{"id":7229,"date":"2017-08-22T18:22:28","date_gmt":"2017-08-22T22:22:28","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/new-actemra-clinical-trials-move-forward\/"},"modified":"2017-08-22T18:22:28","modified_gmt":"2017-08-22T22:22:28","slug":"%e6%96%b0%e7%9a%84-actemra-%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e5%90%91%e5%89%8d%e6%8e%a8%e8%bf%9b","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/zh\/article\/%e6%96%b0%e7%9a%84-actemra-%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e5%90%91%e5%89%8d%e6%8e%a8%e8%bf%9b\/","title":{"rendered":"\u65b0\u7684 Actemra \u4e34\u5e8a\u8bd5\u9a8c\u5411\u524d\u63a8\u8fdb"},"content":{"rendered":"<p>\u5c3d\u7ba1\u5bf9\u8be5\u836f\u7684\u5b89\u5168\u6027\u5b58\u7591\uff0c\u4f46\u7f57\u6c0f\u5b50\u516c\u53f8 Genentech \u5ba3\u5e03\u5176\u8ba1\u5212\u5c06\u5176\u63a8\u5411\u5e02\u573a <a href=\"\/zh\/%e7%bb%83%e4%b9%a0%e5%8c%ba\/%e5%8c%bb%e8%8d%af%e8%af%89%e8%ae%bc\/%e7%ba%bd%e7%ba%a6%e5%be%8b%e5%b8%88%e4%ba%8b%e5%8a%a1%e6%89%80\/\">\u963f\u514b\u6cf0\u59c6\u62c9<\/a> \u786c\u5316\u75c7\u60a3\u8005\u5c06\u8fdb\u5165 3 \u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n<p>\u5728\u63a5\u4e0b\u6765\u7684 48 \u5468\u5185\uff0c\u5168\u7403 100 \u591a\u4e2a\u5730\u70b9\u7684 Genentech \u5458\u5de5\u5c06\u4f7f\u7528\u6258\u73e0\u5355\u6297\u6216\u5b89\u6170\u5242\u6765\u6d4b\u8bd5\u88ab\u8bca\u65ad\u60a3\u6709 <a href=\"https:\/\/www.healio.com\/dermatology\/immunology\/news\/online\/%7Ba06fa560-3718-457d-ae81-34ac443794f5%7D\/phase-3-trial-of-actemra-for-systemic-sclerosis-completes-enrollment\" target=\"_blank\" rel=\"noopener\">\u7cfb\u7edf\u6027\u786c\u5316\u75c7<\/a>\uff0c\u4e00\u79cd\u7f55\u89c1\u4e14\u65e0\u6cd5\u6cbb\u6108\u7684\u75be\u75c5\uff0c\u6307\u5173\u8282\u53d1\u708e\u5bfc\u81f4\u7ec4\u7ec7\u53d8\u786c\u5e76\u5931\u53bb\u5f39\u6027\uff1b\u6b64\u540e\uff0cActrema \u53d7\u8bd5\u8005\u5c06\u7ee7\u7eed\u63a5\u53d7\u8be5\u836f\u7269 48 \u5468\u3002\u5728\u4e00\u4efd\u58f0\u660e\u4e2d\uff0c\u57fa\u56e0\u6cf0\u514b\u7f55\u89c1\u75be\u75c5\u8d1f\u8d23\u4eba Jeffrey Siegel \u535a\u58eb\u8868\u793a\uff0c\u4ed6\u5e0c\u671b\u8be5\u8bd5\u9a8c\u5c06\u201c\u4e3a\u9700\u6c42\u4e25\u91cd\u672a\u5f97\u5230\u6ee1\u8db3\u7684\u60a3\u8005\u7fa4\u4f53\u5f15\u5165\u4e00\u79cd\u6cbb\u7597\u9009\u62e9\u3002\u201d\u4ed6\u8865\u5145\u8bf4\uff0c\u8be5\u8bd5\u9a8c\u8fd8\u65e8\u5728\u9610\u660e Actemra \u4e0e\u80ba\u90e8\u75be\u75c5\u4e4b\u95f4\u7684\u5173\u7cfb\u3002<\/p>\n<p>2015 \u5e74 6 \u6708\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\u5ba3\u5e03\u6258\u73e0\u5355\u6297\u662f\u4e00\u79cd\u7a81\u7834\u6027\u7684\u786c\u5316\u7597\u6cd5\uff0c\u5e76\u5c06 Actemra \u7f6e\u4e8e\u6279\u51c6\u7684\u5feb\u901f\u8f68\u9053\u4e0a\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>Actemra \u548c\u4e25\u91cd\u7684\u526f\u4f5c\u7528<\/h3>\n<p>\u6240\u6709\u836f\u7269\uff0c\u4ece\u513f\u7ae5\u963f\u53f8\u5339\u6797\u5230 LSD\uff0c\u90fd\u6709\u526f\u4f5c\u7528\u3002\u5728\u8bb8\u591a\u60c5\u51b5\u4e0b\uff0c\u8fde\u63a5\u5f88\u5bb9\u6613\u5efa\u7acb\uff0c\u56e0\u6b64\u5f88\u5bb9\u6613\u5c06\u98ce\u9669\u964d\u5230\u6700\u4f4e\u3002\u4f8b\u5982\uff0cActemra \u4f1a\u63d0\u9ad8\u8840\u6db2\u4e2d\u7684\u80c6\u56fa\u9187\u6c34\u5e73\uff0c\u4ece\u800c\u589e\u52a0\u4e2a\u4eba\u53d1\u751f\u4e25\u91cd\u5fc3\u810f\u75c5\u53d1\u4f5c\u7684\u98ce\u9669\uff0c\u800c\u5728\u8bb8\u591a\u60c5\u51b5\u4e0b\uff0c\u8fd9\u4e9b\u4eba\u5df2\u7ecf\u5f88\u5bb9\u6613\u53d1\u751f\u6b64\u7c7b\u4e8b\u4ef6\u3002\u4e8b\u5b9e\u4e0a\uff0c\u81ea\u4ece\u7f8e\u56fd\u76d1\u7ba1\u673a\u6784\u4e8e 2010 \u5e74\u6279\u51c6\u8be5\u836f\u7269\u4e0a\u5e02\u4ee5\u6765\uff0c\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5df2\u6536\u5230\u8d85\u8fc7 <a href=\"https:\/\/www.statnews.com\/2017\/06\/05\/actemra-rheumatoid-arthritis-fda\/\" target=\"_blank\" rel=\"noopener\">1,100 \u4efd Actemra \u76f8\u5173\u6b7b\u4ea1\u62a5\u544a<\/a>, \u4e3b\u8981\u7531\u5fc3\u810f\u4e0d\u826f\u4e8b\u4ef6\u5f15\u53d1\u3002<\/p>\n<p>\u6700\u6709\u53ef\u80fd\u4fc3\u8fdb\u836f\u54c1\u9500\u552e\u7684\u662f\uff0c\u7f57\u6c0f\u672a\u80fd\u8b66\u544a\u60a3\u8005\u98ce\u9669\u5347\u9ad8\uff0c\u8fd9\u4e00\u5931\u8d25\u7684\u6cd5\u5f8b\u5f71\u54cd\u5c06\u5728\u4e0b\u6587\u8ba8\u8bba\u3002<\/p>\n<p>\u5176\u4ed6\u526f\u4f5c\u7528\u66f4\u96be\u786e\u5b9a\uff0c\u8fd9\u5c31\u662f\u7f57\u6c0f\u5982\u6b64\u5173\u6ce8 Actemra \u548c <a href=\"http:\/\/www.mayoclinic.org\/diseases-conditions\/interstitial-lung-disease\/home\/ovc-20341378\" target=\"_blank\" rel=\"noopener\">\u95f4\u8d28\u6027\u80ba\u75c5<\/a>\uff0c\u4e00\u4e2a\u63cf\u8ff0\u4e00\u5927\u7fa4\u5065\u5eb7\u95ee\u9898\u7684\u603b\u79f0\uff0c\u5305\u62ec\u7ecf\u5e38\u81f4\u547d\u7684\u77f3\u68c9\u80ba\u3002<\/p>\n<p>\u957f\u671f\u63a5\u89e6\u67d0\u4e9b\u6709\u6bd2\u7269\u8d28\uff08\u663e\u7136\u5305\u62ec