{"id":58256,"date":"2018-10-30T01:00:00","date_gmt":"2018-12-07T02:32:34","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/d1373400a5\/"},"modified":"2018-12-07T10:32:36","modified_gmt":"2018-12-07T02:32:36","slug":"d1373400a5","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/58256\/","title":{"rendered":"\u5b9a\u7a3f\uff01BE\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u548c\u9ad8\u53d8\u5f02\u836f\u7269BE\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u51fa\u6765\u4e86"},"content":{"rendered":"
\n

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\u7279\u6b64\u901a\u544a\u3002<\/span><\/p>\n


<\/p>\n

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1.\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

2.\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219<\/span><\/p>\n


<\/p>\n

\u56fd\u5bb6\u836f\u76d1\u5c40<\/span><\/p>\n

2018\u5e7410\u670817\u65e5<\/span><\/p>\n


<\/p>\n

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 <\/span><\/p>\n

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 <\/span><\/p>\n

\u4e00\u3001\u6982\u8ff0<\/span><\/strong><\/span><\/h1>\n

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 <\/span><\/p>\n

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\n

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 <\/span><\/p>\n

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\n

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\n

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1<\/span><\/p>\n<\/td>\n

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2<\/span><\/p>\n<\/td>\n

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<\/td>\n
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<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

\u88683 \u4e24\u5236\u5242\u3001\u56db\u5468\u671f\u3001\u4e24\u5e8f\u5217\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/p>\n<\/td>\n

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<\/td>\n<\/tr>\n
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1<\/span><\/p>\n<\/td>\n

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2<\/span><\/p>\n<\/td>\n

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3<\/span><\/p>\n<\/td>\n

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<\/td>\n<\/tr>\n<\/thead>\n
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1<\/span><\/p>\n<\/td>\n

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T<\/span><\/p>\n<\/td>\n

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R<\/span><\/p>\n<\/td>\n

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<\/td>\n
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<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

2.\u5e73\u884c\u7ec4\u8bbe\u8ba1<\/span><\/p>\n

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3.\u5176\u4ed6\u8bbe\u8ba1<\/span><\/p>\n

\u5982\u679c\u91c7\u7528\u9002\u5e94\u6027\u8bbe\u8ba1\u7b49\u5176\u4ed6\u8bbe\u8ba1\u65b9\u6cd5\uff0c\u53ef\u53c2\u8003\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\uff0c\u4e14\u5e94\u4e8b\u5148\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u6837\u672c\u91cf<\/span><\/p>\n

\u8bd5\u9a8c\u524d\u9700\u5145\u5206\u4f30\u8ba1\u6240\u9700\u7684\u6837\u672c\u91cf\uff0c\u4ee5\u4fdd\u8bc1\u8db3\u591f\u7684\u68c0\u9a8c\u6548\u80fd\uff0c\u5e76\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u8be6\u7ec6\u8bf4\u660e\u6837\u672c\u91cf\u4f30\u8ba1\u65b9\u6cd5\u548c\u7ed3\u679c\u3002\u4f7f\u7528ABE\u65b9\u6cd5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u65f6\uff0c\u5e94\u57fa\u4e8e\u660e\u786e\u7684\u516c\u5f0f\u5408\u7406\u4f30\u8ba1\u6837\u672c\u91cf\u3002\u4e0d\u540c\u7684\u8bbe\u8ba1\uff0c\u5bf9\u5e94\u7684\u6837\u672c\u91cf\u4f30\u8ba1\u516c\u5f0f\u4e0d\u540c\u3002<\/span><\/p>\n

