{"id":1780,"date":"2017-07-22T09:07:04","date_gmt":"2017-07-22T01:07:04","guid":{"rendered":"http:\/\/edu.secda.info\/wenft\/?p=1780"},"modified":"2017-07-22T09:07:04","modified_gmt":"2017-07-22T01:07:04","slug":"%e5%af%a6%e9%a9%97%e8%a8%ad%e8%a8%88","status":"publish","type":"post","link":"https:\/\/edu.secda.info\/wenft\/?p=1780","title":{"rendered":"\u5be6\u9a57\u8a2d\u8a08"},"content":{"rendered":"<h1><a href=\"http:\/\/www.cna.com.tw\/news\/firstnews\/201602210203-1.aspx\">\u6d69\u9f0e\u89e3\u76f2 \u5c08\u5bb6\uff1a\u79d1\u5b78\u4e0a\u6210\u529f\u6cd5\u898f\u4e0a\u5931\u6557<\/a><\/h1>\n<p>\uff08\u4e2d\u592e\u793e\u8a18\u8005\u97d3\u5a77\u5a77\u53f0\u531721\u65e5\u96fb\uff09\u6d69\u9f0e\u6297\u4e73\u764c\u65b0\u85e5\u4eca\u5929\u89e3\u76f2\uff0c\u7d50\u679c\u5230\u5e95\u5982\u4f55\u89e3\u8b80\uff1f\u6d69\u9f0e\u8463\u4e8b\u9577\u5f35\u5ff5\u6148\u4ee5\u300c\u51fa\u4e4e\u610f\u6599\u3001\u8dcc\u7834\u773c\u93e1\u7684\u6210\u529f\u300d\u4f86\u8a6e\u91cb\uff0c\u4f46\u5c08\u5bb6\u53ca\u6cd5\u4eba\u5247\u4ee5\u300c\u79d1\u5b78\u4e0a\u6210\u529f\uff0c\u6cd5\u898f\u4e0a\u5931\u6557\u300d\u4f86\u770b\u5f85\u3002<\/p>\n<p>\u751f\u6280\u80a1\u80a1\u738b\u6d69\u9f0e\u4e0b\u5348\u8209\u884c\u89e3\u76f2\u7d50\u679c\u91cd\u5927\u8a0a\u606f\u8a18\u8005\u6703\uff0c\u516c\u5e03\u65d7\u4e0b\u6297\u4e73\u764c\u65b0\u85e5OBI-822\u81e8\u5e8a\u4e8c\uff0f\u4e09\u671f\u89e3\u76f2\u6578\u64da\uff0c\u521d\u6b65\u7d50\u679c\u986f\u793a\uff0c\u7528\u85e5\u7d44\u548c\u5c0d\u7167\u7d44\u76f8\u6bd4\uff0c\u4e3b\u8981\u7642\u6548\u6307\u6a19\uff08primary endpoint\uff09<span style=\"color: #ff0000;\">\u672a\u5448\u73fe\u7d71\u8a08\u5b78\u4e0a\u986f\u8457\u610f\u7fa9<\/span>\u3002<\/p>\n<p>\u6d69\u9f0e\u89e3\u76f2\u7d50\u679c\u4e0d\u5982\u539f\u5148\u5e02\u5834\u9810\u671f\uff0c\u4e26\u672a\u904e\u95dc\uff0c\u4f46\u8a18\u8005\u6703\u9593\u6d69\u9f0e\u7d93\u71df\u5718\u968a\u4e00\u518d\u5f37\u8abf\uff0c\u5c0d\u6d69\u9f0e\u800c\u8a00\u662f\u500b\u300c\u51fa\u4e4e\u610f\u6599\u3001\u8dcc\u7834\u773c\u93e1\u7684\u6210\u529f\u300d\uff0c\u53ea\u662f\u7576\u521d\u5728\u81e8\u5e8a\u8a66\u9a57\u7684<span style=\"color: #ff0000;\">\u8a2d\u8a08<\/span>\u4e0a\u4e0d\u5229\uff0c\u5982\u679c\u7528\u65b0\u7684\u8a2d\u8a08\u5c31\u904e\u95dc\u4e86\uff0c\u8b93\u5728\u5834\u8a18\u8005\u4e5f\u807d\u5f97\u300c\u6709\u9ede\u6df7\u4e82\u300d\u3002<\/p>\n<p>\u85e5\u5b78\u535a\u58eb\u3001\u73fe\u4efb\u53f0\u7063\u5de5\u9280\u8b49\u5238\u6295\u9867\u5354\u7406\u7684\u5ed6\u660c\u4eae\u89e3\u91cb\uff0c\u5728\u6cd5\u898f\u4e0a\u5176\u5be6\u7b97\u662f\u5931\u6557\u7684\u3002\u4f46\u5728\u79d1\u5b78\u4e0a\u662f\u6709\u9032\u5c55\u7684\uff0c\u67d0\u7a2e\u5c64\u9762\u4e0a\u4e5f\u7b97\u6210\u529f\uff0c\u5c0d\u6d69\u9f0e\u8ddf\u91ab\u5b78\u754c\u662f\u6709\u610f\u7fa9\u7684\uff0c\u53ef\u4f5c\u70ba\u4e4b\u5f8c<span