{"id":57225,"date":"2024-12-18T12:55:18","date_gmt":"2024-12-18T12:55:18","guid":{"rendered":"https:\/\/copley1.wpenginepowered.com\/blogs\/2024%e5%b9%b4%e8%82%ba%e9%83%a8%e8%8d%af%e7%89%a9%e9%80%92%e9%80%81%e4%bc%9a%e8%ae%ae-ddl-2024%ef%bc%9a35%e5%91%a8%e5%b9%b4%e7%ba%aa%e5%bf%b5%e5%a4%a7%e4%bc%9a%e4%ba%ae%e7%82%b9\/"},"modified":"2025-02-13T11:01:15","modified_gmt":"2025-02-13T11:01:15","slug":"2024%e5%b9%b4%e8%82%ba%e9%83%a8%e8%8d%af%e7%89%a9%e9%80%92%e9%80%81%e4%bc%9a%e8%ae%ae-ddl-2024%ef%bc%9a35%e5%91%a8%e5%b9%b4%e7%ba%aa%e5%bf%b5%e5%a4%a7%e4%bc%9a%e4%ba%ae%e7%82%b9","status":"publish","type":"blog_type","link":"https:\/\/www.copleyscientific.com\/zh-hans\/blogs\/2024%e5%b9%b4%e8%82%ba%e9%83%a8%e8%8d%af%e7%89%a9%e9%80%92%e9%80%81%e4%bc%9a%e8%ae%ae-ddl-2024%ef%bc%9a35%e5%91%a8%e5%b9%b4%e7%ba%aa%e5%bf%b5%e5%a4%a7%e4%bc%9a%e4%ba%ae%e7%82%b9\/","title":{"rendered":"2024\u5e74\u80ba\u90e8\u836f\u7269\u9012\u9001\u4f1a\u8bae (DDL 2024)\uff1a35\u5468\u5e74\u7eaa\u5ff5\u5927\u4f1a\u4eae\u70b9"},"content":{"rendered":"
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\u8fd9\u662f\u4e00\u573a\u5177\u6709\u91cc\u7a0b\u7891\u610f\u4e49\u7684\u91cd\u8981\u4f1a\u8bae\uff0c\u59cb\u7ec8\u80fd\u591f\u63d0\u4f9b\u5b66\u4e60\u548c\u4ea4\u6d41\u7684\u7edd\u4f73\u673a\u4f1a\u3002<\/em><\/h2>\n

1989\u5e74\uff0c\u5373\u9996\u5c4a\u80ba\u90e8\u836f\u7269\u9012\u9001\u4f1a\u8bae (DDL) \u53ec\u5f00\u4e4b\u5e74\uff0c\u5438\u5165\u5236\u5242\u79d1\u5b66\u5bb6\u4eec\u6b63\u5728\u52aa\u529b\u6539\u826f\u5b9a\u91cf\u5438\u5165\u5242 (MDI) \u914d\u65b9\uff0c\u4ee5\u54cd\u5e94\u300a\u8499\u7279\u5229\u5c14\u8bae\u5b9a\u4e66\u300b\u300235\u5e74\u540e\u7684\u4eca\u5929\uff0cMDI\u914d\u65b9\u6539\u826f\u518d\u6b21\u6210\u4e3a\u70ed\u95e8\u8bae\u9898\uff0c\u6b64\u6b21\u8ba8\u8bba\u7684\u662f\u4f7f\u7528\u5168\u7403\u53d8\u6696\u6f5c\u80fd\u503c (GWP) \u8f83\u4f4e\u7684\u63a8\u8fdb\u5242\u53d6\u4ee3\u6c22\u6c1f\u70f7\u70c3\u7c7b (HFA)\u3002
\n\u5728\u8fd9\u51e0\u5341\u5e74\u95f4\uff0c\u6211\u4eec\u5bf9\u5438\u5165\u5236\u5242\u53ca\u5176\u6d4b\u8bd5\u7684\u7406\u89e3\u53d1\u751f\u4e86\u5f88\u5927\u53d8\u5316\uff0c\u6bcf\u5e74\u7684DDL\u4f1a\u8bae\u90fd\u4ee4\u6211\u4eec\u9f50\u805a\u4e00\u5802\uff0c\u5f7c\u6b64\u5206\u4eab\u6210\u529f\u3001\u5931\u8d25\u548c\u77e5\u8bc6\u3002\u9996\u5c4aDDL\u4f1a\u8bae\u4e3a\u671f\u4e00\u5929\uff0c\u4ec5\u6709100\u540d\u4ee3\u8868\u53c2\u52a0\u3002\u800c\u672c\u5c4aDDL\u4f1a\u8bae\u4e3a\u671f\u4e09\u5929\uff0c\u5438\u5f15\u4e86\u5168\u7403\u5404\u57301000\u591a\u540d\u53c2\u4e0e\u8005\u3002\u4f1a\u8bae\u5185\u5bb9\u975e\u5e38\u5145\u5b9e\uff1a<\/p>\n

