{"id":116816,"date":"2019-06-11T12:38:22","date_gmt":"2019-06-11T04:37:32","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/116816\/"},"modified":"2019-06-11T12:37:33","modified_gmt":"2019-06-11T04:37:33","slug":"f4dd73e147","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/116816\/","title":{"rendered":"\u836f\u4f01\u836f\u7269\u8b66\u6212\u5de5\u4f5c\uff0c\u5b9e\u6218\u5206\u4eab"},"content":{"rendered":"
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\u4e94\u3001PV\u7cfb\u7edf\u7ba1\u7406\u3002 <\/span><\/p>\n<\/section>\n<\/section>\n<\/blockquote>\n

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1961\u5e7412\u6708\uff0c\u6fb3\u5927\u5229\u4e9a\u4ea7\u79d1\u533b\u751f\u5a01\u5ec9\u00b7\u9ea6\u514b\u5e03\u91cc\u5fb7\u5728\u82f1\u56fd\u300a\u67f3\u53f6\u5200\u300b\u6742\u5fd7\u4e0a\u53d1\u8868\u6587\u7ae0\uff0c\u6307\u51fa\u53cd\u5e94\u505c\u53ef\u81f4\u5a74\u513f\u7578\u5f62\u3002\u8fd9\u662f\u4e00\u79cd\u56db\u80a2\u53d1\u80b2\u4e0d\u5168\u7684\u51fa\u751f\u7f3a\u9677\uff0c\u56e0\u4e3a\u77ed\u5982\u6d77\u8c79\u7684\u9ccd\u8db3\u800c\u88ab\u79f0\u4e3a\u6d77\u8c79\u80a2\u75c7\u3002\u6d77\u8c79\u80a2\u75c7\u539f\u672c\u5f88\u7f55\u89c1\uff0c\u8fd9\u51e0\u5e74\u7a81\u7136\u589e\u591a\uff0c\u6bcd\u4eb2\u5728\u6000\u5b55\u671f\u95f4\u90fd\u670d\u7528\u8fc7\u53cd\u5e94\u505c\uff0c\u9ea6\u514b\u5e03\u91cc\u5fb7\u8ba4\u4e3a\u662f\u53cd\u5e94\u505c\u5bfc\u81f4\u6d77\u8c79\u80a2\u75c7\u3002\u5fb7\u56fd\u513f\u79d1\u533b\u751f\u7ef4\u675c\u91d1\u5fb7\u00b7\u4f26\u5179\u4e5f\u5f97\u51fa\u76f8\u540c\u7684\u7ed3\u8bba\u3002<\/span><\/p>\n

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1962\u5e747\u670815\u65e5\uff0c\u300a\u534e\u76db\u987f\u90ae\u62a5\u300b\u62a5\u9053\u4e86\u51ef\u5c14\u897f\u5728\u53cd\u5e94\u505c\u7533\u8bf7\u4e2d\u7684\u8868\u73b0\uff0c\u8ba4\u4e3a\u5982\u679c\u4e0d\u662f\u5979\u7684\u575a\u6301\u548c\u52c7\u6c14\uff0c\u4f1a\u6709\u6210\u5343\u4e0a\u4e07\u7684\u7f8e\u56fd\u5a74\u513f\u51fa\u751f\u7f3a\u9677\u3002\u4e00\u591c\u4e4b\u95f4\uff0c\u51ef\u5c14\u897f\u4ece\u9ed8\u9ed8\u65e0\u95fb\u6210\u4e3a\u7f8e\u56fd\u82f1\u96c4\uff0c\u5f53\u5e74\u88ab\u6388\u4e88\u7ed9\u4e88\u8054\u90a6\u96c7\u5458\u7684\u6700\u9ad8\u8363\u8a89\u4f18\u5f02\u8054\u90a6\u516c\u6c11\u670d\u52a1\u603b\u7edf\u5956\u3002<\/span><\/p>\n

\u836f\u7269\u8b66\u6212\u5de5\u4f5c\u7684\u91cc\u7a0b\u7891 <\/span><\/strong><\/p>\n

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\uff082\uff09\u836f\u7269\u8b66\u6212\u7684\u5b97\u65e8\u3001\u613f\u666f\u548c\u76ee\u6807 <\/span><\/p>\n

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\u613f\u666f\uff1a\u836f\u7269\u5b89\u5168\u7684\u4f7f\u547d<\/span><\/p>\n

  \u4fdd\u62a4\u75c5\u60a3\u7528\u836f\u5b89\u5168\uff0c\u63a8\u8fdb\u516c\u4f17\u5065\u5eb7<\/span><\/p>\n

  \u6700\u5c0f\u5316\u836f\u7269\u4f7f\u7528\u98ce\u9669<\/span><\/p>\n

  \u6700\u5927\u5316\u836f\u7269\u6cbb\u7597\u6548\u76ca<\/span><\/p>\n

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l \u6211\u56fd\u836f\u7269\u8b66\u6212\u662f\u5e94MAH\u800c\u751f<\/span><\/strong><\/p>\n

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\u7b2c\u4e09\u5341\u56db\u6761 \u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u5e94\u5f53\u4e3b\u52a8\u5f00\u5c55\u836f\u54c1\u518d\u8bc4\u4ef7\uff1a<\/span><\/p>\n

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\uff08\u4e8c\uff09\u53d1\u73b0\u65b0\u7684\u6f5c\u5728\u98ce\u9669\u6216\u8005\u98ce\u9669\u6539\u53d8\u7684\uff1b<\/span><\/p>\n

\uff08\u4e09\uff09\u901a\u8fc7\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u53ca\u5176\u4ed6\u4e0e\u7528\u836f\u6709\u5173\u7684\u6709\u5bb3\u53cd\u5e94\u76d1\u6d4b\u3001\u98ce\u9669\u8bc4\u4f30\u7b49\u53d1\u73b0\u836f\u54c1\u53ef\u80fd\u98ce\u9669\u5927\u4e8e\u83b7\u76ca\u7684\u3002 <\/span><\/p>\n

\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u672a\u6309\u89c4\u5b9a\u5c65\u884c\u836f\u54c1\u518d\u8bc4\u4ef7\u4e49\u52a1\u7684\uff0c\u56fd\u52a1\u9662\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u5e94\u5f53\u8d23\u4ee4\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u5f00\u5c55\u518d\u8bc4\u4ef7\u3002\u5fc5\u8981\u65f6\uff0c\u56fd\u52a1\u9662\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u53ef\u4ee5\u76f4\u63a5\u7ec4\u7ec7\u5f00\u5c55\u836f\u54c1\u518d\u8bc4\u4ef7\u3002 <\/span><\/p>\n

l \u836f\u54c1\u7ba1\u7406\u6cd5\u4fee\u8ba2\u65b0\u7406\u5ff5-\u836f\u7269\u8b66\u6212\u4e0e\u5b89\u5168\u4e8b\u4ef6<\/span><\/strong><\/p>\n

1\u3001\u836f\u54c1ADR\u53ca\u4e0e\u7528\u836f\u6709\u5173\u7684\u6709\u5bb3\u53cd\u5e94\u8fdb\u884c\u76d1\u6d4b\uff0c\u98ce\u9669\u8bc6\u522b\uff0c\u8bc4\u4f30\uff0c\u6709\u6548\u63a7\u5236\uff1b<\/span><\/p>\n

2\u3001PV\u62a5\u544a\u3001MAH\u8b66\u6212\u8d23\u4efb\u3001\u4f7f\u7528\u5355\u4f4d\u8b66\u6212\u8d23\u4efb\uff1b<\/span><\/p>\n

3\u3001\u98ce\u9669\u7ba1\u7406\u3001\u4e0a\u5e02\u540e\u7814\u7a76\uff1b<\/span><\/p>\n

4\u3001\u836f\u54c1\u518d\u8bc4\u4ef7\uff1b<\/span><\/p>\n

5\u3001\u53ec\u56de <\/span><\/p>\n

l MAH\u6301\u6709\u4eba\u627f\u62c5\u836f\u7269\u8b66\u6212\u4e3b\u4f53\u8d23\u4efb<\/span><\/strong><\/p>\n

1\u3001\u836f\u7269\u8b66\u6212\u662f\u53d1\u73b0\u3001\u8bc4\u4f30\u3001\u8ba4\u8bc6\u548c\u9884\u9632\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u53ca\u5176\u4ed6\u836f\u54c1\u5b89\u5168\u6027\u95ee\u9898\u7684\u79d1\u5b66\u6d3b\u52a8\u3002<\/span><\/p>\n

2\u3001\u6301\u6709\u4eba\u662f\u836f\u7269\u8b66\u6212\u5de5\u4f5c\u7684\u8d23\u4efb\u4e3b\u4f53\uff0c\u5e94\u8bbe\u7acb\u72ec\u7acb\u4e8e\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u7684\u4e13\u95e8\u673a\u6784\uff0c\u914d\u5907\u4e13\u804c\u4eba\u5458\uff0c\u5efa\u7acb\u5065\u5168\u76f8\u5173\u7ba1\u7406\u5236\u5ea6\uff0c\u76f4\u63a5\u62a5\u544a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\/\u4e8b\u4ef6\uff0c\u5b9a\u671f\u5f00\u5c55\u836f\u54c1\u98ce\u9669\u83b7\u76ca\u8bc4\u4f30\uff0c\u91c7\u53d6\u6709\u6548\u7684\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u3002<\/span><\/p>\n

 l \u836f\u7269\u8b66\u6212\u53ef\u4ee5\u59d4\u6258\u7b2c\u4e09\u65b9\u5f00\u5c55\uff1a<\/span><\/p>\n

1\u3001\u5bf9\u4e0d\u5177\u5907\u5f00\u5c55\u836f\u7269\u8b66\u6212\u6761\u4ef6\u7684\u6301\u6709\u4eba\uff0c\u5e94\u59d4\u6258\u5177\u6709\u836f\u7269\u8b66\u6212\u80fd\u529b\u7684\u673a\u6784\u5f00\u5c55\u836f\u7269\u8b66\u6212\u5de5\u4f5c\uff0c\u7b7e\u8ba2\u59d4\u6258\u5408\u540c\uff0c\u6301\u6709\u4eba\u5e94\u505a\u597d\u5bf9\u53d7\u6258\u65b9\u7684\u76d1\u7763\u548c\u7ba1\u7406\u7b49\u5de5\u4f5c\uff0c\u5e76\u627f\u62c5\u76f8\u5e94\u6cd5\u5f8b\u8d23\u4efb\u3002<\/span><\/p>\n

2\u3001\u8fdb\u53e3\u836f\u54c1\u5e94\u6307\u5b9a\u5177\u6709\u72ec\u7acb\u6cd5\u4eba\u8d44\u8d28\u7684\u4f01\u4e1a\u4f5c\u4e3a\u6388\u6743\u4ee3\u7406\u4eba\uff0c\u627f\u62c5\u836f\u7269\u8b66\u6212\u8d23\u4efb\u3002 <\/span><\/p>\n

\u6240\u4ee5\u8bf4\u6ca1\u6709MAH\u7684\u5b9e\u65bd\uff0c\u836f\u7269\u8b66\u6212\u5de5\u4f5c\u5e94\u8be5\u8bf4\u8fd8\u9700\u8981\u6709\u4e00\u6bb5\u76f8\u5f53\u957f\u65f6\u95f4\u7684\u6478\u7d22\u4e2d\uff0c\u968f\u7740MAH\u7684\u8bd5\u884c\u548c\u6df1\u5165\u5f00\u5c55\uff0c\u836f\u7269\u8b66\u6212\u5de5\u4f5c\u66f4\u662f\u8feb\u5728\u7709\u776b\u3002 <\/span><\/p>\n