\u4ea4\u53c9\u8bbe\u8ba1\u7684\u6837\u672c\u91cf\u9700\u8003\u8651\u7684\u56e0\u7d20\u5305\u62ec\uff1a\uff081\uff09\u68c0\u9a8c\u6c34\u51c6\u03b1\uff0c\u901a\u5e38\u4e3a\u53cc\u4fa70.1\uff08\u53cc\u5355\u4fa70.05\uff09\uff1b\uff082\uff09\u68c0\u9a8c\u6548\u80fd1-\u03b2\uff0c\u901a\u5e38\u81f3\u5c11\u4e3a80%\uff1b\uff083\uff09\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\uff08Within-subject coefficient of variation\uff0cCVw<\/sub><\/em>%\uff09\uff0c\u53ef\u57fa\u4e8e\u6587\u732e\u62a5\u9053\u6216\u9884\u8bd5\u9a8c\u7ed3\u679c\u8fdb\u884c\u4f30\u8ba1\uff1b\uff084\uff09\u51e0\u4f55\u5747\u503c\u6bd4\uff08Geometric mean ratio, GMR\uff09\uff1b\uff085\uff09\u7b49\u6548\u6027\u754c\u503c\u3002\u5e73\u884c\u7ec4\u8bbe\u8ba1\u7684\u6837\u672c\u91cf\u4f30\u8ba1\u53ef\u53c2\u8003\u4e00\u822c\u8fde\u7eed\u578b\u53d8\u91cf\u7684\u6837\u672c\u91cf\u8ba1\u7b97\u516c\u5f0f\u3002<\/span><\/p>\n

\u5982\u679c\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\u6ca1\u6709\u660e\u786e\u7684\u6837\u672c\u91cf\u8ba1\u7b97\u516c\u5f0f\uff0c\u4e5f\u53ef\u4ee5\u91c7\u7528\u8ba1\u7b97\u673a\u6a21\u62df\u7684\u65b9\u6cd5\u4f30\u8ba1\u6837\u672c\u91cf\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u53d7\u8bd5\u8005\u8131\u843d<\/span><\/p>\n

\u4e3a\u4e86\u907f\u514d\u7814\u7a76\u8fc7\u7a0b\u4e2d\u56e0\u53d7\u8bd5\u8005\u7684\u8131\u843d\u5bfc\u81f4\u6837\u672c\u91cf\u4e0d\u8db3\uff0c\u7533\u8bf7\u4eba\u5728\u8fdb\u884c\u6837\u672c\u91cf\u4f30\u8ba1\u65f6\u5e94\u8003\u8651\u9002\u5f53\u589e\u52a0\u6837\u672c\u91cf\u3002<\/span><\/p>\n

\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u8bd5\u9a8c\u5f00\u59cb\u540e\u4e0d\u5e94\u518d\u8ffd\u52a0\u53d7\u8bd5\u8005\u3002\u5df2\u5206\u914d\u968f\u673a\u53f7\u7684\u53d7\u8bd5\u8005\u901a\u5e38\u4e0d\u53ef\u4ee5\u88ab\u66ff\u4ee3\u3002<\/span><\/p>\n

\uff08\u56db\uff09\u6b8b\u7559\u6548\u5e94<\/span><\/p>\n

\u4f7f\u7528\u4ea4\u53c9\u8bbe\u8ba1\u8fdb\u884cBE\u7814\u7a76\u901a\u8fc7\u6bcf\u4e2a\u53d7\u8bd5\u8005\u81ea\u8eab\u5bf9\u7167\u6765\u589e\u52a0\u6bd4\u8f83\u7684\u7cbe\u5ea6\uff0c\u5176\u57fa\u672c\u5047\u8bbe\u662f\u6240\u6bd4\u8f83\u7684\u5236\u5242\u5728\u4e0b\u4e00\u5468\u671f\u8bd5\u9a8c\u65f6\u5747\u4e0d\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u6216\u6b8b\u7559\u6548\u5e94\u76f8\u8fd1\u3002\u5982\u679c\u4ea4\u53c9\u8bbe\u8ba1\u4e2d\u5b58\u5728\u4e0d\u76f8\u7b49\u7684\u6b8b\u7559\u6548\u5e94\uff0c\u90a3\u4e48\u5bf9\u4e8eGMR\u7684\u4f30\u8ba1\u53ef\u80fd\u6709\u504f\u3002<\/span><\/p>\n