\u8ba8\u8bba<\/strong><\/span>\u6d4b\u8bd5\u8981\u6c42\u662f\u5982\u4f55\u6f14\u53d8\u7684\u3002<\/p>\n

\u5f00\u53d1\u65b0\u4e00\u4ee3\u4f4eGWP\u5b9a\u91cf\u5438\u5165\u5242\u9700\u8981\u5927\u91cf\u4eba\u529b\u6295\u5165\uff0c\u800c\u81ea\u52a8\u5316\u662f\u6240\u6d89\u53ca\u4eba\u5458\u7684\u4e00\u4e2a\u5173\u952e\u4e3b\u9898\u3002\u60f3\u8981\u6ee1\u8db3\u7d27\u8feb\u7684\u4ea7\u54c1\u5546\u4e1a\u5316\u65f6\u95f4\u8868\uff0c\u63d0\u9ad8\u6d4b\u8bd5\u751f\u4ea7\u7387<\/a>\u53d1\u6325\u7740\u91cd\u8981\u4f5c\u7528\u3002<\/p>\n

FDA\u7684\u5177\u4f53\u4ea7\u54c1\u6307\u5357\u73b0\u5728\u7279\u522b\u63d0\u53ca\u4e86\u771f\u5b9e\u7684\u7a7a\u6c14\u52a8\u529b\u5b66\u7c92\u5f84\u5206\u5e03 (rAPSD)<\/a> \u6d4b\u91cf\uff0c\u8fd9\u53ef\u4ee5\u5728\u786e\u5b9a\u751f\u7269\u7b49\u6548\u6027\u65f6\u51cf\u5c11\u5bf9\u4f53\u5185<\/em>\u6d4b\u8bd5\u7684\u4f9d\u8d56\u3002\u56e0\u6b64\uff0c\u8d8a\u6765\u8d8a\u591a\u7684\u4eba\u5e0c\u671b\u5728\u5de5\u4f5c\u6d41\u7a0b\u4e2d\u6574\u5408\u66f4\u5177\u4e34\u5e8a\u76f8\u5173\u6027\u7684\u6d4b\u8bd5\u88c5\u7f6e\u3002<\/p>\n <\/div>\n <\/div>\n\n \n <\/div>\n <\/section>\n\n\n\n

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\n \"Team\n <\/div>\n \n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n
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<\/span>\u6c47\u805a<\/strong>\u66f4\u591a\u7684Copley\u201c\u5927\u5bb6\u5ead\u201d\u6210\u5458\u3002<\/p>\n

\u968f\u7740DDL\u4f1a\u8bae\u9010\u5e74\u5438\u5f15\u8d8a\u6765\u8d8a\u591a\u7684\u56fd\u9645\u53d7\u4f17\uff0c\u6765\u81ea\u4e2d\u56fd\u548c\u5370\u5ea6\u7684Copley\u7ecf\u9500\u5546\u4e5f\u4e0e\u6211\u4eec\u4e00\u540c\u51fa\u5e2d\uff0c\u5e76\u4e14\u6211\u4eec\u5f88\u9ad8\u5174\u4e3a\u6765\u81ea\u4e2d\u56fd\u53f0\u6e7e\u548c\u5927\u9646\u7684\u7ea620\u5bb6\u5ba2\u6237\u4e3e\u529e\u665a\u5bb4\u3002<\/p>\n

