{"id":4628,"date":"2021-02-26T10:44:40","date_gmt":"2021-02-26T02:44:40","guid":{"rendered":"http:\/\/www.tipr.com.cn\/wordpress2\/?p=4628"},"modified":"2021-03-01T10:08:40","modified_gmt":"2021-03-01T02:08:40","slug":"huigu","status":"publish","type":"post","link":"https:\/\/www.tipr.com.cn\/index.php\/2021\/02\/26\/huigu\/","title":{"rendered":"\u836f\u54c1\u76d1\u7ba1\u79d1\u5b66\u53d1\u5c55\u5341\u5e74(2010\u20142020)\u56de\u987e"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4628\" class=\"elementor elementor-4628\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1dc2763 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1dc2763\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element 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class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>\u6458\u8981\uff1a\u81ea2010\u5e74\u56fd\u9645\u4e0a\u5021\u5bfc\u53d1\u5c55\u76d1\u7ba1\u79d1\u5b66\u4ee5\u6765\u768410\u5e74\u95f4\uff0c\u5bf9\u76d1\u7ba1\u79d1\u5b66\u8fd9\u4e00\u65b0\u5b66\u79d1\u7684\u53d1\u5c55\u53ca\u5176\u7814\u7a76\u5f00\u53d1\u65b0\u7684\u5de5\u5177\u3001\u6807\u51c6\u548c\u65b9\u6cd5\u6765\u8bc4\u4f30\u53d7\u76d1\u7ba1\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u3001\u8d28\u91cf\u548c\u6027\u80fd\uff0c\u4e3a\u6307\u5bfc\u836f\u7269\u521b\u65b0\u3001\u8bc4\u4f30\u3001\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u4ea7\u751f\u4e86\u79ef\u6781\u4f5c\u7528\u3002\u4ece6\u65b9\u9762\u56de\u987e\u548c\u8bba\u8ff0\uff1a\uff081\uff09\u4e16\u754c\u836f\u54c1\u76d1\u7ba1\u79d1\u5b6610\u5e74\u53d1\u5c55\u6982\u51b5\uff1b(2)\u56fd\u9645\u653f\u5e9c-\u4ea7\u4e1a-\u79d1\u5b66\u7814\u7a763\u65b9\u9762\u7684\u79ef\u6781\u5408\u4f5c\uff0c\u7279\u522b\u662f\u975e\u653f\u5e9c\u673a\u6784\u63a8\u8fdb\u56fd\u5bb6\u7ba1\u7406\u90e8\u95e8\u91cd\u89c6\u76d1\u7ba1\u79d1\u5b66\u7684\u53d1\u5c55\uff1b\uff083\uff09\u7ed3\u5408\u56fd\u60c5\u91cd\u89c6\u4e2d\u836f\u7814\u53d1\u7684\u76d1\u7ba1\u79d1\u5b66\u5efa\u8bbe\uff1b\uff084\uff09\u63a8\u8fdb\u751f\u7269\u6280\u672f\u836f\u7269\u76d1\u7ba1\u79d1\u5b66\u7684\u6700\u65b0\u53d1\u5c55\u52a8\u5411\uff1b\uff085\uff09\u4e2d\u56fd\u836f\u54c1\u76d1\u7ba1\u79d1\u5b66\u884c\u52a8\u8ba1\u5212\u5bf9\u63d0\u9ad8\u76d1\u7ba1\u6c34\u5e73\u7684\u65b0\u5f15\u64ce\u4f5c\u7528\uff1b\uff086\uff09\u5728\u75ab\u60c5\u7279\u6b8a\u65f6\u671f\u76d1\u7ba1\u79d1\u5b66\u4e3a\u9632\u63a7\u65b0\u51a0\u80ba\u708e\uff08COVID-19\uff09\u6240\u83b7\u5f97\u7684\u6210\u7ee9\u548c\u5b58\u5728\u7684\u95ee\u9898\u3002\u6700\u540e\uff0c\u4e3a\u63a8\u8fdb\u76d1\u7ba1\u79d1\u5b66\u5728\u6211\u56fd\u7684\u53d1\u5c55\u63d0\u51fa10\u6761\u5efa\u8bae\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0a67f69 