\u7814\u7a76\u8bbe\u8ba1\u65f6\u5e94\u907f\u514d\u53d1\u751f\u6b8b\u7559\u6548\u5e94\u3002\u5982\u679c\u53d1\u73b0\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u7533\u8bf7\u4eba\u5e94\u5f53\u5206\u6790\u4ea7\u751f\u7684\u53ef\u80fd\u539f\u56e0\uff0c\u63d0\u4f9b\u76f8\u5e94\u7684\u5224\u65ad\u4f9d\u636e\uff0c\u8bc4\u4f30\u5176\u5bf9\u6700\u7ec8\u7ed3\u8bba\u7684\u5f71\u54cd\u3002<\/span><\/p>\n


<\/p>\n

\u4e09\u3001\u6570\u636e\u5904\u7406\u548c\u5206\u6790<\/span><\/strong><\/span><\/h1>\n

\uff08\u4e00\uff09\u6570\u636e\u96c6<\/span><\/p>\n

\u6570\u636e\u96c6\u4e8b\u5148\u9700\u8981\u5728\u65b9\u6848\u4e2d\u660e\u786e\u5b9a\u4e49\uff0c\u5305\u62ec\u5177\u4f53\u7684\u53d7\u8bd5\u8005\u5254\u9664\u6807\u51c6\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\uff0cBE\u7814\u7a76\u7684\u6570\u636e\u96c6\u5e94\u81f3\u5c11\u5305\u62ec\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6\uff08Pharmacokinetics Parameter Set\uff0cPKPS\uff09\u3001\u751f\u7269\u7b49\u6548\u6027\u96c6\uff08Bioequivalence Set\uff0cBES\uff09\u3002\u7528\u4e8e\u4e0d\u540c\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u5206\u6790\u7684\u53d7\u8bd5\u8005\u6570\u91cf\u53ef\u80fd\u4e0d\u540c\u3002<\/span><\/p>\n

\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6\uff08PKPS\uff09\uff1a\u5305\u62ec\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u6b21\u7814\u7a76\u836f\u7269\u7684\u53d7\u8bd5\u8005\u4e2d\u83b7\u5f97\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u96c6\u3002\u672c\u6570\u636e\u96c6\u7684\u4f5c\u7528\u5728\u4e8e\u63cf\u8ff0\u6027\u7edf\u8ba1\u53d7\u8bd5\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u3002<\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u96c6\uff08BES\uff09\uff1a\u901a\u5e38\u5305\u62ec\u81f3\u5c11\u4e00\u4e2a\u5468\u671f\u4e14\u5177\u6709\u81f3\u5c11\u4e00\u4e2a\u53ef\u8bc4\u4ef7\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u7edf\u8ba1\u5206\u6790\u96c6\u3002\u672c\u6570\u636e\u96c6\u662f\u63a8\u65ad\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u662f\u5426\u751f\u7269\u7b49\u6548\u7684\u4e3b\u8981\u6570\u636e\u96c6\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u6570\u636e\u8f6c\u6362<\/span><\/p>\n

\u5efa\u8bae\u5bf9\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\uff08\u5982AUC\u548cCmax<\/sub>\uff09\u4f7f\u7528\u81ea\u7136\u5bf9\u6570\u8fdb\u884c\u6570\u636e\u8f6c\u6362\u3002\u9009\u62e9\u7684\u5bf9\u6570\u8f6c\u6362\u65b9\u5f0f\u5e94\u5728\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u4fdd\u6301\u4e00\u81f4\uff0c\u4e14\u9700\u5728\u65b9\u6848\u4e2d\u6307\u660e\u3002\u5728\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\uff0c\u7531\u4e8e\u6837\u672c\u91cf\u8f83\u5c11\uff0c\u96be\u4ee5\u786e\u5b9a\u6570\u636e\u7684\u5206\u5e03\u3002\u56e0\u6b64\uff0c\u4e0d\u5efa\u8bae\u4ee5\u5bf9\u6570\u8f6c\u6362\u540e\u6570\u636e\u4e0d\u670d\u4ece\u6b63\u6001\u5206\u5e03\uff0c\u6216\u539f\u59cb\u6570\u636e\u670d\u4ece\u6b63\u6001\u5206\u5e03\u4e3a\u7531\uff0c\u800c\u4f7f\u7528\u539f\u59cb\u6570\u636e\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u7edf\u8ba1\u5047\u8bbe\u4e0e\u63a8\u65ad<\/span><\/p>\n