\u63a2\u7d22<\/strong><\/span>\u66f4\u5177\u89e3\u5256\u5b66\u771f\u5b9e\u6027\u7684\u53e3\u5589\u6a21\u578b\u3002<\/p>\n

\u5728\u8bb8\u591a\u6f14\u8bb2\u4f1a\u4e2d\uff0c\u53e3\u8154\u3001\u54bd\u5589\u548c\u9f3b\u8154\u5728\u7ecf\u53e3\u5438\u5165\u5236\u5242\u53ca\u9f3b\u7528\u5236\u5242 (OINDP) \u6d4b\u8bd5\u4e2d\u7684\u8868\u5f81\u662f\u4e00\u4e2a\u503c\u5f97\u6ce8\u610f\u7684\u8981\u7d20\u3002\u76f8\u6bd4\u6807\u51c6\u836f\u5178\u5438\u5165\u53e3\u63d0\u4f9b\u66f4\u597d\u7684\u8868\u5f81\u662f\u5b9e\u73b0rAPSD\u6d4b\u91cf\u7684\u8981\u6c42\uff0c\u66f4\u5e7f\u6cdb\u5730\u8bf4\uff0c\u4e5f\u662f\u786e\u4fdd\u4f53\u5916<\/em>\u65b9\u6cd5\u4ef7\u503c\u6700\u5927\u5316\u7684\u8981\u6c42\u3002\u8fd9\u662f\u9f3b\u7528\u5236\u5242\u4f1a\u8bae\u7684\u4e00\u4e2a\u91cd\u8981\u8bae\u9898\uff0c\u591a\u4f4d\u7814\u7a76\u4eba\u5458\u63a2\u8ba8\u4e86\u5982\u4f55\u5728\u771f\u5b9e\u6027\u3001\u518d\u73b0\u6027\u548c\u6613\u7528\u6027\u4e4b\u95f4\u53d6\u5f97\u6700\u4f73\u5e73\u8861\u3002<\/p>\n

\u4f26\u6566\u5927\u5b66\u56fd\u738b\u5b66\u9662\u7684\u5de5\u4f5c\u975e\u5e38\u5f15\u4eba\u5165\u80dc\uff0c\u5176\u5f3a\u8c03\u4e86\u5e26\u6d82\u5c42\u9f3b\u8154\u6a21\u578b\u5728\u6a21\u62df\u7c98\u6db2\u548c\u6539\u8fdb\u6c89\u79ef\u7814\u7a76\u65b9\u9762\u7684\u4ef7\u503c\u3002\u7814\u7a76\u4eba\u5458\u4f7f\u7528\u5e26\u6d82\u5c42\u963f\u5c14\u4f2f\u7279\u7406\u60f3\u5316\u9f3b\u8154\u5165\u53e3 (AINI)<\/a>\uff0c\u5bf9\u9f3b\u8154\u7279\u5b9a\u533a\u57df\u7684\u6c89\u79ef\u8fdb\u884c\u4e86\u975e\u5e38\u6709\u4ee3\u8868\u6027\u7684\u7814\u7a76\u3002\u91c7\u7528AINI\u7684\u7814\u7a76\u9879\u76ee\u6570\u91cf\u4e4b\u591a\uff0c\u5f62\u5f0f\u4e4b\u591a\u6837\uff0c\u4ee4\u4eba\u53f9\u4e3a\u89c2\u6b62\u3002\u4ece\u7ed3\u6838\u75c5\u75ab\u82d7\u5f00\u53d1\u5230\u9f3b\u8154\u7c89\u672b\u704c\u88c5\u5de5\u827a\u5f71\u54cd\u7684\u8bc4\u4f30\uff0cAINI\u786e\u5b9e\u662f\u76f8\u5173\u9886\u57df\u7684\u5b9e\u7528\u5de5\u5177\u3002<\/p>\n <\/div>\n <\/div>\n\n \n <\/div>\n <\/section>\n\n\n\n