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0a67f69\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5cdfd6a\" data-id=\"5cdfd6a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-36d6dec elementor-widget elementor-widget-text-editor\" data-id=\"36d6dec\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>\u00a0 \u00a0 \u00a0 \u00a0 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GSRS\u5cf0\u4f1a\u8bd5\u56fe\u4e3a\u5168\u7403\u533b\u836f\u521b\u65b0\u4ea7\u54c1\u7684\u76d1\u7ba1\u653f\u7b56\u5236\u5b9a\u8005\u3001\u524d\u6cbf\u79d1\u5b66\u5bb6\u3001\u8f6c\u5316\u533b\u5b66\u4ee5\u53ca\u751f\u7269\u5c16\u7aef\u79d1\u6280\u521b\u4e1a\u8005\u63d0\u4f9b\u4e00\u4e2a\u534f\u540c\u521b\u65b0\u5e73\u53f0\u3002\u6bcf\u5c4aGSRS\u4f1a\u8bae\u90fd\u9080\u8bf7\u591a\u4f4d\u6765\u81ea\u4e16\u754c\u4e3b\u8981\u56fd\u5bb6\u7684\u76d1\u7ba1\u79d1\u5b66\u5bb6\u548c\u884c\u653f\u7ba1\u7406\u90e8\u95e8\u7684\u4e13\u5bb6\u62c5\u4efb\u5168\u7403\u76d1\u7ba1\u79d1\u5b66\u59d4\u5458\u4f1a(Global Regulatory Science Board,GRSB)\u59d4\u5458\u3002\u901a\u8fc7GSRS\u5bf9\u751f\u7269\u533b\u836f\u754c\u65b0\u5174\u7684\u7814\u7a76\u70ed\u70b9\u95ee\u9898\u662f\u5982\u4f55\u4fc3\u8fdb\u533b\u836f\u521b\u65b0\u6210\u679c\u7684\u8f6c\u5316\u548c\u4e34\u5e8a\u5e94\u7528\u8fdb\u884c\u8ba8\u8bba\uff0c\u76d1\u7ba1\u79d1\u5b66\u662f\u63a8\u52a8\u533b\u836f\u4ea7\u54c1\u521b\u65b0\u7684\u91cd\u8981\u5b66\u79d1\u548c\u524d\u77bb\u79d1\u6280\u9886\u57df<sup>[11-12]<\/sup>\u3002<\/p><p>\u00a0 \u00a0 \u00a0 \u00a0 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2<\/strong>\u3000\u63a8\u8fdb\u56fd\u5bb6\u7ba1\u7406\u90e8\u95e8\u91cd\u89c6\u76d1\u7ba1\u79d1\u5b66\u7684\u53d1\u5c55<\/p><p>\u00a0 \u00a0 \u00a0 \u00a0 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2019\u5e7411\u201412\u6708\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u590d\u5c71\u4e1c\u5927\u5b66\u3001\u6c88\u9633\u836f\u79d1\u5927\u5b66\u3001\u534e\u5357\u7406\u5de5\u5927\u5b66\u548c\u5317\u4eac\u5de5\u5546\u5927\u5b66\u4e3a\u5316\u5986\u54c1\u76d1\u7ba1\u79d1\u5b66\u7814\u7a76\u57fa\u5730\u7b49\u3002\u8fd9\u4e9b\u4f9d\u6258\u56fd\u5185\u77e5\u540d\u9ad8\u7b49\u9662\u6821\u3001\u79d1\u7814\u673a\u6784\u5efa\u8bbe\u7684\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u79d1\u5b66\u7814\u7a76\u57fa\u5730\u5bf9\u8fdb\u4e00\u6b65\u63d0\u9ad8\u836f\u54c1\u76d1\u7ba1\u6548\u80fd\u548c\u6c34\u5e73\u53d1\u6325\u5927\u5b66\u4f18\u52bf\uff0c\u7d27\u7d27\u56f4\u7ed5\u6211\u56fd\u836f\u54c1\u521b\u