\u5e73\u5747\u751f\u7269\u7b49\u6548\u8981\u6c42\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u5dee\u5f02\u5728\u4e00\u5b9a\u53ef\u63a5\u53d7\u8303\u56f4\u5185\uff0c\u901a\u8fc7\u4ee5\u4e0b\u5047\u8bbe\u68c0\u9a8c\u6765\u8fdb\u884c\u7edf\u8ba1\u63a8\u65ad\u3002<\/span><\/p>\n

\u539f\u5047\u8bbeH<\/em>0<\/sub>\uff1a<\/span><\/span>\u6216<\/span><\/span><\/span><\/p>\n

\u5907\u62e9\u5047\u8bbe<\/span>H<\/span><\/em>1<\/span><\/sub>\uff1a<\/span><\/span><\/span><\/p>\n

\u5176\u4e2d\u03bcT<\/sub><\/em>\u4e3a\u53d7\u8bd5\u5236\u5242\u5bf9\u6570\u53d8\u6362\u540e\u836f\u4ee3\u53c2\u6570\u603b\u4f53\u5747\u6570\uff0c\u03bcR<\/sub><\/em>\u4e3a\u53c2\u6bd4\u5236\u5242\u5bf9\u6570\u53d8\u6362\u540e\u836f\u4ee3\u53c2\u6570\u603b\u4f53\u5747\u6570\uff0c\u03b8<\/em>\u4e3a\u751f\u7269\u7b49\u6548\u6027\u754c\u503c\u3002\u5728\u8bbe\u5b9a\u7684\u68c0\u9a8c\u6c34\u51c6\u4e0b\uff0c\u82e5\u62d2\u7edd\u539f\u5047\u8bbe<\/span>H<\/span><\/em>0<\/span><\/sub>\uff0c\u5219\u8868\u660e\u751f\u7269\u7b49\u6548\u3002\u901a\u5e38\u8bbe\u5b9a\u03b8<\/em>=ln\uff081.25\uff09\uff0c-\u03b8<\/em>=ln\uff080.8\uff09\uff0c\u5373\u751f\u7269\u7b49\u6548\u6027\u8981\u6c42\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684GMR\u843d\u572880.00%\u2014125.00%\u8303\u56f4\u5185\u3002<\/span><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u6807\u51c6\u5e94\u540c\u65f6\u9002\u7528\u4e8e\u5404\u4e3b\u8981\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\uff0c\u5305\u62ecCmax<\/sub>\u3001AUC0-t<\/sub>\u548cAUC0-<\/sub>\u221e<\/sub>\u3002<\/span><\/p>\n

\u901a\u5e38\u60c5\u51b5\u4e0b\uff0c\u5982\u679c\u7814\u7a76\u836f\u7269\u5305\u542b\u591a\u4e2a\u7ec4\u5206\uff0c\u5219\u6bcf\u4e2a\u7ec4\u5206\u5747\u5e94\u7b26\u5408\u751f\u7269\u7b49\u6548\u6027\u6807\u51c6\u3002<\/span><\/p>\n

\u5f53Tmax<\/sub>\u4e0e\u836f\u7269\u7684\u4e34\u5e8a\u7597\u6548\u5bc6\u5207\u76f8\u5173\u65f6\uff0c\u901a\u5e38\u91c7\u7528\u914d\u5bf9\u975e\u53c2\u6570\u65b9\u6cd5\u5bf9Tmax<\/sub>\u8fdb\u884c\u5dee\u5f02\u6027\u68c0\u9a8c\u3002<\/span><\/p>\n