\n
\n
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\n
\n \"DDL\n <\/div>\n \n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n
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<\/span>\u4eab\u7528<\/strong>\u7f8e\u5473\u7684\u51b0\u6dc7\u6dcb\u548c\u8d85\u7ea7\u5065\u5eb7\u7684\u51b0\u6c99\u996e\u54c1\uff0c\u8fdb\u884c\u9762\u5bf9\u9762\u7684\u7cbe\u5f69\u8ba8\u8bba\u3002<\/p>\n

\u4ece\u4e0e\u957f\u671f\u5408\u4f5c\u65b9\u548c\u8001\u5ba2\u6237\u53d9\u65e7\uff0c\u5230\u4e0e\u65b0\u7814\u7a76\u4eba\u5458\u63a5\u89e6\u3002\u4ece\u5236\u5b9a2025\u5e74\u6b27\u6d32\u836f\u7528\u6c14\u96fe\u5242\u7ec4\u7ec7 (EPAG – \u649e\u51fb\u5668\u7ec4\u7ec7) \u8ba1\u5212\uff0c\u5230\u901a\u8fc7\u5927\u91cf\u542f\u53d1\u6027\u6d77\u62a5\u5206\u4eab\u89c1\u89e3\u3002\u5728DDL\u4f1a\u8bae\u4e0a\uff0c\u4eba\u4eec\u603b\u662f\u5f88\u5bb9\u6613\u53c2\u4e0e\u5230\u5bcc\u6709\u6210\u679c\u3001\u5f15\u4eba\u5165\u80dc\u7684\u8ba8\u8bba\u4e2d\u3002<\/p>\n <\/div>\n <\/div>\n\n \n <\/div>\n <\/section>\n\n\n\n

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\n \"Ice-cream\n <\/div>\n \n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n
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\u4e86\u89e3<\/strong><\/span>\u751f\u7269\u5236\u54c1\u548c\u60a3\u8005\u4f9d\u4ece\u6027\u65b9\u9762\u7684\u8fdb\u6b65\u6210\u679c\u3002<\/p>\n

\u751f\u7269\u5236\u54c1\u7814\u7a76\u4eba\u5458\u6b63\u5728\u4e3a\u5982\u4f55\u5851\u9020\u5438\u5165\u836f\u7269\u9012\u9001\u65b9\u6cd5\u5960\u5b9a\u77e5\u8bc6\u57fa\u7840\uff0c\u4ee5\u4fbf\u6ee1\u8db3\u8fd9\u7c7b\u7279\u6b8a\u836f\u7269\u7684\u9700\u6c42\u3002\u836f\u7269\u9012\u9001\u6548\u7387\u6b63\u5728\u63d0\u5347\uff0c\u4f46\u56fa\u6709\u7684\u5206\u5b50\u4e0d\u7a33\u5b9a\u6027\u662f\u786e\u4fdd\u5728\u4f5c\u7528\u65f6\u4fdd\u6301\u6d3b\u6027\u6548\u529b\u7684\u4e00\u5927\u969c\u788d\u3002\u5965\u9a6c\u73e0\u5355\u6297 (omalizumab) \u548c\u7532\u6ce2\u73e0\u5355\u6297 (mepolizumab) \u7b49\u6ce8\u5c04\u751f\u7269\u5236\u54c1\u5df2\u7ecf\u5728\u4e3a\u4e25\u91cd\u54ee\u5598\u60a3\u8005\u63d0\u4f9b\u5e2e\u52a9\uff0c\u7a81\u663e\u4e86\u6709\u671b\u5f88\u5feb\u6210\u4e3a\u65b0\u578b\u5438\u5165\u7597\u6cd5\u7684\u6f5c\u529b\u3002<\/p>\n