\u4e8c\u3001\u56fd\u5185\u5916\u6cd5\u89c4<\/span><\/strong><\/span><\/p>\n

\uff081\uff09ICH\u548c\u836f\u7269\u8b66\u6212\u76f8\u5173\u7684\u6cd5\u89c4<\/span><\/strong><\/p>\n

2017\u5e746\u670819\u65e5\uff0cCFDA\u6b63\u5f0f\u52a0\u5165ICH\u3002<\/span><\/p>\n

2018\u5e74\u521d\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7ba1\u603b\u5c40\u53d1\u5e03\u516c\u544a\uff0c\u660e\u786e\u6211\u56fd\u9002\u7528\u300aM4\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09\u300b\u300aE2A\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\u300b\u300aE2D\uff1a\u4e0a\u5e02\u540e\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\u300b\u300aM1\uff1a\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09\u300b\u548c\u300aE2B\uff08R3\uff09\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u4f20\u8f93\u7684\u6570\u636e\u5143\u7d20\u300b\u4e94\u4e2a\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff09\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u7684\u76f8\u5173\u4e8b\u9879\uff0c\u63a8\u52a8\u836f\u54c1\u6ce8\u518c\u6280\u672f\u6807\u51c6\u4e0e\u56fd\u9645\u63a5\u8f68\u3002<\/span><\/p>\n

l \u4e94\u4e2a\u6307\u5bfc\u539f\u5219\u5177\u4f53\u5b9e\u65bd\u8fdb\u7a0b<\/span><\/strong><\/p>\n

1\u30012018\u5e742\u67081\u65e5\u8d77\uff0c\u5316\u5b66\u836f\u54c1\u6ce8\u518c\u5206\u7c7b1\u7c7b\u30015.1\u7c7b\u4ee5\u53ca\u6cbb\u7597\u7528\u751f\u7269\u5236\u54c11\u7c7b\u548c\u9884\u9632\u7528\u751f\u7269\u5236\u54c11\u7c7b\u6ce8\u518c\u7533\u8bf7\u9002\u7528\u300aM4\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09\u300b\u3002\u5176\u4e2d\uff0c\u300aM4\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09\u300b\u5305\u62ec\u300aM4\uff08R4\uff09\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\u7684\u7ec4\u7ec7\u300b\u3001\u300a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u901a\u7528\u6280\u672f\u6587\u6863\uff1a\u884c\u653f\u7ba1\u7406\u4fe1\u606f\u300b\u3001\u300aM4Q\uff08R1\uff09\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u901a\u7528\u6280\u672f\u6587\u6863\uff1a\u836f\u5b66\u90e8\u5206\u300b\u3001\u300aM4S\uff08R2\uff09\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u901a\u7528\u6280\u672f\u6587\u6863\uff1a\u5b89\u5168\u6027\u90e8\u5206\u300b\u548c\u300aM4E\uff08R2\uff09\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u901a\u7528\u6280\u672f\u6587\u6863\uff1a\u6709\u6548\u6027\u90e8\u5206\u300b\u3002<\/span><\/p>\n

2\u3001\u81ea2018\u5e745\u67081\u65e5\u8d77\uff0c\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u671f\u95f4\u62a5\u544a\u4e25\u91cd\u4e14\u975e\u9884\u671f\u7684\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u9002\u7528 \u300aE2A\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\u300b\u3001 \u300aM1\uff1a\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09\u300b \u548c \u300aE2B\uff08R3\uff09\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u4f20\u8f93\u7684\u6570\u636e\u5143\u7d20\u300b\u3002 <\/span><\/p>\n

3\u3001\u81ea2018\u5e747\u67081\u65e5\u8d77\uff0c\u62a5\u544a\u4e0a\u5e02\u540e\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u9002\u7528\u300aE2D\uff1a\u4e0a\u5e02\u540e\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\u300b\u3002 <\/span><\/p>\n

4\u3001\u81ea2019\u5e747\u67081\u65e5\u8d77\uff0c\u62a5\u544a\u4e0a\u5e02\u540e\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u53ef\u9002\u7528M1\u548cE2B\uff08R3\uff09\u7684\u8981\u6c42\u3002<\/span><\/p>\n

5\u3001\u81ea2022\u5e747\u67081\u65e5\u8d77\uff0c\u62a5\u544a\u4e0a\u5e02\u540e\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u9002\u7528\u4ee5\u4e0a\u6240\u67095\u4e2a\u6280\u672f\u6307\u5bfc\u539f\u5219\u3002 <\/span><\/p>\n

ICH\u8fd9\u4e9b\u89c4\u5b9a\u5b9e\u65bd\u65f6\u95f4\u8868\uff1a<\/span><\/strong><\/p>\n

\u5148\u671f\u5b9e\u65bd\u76845\u4e2aICH\u6307\u5357<\/span><\/p>\n

\u2022 M4\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09<\/span><\/p>\n

\u2022 E2A\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6<\/span><\/p>\n

\u2022 E2D\uff1a\u4e0a\u5e02\u540e\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6<\/span><\/p>\n

\u2022 M1\uff1a\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09<\/span><\/p>\n

\u2022 E2B\uff08R3\uff09\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u4f20\u8f93\u7684\u6570\u636e\u5143\u7d20 <\/span><\/p>\n

\u5173\u4e8eICH\u8981\u6c42\u6709\u4e00\u4e2aII\u7ea7\u6307\u5bfc\u539f\u5219\u548cIII\u7ea7\u6307\u5bfc\u539f\u5219\uff0c2018\u5e74\u8d77\u5bf9\u4e8eII\u7ea7\u6307\u5bfc\u539f\u5219\u6211\u4eec\u56fd\u5bb6\u81f3\u5c11\u8981\u5b8c\u5168\u5b9e\u65bd\u4e00\u4e2a\uff0c\u5176\u4f59\u7684\u8981\u90e8\u5206\u5b9e\u65bd\u3002\u5bf9\u4e8eIII\u7ea7\u6307\u5bfc\u539f\u5219\u81f3\u5c11\u5b8c\u5168\u5b9e\u65bd12\u4e2a\uff0c\u4e5f\u5c31\u662f\u5360\u5230\u4e86\u6240\u6709\u6307\u5bfc\u539f\u5219\u7684\u56db\u5206\u4e4b\u4e00\u3002 <\/span><\/p>\n

2021\u5e74\u8d77\uff0c\u6211\u4eec\u5bf9\u4e0a\u8ff0\u8fd9\u4e9b\u81f3\u5c11\u8981\u5b8c\u5168\u5b9e\u65bd\u4e09\u4e2a\u3002\u5176\u4f59\u90e8\u5206\u5b9e\u65bd\uff0c\u5bf9\u4e8e\u4e09\u7ea7\u7684\u6307\u5bfc\u539f\u5219\uff0c\u6211\u4eec\u81f3\u5c11\u8981\u5b8c\u5168\u5b9e\u65bd24\u4e2a\uff0c\u8fd9\u4e9b\u90fd\u662f\u6709\u76ee\u6807\u7684\u3002 <\/span><\/p>\n

2022\u5e74\u672b\u6211\u4eec\u8981\u5b8c\u5168\u5b9e\u65bd\u6240\u5217\u7684\u4e0a\u9762\u7684\u4e94\u4e2a\u3002 <\/span><\/p>\n

\u6240\u4ee5\u8bf4\u6211\u4eec\u56fd\u5bb6\u5c40\u5bf9\u4e8e\u8fd9\u4e2aICH\u7684\u627f\u8bfa\uff0c\u4e5f\u662f\u50ac\u4fc3\u6211\u4eec\u5728\u836f\u7269\u8b66\u6212\u5de5\u4f5c\u4e0a\u9762\u5feb\u9a6c\u52a0\u97ad\uff0c\u5e94\u8be5\u8bf4\u662f\u8981\u5b9e\u65bd\u7684\u975e\u5e38\u7d27\u51d1\u3002 <\/span><\/p>\n

l \u89e3\u91ca\u4e94\u4e2a\u6307\u5357\u7684\u76f8\u5173\u8981\u6c42 <\/span><\/strong><\/p>\n

1\u3001M1 MedDRA<\/span><\/strong><\/p>\n

CDE\u5b98\u7f51\u7684\u201dICH\u5de5\u4f5c\u529e\u516c\u5ba4\u201c\u677f\u5757\u5185\u8bbe\u6709\u201c\u4e86\u89e3MedDRA\u201d\u680f\u76ee\u65f6\uff0c\u5927\u5bb6\u53ef\u4ee5\u5b66\u4e60\u3002<\/span><\/p>\n

MedDRA\u56fd\u9645\u533b\u5b66\u7528\u8bed\u8bcd\u5178\uff0c\u662f\u572820\u4e16\u7eaa90\u5e74\u4ee3\u4e3a\u4e86\u6ee1\u8db3\u76d1\u7ba1\u673a\u6784\u548c\u884c\u4e1a\u6240\u9700\u5e94\u8fd0\u800c\u751f\u7684\uff0c\u7531ICH\u5408\u4f5c\u4f19\u4f34\uff08\u5305\u62ecWHO\uff09\u57fa\u4e8e\u82f1\u56fdMHRA\u6240\u4f7f\u7528\u7684\u672f\u8bed\u5f00\u53d1\u51fa\u7684\u4e00\u4e2a\u63d0\u4f9b\u6807\u51c6\u5316\u533b\u5b66\u672f\u8bed\u7684\u8bcd\u5178\u3002<\/span><\/p>\n

MedDRA\u662f\u4e00\u79cd\u591a\u8bed\u8a00\u672f\u8bed\uff0c\u76ee\u524d\u670911 \u79cd\u8bed\u8a00\u7248\u672c (\u5305\u62ec\u4e2d\u6587\u7248) \uff0c\u5141\u8bb8\u5927\u591a\u6570\u7528\u6237\u4f7f\u7528\u5176\u6bcd\u8bed\u8fdb\u884c\u64cd\u4f5c\u3002<\/span><\/p>\n

\u5728\u5f00\u53d1\u548c\u6301\u7eed\u7ef4\u62a4MedDRA\u65f6\uff0cICH\u81f4\u529b\u4e8e\u63d0\u4f9b\u7edf\u4e00\u7684\u6807\u51c6\u5316\u56fd\u9645\u533b\u5b66\u672f\u8bed\uff0c\u7528\u4e8e\u4e0e\u4eba\u7528\u533b\u7597\u4ea7\u54c1\u76f8\u5173\u7684\u76d1\u7ba1\u6c9f\u901a\u548c\u6570\u636e\u8bc4\u4f30\u3002\u56e0\u6b64\uff0cMedDRA\u65e8\u5728\u7528\u4e8e\u5f00\u53d1\u5468\u671f\u5404\u4e2a\u9636\u6bb5\uff08\u5982\u4ece\u4e34\u5e8a\u8bd5\u9a8c\u5230\u4e0a\u5e02\u540e\u76d1\u7ba1\uff09\u836f\u54c1\u7684\u6ce8\u518c\u3001 \u8bb0\u5f55\u53ca\u5b89\u5168\u76d1\u63a7\u3002\u6b64\u5916\uff0cMedDRA\u662fICH\u7684\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09\u548cE2B \u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u7535\u5b50\u62a5\u544a\u8868\u4e0d\u53ef\u7f3a\u5c11\u7684\u4e00\u90e8\u5206\u3002  <\/span><\/p>\n

MedDRA\u5f00\u53d1\u76ee\u7684\u662f\uff1a<\/span><\/p>\n

\u2013 ADR\u4e0e\u75be\u75c5\u672f\u8bed\u4e0d\u7edf\u4e00<\/span><\/p>\n

\u2022 \u300aWHO\u4e0d\u826f\u53cd\u5e94\u672f\u8bed\u96c6\u300b(WHO-ART)<\/span><\/p>\n

\u2022 \u300a\u56fd\u9645\u75be\u75c5\u5206\u7c7b \u7f16\u7801\u7b2c\u4e5d\u7248\u300b(ICD-9)<\/span><\/p>\n