style=\"color: #ff0000;\">\u5be6\u9a57\u8a2d\u8a08<\/span>\u7684\u53c3\u8003\u3002<\/p>\n<p>\u5ed6\u660c\u4eae\u8868\u793a\uff0c\u6309\u7167\u73fe\u6709\u904a\u6232\u898f\u5247\u800c\u8a00\uff0c\u89e3\u76f2\u300c\u672a\u904e\u95dc\u300d\u662f\u4e8b\u5be6\uff0c\u5728\u73fe\u6709\u6cd5\u898f\u4e0a\u662f\u7121\u6cd5\u7533\u8acb\u85e5\u8b49\u7684\uff0c\u53ef\u4ee5\u8aaa\u662f\u632b\u6557\uff1b\u4f46\u5f9e\u73fe\u6709\u7684\u8cc7\u8a0a\u5224\u8b80\uff0c\u5728\u79d1\u5b78\u8a66\u9a57\u7684\u6578\u64da\u662f\u6709\u9032\u5c55\u7684\uff0c\u6d69\u9f0e\u61c9\u8a72\u662f\u770b\u5230\u5176\u4ed6\u6b21\u65cf\u7fa4\u6216\u7d30\u90e8\u7d50\u679c\uff0c\u8a8d\u70ba\u672a\u4f86\u5982\u679c\u91cd\u65b0\u8a2d\u8a08\u81e8\u5e8a\u8a66\u9a57\uff0c\u6210\u529f\u7684\u6a5f\u7387\u5c07\u5927\u5927\u62c9\u9ad8\u3002\u56e0\u6b64\uff0c\u5f9e\u300c\u79d1\u5b78\u300d\u4e0a\u800c\u8a00\u662f\u6709\u9032\u5c55\u7684\uff0c\u56e0\u6b64\u6d69\u9f0e\u624d\u6703\u8a8d\u70ba\u6b64\u6b21\u7684\u81e8\u5e8a\u8a66\u9a57\u662f\u6210\u529f\u7684\u3002<\/p>\n<p>\u5c31\u5982\u5f35\u5ff5\u6148\u5728\u8a18\u8005\u6703\u4e0a\u5f37\u8abf\u7684\uff0c\u5728\u6b64\u6b21\u7b2c\u4e8c\/\u4e09\u671f\u96d9\u76f2\u81e8\u5e8a\u8a66\u9a57\uff0c\u50b3\u7d71\u6307\u6a19\u4e0a\u96d6\u7136\u4e3b\u8981\u7642\u6548\u6307\u6a19<span style=\"color: #ff0000;\">\u672a\u5448\u73fe\u7d71\u8a08\u5b78\u4e0a\u986f\u8457\u610f\u7fa9<\/span>\uff0c\u4f46\u7372\u5f97\u76f8\u7576\u8c50\u5bcc\u7684\u8cc7\u8a0a\u6578\u64da\uff0c\u6709\u5229\u63a5\u4e0b\u4f86\u5728\u5168\u7403\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u8a2d\u8a08\u3002<\/p>\n<p>\u5728\u5f35\u5ff5\u6148\u770b\u4f86\uff0c\u9019\u662f\u4e00\u500b\u975e\u5e38\u6210\u529f\u7684\u4e00\u6b21\u89e3\u76f2\uff0c\u6c92\u6709\u6240\u8b02\u7684\u632b\u6557\uff0c\u5be6\u969b\u4e0a\u9054\u5230\u7684\u7d50\u679c\u6bd4\u9810\u671f\u7d50\u679c\u66f4\u597d\uff0c\u6578\u64da\u662f\u975e\u5e38\u6709\u610f\u7fa9\u7684\u6578\u64da\u3002\u4ed6\u8a8d\u70ba\uff0c\u5c0d\u65bc\u5168\u7403\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u9032\u5ea6\u4e0d\u6703\u6709\u5ef6\u5b95\uff0c\u4e14\u8b93\u6d69\u9f0e\u5728\u4e0b\u968e\u6bb5\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u6709\u66f4\u660e\u78ba\u7684\u65b9\u5411\u3002<\/p>\n<p>\u6d69\u9f0e\u7e