65b0\u53d1\u5c55\u548c\u76d1\u7ba1\u79d1\u5b66\u7684\u6218\u7565\u9700\u6c42\uff0c\u805a\u7126\u836f\u54c1\u79d1\u6280\u524d\u6cbf\u3001\u79d1\u6280\u6210\u679c\u8f6c\u79fb\u8f6c\u5316\u3001\u9ad8\u7aef\u4eba\u624d\u57f9\u517b\u3001\u836f\u54c1\u76d1\u7ba1\u65b0\u65b9\u6cd5\u3001\u68c0\u9a8c\u68c0\u6d4b\u65b0\u6280\u672f\u3001\u6807\u51c6\u5236\u4fee\u8ba2\u3001\u98ce\u9669\u5206\u6790\u548c\u9884\u8b66\u3001\u5b89\u5168\u8bc4\u4ef7\u3001\u5e94\u6025\u5904\u7f6e\u7b49\u91cd\u70b9\u9886\u57df\u5f00\u5c55\u7814\u7a76\uff0c\u6709\u5229\u4e8e\u539f\u521b\u6027\u7814\u7a76\u548c\u79d1\u6280\u653b\u5173\uff0c\u5176\u4ea7\u51fa\u6210\u679c\u6709\u529b\u670d\u52a1\u4e86\u836f\u54c1\u76d1\u7ba1\u5927\u5c40\uff0c\u8fbe\u5230\u79d1\u5b66\u76d1\u7ba1\u3002\u7b14\u8005\u8ba4\u4e3a\u5e94\u8be5\u53d1\u6325\u9662\u6821\u5728\u57f9\u517b\u9ad8\u7aef\u76d1\u7ba1\u4eba\u624d\u7684\u4f18\u52bf\uff0c\u5efa\u8bae\u5728\u4e13\u4e1a\u4eba\u624d\u57f9\u517b\u4ece\u4ee5\u4e0b\u8bfe\u7a0b\u5165\u624b\u662f\u5b8c\u5168\u53ef\u884c\u7684<sup>[8]<\/sup>\uff08\u88681\uff09\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-28e3389 elementor-widget elementor-widget-image\" data-id=\"28e3389\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"737\" height=\"664\" src=\"https:\/\/www.tipr.com.cn\/wp-content\/uploads\/2021\/02\/\u5fae\u4fe1\u56fe\u7247_20210226104824.png\" class=\"attachment-large size-large wp-image-4632\" alt=\"\" srcset=\"https:\/\/www.tipr.com.cn\/wp-content\/uploads\/2021\/02\/\u5fae\u4fe1\u56fe\u7247_20210226104824.png 737w, https:\/\/www.tipr.com.cn\/wp-content\/uploads\/2021\/02\/\u5fae\u4fe1\u56fe\u7247_20210226104824-300x270.png 300w, https:\/\/www.tipr.com.cn\/wp-content\/uploads\/2021\/02\/\u5fae\u4fe1\u56fe\u7247_20210226104824-150x135.png 150w\" sizes=\"(max-width: 737px) 100vw, 737px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-597491c elementor-widget elementor-widget-text-editor\" data-id=\"597491c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>\u00a0 \u00a0 \u00a0 \u00a0 6<\/strong>\u3000\u76d1\u7ba1\u79d1\u5b66\u5728\u9632\u63a7\u65b0\u51a0\u80ba\u708e\uff08<strong>COVID-19<\/strong>\uff09\u4e2d\u7684\u4f5c\u7528<\/p><p>\u00a0 \u00a0 \u00a0 \u00a0 