tocilizumab\uff09\u540e\uff0c\u80ba\u90e8\u4f1a\u5f62\u6210\u8fc7\u591a\u7684\u75a4\u75d5\u7ec4\u7ec7\uff0c\u6700\u7ec8\u635f\u5bb3\u60a3\u8005\u7684\u547c\u5438\u80fd\u529b\uff0c\u5bfc\u81f4\u91cd\u8981\u5668\u5b98\u7f3a\u6c27\u3002\u6b64\u5916\uff0c\u4e00\u4e9b\u7279\u522b\u5f3a\u6548\u7684\u6297\u708e\u836f\uff08Actemra \u662f\u533b\u5b66\u754c\u5df2\u77e5\u7684\u6700\u5f3a\u836f\u7269\u4e4b\u4e00\uff09\u53ef\u80fd\u6548\u679c\u592a\u597d\uff0c\u4e0d\u4ec5\u4f1a\u51cf\u5c11\u4e0d\u5fc5\u8981\u7684\u708e\u75c7\uff0c\u8fd8\u4f1a\u635f\u5bb3\u80ba\u90e8\u6269\u5f20\u548c\u6536\u7f29\u7684\u80fd\u529b\u3002<\/p>\n<p>\u597d\u50cf\u75be\u75c5\u672c\u8eab\u8fd8\u4e0d\u591f\u4e25\u91cd\uff0cILD \u7ecf\u5e38\u5f15\u53d1\u4e25\u91cd\u7684\u5e76\u53d1\u75c7\uff0c\u4f8b\u5982\u80ba\u5fc3\u75c5\uff08\u90e8\u5206\u5fc3\u529b\u8870\u7aed\uff09\u548c\u80ba\u52a8\u8109\u9ad8\u538b\uff08\u80ba\u90e8\u9ad8\u8840\u538b\uff09\u3002<\/p>\n<p>Actemra \u7684\u5176\u4ed6\u5e76\u53d1\u75c7\u5305\u62ec\u80f0\u817a\u708e\u7684\u98ce\u9669\u5347\u9ad8\uff0c\u8fd9\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u75be\u75c5\uff0c\u901a\u5e38\u662f\u80f0\u817a\u764c\u7684\u524d\u5146\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>\u6cd5\u5f8b\u95ee\u9898<\/h3>\n<p>\u5f53\u79d1\u5b66\u5bb6\u548c\u533b\u751f\u4e3a\u56e0\u679c\u95ee\u9898\u800c\u82e6\u82e6\u601d\u7d22\u65f6\uff0c\u8fc7\u5931\u6848\u4ef6\u4e2d\u7684\u539f\u544a\u5219\u4e0d\u53d7\u6b64\u7c7b\u9650\u5236\uff0c\u56e0\u4e3a\u6240\u9700\u7684\u8bc1\u636e\u6c34\u5e73\u5f88\u9ad8\u3002\u5982\u679c\u539f\u544a\u786e\u5b9a\u4ed6\u4eec\u7684\u635f\u5931\u4e0e\u5371\u9669\u836f\u7269\u6709\u5173\uff0c\u4ed6\u4eec\u6709\u6743\u83b7\u5f97\u8d54\u507f\uff0c\u65e0\u8bba\u5177\u4f53\u7ec6\u8282\u5982\u4f55\u3002<\/p>\n<p>\u5982\u679c\u4ea7\u54c1\u5236\u9020\u5546\u6ca1\u6709\u63d0\u9192\u5ba2\u6237\u6240\u6709\u5df2\u77e5\u7684\u6f5c\u5728\u98ce\u9669\uff0c\u5236\u9020\u5546\u53ef\u80fd\u4f1a\u6839\u636e <a href=\"https:\/\/www.justia.com\/products-liability\/failure-to-warn\/\" target=\"_blank\" rel=\"noopener\">\u6ca1\u6709\u8b66\u544a<\/a> \u7406\u8bba\u3002\u4e25\u683c\u8d23\u4efb\u610f\u5473\u7740\uff0c\u65e0\u8bba\u5236\u9020\u5546\u53ef\u80fd\u8868\u73b0\u51fa\u4efb\u4f55\u5584\u610f\u6216\u8c28\u614e\u884c\u4e8b\uff0c\u88ab\u544a\u90fd\u8981\u4f9d\u6cd5\u627f\u62c5\u635f\u5bb3\u8d54\u507f\u8d23\u4efb\u3002<\/p>\n<p>\u9664\u4e86\u539f\u56e0\u4e4b\u5916\uff0c\u53d7\u5bb3\u4eba\/\u539f\u544a\u8fd8\u5fc5\u987b\u786e\u5b9a\u672a\u80fd\u8b66\u544a\u6848\u4ef6\u7684\u975e\u663e\u800c\u6613\u89c1\u6027\u3002\u6d74\u