\u2022 FDA\u300a\u4e0d\u826f\u53cd\u5e94\u8bcd\u6c47\u5e93 \u6807\u51c6\u7f16\u7801(COSTART)<\/span><\/p>\n

\u2022 \u300aICD-9 \u4e34\u5e8a\u4fee\u8ba2\u7248\u300b(ICD-9-CM)<\/span><\/p>\n

\u2022 \u300a\u65e5\u672c\u4e0d\u826f\u53cd\u5e94\u672f\u8bed\u96c6\u300b (J-ART)<\/span><\/p>\n

\u2022 \u533b\u5b66\u4fe1\u606f\u7cfb\u7edf(\u65e5\u672c)(MEDIS)<\/span><\/p>\n

\u2013 \u4e0a\u5e02\u524d\u3001\u4e0a\u5e02\u540e\u672f\u8bed\u4e0d\u7edf\u4e00<\/span><\/p>\n

\u2013 \u8de8\u56fd\u5236\u836f\u516c\u53f8\u9762\u4e34\u969c\u788d<\/span><\/p>\n

\u76ee\u7684\uff1a\u51cf\u5c11\u6570\u636e\u5f55\u5165\u4e3b\u89c2\u6027\uff0c\u63d0\u9ad8\u6570\u636e\u8f93\u5165\u4e00\u81f4\u6027\u3002<\/span><\/p>\n

MedDRA\u53ef\u7528\u4e8e\uff1a<\/span><\/p>\n

\u2022 \u4e34\u5e8a\u7814\u7a76<\/span><\/p>\n

\u2022 \u81ea\u53d1\u6027\u4e0d\u826f\u53cd\u5e94\u53ca\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a<\/span><\/p>\n

\u2022 \u836f\u4e8b\u7ba1\u7406\u8d44\u6599\u63d0\u4ea4<\/span><\/p>\n

\u2022 \u4ea7\u54c1\u4fe1\u606f\u76d1\u7ba1 <\/span><\/p>\n

2\u3001 E2A\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6<\/span><\/strong><\/p>\n

\u65e9\u57281994\u5e7410\u670827\u65e5\uff0cE2A\u5728ICH\u6307\u5bfc\u59d4\u5458\u4f1a\u4f1a\u8bae\u4e0a\u8fbe\u5230ICH\u8fdb\u7a0b\u7b2c\u56db\u9636\u6bb5\uff0c\u8be5\u6307\u5bfc\u539f\u5219\u5bf9\u4e34\u5e8a\u5b89\u5168\u6027\u8d44\u6599\u7ba1\u7406\u63d0\u51fa\u8981\u6c42\uff0c\u4e3b\u8981\u5c31\u201c\u4e3a\u4e34\u5e8a\u5b89\u5168\u62a5\u544a\u5173\u952e\u65b9\u9762\u5236\u5b9a\u6807\u51c6\u5b9a\u4e49\u548c\u672f\u8bed\u201d\u548c\u201c\u5728\u7814\u7a76\u9636\u6bb5\uff08\u5373\u6279\u51c6\u4e0a\u5e02\u524d\uff09\u5efa\u7acb\u9002\u5f53\u7684\u52a0\u901f\uff08\u5feb\u901f\uff09\u62a5\u544a\u673a\u5236\u201d\u4e24\u4e2a\u95ee\u9898\u8fdb\u884c\u534f\u8c03\u3002<\/span><\/p>\n

\u4e0d\u826f\u4e8b\u4ef6(AE)<\/span><\/p>\n

\u2013 \u6307\u7684\u662f\u4efb\u4f55\u53d1\u751f\u5728\u75c5\u4eba\u6216\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u53d7\u8bd5\u8005\u4e2d\u7684\u4e0d\u5229\u4e8b\u4ef6\u3002\u5b83\u5e76\u4e0d\u4e00\u5b9a\u540c\u836f\u7269\u6cbb\u7597\u6709\u56e0\u679c\u5173\u7cfb\u3002 <\/span><\/p>\n

\u2013 \u4e0d\u826f\u4e8b\u4ef6\u53ef\u4ee5\u662f\u4e00\u79cd\u4e0d\u826f\u7684\u672a\u9884\u671f\u7684\u5f81\u8c61(\u4f8b\u5982\uff0c\u5305\u62ec\u5f02\u5e38\u7684\u5b9e\u9a8c\u5ba4\u68c0\u67e5\u7b49)\u3001\u75c7\u72b6\u6216\u4e0e\u836f\u54c1\u4f7f\u7528\u4e2d\u6709\u65f6\u95f4\u76f8\u5173\u6027\u7684\u75be\u75c5\uff0c\u4e0d\u8003\u8651\u662f\u5426\u540c\u836f\u54c1\u6709\u56e0\u679c\u5173\u7cfb\u3002 <\/span><\/p>\n

\u4e0d\u826f\u53cd\u5e94ADR<\/span><\/strong><\/p>\n

\u2013 \u65b0\u836f\u5728\u83b7\u51c6\u6279\u51c6\u524d\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\u6216\u65b0\u9002\u5e94\u75c7\u6279\u51c6\u4e4b\u524d\uff0c\u5c24\u5176\u6cbb\u7597\u5242\u91cf\u672a\u5efa\u7acb\u4e4b\u524d\uff0c\u4efb\u4f55\u6709\u5bb3\u548c\u672a\u9884\u671f\u7684\u836f\u54c1\u53cd\u5e94(\u4efb\u4f55\u5242\u91cf)\u90fd\u8ba4\u4e3a\u662f\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u3002 <\/span><\/p>\n

\u4e0a\u5e02\u540e\u4e0d\u826f\u53cd\u5e94<\/span><\/strong><\/p>\n

\u2013 \u5728\u4eba\u4f53\u4e0a\u4f7f\u7528\u6b63\u5e38\u5242\u91cf\u6765\u9884\u9632\u3001\u8bca\u65ad\u3001\u6cbb\u7597\u6216\u6539\u5584\u751f\u7406\u529f\u80fd\u65f6\u51fa\u73b0\u7684\u6709\u5bb3\u548c\u975e\u9884\u671f\u7684\u5bf9\u836f\u54c1\u7684\u53cd\u5e94\u3002 <\/span><\/p>\n

\u672a\u9884\u671f\u7684\u836f\u54c1\u4e0d\u826f\u53cd\u5e94<\/span><\/strong><\/p>\n

\u2013\u6307\u7684\u662f\u4e0d\u826f\u53cd\u5e94\u7684\u6027\u8d28\u548c\u4e25\u91cd\u7a0b\u5ea6\u540c\u5df2\u6709\u7684\u836f\u54c1\u8d44\u6599\u4e0d\u7b26\u3002<\/span><\/p>\n

\u2013\u6bd4\u5982\u5728\u4e00\u4e2a\u672a\u83b7\u6279\u51c6\u7684\u836f\u7269\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\u7684\u7814\u7a76\u8005\u624b\u518c\u3002 <\/span><\/p>\n

\u4e25\u91cd\u7684\u4e0d\u826f\u4e8b\u4ef6\u6216\u4e0d\u826f\u53cd\u5e94<\/span><\/strong><\/p>\n

\u2013 \u5728\u4e34\u5e8a\u7814\u7a76\u8fc7\u7a0b\u4e2d\uff0c\u5982\u4e0d\u826f\u4e8b\u4ef6\u6000\u7591\u4e0e\u836f\u54c1\u76f8\u5173(\u836f\u54c1\u4e0d\u826f\u53cd\u5e94)\uff0c\u4e5f\u53ef\u4ee5\u662f\u975e\u5e38\u663e\u8457\u8db3\u4ee5\u5bfc\u81f4\u836f\u54c1\u7814\u53d1\u4e0a\u7684\u91cd\u5927\u6539\u53d8(\u5982\u5728\u5242\u91cf\u3001\u4eba\u7fa4\u3001\u9700\u8981\u76d1\u6d4b\u3001\u77e5\u60c5\u540c\u610f\u7b49\u65b9\u9762\u7684\u6539\u53d8)\u3002 <\/span><\/p>\n

\u2013\u5f53\u53cd\u5e94\u8868\u73b0\u6700\u4e25\u91cd\u65f6\uff0c\u5371\u53ca\u751f\u547d\u6216\u529f\u80fd\u65f6\u5c24\u5176\u91cd\u8981\u5fc5\u987b\u7acb\u5373\u5411\u7ba1\u7406\u90e8\u95e8\u62a5\u544a <\/span><\/p>\n

\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u6216\u53cd\u5e94\u662f\u6307\u4ee5\u4e0b\u672a\u9884\u671f\u7684\u533b\u5b66\u4e8b\u4ef6(\u5728\u4efb\u4f55\u5242\u91cf\u4e0b)<\/span><\/strong><\/p>\n

v \u5bfc\u81f4\u6b7b\u4ea1<\/span><\/p>\n

v \u5371\u53ca\u751f\u547d<\/span><\/p>\n

\u2022 \u662f\u6307\u4e25\u91cd\u75c5\u4eba\u5373\u523b\u5b58\u5728\u6b7b\u4ea1\u7684\u98ce\u9669<\/span><\/p>\n

v \u9700\u8981\u4f4f\u9662\u6216\u73b0\u6709\u4f4f\u9662\u65f6\u95f4\u5ef6\u957f<\/span><\/p>\n

v \u6c38\u4e45\u6216\u663e\u8457\u7684\u529f\u80fd\u4e27\u5931<\/span><\/p>\n

v \u5148\u5929\u6027\u7578\u5f62\u6216\u51fa\u751f\u7f3a\u9677 <\/span><\/p>\n

E2A\u62a5\u544a\u65f6\u9650\u89c4\u5b9a\uff1a<\/span><\/strong><\/p>\n

\u81f4\u547d\u7684\u6216\u751f\u547d\u5a01\u80c1\u7684\u975e\u9884\u671f\u4e0d\u826f\u53cd\u5e94<\/span><\/p>\n

\u2013\u7533\u529e\u8005\u5728\u9996\u6b21\u83b7\u77e5\u540e7\u5929\u5185\uff0c\u5e94\u5c3d\u5feb(\u901a\u8fc7\u7535\u8bdd\u3001\u4f20\u771f\u3001 \u4e66\u9762\u7b49)\u901a<\/span><\/p>\n

\u77e5\u836f\u54c1\u7ba1\u7406\u673a\u6784\u3002<\/span><\/p>\n

\u2013\u968f\u540e\u76848\u5929\u5185\u5c3d\u91cf\u5b8c\u5584\u4e3a\u5b8c\u6574\u7684\u62a5\u544a\uff0c\u5e76\u8ddf\u8e2a\u62a5\u544a\u3002 <\/span><\/p>\n

\u2022 \u6240\u6709\u5176\u4ed6\u4e25\u91cd\u7684\u3001\u975e\u9884\u671f\u7684\u4e0d\u826f\u53cd\u5e94<\/span><\/p>\n

\u2013 \u7533\u529e\u8005\u5e94\u5728\u9996\u6b21\u83b7\u77e5\u540e15\u5929\u5185\u5c3d\u5feb\u5907\u6848\u3002 <\/span><\/p>\n

\u2022 \u521d\u59cb\u62a5\u544a\u5728\u89c4\u5b9a\u7684\u65f6\u9650\u5185\u5fc5\u987b\u505a\u5230\u4ee5\u4e0b\u51e0\u70b9<\/span><\/p>\n