2020\u5e74\u4f0a\u59cb\uff0cCOVID-19\u75ab\u60c5\u66b4\u53d1\uff0c\u5e72\u7ec6\u80de\u7597\u6cd5\u88ab\u5217\u5165COVID-19\u60a3\u8005\u7684\u6cbb\u7597\u65b9\u6848\u4e2d\u3002\u300a\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u6280\u672f\u8bc4\u4ef7\u4e0e\u76d1\u7ba1\u4f53\u7cfb\u7814\u7a76\u300b\u9879\u76ee\u4f5c\u4e3a\u836f\u54c1\u76d1\u7ba1\u79d1\u5b66\u884c\u52a8\u8ba1\u52129\u5927\u9879\u76ee\u7684\u884c\u52a8\u4e4b\u4e00\u3002\u7814\u7a76\u9879\u76ee\u6210\u679c\u5feb\u901f\u8f6c\u5316\u4e3a\u5e72\u7ec6\u80de\u6cbb\u7597COVID-19\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u8003\u8651\u8981\u70b9\u548c\u7533\u62a5\u8d44\u6599\u8981\u70b9\uff0c\u660e\u786e\u4e86\u6280\u672f\u5ba1\u8bc4\u6807\u51c6\uff0c\u89c4\u8303\u4e86\u76f8\u5173\u4ea7\u54c1\u7684\u7814\u7a76\u548c\u7533\u62a5\u3002\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u4e2d\u56fd\u79d1\u5b66\u9662\u52a8\u7269\u7814\u7a76\u6240\u5e72\u7ec6\u80de\u9879\u76ee\u548c\u5317\u4eac\u8d1d\u6765\u4eba\u8110\u5e26\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u5f00\u5c55\u91cd\u75c7\u60a3\u8005\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6839\u636e\u5e94\u6025\u5ba1\u8bc4\u539f\u5219\uff0c\u4e8e\u4eca\u5e743\u67085\u65e5\u53d1\u5e03\u4e86\u300a\u80ba\u708eCT\u5f71\u50cf\u8f85\u52a9\u5206\u8bca\u4e0e\u8bc4\u4f30\u8f6f\u4ef6\u5ba1\u8bc4\u8981\u70b9\uff08\u8bd5\u884c\uff09\u300b\uff0c\u6210\u4e3a\u201c\u4eba\u5de5\u667a\u80fd\u533b\u7597\u5668\u68b0\u5b89\u5168\u6709\u6548\u6027\u8bc4\u4ef7\u7814\u7a76\u201d\u7684\u9636\u6bb5\u6027\u6210\u679c\u7684\u4e00\u90e8\u5206\u3002<\/p><p>\u00a0 \u00a0 \u00a0 \u00a0 2020\u5e741\u670831\u65e5\uff0c\u7f8e\u56fd\u536b\u751f\u4e0e\u516c\u4f17\u670d\u52a1\u90e8\uff08HHS\uff09\u53d1\u5e03\u4e86\u4e0eCOVID-19\u76f8\u5173\u7684\u7a81\u53d1\u516c\u5171\u536b\u751f\u4e8b\u4ef6\u58f0\u660e\uff0c\u968f\u540eFDA\u53d1\u5e03\u5173\u4e8e\u5728COVID-19\u75ab\u60c5\u671f\u95f4\u5f00\u5c55\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6307\u5357\uff08FDA Guidance onConduct of Clinical Trials of Medical Products during the COVID-19 PublicHealth Emergency\uff09<sup>[30]<\/sup>\u3002\u8be5\u6307\u5357\u65e8\u5728\u63d0\u4f9bCOVID-19\u75ab\u60c5\u671f\u95f4\u7684\u4e00\u822c\u6ce8\u610f\u4e8b\u9879\uff0c\u5e2e\u52a9\u7533\u529e\u65b9\u5fc5\u987b\u786e\u4fdd\u8bd5\u9a8c\u53c2\u4e0e\u8005\u7684\u5b89\u5168\u6027\uff0c\u4fdd\u6301\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GCP\uff09\u5408\u89c4\u6027\uff0c\u5e76\u5c3d\u53ef\u80fd\u964d\u4f4e\u5bf9\u8bd5\u9a8c\u5b8c\u6574\u6027\u7684\u98ce\u9669\u3002\u5728\u8fd9\u4e00\u7a81\u53d1\u516c\u5171\u536b\u751f\u4e8b\u4ef6\u65f6\u671f\uff0c\u8be5\u6307\u5357\u7684\u5b9e\u65bd\u5e76\u672a\u4e8b\u5148\u5f81\u6c42\u516c\u4f17\u610f\u89c1\uff0c\u539f\u56e0\u662fFDA\u8ba4\u4e3a\u5c31\u672c\u6307\u5357\u4e8b\u5148\u5f81\u6c42\u516c\u4f17\u610f\u89c1\u7684\u505a\u6cd5\u4e0d\u53ef\u884c\u6216\u4e0d\u9002\u5f53\u3002\u5c3d\u7ba1COVID-19\u9632\u63a7\u63aa\u65bd\u5bf9\