7f38\u5236\u9020\u5546\u65e0\u9700\u544a\u77e5\u6d88\u8d39\u8005\u5c0f\u5b69\u5b50\u53ef\u80fd\u4f1a\u6df9\u6b7b\u5728\u4ed6\u4eec\u7684\u4ea7\u54c1\u4e2d\uff0c\u56e0\u4e3a\u8fd9\u79cd\u5371\u9669\u662f\u663e\u800c\u6613\u89c1\u7684\u3002\u7136\u800c\uff0c\u836f\u54c1\u5236\u9020\u5546\u5e94\u8be5\u8b66\u544a\u60a3\u8005\u6240\u6709\u5df2\u77e5\u7684\u526f\u4f5c\u7528\uff0c\u56e0\u4e3a\u5371\u9669\u662f\u9690\u85cf\u7684\uff0c\u8fd9\u4e9b\u53d7\u5bb3\u8005\u6ca1\u6709\u5176\u4ed6\u9014\u5f84\u4e86\u89e3\u5371\u9669\u3002<\/p>\n<p>\u5728\u672a\u8b66\u544a\u548c\u5176\u4ed6\u5371\u9669\u836f\u7269\u6848\u4ef6\u4e2d\uff0c\u4f8b\u5982\u8fdd\u53cd\u4fdd\u8bc1\u6216\u8bbe\u8ba1\u7f3a\u9677\uff0c\u88ab\u544a\u5e94\u5bf9\u53d7\u5bb3\u4eba\u7684\u91d1\u94b1\u635f\u5931\uff08\u4f8b\u5982\u4ed6\u4eec\u7684\u533b\u7597\u8d39\uff09\u548c\u975e\u7ecf\u6d4e\u635f\u5931\uff08\u4f8b\u5982\u7cbe\u795e\u75db\u82e6\uff09\u627f\u62c5\u8d23\u4efb\u3002\u6b64\u5916\uff0c\u4e3a\u4e86\u60e9\u7f5a\u88ab\u544a\u5e76\u963b\u6b62\u672a\u6765\u7684\u4e0d\u6cd5\u884c\u4e3a\uff0c\u6709\u7f3a\u9677\u7684\u4ea7\u54c1\u966a\u5ba1\u56e2\u901a\u5e38\u4f1a\u5224\u5904\u53ef\u89c2\u7684\u60e9\u7f5a\u6027\u8d54\u507f\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>\u76d1\u7ba1\u7a0b\u5e8f<\/h3>\n<p>\u5bf9 Actemra \u7684\u6124\u6012\u4e0d\u4ec5\u662f\u5bf9\u7f57\u6c0f\u7684\u63a7\u8bc9\uff0c\u4e5f\u662f\u5bf9\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\u7684\u63a7\u8bc9\uff0c\u56e0\u4e3a\u8be5\u673a\u6784\u663e\u7136\u4e0d\u518d\u50cf\u8fc7\u53bb\u51e0\u5341\u5e74\u90a3\u6837\u662f\u6d88\u8d39\u8005\u76d1\u7ba1\u673a\u6784\u3002<\/p>\n<p>\u4f8b\u5982\uff0cFDA\u7ecf\u5e38\u5229\u7528\u76d1\u7ba1\u6f0f\u6d1e\u6765\u52a0\u5feb\u5ba1\u6279\u6d41\u7a0b\uff0c\u8ba9\u5236\u836f\u516c\u53f8\u8d5a\u66f4\u591a\u7684\u94b1\u3002\u4e00\u4e2a\u662f <a href=\"https:\/\/www.fda.gov\/MedicalDevices\/ProductsandMedicalProcedures\/DeviceApprovalsandClearances\/510kClearances\/\" target=\"_blank\" rel=\"noopener\">510(k) \u534f\u8bae<\/a>\uff0c\u8fd9\u5141\u8bb8\u76d1\u7ba1\u673a\u6784\u57fa\u672c\u4e0a\u5bf9\u4e0e\u73b0\u6709\u4ea7\u54c1\u201c\u57fa\u672c\u76f8\u4f3c\u201d\u7684\u8bbe\u5907\u6216\u836f\u7269\u52a0\u76d6\u6a61\u76ae\u56fe\u7ae0\u3002\u4e0d\u5e78\u7684\u662f\uff0c\u6839\u672c\u65e0\u6cd5\u4fdd\u8bc1\u201c\u57fa\u672c\u76f8\u4f3c\u201d\u7684\u4ea7\u54c1\u662f\u5b89\u5168\u6709\u6548\u7684\uff0c\u52a0\u4e0aFDA\u62d2\u7edd\u5f7b\u5e95\u68c0\u67e5510(k)\u4ea7\u54c1\uff0c\u8fd9\u4e9b\u5b89\u5168\u95ee\u9898\u53ef\u80fd\u5728\u65b0\u4ea7\u54c1\u4e2d\u88ab\u653e\u5927\u3002<\/p>\n<p>2012 \u5e74\uff0cFDA \u4fee\u6539\u4e86\u89c4\u5219\uff0c\u5141\u8bb8 <a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/LawsEnforcedbyFDA\/SignificantAmendmentstotheFDCAct\/FDASIA\/ucm329491.htm\" target=\"_blank\" rel=\"noopener\">\u7a81\u7834\u6307\u5b9a<\/a>\uff0c\u9002\u7528\u4e8e\u4efb\u4f55\u6709\u6548\u201c\u6cbb\u7597\u4e25\u91cd\u6216\u5371\u53ca\u751f\u547d\u7684\u75be\u75c5\u201d\u5e76\u4e14\u662f\u201c\u5bf9\u73b0\u6709\u7597\u6cd5\u7684\u5b9e\u8d28\u6027\u6539\u8fdb\u201d\u7684\u65b0\u836f\u3002\u6839\u636e\u89c4\u5219\uff0c\u5b89\u5168\u7edd\u5bf9\u4e0d\u662f\u8003\u8651\u56e0\u7d20\u3002<\/p>\n<p>\u901a\u5e38\uff0c\u5728 FDA \u91c7\u53d6\u7ea0\u6b63\u63aa\u65bd\u65f6\uff0c\u8bb8\u591a\u53d7\u5bb3\u8005\u5df2\u7ecf\u53d7\u4e86\u91cd\u4f24\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>\u4e0e\u987d\u5f3a\u7684\u5f8b\u5e08\u8054\u7cfb<\/h3>\n<p>\u8bb8\u591a\u670d\u7528 Actemra \u7684\u4eba\u73b0\u5728\u90fd\u51fa\u73b0\u4e86\u4e25\u91cd\u7684\u526f\u4f5c\u7528\u3002\u514d\u8d39\u54a8\u8be2 <a href=\"\/zh\/%e8%81%94%e7%b3%bb%e6%88%91%e4%bb%ac\/\">\u7ebd\u7ea6\u7ecf\u9a8c\u4e30\u5bcc\u7684\u4eba\u8eab\u4f24\u5bb3\u5f8b\u5e08<\/a>, contact Napoli Shkolnik . We handle dangerous drug matters on a nationwide basis.<\/p>","protected":false},"excerpt":{"rendered":"<p>\u5c3d\u7ba1\u5bf9\u8be5\u836f\u7684\u5b89\u5168\u6027\u5b58\u7591\uff0c\u4f46\u7f57\u6c0f\u5b50\u516c\u53f8 Genentech \u5ba3\u5e03\u5176\u5411\u786c\u5316\u75c7\u60a3\u8005\u9500\u552e Actemra \u7684\u8ba1\u5212\u5c06\u8fdb\u5165 3 \u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u5728...<\/p>","protected":false},"author":3,"featured_media":7230,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[809],"class_list":["post-7229","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation","tag-asbestos-exposure"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/7229","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/comments?post=7229"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/7229\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media\/7230"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media?parent=7229"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/categories?post=7229"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/tags?post=7229"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}