\u2013 \u53ef\u786e\u8ba4\u7684\u60a3\u8005<\/span><\/p>\n

\u2013 \u6000\u7591\u836f\u54c1<\/span><\/p>\n

\u2013 \u53ef\u786e\u8ba4\u7684\u62a5\u544a\u6765\u6e90<\/span><\/p>\n

\u2013 \u4e0d\u826f\u4e8b\u4ef6\u6216\u7ed3\u5c40<\/span><\/p>\n

\u2022 \u53ef\u8ba4\u5b9a\u662f\u4e25\u91cd\u548c\u975e\u9884\u671f\u3001\u5728\u4e34\u5e8a\u7814\u7a76\u4e2d\u7684\uff0c\u4e0e\u7528\u836f\u6709\u5408\u7406\u56e0\u679c\u5173\u7cfb\u3002 <\/span><\/p>\n

3\u3001E2D \u4e0a\u5e02\u540e\u5b89\u5168\u6570\u636e\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u4e0e\u6807\u51c6<\/span><\/strong><\/p>\n

\u73b0\u4e3a2003\u5e7411\u670812\u65e5ICH\u7b2c\u56db\u9636\u6bb5\u7248\u3002<\/span><\/p>\n

\u5185\u5bb9\u5305\u62ec\uff1a<\/span><\/p>\n

\u2022 \u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\u6765\u6e90<\/span><\/p>\n

   -\u975e\u5f81\u96c6\u6765\u6e90\uff1a\u81ea\u53d1\u62a5\u544a\uff1b\u6587\u732e\uff1b\u4e92\u8054\u7f51\uff1b\u5176\u4ed6\u6765\u6e90 <\/span><\/p>\n

   -\u5f81\u96c6\u62a5\u544a <\/span><\/p>\n

   -\u5408\u540c\u534f\u8bae <\/span><\/p>\n

   -\u76d1\u7ba1\u673a\u6784\u6765\u6e90 <\/span><\/p>\n

\u2022 \u62a5\u544a\u7684\u6700\u4f4e\u8981\u6c42<\/span><\/p>\n

\u2013 \u53ef\u8bc6\u522b\u7684\u62a5\u544a\u8005<\/span><\/p>\n

\u2013 \u53ef\u8bc6\u522b\u7684\u60a3\u8005<\/span><\/p>\n

\u2013 \u4e0d\u826f\u53cd\u5e94<\/span><\/p>\n

\u2013 \u6000\u7591\u4ea7\u54c1<\/span><\/p>\n

\u4ee5\u4e0a\u56db\u4e2a\u5143\u7d20\u7f3a\u5c11\u4efb\u4f55\u4e00\u4e2a\u90fd\u88ab\u8ba4\u4e3a\u62a5\u544a\u662f\u4e0d\u5b8c\u6574\u7684\uff1bMAH \u5e94\u5f53\u52aa\u529b\u5730\u53bb\u6536\u96c6\u7f3a\u5931\u7684\u6570\u636e\u8981\u7d20\u3002 <\/span><\/p>\n

\u5feb\u901f\u62a5\u544a\u8fd8\u5305\u62ec<\/span><\/strong><\/p>\n

\u2013\u5176\u4ed6\u89c2\u5bdf<\/span><\/p>\n

\u2022 \u7f3a\u4e4f\u7597\u6548<\/span><\/p>\n

\u2022 \u836f\u7269\u8fc7\u91cf<\/span><\/p>\n

\u62a5\u544a\u65f6\u9650<\/span><\/p>\n

\u2013\u4e25\u91cd\u4e14\u975e\u9884\u671f ADR \u7684\u5feb\u901f\u62a5\u544a\u8981\u5c3d\u53ef\u80fd\u8fc5\u901f\uff0c MAH\u6536\u5230\u62a5\u544a\u4fe1\u606f\u4e0d\u8fdf\u4e8e15\u4e2a\u65e5\u5386\u65e5\u3002\u5176\u4ed6\u7c7b\u578b\u4e25\u91cd\u4e8b\u4ef6\u62a5\u544a\u7684\u671f\u9650\u56e0\u56fd\u5bb6\u800c\u5f02\uff0c\u53d6\u51b3\u4e8e\u62a5\u544a\u6765\u6e90\u3001\u9884\u671f\u6027\u548c\u4e8b\u4ef6\u7ed3\u5c40\u3002 <\/span><\/p>\n

E2D \u975e\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff1a\u65e0\u8bba\u662f\u9884\u671f\u7684\u6216\u975e\u9884\u671f\u7684\uff0c\u901a\u5e38\u90fd\u4e0d\u8003\u8651\u5feb\u901f\u62a5\u544a\uff1b\u4f46\u5e94\u5305\u542b\u5728PSUR\u4e2d\u3002 <\/span><\/p>\n

4\u3001ICH E2B \u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u4f20\u8f93\u7684\u6570\u636e\u5143\u7d20 <\/span><\/strong><\/p>\n

\u4e3a\u6307\u5bfc\u6301\u6709\u4eba\u63092B\uff08R3\uff09\u683c\u5f0f\u9012\u4ea4\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\uff0c\u589e\u5f3a\u6301\u6709\u4eba\u7b49\u673a\u6784\u4e0e\u76d1\u7ba1\u673a\u6784\u5728\u4fe1\u606f\u4f20\u8f93\u65b9\u9762\u7684\u534f\u8c03\u6027\u548c\u4e00\u81f4\u6027\uff0c\u7279\u5236\u5b9a\u672c\u6307\u5357\u3002  <\/span><\/p>\n

\u672c\u6307\u5357\u6587\u4ef6\u4f9d\u636eICH E2B\uff08R3\uff09\u6307\u5357\u548c\u4e2d\u56fd\u836f\u54c1\u76d1\u7ba1\u8981\u6c42\u7f16\u5236\uff0c\u63cf\u8ff0\u4e86\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\u7535\u5b50\u4f20\u8f93\u4e2d\u6570\u636e\u5143\u7d20\u9879\u76ee\u3001\u5143\u7d20\u7f16\u7801\u89c4\u5219\u3001\u5143\u7d20\u95f4\u903b\u8f91\u6821\u9a8c\u5173\u7cfb\u4ee5\u53ca\u4f20\u8f93\u6807\u51c6\u7b49\u5185\u5bb9\uff0c\u4ee5\u4fc3\u8fdb\u4e0a\u5e02\u540e\u836f\u54c1\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\uff08ICSRs\uff09\u5728\u4e0d\u540c\u673a\u6784\u4e4b\u95f4\u5171\u4eab\u548c\u4ea4\u6362\u3002 <\/span><\/p>\n

\u2022 \u62a5\u544a\u57fa\u672c\u4fe1\u606f<\/span><\/p>\n

\u2022 \u60a3\u8005\u4fe1\u606f<\/span><\/p>\n

\u2022 \u5316\u9a8c\u7ed3\u679c<\/span><\/p>\n

\u2022 \u76f8\u5173\u75c5\u53f2<\/span><\/p>\n

\u2022 \u76f8\u5173\u7528\u836f\u53f2<\/span><\/p>\n

\u2022 ADR\u63cf\u8ff0<\/span><\/p>\n

\u6570\u636e\u8981\u7d20\uff08dataelement\uff09<\/span><\/strong><\/p>\n

A\u90e8\u5206 \u62a5\u544a\u7ba1\u7406\u53ca\u9274\u522b\u4fe1\u606f<\/span><\/p>\n

\uff081\uff09\u75c5\u4f8b\u62a5\u544a\u7684\u9274\u522b\u4fe1\u606f\uff08\u521d\u59cb\u6765\u6e90\u56fd\u3001\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u56fd\u5bb6\u3001\u4f20\u9001\u65e5\u671f\u3001\u62a5\u544a\u7c7b\u578b\u3001\u4e0d\u826f\u53cd\u5e94\u4e25\u91cd\u7a0b\u5ea6\u53ca\u5176\u79cd\u7c7b\u3001\u6536\u5230\u65e5\u671f\u3001\u9644\u52a0\u6587\u4ef6\u6e05\u5355\u3001\u62a5\u544a\u9274\u522b\u53f7\u7801\u7b49\uff09\uff1b<\/span><\/p>\n

\uff082\uff09\u4fe1\u606f\u7684\u6765\u6e90\uff1b<\/span><\/p>\n

\uff083\uff09\u62a5\u544a\u53d1\u9001\u8005\u7684\u4fe1\u606f\u3002 <\/span><\/p>\n

B\u90e8\u5206 \u75c5\u4f8b\u4fe1\u606f\u7ec4\u6210\uff1a<\/span><\/p>\n

\uff081\uff09\u60a3\u8005\u7279\u5f81<\/span><\/p>\n

\uff082\uff09\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6216\u4e8b\u4ef6\u63cf\u8ff0\uff1b<\/span><\/p>\n

\uff083\uff09\u68c0\u9a8c\u7ed3\u679c\u548c\u7a0b\u5e8f\uff1b<\/span><\/p>\n

\uff084\uff09\u836f\u54c1\u4fe1\u606f\uff1b<\/span><\/p>\n

\uff085\uff09\u75c5\u4f8b\u6458\u8981\u53ca\u5176\u4ed6\u4fe1\u606f <\/span><\/p>\n

\u4e2a\u4f8b\u62a5\u544a\u6700\u4f4e\u56db\u8981\u7d20\uff1a\u6700\u4f4e\u4fe1\u606f<\/span><\/p>\n

\u2013 \u60a3\u8005<\/span><\/p>\n

\u2013 \u62a5\u544a\u8005<\/span><\/p>\n

\u2013 ADR\/ADE<\/span><\/p>\n

\u2013 \u53ef\u7591\u836f\u54c1 <\/span><\/p>\n

\uff082\uff09\u6211\u56fd\u6cd5\u89c4\u52a8\u6001<\/span><\/p>\n

2010\u5e74\u7248<\/span><\/p>\n

\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08\u7b2c\u4e5d\u8282\u6295\u8bc9\u4e0e\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\uff09 <\/span><\/p>\n

2011\u5e747\u67081\u65e5<\/span><\/p>\n

\u300a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\u548c\u76d1\u6d4b\u7ba1\u7406\u529e\u6cd5\u300b81\u53f7\u4ee4 <\/span><\/p>\n

2017\u5e7410\u67088\u65e5<\/span><\/p>\n

\u300a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1\u300b\uff08\u56db\u3001\u52a0\u5f3a\u836f\u54c1\u533b\u7597\u5668\u68b0\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\uff09\u4e24\u529e42\u53f7\u6587 <\/span><\/p>\n

2017\u5e7412\u670828\u65e5<\/span><\/p>\n

\u300a\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u76f4\u63a5\u62a5\u544a\u4e0d\u826f\u53cd\u5e94\u4e8b\u5b9c\u7684\u516c\u544a\u300b\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09 <\/span><\/p>\n

2018\u5e741\u67089\u65e5<\/span><\/p>\n

\u603b\u5c40\u300a\u5173\u4e8e\u9002\u7528ICH\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u7684\u516c\u544a\u300b <\/span><\/p>\n

2018\u5e749\u670830\u65e5<\/span><\/p>\n

\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u5173\u4e8e\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u76f4\u63a5\u62a5\u544a\u4e0d\u826f\u53cd\u5e94\u4e8b\u5b9c\u7684\u516c\u544a\u300b\uff082018\u5e74\u7b2c66\u53f7\uff09 <\/span><\/p>\n

2018\u5e749\u67087\u65e5<\/span><\/p>\n

\u300a\u4e2a\u4f8b\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6536\u96c6\u548c\u62a5\u544a\u6307\u5bfc\u539f\u5219\u300b\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09 <\/span><\/p>\n

2018\u5e7412\u670821\u65e5<\/span><\/p>\n

 \u300a\u4e2a\u4f8b\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6536\u96c6\u548c\u62a5\u544a\u6307\u5bfc\u539f\u5219\u300b\uff08131\u53f7\u6587\uff09 <\/span><\/p>\n

\u76f4\u62a5\u5236\u5ea6\u6b63\u5f0f\u53d1\u5e03\uff0c\u5f3a\u8c03\u4f01\u4e1a\u4e3b\u4f53\u8d23\u4efb\uff01<\/span><\/p>\n

