80fd\u635f\u5bb3<\/strong><\/p>\n<ul class=\"list-paddingleft-1\">\n<li>\u8f7b\u5ea6\uff08TB \u2264ULN \u548c AST &gt;ULN \u6216 TB &gt;1 \u81f3 1.5x ULN \u548c\u4efb\u4f55 AST\uff09\uff1a\u672a\u89c2\u5bdf\u5230\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u8d8b\u52bf\uff1b\u4e0d\u5efa\u8bae\u8c03\u6574\u5242\u91cf<\/li>\n<li>\n<section data-role=\"paragraph\">\u4e2d\u5ea6\u6216\u91cd\u5ea6<\/p>\n<\/section>\n<\/li>\n<\/ul>\n<\/section>\n<section data-role=\"title\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"119028\">\n<section>\n<section>\n<section>\n<section>\n<section>\n<section><strong>08<\/strong><\/section>\n<section data-width=\"100%\"><\/section>\n<\/section>\n<section><strong data-brushtype=\"text\">\u670d\u7528\u5384\u8fbe\u66ff\u5c3c\u7684\u6ce8\u610f\u4e8b\u9879<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section data-role=\"paragraph\">\u60a3\u8005\u9009\u62e9\uff1aFDA\u6279\u51c6\u7684\u643a\u5e26\u6709FGFR\u7a81\u53d8\u7684\u8180\u80f1\u764c\uff08\u5c3f\u8def\u4e0a\u76ae\u764c\uff09\u60a3\u8005\u3002<\/p>\n<p>\u76d1\u63a7<\/p>\n<p>\u5f00\u59cb\u540e 14-21 \u5929\u8bc4\u4f30\u8840\u6e05\u78f7\u9178\u76d0\u6c34\u5e73<\/p>\n<p>\u6bcf\u6708\u76d1\u6d4b\u78f7\u9178\u76d0\u6c34\u5e73\u662f\u5426\u6709\u9ad8\u78f7\u8840\u75c7<\/p>\n<\/section>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; 01 \u4ec0\u4e48\u662f\u8180\u80f1\u764c\uff08\u5c3f\u8def\u4e0a\u76ae\u764c\uff09\uff1f 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