u8bd5\u9a8c\u7684\u5fc5\u8981\u6027\u548c\u5f71\u54cd\u4f1a\u56e0\u8bb8\u591a\u56e0\u7d20\u800c\u4e0d\u540c\uff0c\u5305\u62ec\u7814\u7a76\u75be\u75c5\u7684\u6027\u8d28\u3001\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u7814\u7a76\u5f00\u5c55\u7684\u5730\u533a\uff0cFDA\u63d0\u51fa\u4e00\u822c\u6ce8\u610f\u4e8b\u9879\uff0c\u4ee5\u5e2e\u52a9\u7533\u529e\u65b9\u786e\u4fdd\u8bd5\u9a8c\u53c2\u4e0e\u8005\u7684\u5b89\u5168\u6027\uff0c\u4fdd\u6301GCP\u5408\u89c4\u6027\uff0c\u5e76\u5c3d\u53ef\u80fd\u964d\u4f4e\u5bf9\u8bd5\u9a8c\u5b8c\u6574\u6027\u7684\u98ce\u9669\u3002<\/p><p>\u00a0 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claims,MERSC)<sup>[40]<\/sup>\u3002\u4e24\u8005\u7ed3\u5408\u662f\u53d1\u5c55\u76d1\u7ba1\u79d1\u5b66\u7814\u7a76\u8fbe\u5230\u63d0\u9ad8\u76d1\u7ba1\u6c34\u5e73\u548c\u80fd\u529b\u7684\u57fa\u672c\u539f\u5219\u548c\u65b9\u6cd5\u7684\u51fa\u53d1\u70b9\u30022019\u5e744\u6708\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u51b3\u5b9a\u56f4\u7ed5\u201c\u521b\u65b0\u3001\u8d28\u91cf\u3001\u6548\u7387\u3001\u4f53\u7cfb\u3001\u80fd\u529b\u201d\u4e3b\u9898\uff0c\u63a8\u52a8\u76d1\u7ba1\u7406\u5ff5\u5236\u5ea6\u673a\u5236\u521b\u65b0\uff0c\u52a0\u5feb\u63a8\u8fdb\u6211\u56fd\u4ece\u5236\u836f\u5927\u56fd\u5411\u5236\u836f\u5f3a\u56fd\u8fc8\u8fdb\uff0c\u542f\u52a8\u4e86\u4e2d\u56fd\u836f\u54c1\u76d1\u7ba1\u79d1\u5b66\u884c\u52a8\u8ba1\u5212\uff0c\u786e\u5b9a\u4e86\u9996\u62799\u4e2a\u91cd\u70b9\u7814\u7a76\u9879\u76ee<sup>[41]<\/sup>\u3002\u8be5\u76d1\u7ba1\u79d1\u5b66\u884c\u52a8\u8ba1\u5212\u56f4\u7ed5\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u521b\u65b0\uff0c\u5bc6\u5207\u8ddf\u8e2a\u56fd\u9645\u76d1\u7ba1\u53d1\u5c55\u524d\u6cbf\uff0c\u62df\u901a\u8fc7\u76d1\u7ba1\u5de5\u5177\u3001\u6807\u51c6\u3001\u65b9\u6cd5\u7b49\u7cfb\u5217\u521b\u65b0\u7684\u4e00\u5e74\u5b9e\u8df5\uff0c\u4e3a\u6709\u6548\u89e3\u51b3\u5f71\u54cd\u548c\u5236\u7ea6\u836f\u54c1\u521b\u65b0\u3001\u8d28\u91cf\u3001\u6548\u7387\u7684\u7a81\u51fa\u6027\u95ee\u9898\u83b7\u5f97\u6210\u6548\u3002\u56e0\u6b64\uff0c\u4e0d\u8bba\u4ece\u5168\u7403\u76d1\u7ba1\u79d1\u5b6610\u5e74\u7684\u53d1\u5c55\uff0c\u8fd8\u662f\u56fd\u5185\u76d1\u7ba1\u79d1\u5b66\u4e00\u5e74\u7684\u884c\u52a8\uff0c\u5747\u4f7f\u6211\u4eec\u770b\u5230\u79d1\u5b66\u76d1\u7ba1\u548c\u63d0\u9ad8\u76d1\u7ba1\u6548\u7387\u7684\u6210\u6548\u3002\u4e3a\u5171\u540c\u5b9e\u73b0\u66f4\u9ad8\u76ee\u6807\uff0c\u7b14\u8005\u8ba4\u4e3a\u9700\u8981\u5728\u4ee5\u4e0b10\u4e2a\u65b9\u9762\u53d1\u5c55\u76d1\u7ba1\u79d1\u5b66\uff1a<\/p><p>\u00a0 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