\u8981\u6c42\uff1a<\/span><\/p>\n

\uff081\uff09\u6301\u6709\u4eba\u5e94\u5f53\u5efa\u7acb\u5065\u5168\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4f53\u7cfb\uff1b<\/span><\/p>\n

\uff082\uff09\u6301\u6709\u4eba\u5e94\u5f53\u53ca\u65f6\u62a5\u544a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\uff1b<\/span><\/p>\n

\uff083\uff09\u6301\u6709\u4eba\u5e94\u5f53\u62a5\u544a\u83b7\u77e5\u7684\u6240\u6709\u4e0d\u826f\u53cd\u5e94\uff1b<\/span><\/p>\n

\uff084\uff09\u6301\u6709\u4eba\u5e94\u5f53\u52a0\u5f3a\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u6570\u636e\u7684\u5206\u6790\u8bc4\u4ef7\uff1b<\/span><\/p>\n

\uff085\uff09\u6301\u6709\u4eba\u5e94\u5f53\u4e3b\u52a8\u91c7\u53d6\u6709\u6548\u7684\u98ce\u9669\u63a7\u5236\u63aa\u65bd\uff1b<\/span><\/p>\n

\uff086\uff09\u52a0\u5f3a\u5bf9\u6301\u6709\u4eba\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u5de5\u4f5c\u7684\u6280\u672f\u5ba1\u6838\uff1b<\/span><\/p>\n

\uff087\uff09\u7701\u7ea7\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u627f\u62c5\u5c5e\u5730\u76d1\u7ba1\u8d23\u4efb\uff1b<\/span><\/p>\n

\uff088\uff09\u4e25\u5389\u67e5\u5904\u6301\u6709\u4eba\u4e0d\u5c65\u884c\u76f4\u63a5\u62a5\u544a\u8d23\u4efb\u7684\u884c\u4e3a\u3002 <\/span><\/p>\n

\u4e09\u3001\u836f\u7269\u8b66\u6212\u662f\u4ec0\u4e48\uff1f\u600e\u4e48\u5f00\u5c55\uff1f<\/span><\/strong><\/span><\/p>\n

\uff081\uff09\u836f\u7269\u8b66\u6212\u5b9a\u4e49<\/span><\/p>\n

l WHO\u7684\u5b9a\u4e49\uff1a<\/span><\/p>\n

\u201c\u662f\u6307\u5c31\u53d1\u73b0\u3001\u76d1\u6d4b\u3001\u7814\u7a76\u3001\u8bc4\u4f30\u836f\u7269\u4e0d\u826f\u4e8b\u4ef6\u4fe1\u606f\uff0c\u4ece\u800c\u786e\u8ba4\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u89c4\u5f8b\uff0c\u8fbe\u5230\u9884\u9632\u5176\u4f24\u5bb3\u7684\u4e00\u7cfb\u5217\u79d1\u5b66\u6d3b\u52a8\u3002\u201d <\/span><\/p>\n

l \u7f8e\u56fdFDA\u5b9a\u4e49\uff1a<\/span><\/p>\n

\u201c\u6307\u4e0e\u4e0d\u826f\u4e8b\u4ef6\u7684\u68c0\u51fa\u3001\u8bc4\u4f30\u548c\u63a8\u6d4b\u6709\u5173\u7684\u6240\u6709\u79d1\u5b66\u6d3b\u52a8\u548c\u6570\u636e\u91c7\u96c6\u6d3b\u52a8\u3002\u201d <\/span><\/p>\n

\uff082\uff09\u836f\u7269\u8b66\u6212\u6211\u4eec\u662f\u600e\u4e48\u5f00\u5c55\uff1f<\/span><\/p>\n

1\u3001\u6cd5\u89c4\u8bc6\u522b\uff0c\u5dee\u8ddd\u5206\u6790<\/span><\/p>\n

2\u3001\u7ec4\u5efa\u56e2\u961f\uff0c\u62db\u9a8bPV\u4eba\u5458\uff0c\u4efb\u547dPV\u8d1f\u8d23\u4eba\uff0c\u67b6\u6784\u5efa\u7acb<\/span><\/p>\n

3\u3001\u5916\u8bad\u548c\u53c2\u52a0\u534f\u4f1a<\/span><\/p>\n

4\u3001PV\u8d28\u91cf\u4f53\u7cfb<\/span><\/p>\n

5\u3001\u8d2d\u4e70\u4fdd\u9669<\/span><\/p>\n

6\u3001PV\u8ba1\u7b97\u673a\u7cfb\u7edf\u3001\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09<\/span><\/p>\n

7\u3001\u5f00\u5c55\u5185\u90e8\u5168\u5458\u57f9\u8bad<\/span><\/p>\n

8\u3001\u76f4\u62a5<\/span><\/p>\n

9\u3001\u5b63\u62a5\u3001\u5e74\u62a5<\/span><\/p>\n

10\u3001\u6301\u7eed\u7ef4\u62a4<\/span><\/p>\n

\uff083\uff09\u836f\u7269\u8b66\u6212\u5b9e\u64cd<\/span>
<\/p>\n

\uff084\uff09\u836f\u7269\u8b66\u6212\u5de5\u4f5c\u5f00\u5c55\u8fdb\u5ea6<\/span><\/p>\n

1\u3001\u4efb\u547d\u836f\u7269\u8b66\u6212\u603b\u8d1f\u8d23\u4eba\uff0c\u6210\u7acbPV\u5de5\u4f5c\u7ec4\uff0c\u6210\u7acb\u836f\u54c1\u5b89\u5168\u59d4\u5458\u4f1a\uff1b<\/span><\/p>\n

2\u3001PV\u5de5\u4f5c\uff1a\u76ee\u524d\u914d\u59071\u540dPV\u8d1f\u8d23\u4eba\u548c\u591a\u540d\u836f\u7269\u8b66\u6212\u4e13\u5458\uff0c\u4ee5\u53ca\u8d28\u91cf\u603b\u76d1\u3001\u526f\u603b\u76d1\u8fdb\u884c\u7ba1\u7406\uff1b<\/span><\/p>\n

3\u3001\u7b79\u5efa\u6211\u4eec\u836f\u7269\u8b66\u6212\u7684\u8d28\u91cf\u4f53\u7cfb\uff0c\u8ba1\u5212\u5236\u5b9a\u517130\u4efdPV\u5236\u5ea6\u6587\u4ef6\uff0c\u76ee\u524d24\u4efd\u6587\u4ef6\u5df2\u7b7e\u6279\u751f\u6548\uff0c\u5176\u5b83\u9646\u9646\u7eed\u7eed\u5b8c\u5584\u5f53\u4e2d\uff1b<\/span><\/p>\n

4\u3001\u5df2\u91c7\u8d2d\u836f\u7269\u8b66\u6212\u8ba1\u7b97\u673a\u7cfb\u7edf\uff1b<\/span><\/p>\n

5\u3001\u5df2\u7533\u8bf7\u91c7\u8d2dMedDRA\u533b\u5b66\u8bcd\u5178\uff08\u836f\u4e8b\u7ba1\u7406\u7684\u6807\u51c6\u533b\u5b66\u672f\u8bed\u96c6\uff09\uff1b<\/span><\/p>\n

6\u3001\u76f4\u62a5\u4e0d\u826f\u53cd\u5e94\uff0c\u6301\u7eed\u836f\u7269\u8b66\u6212\u8fd0\u884c\u548c\u7ef4\u62a4\u4e2d\u3002 <\/span><\/p>\n

\uff085\uff09\u836f\u7269\u8b66\u6212\u7684\u8d28\u91cf\u4f53\u7cfb\u6587\u4ef6\uff08\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u4ee5\u4e0b\uff09<\/span><\/p>\n

\u300a\u836f\u7269\u8b66\u6212\u4e3b\u6587\u4ef6\u300b<\/span><\/p>\n

\u300a\u836f\u7269\u8b66\u6212\u4e0e\u98ce\u9669\u6700\u5c0f\u5316\u7ba1\u7406\u7a0b\u5e8f\u300b<\/span><\/p>\n

\u300a\u4e0d\u826f\u53cd\u5e94\u6587\u732e\u68c0\u7d22\u548c\u5229\u7528\u64cd\u4f5c\u89c4\u7a0b\u300b<\/span><\/p>\n

\u300a\u836f\u7269\u8b66\u6212\u5e74\u5ea6\u62a5\u544a\u64cd\u4f5c\u7a0b\u5e8f\u300b<\/span><\/p>\n

\u300a\u76f4\u62a5\u7cfb\u7edf\u4e0a\u62a5\u586b\u5199\u64cd\u4f5c\u7a0b\u5e8f\u300b<\/span><\/p>\n

\u300a\u836f\u7269\u8b66\u6212\u7cfb\u7edf\u6743\u9650\u7ba1\u7406\u64cd\u4f5c\u7a0b\u5e8f\u300b<\/span><\/p>\n

\u300a\u5b89\u5168\u6027\u4fe1\u53f7\u5b9a\u671f\u68c0\u6d4b\u7a0b\u5e8f\u300b<\/span><\/p>\n

\u300a\u5904\u7406\u533b\u5b66\u54a8\u8be2\u548c\u6295\u8bc9\u7a0b\u5e8f\u300b<\/span><\/p>\n

\u2026\u2026 <\/span><\/p>\n

\uff086\uff09\u836f\u7269\u8b66\u6212\u57f9\u8bad\u5efa\u8bbe<\/span><\/p>\n

2017\u5e74\u4ee5\u6765\uff0c\u5171\u53c2\u52a011\u6b21\u76d1\u7ba1\u673a\u6784\u7ec4\u7ec7\u53ec\u5f00\u7684\u836f\u7269\u8b66\u6212\u76f8\u5173\u57f9\u8bad\/\u5ea7\u8c08\u4f1a\uff0c\u5171\u8ba115\u4eba\u6b21\uff0c\u5171\u7ec4\u7ec7\u8bb2\u63884\u6b21\u4e8c\u6b21\u57f9\u8bad\u3002 <\/span><\/p>\n

\u5171\u5b8c\u62107\u5bb6\u836f\u7269\u8b66\u6212PV\u8ba1\u7b97\u673a\u7cfb\u7edf\u76f8\u5173\u673a\u6784\u8c03\u7814\u53ca\u4ea4\u6d41\u5b66\u4e60\uff0c\u5e76\u5411\u884c\u4e1a\u4e13\u5bb6\u8fdb\u884c\u5b66\u4e60\u63a2\u8ba8\u3002 <\/span><\/p>\n

\u56db\u3001\u836f\u7269\u8b66\u6212\u505a\u54ea\u4e9b\u5de5\u4f5c\uff1f <\/span><\/strong><\/span><\/p>\n

\uff081\uff09\u5b89\u5168\u6027\u4fe1\u53f7\u7684\u8bc6\u522b\u548c\u8bc4\u4ef7 <\/span><\/strong><\/p>\n

\u2022 \u5b89\u5168\u6027\u4fe1\u53f7\u662f\u6307\u4e0e\u67d0\u79cd\u4ea7\u54c1\u4f7f\u7528\u6709\u5173\u7684\u4e0d\u826f\u4e8b\u4ef6\u8d85\u8fc7\u9884\u671f\u4e0d\u826f\u4e8b\u4ef6\u6570\u91cf\u3002<\/span><\/p>\n

\u4fe1\u53f7\u53ef\u4ee5\u6e90\u81ea\u4e0a\u5e02\u540e\u6570\u636e\u548c\u5176\u4ed6\u6765\u6e90\uff0c\u5982\u4e34\u5e8a\u524d\u6570\u636e\u4ee5\u53ca\u4e0e\u540c\u4e00\u7c7b\u522b\u836f\u7269<\/span><\/p>\n