3d\u7d93\u7406\u9ec3\u79c0\u7f8e\u8868\u793a\uff0c\u6d69\u9f0e\u6703\u6839\u64da\u9019\u6b21\u89e3\u76f2\u7d50\u679c\u7684\u767c\u73fe\uff0c\u7a4d\u6975\u5c55\u958b\u4e0b\u968e\u6bb5\u7684\u4f48\u5c40\u53ca\u7b56\u7565\uff0c\u9664\u4e86\u5c07\u6309\u539f\u8a02\u8a08\u5283\u8207\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff08FDA\uff09\u3001\u6b50\u6d32\u85e5\u7269\u7ba1\u7406\u5c40\uff08EMA\uff09\u5c31\u5168\u7403\u7b2c\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u8a08\u5283\u5354\u5546\u5916\uff0c\u4e5f\u5c07\u548c\u53f0\u7063\u98df\u85e5\u7f72\uff08TFDA\uff09\u5c55\u958b\u8aee\u5546\u6703\u8b70\uff0c\u4e26\u7533\u8acb\u524d\u5f80\u570b\u969b\u77e5\u540d\u91ab\u5b78\u6703\u53ca\u91cd\u8981\u91ab\u5b78\u671f\u520a\u8ad6\u6587\u767c\u8868\u3002<\/p>\n<p>\u9ec3\u79c0\u7f8e\u8868\u793a\uff0c\u6d69\u9f0e\u4e5f\u5df2\u7d93\u9001\u4ef6\u7533\u8acb\u57286\u6708\u4efd\u8209\u884c\u7684\u7f8e\u570b\u816b\u7624\u91ab\u5b78\u5e74\u6703\uff08ASCO\uff09\u767c\u8868\uff0c\u5c07\u9019\u6b21\u89e3\u76f2\u5b8c\u6574\u6578\u64da\u5728\u767c\u8868\u6703\u4e0a\u767c\u8868\u30021050221<\/p>\n<p><strong><br \/>\n<\/strong><\/p>\n<h3><a href=\"http:\/\/www.obipharma.com\/index.aspx?lang=chi&amp;fn=news_content&amp;no=72\">201605.19\u6d69\u9f0eASCO 2016\u8ad6\u6587\u6458\u8981: OPT-822\/OPT-821\u4e3b\u52d5\u5f0f\u514d\u75ab\u7642\u6cd5\u6cbb\u7642\u8f49\u79fb\u6027\u4e73\u764c\u7684\u96d9\u76f2\u96a8\u6a5f\u4e8c\u3001\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57<\/a><\/h3>\n<p>&nbsp;<\/p>\n<p><strong>\u80cc\u666f\uff1a<\/strong><br \/>\nGlobo H \u662f\u4e00\u7a2e\u5728\u4e73\u764c\u7d30\u80de\u4e2d\u9ad8\u5ea6\u8868\u73fe\u7684\u91a3\u8102\u8cea\u3002\u5728\u5169\u500b\u4f7f\u7528\u4e3b\u52d5\u514d\u75ab\u7642\u6cd5OPT-822(Globo H-KLH\u8907\u5408\u9ad4)\u53ca\u4f50\u5291OPT-821\u7684\u4e00\u671f\u81e8\u5e8a\u8a66\u9a57\u986f\u793a\uff0c\u6b64\u4e3b\u52d5\u514d\u75ab\u7642\u6cd5\u53ef\u8a98\u5c0e\u7522\u751fGlobo H \u7279\u7570\u6027\u6297\u9ad4\uff0c\u5176\u65bc\u9ad4\u5916\u8a66\u9a57\u986f\u793a\u53ef\u8207\u8868\u73feGlobo H\u7684\u4e73\u764c\u7d30\u80de\u7d50\u5408\uff0c\u4e26\u7522\u751f\u7d30\u80de\u6bd2\u6bba\u4f5c\u7528\u3002<\/p>\n<p><strong>\u65b9\u6cd5\uff1a<\/strong><br \/>\n\u5728\u6b64\u591a\u570b\u3001\u591a\u4e2d\u5fc3\u3001\u96a8\u6a5f\u3001\u96d9\u76f2\u3001\u5b89\u6170\u5291\u5c0d\u7167\u7684\u4e8c\/\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\uff08NCT01516307) \u4e2d\uff0c\u7d93\u904e\u81f3\u5c11\u4e00\u7a2e\u6297\u764c\u7642\u7a0b\u6cbb\u7642\u5f8c\uff0c\u6709\u6700\u591a2\u6b21\u75be\u75c5\u60e1\u5316 (PD) \u4ee5\u53ca\u9054\u5230\u75be\u75c5\u7a69\u5b9a (SD) \u7684\u8f49\u79fb\u6027\u4e73\u764c\u60a3\u8005\uff0c\u4ee52:1\u7684\u6bd4\u4f8b\uff0c\u5728\u7b2c 1\u30012\u30013\u30015\u30019\u300113\u300117\u300125 \u548c 37 \u5468\uff0c\u76ae\u4e0b\u6ce8\u5c04 OPT-822 (30 \u03bcg Globo H)\/OPT-821 (100 \u03bcg) \u6216\u5c0d\u7167\u5291 (PBS) \u53ca\u4f4e\u5291\u91cf\u74b0\u78f7\u91af\u80fa (cyclophosphamide) (300 mg\/m2) \u6cbb\u7642\uff0c\u76f4\u5230\u75be\u75c5\u60e1\u5316(PD)\u6216\u6253\u5b8c9\u91dd\u3002\u53ef\u540c\u6642\u7d66\u4e88\u8377\u723e\u8499\u7642\u6cd5\u3002\u4e3b\u8981\u548c\u6b21\u8981\u7642\u6548\u6307\u6a19\u5206\u5225\u70ba\u7121\u60e1\u5316\u5b58\u6d3b\u671f (PFS) \u548c\u7e3d\u5b58\u6d3b\u671f (OS)\u3002<\/p>\n<p><strong>\u7d50\u679c\uff1a<\/strong><br \/>\n\u5171\u6709349\u540d\u60a3\u8005\u53c3\u8207\u96a8\u6a5f\u5206\u7d44\u8a66\u9a57\uff0c\u5176\u4e2d 348 \u4f8b\u60a3\u8005\u63a5\u53d7\u7814\u7a76\u85e5\u7269\u6216\u5b89\u6170\u5291\u6cbb\u7642\u3014\u610f\u5716\u6cbb\u7642 (ITT)\u3015\uff0c168 \u4f8b\u60a3\u8005 (48%) \u5b8c\u6210 9 \u6b21\u6ce8\u5c04\u7642\u7a0b\u300270% \u70ba\u8377\u723e\u8499\u53d7\u9ad4\u967d\u6027\u4e73\u764c\u60a3\u8005\u300213% \u70ba\u4e09\u9670\u6027\u4e73\u764c\u60a3\u8005\u300262% \u60a3\u8005\u63a5\u53d7\u8377\u723e\u8499\u6cbb\u7642\u3002\u672c\u8a66\u9a57\u7d50\u679c\u672a\u89c0\u5bdf\u5230\u7121\u60e1\u5316\u5b58\u6d3b\u671f(PFS)\u9054\u5230\u7d71\u8a08\u986f\u8457\u5dee\u7570(HR = 0.96 [95% CI 0.74-1.25]\uff0c<span style=\"color: #ff0000;\">p= 0.77<\/span>)\uff0c\u7e3d\u5b58\u6d3b\u671f(OS)\u7684\u671f\u4e2d\u5206\u6790(Interim OS)\u4ea6\u672a\u9054\u986f\u8457\u5dee\u7570(HR = 0.79 [95% CI 0.51-1.22]\uff0c<span style=\"color: #ff0000;\">p = 0.29<\/span>)\u3002\u4f46\u662f\uff0c\u670950%\u7684\u5be6\u9a57\u7d44\u60a3\u8005\uff0c\u5c0d OPT-822\/OPT-821 \u7522\u751f Globo H \u7279\u7570IgG \u6297\u9ad4 (\u9019\u662f\u6307\u6297\u9ad4\u6548\u50f9\u66fe\u5728\u6cbb\u7642\u671f\u9593\u5167\u9054\u5230 \u2265 1:160)\u3002\u9019\u4e9b\u7522\u751f\u514d\u75ab\u53cd\u61c9\u7684\u60a3\u8005\uff0c\u7576\u8207\u5c0d\u7167\u7d44\u6bd4\u8f03\uff0c\u6709\u4ee5\u4e0b\u7d50\u679c: PFS\uff0cHR = 0.71 [95%CI 0.52-0.97]\uff0c<span style=\"color: #ff0000;\">p= 0.029<\/span>\uff1bOS\uff0cHR=0.57 [95%CI 0.33-0.97]\uff0c<span style=\"color: #ff0000;\">p = 0.04<\/span>\uff1b\u7522\u751f\u514d\u75ab\u53cd\u61c9\u7684\u60a3\u8005\uff0c\u548c\u7121\u514d\u75ab\u53cd\u61c9\u60a3\u8005\u6bd4\u8f03\uff0c\u6709\u4ee5\u4e0b\u7d50\u679c: PFS\uff0cHR = 0.52 [95%CI 0.37-0.71]\uff0c<span style=\"color: #3366ff;\">p&lt; 0.0001<\/span>\uff1bOS\uff0cHR = 0.52 [95%CI 0.29-0.92]\uff0c<span style=\"color: #ff0000;\">p= 0.025<\/span>\uff08\u7d50\u679c\u7d93\u57fa\u790e\u75be\u75c5\u72c0\u614b\/\u8377\u723e\u8499\u7642\u6cd5\u4f7f\u7528\u60c5\u6cc1\u6821\u6b63)\u3002\u9019\u5169\u500b\u7d50\u679c\u986f\u793a\uff0c\u7522\u751f\u514d\u75ab\u53cd\u61c9\u60a3\u8005\u7684PFS \u548cOS\u90fd\u6709\u986f\u8457\u6539\u5584\u3002\u7d93\u6642\u9593\u76f8\u4f9dCox \u5206\u6790\u4e26\u8207\u5c0d\u7167\u7d44\u76f8\u6bd4\u4e4b\u5f8c\uff0c\u5c0d\u65bc\u5b8c\u6210 9 \u6b21OPT\u6ce8\u5c04\u7642\u7a0b\u8005\uff0c\u5176PFS\u4e5f\u6709\u6539\u5584\u8da8\u52e2(HR = 0.66 [95% CI 0.42-1.01]\uff0c<span style=\"color: #ff0000;\">P = 0.057<\/span>)\u3002\u6574\u9ad4\u800c\u8a00\uff0cOPT-822\/OPT-821 \u8010\u53d7\u6027\u826f\u597d\uff1b\u6700\u5e38\u898b\u7684\u85e5\u7269\u76f8\u95dc\u4e0d\u826f\u4e8b\u4ef6\u70ba 1\u30012 \u7d1a\u7684\u6ce8\u5c04\u90e8\u4f4d\u76ae\u819a\u53cd\u61c9\u3002<\/p>\n<p><strong>\u7d50\u8ad6\uff1a<\/strong><br \/>\n\u672c\u81e8\u5e8a\u8a66\u9a57PFS\u96d6\u672a\u9054\u5230\u7d71\u8a08\u986f\u8457\u5dee\u7570\uff0c\u7136\u800c\uff0c\u5c0d\u65bc\u6709\u7522\u751f\u514d\u75ab\u53cd\u61c9\u60a3\u8005\u7684PFS \u548cInterim OS\u5747\u6709\u986f\u8457\u6539\u5584\u3002\u672a\u4f86\u5c07\u4f7f\u7528\u9019\u4e9b\u6b21\u65cf\u7fa4\u5206\u6790\u6578\u64da\uff0c\u8a2d\u8a08\u660e\u78ba\u7684\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u6d69\u9f0e\u89e3\u76f2 \u5c08\u5bb6\uff1a\u79d1\u5b78\u4e0a\u6210\u529f\u6cd5\u898f\u4e0a\u5931\u6557 \uff08\u4e2d\u592e\u793e\u8a18\u8005\u97d3\u5a77\u5a77\u53f0\u531721\u65e5\u96fb\uff09\u6d69\u9f0e\u6297\u4e73\u764c<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0},"categories":[3],"tags":[],"_links":{"self":[{"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=\/wp\/v2\/posts\/1780"}],"collection":[{"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1780"}],"version-history":[{"count":1,"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=\/wp\/v2\/posts\/1780\/revisions"}],"predecessor-version":[{"id":1781,"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=\/wp\/v2\/posts\/1780\/revisions\/1781"}],"wp:attachment":[{"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1780"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1780"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/edu.secda.info\/wenft\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}