\u53e6\u4e00\u65b9\u9762\uff0c\u60a3\u8005\u4f9d\u4ece\u6027\u901a\u5e38\u6d89\u53ca\u66f4\u6709\u6548\u5730\u4f7f\u7528\u73b0\u6709\u836f\u7269\u3002\u4ece\u76d1\u6d4b\u5438\u6c14\u58f0\u97f3\u7279\u5f81\u5230\u4e92\u8054\u751f\u6001\u7cfb\u7edf\u4e2d\u7684\u667a\u80fd\u96fe\u5316\u673a\uff0c\u73b0\u573a\u5c55\u793a\u4e86\u5927\u91cf\u65b0\u9896\u6709\u8da3\u7684\u6280\u672f\uff0c\u8868\u660e\u4e86\u6211\u4eec\u5982\u4f55\u5728\u8fd9\u65b9\u9762\u53d6\u5f97\u8fdb\u5c55\u3002<\/p>\n

\u611f\u8c22<\/strong><\/span>\u5ba2\u6237\u63d0\u51fa\u7684\u5b9d\u8d35\u53cd\u9988\u610f\u89c1\u3002<\/p>\n

DDL\u4f1a\u8bae\u662f\u503e\u542c\u5ba2\u6237\u5fc3\u58f0\u7684\u7edd\u4f73\u5e73\u53f0\uff1b\u5ba3\u4f20\u518c<\/a>\u548c\u7f51\u7ad9<\/a>\u505a\u5f97\u518d\u597d\uff0c\u4e5f\u6bd4\u4e0d\u4e0a\u4eb2\u81ea\u4e0a\u624b\u64cd\u4f5c\u4eea\u5668\u3002\u6211\u4eec\u5f88\u9ad8\u5174\u5730\u542c\u5230\uff0c\u6211\u4eec\u5c55\u53f0\u6d41\u7545\u800c\u9192\u76ee\u7684\u8bbe\u8ba1\u53cd\u6620\u4e86\u65e5\u590d\u4e00\u65e5\u4f7f\u7528Copley\u8bbe\u5907\u7684\u5de5\u4f5c\u4eba\u5458\u7684\u8bbe\u8ba1\u4f53\u9a8c\uff01\u5bf9\u4e8e\u6211\u4eec\u800c\u8a00\uff0c\u4e86\u89e3\u5ba2\u6237\u9762\u4e34\u7684\u6311\u6218\u662f\u4e00\u4ef6\u6781\u5177\u5438\u5f15\u529b\u7684\u4e8b\u60c5\uff0c\u56e0\u6b64\u6211\u4eec\u8981\u611f\u8c22\u6bcf\u4e00\u4f4d\u5230\u8bbf\u8005\u3002\u53ea\u8981\u5411\u6211\u4eec\u8bc9\u8bf4\u60a8\u7684\u76ee\u6807\u548c\u8981\u6c42\uff0c\u6211\u4eec\u5c31\u80fd\u66f4\u8f7b\u677e\u5730\u5f00\u53d1\u51fa\u63a8\u52a8OINDP\u6d4b\u8bd5\u53d1\u5c55\u6240\u9700\u7684\u4ea7\u54c1\u3002<\/p>\n <\/div>\n <\/div>\n\n \n <\/div>\n <\/section>\n\n\n\n

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\n \"Copley\n <\/div>\n \n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n
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\u6d77\u62a5\u5c55\u793a<\/strong><\/span>\u3002<\/p>\n