\u4e2d\u5176\u4ed6\u4ea7\u54c1\u7684\u76f8\u5173\u4e8b\u4ef6\u3002 <\/span><\/p>\n

\u2022 \u5373\u4f7f\u5355\u72ec\u4e00\u4efd\u8bb0\u5f55\u7fd4\u5b9e\u7684\u75c5\u4f8b\u62a5\u544a\u4e5f\u6709\u53ef\u80fd\u88ab\u770b\u4f5c\u4e00\u4e2a\u4fe1\u53f7\uff0c\u5982\u679c\u8be5\u62a5\u544a<\/span><\/p>\n

\u8bf4\u660e\u518d\u6fc0\u53d1\u8bd5\u9a8c\u9633\u6027\uff0c\u6216\u8005\u4e0d\u7528\u8fd9\u79cd\u836f\u7269\u7684\u60c5\u51b5\u4e0b\u8be5\u4e8b\u4ef6\u7684\u51fa\u73b0\u975e\u5e38\u7f55\u89c1\uff0c<\/span><\/p>\n

\u5c31\u66f4\u662f\u5982\u6b64\u3002 <\/span><\/p>\n

\u2022 \u4fe1\u53f7\u4e00\u822c\u8868\u793a\u9700\u8981\u8fdb\u884c\u8fdb\u4e00\u6b65\u7684\u8c03\u67e5\u7814\u7a76\uff0c\u8c03\u67e5\u7684\u7ed3\u679c\u53ef\u80fd\u5f97\u51fa\u8be5\u4ea7\u54c1\u5f15<\/span><\/p>\n

\u8d77\u8fd9\u4e00\u4e8b\u4ef6\u7684\u7ed3\u8bba\uff0c\u4e5f\u53ef\u80fd\u65e0\u6cd5\u5f97\u51fa\u8fd9\u79cd\u7ed3\u8bba\u3002 <\/span><\/p>\n

\u2022 \u4e00\u4e2a\u4fe1\u53f7\u88ab\u53d1\u73b0\u4e4b\u540e\uff0c\u5e94\u5f53\u5bf9\u5176\u8fdb\u884c\u6df1\u5165\u8bc4\u4ef7\uff0c\u660e\u786e\u8be5\u4fe1\u53f7\u662f\u5426\u4ee3\u8868\u6f5c\u5728\u7684<\/span><\/p>\n

\u5b89\u5168\u6027\u98ce\u9669\uff0c\u662f\u5426\u5e94\u5f53\u91c7\u53d6\u5176\u4ed6\u884c\u52a8\u3002 <\/span><\/p>\n

\u2022 \u62a5\u7ed9\u7533\u529e\u8005\u548cFDA\u7684\u81ea\u53d1\u6027\u4e0d\u826f\u4e8b\u4ef6\u75c5\u4f8b\u62a5\u544a\u4ee5\u53ca\u5176\u4ed6\u6765\u6e90\uff0c\u4f8b\u5982\u533b\u5b66<\/span><\/p>\n

\u6587\u732e\u6216\u4e34\u5e8a\u7814\u7a76\u7684\u62a5\u544a\uff0c\u53ef\u80fd\u5f97\u5230\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u7684\u4fe1\u53f7\u3002 <\/span><\/p>\n

\u2022 FDA\u5efa\u8bae\uff0c\u7533\u529e\u8005\u8981\u5728\u9996\u6b21\u63a5\u89e6\u548c\u968f\u8bbf\u4e2d\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u5c3d<\/span><\/p>\n

\u53ef\u80fd\u83b7\u5f97\u5b8c\u6574\u7684\u4fe1\u606f\uff0c\u4ee5\u4fbf\u5bf9\u75c5\u4f8b\u8fdb\u884c\u8bc4\u4ef7\u3002 <\/span><\/p>\n

\u2022 FDA\u5efa\u8bae\u7533\u529e\u8005\u901a\u8fc7\u5bf9\u75c5\u4f8b\u7684\u8ba4\u771f\u5ba1\u67e5\u548c\u68c0\u7d22\u66f4\u591a\u7684\u75c5\u4f8b\uff0c\u5bf9\u4e0a\u5e02\u540e<\/span><\/p>\n

\u81ea\u53d1\u6027\u62a5\u544a\u4e2d\u5f97\u5230\u7684\u4fe1\u53f7\u8fdb\u884c\u521d\u6b65\u8bc4\u4ef7\u3002 <\/span><\/p>\n

\u2022 FDA\u5efa\u8bae\u7533\u529e\u8005\u5e94\u5bfb\u627e\u53ef\u80fd\u63d0\u793a\u836f\u7269\u548c\u4e0d\u826f\u4e8b\u4ef6\u4e4b\u95f4\u5173\u8054\u6027\u7684\u4e00\u4e9b\u7279\u5f81<\/span><\/p>\n

\u5bf9\u75c5\u4f8b\u7cfb\u5217\u7684\u63cf\u8ff0\u6027\u5206\u6790\u603b\u7ed3\u3002 <\/span><\/p>\n

\u2022 \u4e8b\u4ef6\u7684\u4e34\u5e8a\u548c\u5b9e\u9a8c\u5ba4\u8868\u73b0\u4ee5\u53ca\u7ecf\u8fc7\u3002 <\/span><\/p>\n

\u2022 \u60a3\u8005\u7684\u4eba\u53e3\u7edf\u8ba1\u5b66\u7279\u5f81(\u5982,\u5e74\u9f84\u3001\u6027\u522b\u3001\u79cd\u65cf)\u3002 <\/span><\/p>\n

\u2022 \u66b4\u9732\u7684\u6301\u7eed\u65f6\u95f4\u3002 <\/span><\/p>\n

\u2022 \u4ece\u6700\u521d\u4ea7\u54c1\u66b4\u9732\u5f00\u59cb\u5230\u53d1\u751f\u4e0d\u826f\u4e8b\u4ef6\u7684\u65f6\u95f4\u3002 <\/span><\/p>\n

\u2022 \u75c5\u4f8b\u6240\u7528\u7684\u5242\u91cf\uff0c\u5305\u62ec\u8bf4\u660e\u4e66\u6240\u6807\u5242\u91cf\uff0c\u5927\u4e8e\u8bf4\u660e\u4e66\u6240\u6807\u5242\u91cf\uff0c\u4ee5\u53ca\u8fc7\u91cf\u3002 <\/span><\/p>\n

\u2022 \u5408\u5e76\u7528\u836f\u3002 <\/span><\/p>\n

\u2022 \u6709\u5408\u5e76\u75c7\uff0c\u7279\u522b\u662f\u5df2\u77e5\u4f1a\u5f15\u8d77\u8fd9\u79cd\u4e0d\u826f\u4e8b\u4ef6\u7684\u90a3\u4e9b\u5408\u5e76\u75c7\uff0c\u4f8b\u5982\u5df2\u5b58\u5728\u7684\u3002 <\/span><\/p>\n

\u2022 \u809d\u529f\u80fd\u6216\u80be\u529f\u80fd\u635f\u5bb3\u3002 <\/span><\/p>\n

\u2022 \u7ed9\u836f\u9014\u5f84(\u5982\uff0c\u53e3\u670d\u8fd8\u662f\u80c3\u80a0\u9053\u5916\u7ed9\u836f)\u3002 <\/span><\/p>\n

\u2022 \u5982\u679c\u6709\u751f\u4ea7\u6279\u53f7\uff0c\u5e94\u8bf4\u660e\u4e8b\u4ef6\u53d1\u751f\u60a3\u8005\u4e2d\u6240\u7528\u4ea7\u54c1\u7684\u6279\u53f7\u3002 <\/span><\/p>\n

\u2022 \u968f\u7740\u65f6\u95f4\u63a8\u79fb\u6216\u4ea7\u54c1\u751f\u547d\u5468\u671f\u4e2d\u4e8b\u4ef6\u62a5\u544a\u7387\u7684\u53d8\u5316\u60c5\u51b5\u3002 <\/span><\/p>\n

\u5728\u98ce\u9669\u8bc6\u522b\u548c\u8bc4\u4ef7\u7684\u5404\u4e2a\u9636\u6bb5\uff0c\u7528\u7edf\u8ba1\u5b66\u6216\u6570\u5b66\u5de5\u5177\u5bf9\u6240\u62a5\u544a\u7684\u4e0d\u826f\u4e8b\u4ef6\u8fdb\u884c\u7cfb\u7edf\u8003\u5bdf\uff0c\u53ef\u4ee5\u63d0\u4f9b\u66f4\u591a\u7684\u4fe1\u606f\uff0c\u6709\u52a9\u4e8e\u8bf4\u660e\u67d0\u4e2a\u4ea7\u54c1\u6240\u62a5\u544a\u7684\u4e0d\u826f\u4e8b\u4ef6\u662f\u5426\u8fc7\u591a\u3002 <\/span><\/p>\n

\u901a\u8fc7\u5c06\u6570\u636e\u6316\u6398\u6280\u672f\u5e94\u7528\u4e8e\u5927\u89c4\u6a21\u7684\u4e0d\u826f\u4e8b\u4ef6\u6570\u636e\u5e93\uff0c\u5982FDA\u7684AERS\u6216VAERS\u6570\u636e\u5e93\uff0c\u6709\u53ef\u80fd\u4f1a\u53d1\u73b0\u503c\u5f97\u8fdb\u4e00\u6b65\u8c03\u67e5\u7814\u7a76\u7684\u4e0d\u5e38\u89c1\u6216\u9884\u6599\u4e4b\u5916\u7684\u4ea7\u54c1–\u4e8b\u4ef6\u7ec4\u5408\u3002 <\/span><\/p>\n

\u6570\u636e\u6316\u6398\u6280\u672f\u53ef\u7528\u4e8e\u589e\u5f3a\u73b0\u6709\u7684\u4fe1\u53f7\u68c0\u6d4b\u7b56\u7565\uff0c\u5bf9\u4e8e\u8bc4\u4ef7\u4e8b\u4ef6\u7684\u89c4\u5f8b\u3001\u65f6\u95f4\u8d8b\u52bf\u4ee5\u53ca\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u6709\u5173\u4e8b\u4ef6\u7279\u522b\u6709\u7528\u3002 <\/span><\/p>\n

\u6570\u636e\u6316\u6398\u4e0d\u662f\u7528\u4e8e\u786e\u5b9a\u4ea7\u54c1\u548c\u4e0d\u826f\u4e8b\u4ef6\u4e4b\u95f4\u56e0\u679c\u5173\u7cfb\u7684\u5de5\u5177\u3002<\/span><\/p>\n

\uff082\uff09\u503c\u5f97\u8fdb\u4e00\u6b65\u8c03\u67e5\u7814\u7a76\u7684\u5b89\u5168\u6027\u4fe1\u53f7\uff1a<\/span><\/strong><\/p>\n

1. \u5728\u4ea7\u54c1\u8bf4\u660e\u4e66\u91cc\u672a\u63d0\u53ca\u7684\u65b0\u4e0d\u826f\u4e8b\u4ef6\uff0c\u7279\u522b\u662f\u4e25\u91cd\u7684\u4e0d\u826f\u4e8b\u4ef6;<\/span><\/p>\n

2. \u5df2\u5728\u4ea7\u54c1\u8bf4\u660e\u4e66\u91cc\u63d0\u53ca\u7684\u4e8b\u4ef6\uff0c\u4f46\u5176\u4e25\u91cd\u7a0b\u5ea6\u660e\u663e\u589e\u52a0;<\/span><\/p>\n

3. \u53d1\u751f\u4e86\u5728\u666e\u901a\u4eba\u7fa4\u4e2d\u6781\u5176\u7f55\u89c1\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6;<\/span><\/p>\n

4.\u65b0\u7684\u4ea7\u54c1-\u4ea7\u54c1\u3001\u4ea7\u54c1-\u5668\u68b0\u3001\u4ea7\u54c1-\u98df\u7269\u6216\u8005\u4ea7\u54c1-\u8425\u517b\u54c1\u4e4b\u95f4\u7684\u76f8\u4e92\u4f5c\u7528;<\/span><\/p>\n

5.\u53d1\u73b0\u4e86\u4ee5\u524d\u6ca1\u6709\u8ba4\u8bc6\u5230\u7684\u5371\u9669\u4eba\u7fa4(\u5982,\u6709\u7279\u5b9a\u79cd\u65cf\u6216\u9057\u4f20\u503e\u5411\u6216\u5408\u5e76\u75c7<\/span><\/p>\n

\u7684\u4eba\u7fa4);<\/span><\/p>\n

6. \u4ea7\u54c1\u540d\u79f0\u3001\u6807\u7b7e\u3001\u5305\u88c5\u6216\u4f7f\u7528\u6df7\u6dc6\u4e0d\u6e05\u7684\u60c5\u51b5;<\/span><\/p>\n

7.\u5bf9\u4ea7\u54c1\u7528\u6cd5\u7684\u62c5\u5fc3(\u5982\uff0c\u6309\u9ad8\u4e8e\u8bf4\u660e\u4e66\u6240\u6807\u5242\u91cf\u4f7f\u7528\u65f6\u51fa\u73b0\u7684\u4e0d\u826f\u4e8b\u4ef6\u6216\u8005\u5728\u4e0d\u63a8\u8350\u4f7f\u7528\u7684\u4eba\u7fa4\u4e2d\u7528\u836f\u65f6\u51fa\u73b0\u7684\u4e0d\u826f\u4e8b\u4ef6);<\/span><\/p>\n

8. \u76ee\u524d\u6240\u6267\u884c\u7684\u98ce\u9669\u6700\u5c0f\u5316\u8ba1\u5212\u53ef\u80fd\u6709\u6b20\u7f3a\u6240\u5f15\u8d77\u7684\u62c5\u5fc3\uff1b<\/span><\/p>\n

9. \u7533\u529e\u8005\u6216FDA\u53d1\u73b0\u7684\u5176\u4ed6\u9700\u8981\u5173\u6ce8\u7684\u95ee\u9898\u3002 <\/span><\/p>\n

\uff083\uff09\u8003\u8651\u4fe1\u53f7\u80cc\u666f:\u8ba1\u7b97\u62a5\u544a\u7387\u8fd8\u662f\u53d1\u751f\u7387<\/span><\/strong><\/p>\n

\u5b89\u5168\u6027\u4fe1\u53f7\u7684\u89e3\u8bfb:\u4ece\u4fe1\u53f7\u5230\u6f5c\u5728\u5b89\u5168\u6027\u98ce\u9669<\/span><\/p>\n

\u5f53\u5bf9\u4e00\u4e2a\u5b89\u5168\u6027\u4fe1\u53f7\u7684\u8bc4\u4ef7\u63d0\u793a\u5b83\u53ef\u80fd\u662f\u4e00\u4e2a\u6f5c\u5728\u7684\u5b89\u5168\u6027\u98ce\u9669\u65f6\uff0cFDA \u5efa\u8bae\u7533\u529e\u8005\u9012\u4ea4\u6240\u6709\u5df2\u6536\u96c6\u7684\u5b89\u5168\u6027\u4fe1\u606f\u7684\u6c47\u603b\u6570\u636e\u4ee5\u53ca\u6240\u8fdb\u884c\u7684\u5206\u6790\uff0c\u5305\u62ec\u4e34\u5e8a\u524d\u53d1\u73b0\u5230\u6700\u65b0\u7684\u89c2\u5bdf\u7ed3\u679c\u3002<\/span><\/p>\n

\u2022 \u81ea\u53d1\u6027\u75c5\u4f8b\u62a5\u544a\u548c\u53d1\u8868\u7684\u75c5\u4f8b\u62a5\u544a\uff1b<\/span><\/p>\n

\u2022 \u5982\u679c\u6709\u666e\u901a\u4eba\u7fa4\u548c\u7279\u6b8a\u60a3\u8005\u4eba\u7fa4\u4e2d\u4e8b\u4ef6\u7684\u80cc\u666f\u53d1\u751f\u7387\uff0c\u4e5f\u8981\u5305\u62ec\u8fd9\u4e9b\u6570\u636e\uff1b<\/span><\/p>\n

\u2022 \u836f\u7269\u6d41\u884c\u75c5\u5b66\u7814\u7a76\u4e2d\u5f97\u5230\u7684\u76f8\u5bf9\u5371\u9669\u5ea6\u3001\u6bd4\u503c\u6bd4\u6216\u5176\u4ed6\u76f8\u5173\u65b9\u9762\u7684\u6d4b\u91cf\u6307\u6807\uff1b<\/span><\/p>\n

\u2022 \u4e34\u5e8a\u524d\u7814\u7a76\u4e2d\u6240\u89c2\u5bdf\u5230\u7684\u751f\u7269\u5b66\u6548\u5e94\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u6216\u836f\u6548\u5b66\u4f5c\u7528\uff1b<\/span><\/p>\n

\u2022 \u4e34\u5e8a\u5bf9\u7167\u8bd5\u9a8c\u4e2d\u7684\u5b89\u5168\u6027\u53d1\u73b0\uff1b<\/span><\/p>\n

\u2022 \u540c\u7c7b\u4e2d\u7c7b\u4f3c\u4ea7\u54c1\u7684\u6574\u4f53\u4e0a\u5e02\u7ecf\u9a8c\u3002<\/span><\/p>\n

\uff084\uff09\u8d85\u8d8a\u5e38\u89c4\u7684\u836f\u7269\u8b66\u6212\uff1a\u5236\u5b9a\u836f\u7269\u8b66\u6212\u8ba1\u5212<\/span><\/strong><\/p>\n

\u5728\u5e38\u89c4\u8981\u6c42\u7684\u62a5\u544a(\u537315\u5929\u62a5\u544a)\u4e4b\u5916\u901a\u8fc7\u52a0\u6025\u62a5\u544a\u7279\u6b8a\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6;<\/span><\/p>\n

\u2022 \u6309\u9884\u5148\u786e\u5b9a\u7684\u95f4\u9694\u65f6\u95f4\uff0c\u66f4\u52a0\u9891\u7e41\u5730\u4e0a\u62a5\u4e0d\u826f\u4e8b\u4ef6\u603b\u7ed3(\u5982\u6bcf\u5b63\u5ea61 \u6b21\uff0c\u800c\u4e0d\u662f\u6bcf\u5e741\u6b21);<\/span><\/p>\n

\u2022 \u4e3b\u52a8\u76d1\u6d4b\uff0c\u4ee5\u4fbf\u53d1\u73b0\u901a\u8fc7\u88ab\u52a8\u76d1\u6d4b\u53ef\u80fd\u62a5\u544a\u6216\u53ef\u80fd\u6ca1\u6709\u62a5\u544a\u7684\u4e0d\u826f\u4e8b\u4ef6\uff1b<\/span><\/p>\n

\u2022 (1)\u57fa\u4e8e\u836f\u7269\uff1a\u53d1\u73b0\u670d\u7528\u67d0\u4e9b\u836f\u7269\u7684\u60a3\u8005\u4e2d\u7684\u4e0d\u826f\u4e8b\u4ef6;<\/span><\/p>\n

\u2022 (2)\u57fa\u4e8e\u573a\u6240\uff1a\u53d1\u73b0\u60a3\u8005\u53ef\u80fd\u5c31\u8bca\u7684\u67d0\u4e9b\u533b\u7597\u573a\u6240\u4e2d\u7684\u4e0d\u826f\u4e8b\u4ef6(\u5982,\u6025\u8bca\u79d1\u7b49);<\/span><\/p>\n

\u2022 (3)\u57fa\u4e8e\u4e8b\u4ef6\uff1a\u53d1\u73b0\u53ef\u80fd\u4e0e\u836f\u54c1\u6709\u5173\u7684\u4e0d\u826f\u4e8b\u4ef6(\u5982\uff0c\u6025\u6027\u809d\u8870\u7aed);<\/span><\/p>\n

\u2022 \u7528\u961f\u5217\u3001\u75c5\u4f8b\u5bf9\u7167\u6216\u5176\u4ed6\u76f8\u5e94\u7684\u7814\u7a76\u8bbe\u8ba1\u5f00\u5c55\u5176\u4ed6\u836f\u7269\u6d41\u884c\u75c5\u5b66\u7814\u7a76(\u4f8b\u5982\uff0c\u81ea\u52a8\u5316\u6295\u8bc9\u6570\u636e\u5e93\u6216\u8005\u5176\u4ed6\u6570\u636e\u5e93\u4e2d\u5efa\u7acb\u767b\u8bb0\u7cfb\u7edf\uff0c\u6216\u8005\u5f00\u5c55\u5bf9\u60a3\u8005\u6216\u533b\u7597\u4eba\u5458\u7684\u95ee\u5377\u8c03\u67e5\u3002<\/span><\/p>\n

\u2022 \u5176\u4ed6\u4e34\u5e8a\u5bf9\u7167\u8bd5\u9a8c <\/span><\/p>\n

\uff085\uff09\u4fe1\u53f7\u68c0\u6d4b\uff1a\u5468\u671f\uff1a\u4e00\u5e74\u4e00\u6b21<\/span><\/strong><\/p>\n

\u6309\u836f\u54c1\u540c\u4e00\u6d3b\u6027\u7269\u8d28\uff0c\u4ee5\u6700\u65e9\u53d6\u5f97\u836f\u54c1\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u7684\u65e5\u671f\u8d77\u70b9\u8ba1\u3002 <\/span><\/p>\n

\uff086\uff09\u9884\u8b66\u4fe1\u53f7\u7684\u5224\u5b9a\uff08\u6839\u636e\u4f01\u4e1a\u5b9e\u9645\u60c5\u51b5\u81ea\u884c\u5236\u5b9a\u6807\u51c6\uff09<\/span><\/strong><\/p>\n

\u4e00\u4e2a\u5468\u671f\u5185\uff0c\u4e0e\u6000\u7591\u836f\u54c1\u76f8\u5173\u7684ADR\u51fa\u73b0\u4ee5\u4e0b\u4fe1\u53f7\u65f6\u9700\u8fdb\u4e00\u6b65\u8bc4\u4f30\u98ce\u9669\uff0c\u5e76\u6839\u636e\u8bc4\u4f30\u7ed3\u679c\u91c7\u53d6\u63a7\u5236\u63aa\u65bd\uff1a<\/span><\/p>\n

\u25c6  \u9884\u8b66\u4fe1\u53f71 \uff1a\u7ed3\u679c\u4e3a\u6b7b\u4ea1ADR\u22651\u6b21\uff1b<\/span><\/p>\n

\u25c6  \u9884\u8b66\u4fe1\u53f72 \uff1a\u65b0\u7684\u4e25\u91cdADR\uff0c\u540c\u4e00\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u540d\u79f0\u51fa\u73b0\u8fc7\u22653\u6b21\u7684\uff1b<\/span><\/p>\n

\u25c6  \u9884\u8b66\u4fe1\u53f73 \uff1a\u65b0\u7684\u4e00\u822c\u7684ADR\uff0c\u4e14\u540c\u4e00\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u540d\u79f0\u51fa\u73b0\u8fc7\u22655\u6b21\u7684\uff1b<\/span><\/p>\n

\u25c6  \u9884\u8b66\u4fe1\u53f74 \uff1a\u4e25\u91cd\u7684ADR\uff0c\u540c\u4e00\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u540d\u79f0\u51fa\u73b0\u8fc7\u22655\u6b21\u7684\u3002 <\/span><\/p>\n