\u6211\u4eec\u4eca\u5e74\u7684\u4e3b\u9898\u662f\uff0c\u4e0d\u540c\u649e\u51fb\u5668 (\u5168\u5206\u8fa8\u7387\u578b\u548c\u7b80\u6613\u578b) \u5728\u4f53\u79ef\u548c\u6d41\u52a8\u963b\u529b\u4e0a\u7684\u5dee\u5f02\u5982\u4f55\u5f71\u54cd\u5e72\u7c89\u5438\u5165\u5242 (DPI) \u6d4b\u8bd5<\/a>\u3002\u5982\u679c\u60a8\u6b63\u5728\u4ece\u4e8bDPI\u76f8\u5173\u5de5\u4f5c\uff0c\u90a3\u4e48\u8fd9\u662f\u4e00\u4e2a\u9700\u8981\u6ce8\u610f\u7684\u91cd\u8981\u95ee\u9898\u3002<\/p>\n <\/div>\n <\/div>\n\n \n <\/div>\n <\/section>\n\n\n\n

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\u5f53\u60a3\u8005\u4f7f\u7528DPI\u65f6\uff0c\u901a\u5e38\u9700\u8981\u6309\u7167\u6307\u793a\u5feb\u901f\u7528\u529b\u5438\u5165<\/span>\u5236\u5242\u3002\u8fd9\u4e00\u64cd\u4f5c\u4f1a\u4f7f\u7a7a\u6c14\u4ee5\u4e00\u5b9a\u901f\u5ea6\u901a\u8fc7\u8bbe\u5907\uff0c\u5e76\u5728\u4e00\u5b9a\u65f6\u95f4 (\u5373\u6d41\u91cf\u4e0a\u5347\u65f6\u95f4) \u5185\u4e0a\u5347\u5230\u5cf0\u503c\u6d41\u91cf\u3002\u5438\u5165\u5236\u5242\u7684\u963b\u529b\u4f1a\u5f71\u54cd\u6d41\u91cf\u4e0a\u5347\u65f6\u95f4\uff0c\u4f46\u6d4b\u8bd5\u88c5\u7f6e\u7684\u7ec4\u4ef6\uff0c\u7279\u522b\u662f\u649e\u51fb\u5668\uff0c\u4e5f\u4f1a\u5f71\u54cd\u6d41\u91cf\u4e0a\u5347\u65f6\u95f4\u3002\u6211\u4eec\u7684\u6d77\u62a5\u4ecb\u7ecd\u4e86\u5982\u4f55\u5e94\u5bf9\u8fd9\u4e00\u4e3b\u9898\uff0c\u4ece\u800c\u4fdd\u969cDPI\u6d4b\u8bd5\u6570\u636e<\/a>\u7684\u4e00\u81f4\u6027\u3002<\/p>\n

\u9664\u4e86\u6211\u4eec\u81ea\u5df1\u7684\u6d77\u62a5\u5916\uff0c\u6211\u4eec\u8fd8\u5f88\u9ad8\u5174\u4e0e\u56fd\u9645\u836f\u7528\u6c14\u96fe\u5242\u76d1\u7ba1\u4e0e\u79d1\u5b66\u8054\u76df\u548cMicrosol\u516c\u53f8\u5408\u4f5c\u6253\u9020\u4e86\u53e6\u5916\u4e24\u4efd\u6d77\u62a5\uff0c\u5206\u522b\u662f\u5173\u4e8eUSP <601>\u548c<1604>\u4e4b\u95f4\u7684\u5dee\u5f02\uff0c\u4ee5\u53ca\u5c06NGI\u6570\u636e\u4e0e\u80ba\u90e8\u6c89\u79ef\u7684\u751f\u7269\u4fe1\u606f\u5b66<\/em>\u6a21\u578b\u76f8\u7ed3\u5408\u3002<\/p>\n

\u8d62\u4e0b<\/strong><\/span>PPD\/Thermo Fisher\u7684\u201c\u731c\u731c\u649e\u51fb\u5668\u548c\u5c42\u7ea7\u201d\u7ade\u731c\u6d3b\u52a8\u3002\u600e\u4e48\u8bf4\u5462\uff0c\u6211\u4eec\u5f88\u5e78\u8fd0\u9009\u4e2d\u4e86\u8fd9\u4e2a\u4e3b\u9898\uff01<\/p>\n <\/div>\n <\/div>\n\n \n <\/div>\n <\/section>\n\n\n\n

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\n \"Winning\n <\/div>\n \n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\n
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