\u4e94\u3001PV\u7cfb\u7edf\u7ba1\u7406<\/span><\/strong><\/span><\/p>\n

\u5173\u4e8ePV\u7cfb\u7edf\u5efa\u7acb\uff0c\u56e0\u6d89\u53caPV\u8ba1\u7b97\u673a\u7cfb\u7edf\u4f9b\u5e94\u5546\uff0c\u4f1a\u6709\u66ff\u5382\u5bb6\u6253\u5e7f\u544a\u5acc\u7591\uff0c\u4e0d\u5728\u6b64\u8be6\u7ec6\u4ecb\u7ecd\u3002\u4f46\u57fa\u672c\u539f\u5219\u662f\uff0c\u8981\u80fd\u6ee1\u8db3\u56fd\u5185\u73b0\u6709\u6cd5\u89c4\u57fa\u672c\u8981\u6c42\uff0c\u6709\u6280\u672f\u652f\u6301\uff0c\u6587\u732e\u68c0\u7d22\u80fd\u5b9e\u73b0\u63d0\u53d6ADR\uff0cPSUR\u3001\u98ce\u9669\u8b66\u793a\u7b49\u529f\u80fd\uff0c\u8fd8\u8981\u6709\u67e5\u91cd\u3001\u4fe1\u53f7\u9884\u8b66\u7b49\u529f\u80fd\uff0c\u6027\u4ef7\u6bd4\u4e3a\u4f01\u4e1a\u6839\u636e\u5b9e\u9645\u60c5\u51b5\u80fd\u63a5\u53d7\uff0c\u8f6f\u3001\u786c\u4ef6\u7b26\u5408\u4fdd\u5bc6\u3001\u5b9e\u7528\u8981\u6c42\u7b49\u3002\u8be5\u7cfb\u7edf\u9700\u8981\u6309\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u8fdb\u884cIQ\u3001OQ\u3001PQ\u7b49\u76f8\u5173\u7684\u9a8c\u8bc1\u5de5\u4f5c\u3002 <\/span><\/p>\n

\u603b\u800c\u8a00\u4e4b\uff0c\u5168\u7403\u767e\u4f59\u5e74\u836f\u7269\u8b66\u6212PV\u53f2\u7684\u80cc\u540e\u662f\u8840\u6dcb\u6dcb\u7684\u836f\u5bb3\u4e8b\u4ef6\u548c\u6b7b\u4ea1\u6848\u4f8b\uff0c\u6211\u56fd\u8981\u4ee5\u53f2\u4e3a\u9274\uff0c\u5438\u53d6\u5404\u56fd\u60e8\u75db\u7ecf\u9a8c\u6559\u8bad\uff0c\u81ea\u89c9\u505a\u597dPV\u5404\u9879\u5de5\u4f5c\uff0c\u9020\u798f\u4e2d\u56fd\u8001\u767e\u59d3\u3002<\/span><\/p>\n

\u4eca\u5929\u5728\u77e5\u836f\u5b66\u793e\u7684\u5206\u4eab\u8bfe\u7a0b\u5230\u6b64\u7ed3\u675f\uff0c\u6709\u4ec0\u4e48\u4e0d\u5bf9\u7684\uff0c\u8bf7\u5927\u5bb6\u63d0\u51fa\uff0c\u8c22\u8c22\u5927\u5bb6\uff01<\/span><\/p>\n

\u8bfe\u5802\u7b54\u7591\uff1a<\/span><\/strong><\/span><\/p>\n

1.\u6536\u5230ADR\u4e4b\u540e\uff0c\u4f1a\u53bb\u53d6\u8bc1\u5417\uff1f <\/span><\/strong><\/p>\n

\u2005\u7b54\uff1a\u76ee\u524d\u53d6\u8bc1\u96be\u5ea6\u8fd8\u662f\u5f88\u5927\uff0c\u56f0\u96be\u5728\u533b\u9662\u4e0d\u4f1a\u628a\u60a3\u8005\u4fe1\u606f\u7ed9\u5230\u4f60\u4f01\u4e1a\uff0c\u8fd9\u662f\u4fb5\u72af\u4e2a\u4eba\u9690\u79c1\u6743\u3002\u6240\u4ee5\uff0c\u5e7f\u4e1c\u7701\u901a\u8fc7\u6210\u7acb\u7684\u8054\u76df\u6216\u5b66\u4f1a\uff0c\u628a\u4fe1\u606f\u8131\u76f2\u540e\uff0c\u5c31\u53ef\u4ee5\u83b7\u53d6\u3002\u8054\u76df\u7531\u533b\u9662\u3001\u4f01\u4e1a\u3001\u5b66\u4f1a\u4e09\u65b9\u5171\u540c\u6784\u6210\uff0c\u5145\u5206\u5229\u7528\u8d44\u6e90\uff0c\u662f\u4e00\u79cd\u89e3\u51b3\u9014\u5f84\u3002 <\/span><\/p>\n

2.PV\u8d1f\u8d23\u4eba\u8d44\u8d28\u4e00\u822c\u6709\u533b\u5b66\u80cc\u666f\u53ca\u548c\u4ea7\u54c1\u76f8\u5173\u4e13\u4e1a\u80cc\u666f\uff0c\u627e\u5230\u9002\u5408\u7684\u4e0d\u5bb9\u6613\u3002<\/span><\/strong><\/p>\n

\u7b54\uff1a\u627e\u5230\u6709\u7ecf\u9a8c\u7684\u4e00\u5b9a\u5f97\u820d\u5f97\u51fa\u9ad8\u4ef7\u85aa\u916c\u3002\u56fd\u5185\u4f20\u8a00\u6709\u5341\u5e74\u4ee5\u4e0a\u5916\u4f01PV\u8d1f\u8d23\u4eba\u5f00\u4ef7\u5230\u5e74\u85aa###\u4e07\u5143\u4ee5\u4e0a\u3002PV\u76f8\u5173\u4ece\u4e1a\u4eba\u5458\u5c06\u6765\u662f\u4e00\u4e2a\u6709\u6f5c\u529b\u3001\u5f85\u9047\u76f8\u5bf9\u4f18\u539a\u7684\u804c\u4e1a\u9009\u62e9\u3002 <\/span><\/p>\n

3.\u63a5\u5230\u4e0d\u826f\u53cd\u5e94\u5982\u679c\u4ec5\u901a\u8fc7\u4e0e\u62a5\u544a\u8005\u8054\u7cfb\uff0c\u4e86\u89e3\u60c5\u51b5\uff0c\u5c31\u8fdb\u884c\u4e0a\u62a5\uff0c\u4f1a\u4e0d\u4f1a\u592a\u8349\u7387\uff1f\u8fd8\u6709\u4e00\u4e2a\u7591\u60d1\uff0c\u4e70\u4e86pv\u7cfb\u7edf\uff0c\u5728\u7cfb\u7edf\u767b\u8bb0\uff0c\u518d\u76f4\u62a5\u7cfb\u7edf\u4e0a\u62a5\u5417\uff1f<\/span><\/strong><\/p>\n

\u7b54\uff1a\u7b2c\u4e00\u4e2a\u95ee\u9898\uff0c\u5173\u4e8e\u4e0d\u826f\u53cd\u5e94\u662f\u4e0d\u662f\u76f4\u63a5\u62a5\u544a\u95ee\u9898\uff0c\u5b9e\u9645\u4e0a\u8fd9\u4e2a\u80af\u5b9a\u8981\u505a\u4e00\u4e2a\u7504\u522b\u7684\uff0c\u7136\u540e\u8981\u8fdb\u884c\u5185\u90e8\u7684\u4e00\u4e2a\u8ba8\u8bba\uff0c\u662f\u4e0d\u662f\u771f\u6b63\u7684\u4e0d\u826f\u53cd\u5e94\uff0c\u6839\u636e\u6240\u83b7\u5f97\u4fe1\u606f\u7684\u6709\u9650\u7a0b\u5ea6\uff0c\u91cc\u9762\u5e94\u8be5\u8bf4\u8fd8\u662f\u6709\u597d\u591a\u5de5\u4f5c\u9700\u8981\u5f00\u5c55\u3002<\/span><\/p>\n

\u7b2c\u4e8c\u4e2a\u95ee\u9898\uff0c\u5c31\u662f\u8bf4\u4e70\u4e86\u8fd9\u4e2aPV\u7cfb\u7edf\u80af\u5b9a\u662f\u8981\u7528\uff0c\u9700\u8981\u5728\u7cfb\u7edf\u4e0a\u8fdb\u884c\u767b\u8bb0\uff0c\u7136\u540e\u901a\u8fc7\u8fd9\u4e2a\u7cfb\u7edf\u53ef\u4ee5\u8ddf\u56fd\u5bb6\u4e0a\u62a5\u7cfb\u7edf\u8fdb\u884c\u5bf9\u63a5\uff0c\u5df2\u5f62\u6210\u7684\u62a5\u544a\u53ef\u4ee5\u76f4\u63a5\u4e0a\u62a5\u3002<\/span><\/p>\n

4.\u627e\u7b2c\u4e09\u65b9\u836f\u7269\u8b66\u6212\u516c\u53f8\u5408\u4f5c\u6700\u4e3b\u8981\u6ce8\u610f\u54ea\u65b9\u9762\uff1f<\/span><\/strong><\/p>\n

\u7b54\uff1a\uff081\uff09\u59d4\u6258\u7b2c\u4e09\u65b9\uff0c\u6388\u6743\u4e0d\u6388\u8d23\uff0c\u51fa\u4e86\u4e8b\u8fd8\u662f\u81ea\u5df1\u8981\u627f\u62c5\u3002 <\/span><\/p>\n

\uff082\uff09\u4ea7\u54c1\u4e0d\u826f\u53cd\u5e94\u7684\u4fe1\u606f\u5b89\u5168\uff0c\u5982\u662f\u672c\u5730\u81ea\u5df1\u7cfb\u7edf\u5b58\u50a8\u4f1a\u5b89\u5168\uff0c\u5168\u6bd4\u8f83\u8d35\u3002\u5982\u679c\u662f\u4e91\u7ba1\u7406\uff0c\u76f8\u5bf9\u4fbf\u5b9c\u4e9b\uff0c\u4f46\u4fe1\u606f\u4e0d\u591f\u5b89\u5168\u3002 <\/span><\/p>\n

\uff083\uff09\u5982\u679c\u81ea\u5df1\u6ca1\u6709\u4e13\u4e1a\u4eba\u58eb\uff0c\u600e\u4e48\u77e5\u9053\u7b2c\u4e09\u65b9\u7ba1\u5f97\u597d\u4e0d\u597d\uff0c\u4f1a\u4e0d\u4f1a\u9057\u6f0f\u4e0a\u62a5\u800c\u8ba9\u5355\u4f4d\u53d7\u5230\u5904\u7f5a\u3002<\/span><\/p>\n

\"\u836f\u4f01\u836f\u7269\u8b66\u6212\u5de5\u4f5c\uff0c\u5b9e\u6218\u5206\u4eab\"<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u4f5c\u8005\uff1a\u963f\u90ce \u6765\u81ea\uff1a\u77e5\u836f\u5b66\u793e \u63d0\u793a\uff1a\u672c\u6587\u8f83\u957f\uff0c\u5efa\u8bae\u5148\u6536\u85cf\u540e\u627e\u65f6\u95f4\u6162\u6162\u9605\u8bfb\uff0c\u672c\u6587\u5206\u4e3a5\u4e2a\u90e8\u5206\uff1a \u4e00\u3001\u836f\u7269\u8b66\u6212\u8d77\u6e90\u3001 […]<\/p>\n","protected":false},"author":1,"featured_media":116817,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/116816"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=116816"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/116816\/revisions"}],"predecessor-version":[{"id":116819,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/116816\/revisions\/116819"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/116817"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=116816"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=116816"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=116816"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}