\uff08\u56db\uff09\u6570\u636e\u5206\u6790<\/span><\/p>\n

1.\u6982\u8ff0<\/span><\/p>\n

\u5bf9\u4e8e\u4e0a\u6587\u63d0\u5230\u7684\u751f\u7269\u7b49\u6548\u6027\u6807\u51c6\uff0c\u901a\u5e38\u662f\u6784\u5efa<\/span><\/span>\u7684\u53cc\u4fa790%\u7f6e\u4fe1\u533a\u95f4\uff0c\u82e5\u6b64\u7f6e\u4fe1\u533a\u95f4\u843d\u5728\u533a\u95f4<\/span>\u5185\uff0c\u5219\u53ef\u63a8\u65ad\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u6ee1\u8db3\u751f\u7269\u7b49\u6548\u3002\u6b64\u65b9\u6cd5\u7b49\u4ef7\u4e8e\u57280.05\u7684\u68c0\u9a8c\u6c34\u51c6\u4e0b\u8fdb\u884c\u53cc\u5355\u4fa7\u5047\u8bbe\u68c0\u9a8c\u3002\u5e94\u6839\u636e\u4e0d\u540c\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u9009\u62e9\u6070\u5f53\u7684\u7f6e\u4fe1\u533a\u95f4\u8ba1\u7b97\u65b9\u6cd5\u3002\u8ba1\u7b97\u51fa<\/span><\/span>\u7684\u53cc\u4fa790%\u7f6e\u4fe1\u533a\u95f4\u540e\uff0c\u53ef\u901a\u8fc7\u9006\u5bf9\u6570\u53d8\u6362\uff08\u6307\u6570\u53d8\u6362\uff09\u5f97\u5230\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u539f\u59cb\u6570\u636e\u7684GMR\u7684\u53cc\u4fa790%\u7f6e\u4fe1\u533a\u95f4\u3002<\/span><\/span><\/p>\n

2.\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/p>\n

\u5bf9\u4e8e\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u5efa\u8bae\u4f7f\u7528\u7ebf\u6027\u6df7\u5408\u6548\u5e94\u6a21\u578b\u8fdb\u884c\u5206\u6790\u8ba1\u7b97\u3002<\/span><\/p>\n

3.\u5e73\u884c\u7ec4\u8bbe\u8ba1<\/span><\/p>\n

\u5efa\u8bae\u91c7\u7528\u57fa\u4e8e\u6b63\u6001\u5206\u5e03\u5747\u6570\u5dee\u503c\u7684\u7f6e\u4fe1\u533a\u95f4\u6784\u5efa\u65b9\u6cd5\u3002<\/span><\/p>\n

\uff08\u4e94\uff09\u79bb\u7fa4\u6570\u636e\u5904\u7406<\/span><\/p>\n

\u901a\u5e38\u4e0d\u5efa\u8bae\u5254\u9664\u79bb\u7fa4\u503c\u3002\u5fc5\u8981\u65f6\u9700\u8981\u9488\u5bf9\u79bb\u7fa4\u503c\u8fdb\u884c\u654f\u611f\u6027\u5206\u6790\uff0c\u5373\u8bc4\u4ef7\u5254\u9664\u548c\u4e0d\u5254\u9664\u79bb\u7fa4\u503c\u5bf9\u751f\u7269\u7b49\u6548\u6027\u7ed3\u679c\u7684\u5f71\u54cd\u3002\u5982\u679c\u7ed3\u8bba\u4e0d\u4e00\u81f4\uff0c\u9700\u89e3\u91ca\u8bf4\u660e\u5e76\u5206\u6790\u539f\u56e0\u3002<\/span><\/p>\n

\uff08\u516d\uff09\u5176\u4ed6\u95ee\u9898<\/span><\/p>\n

\u5982\u679c\u4e00\u4e2a\u4ea4\u53c9\u8bbe\u8ba1\u662f\u5728\u4e24\u4e2a\u53ca\u4ee5\u4e0a\u7684\u4e2d\u5fc3\u8fdb\u884c\uff0c\u7edf\u8ba1\u6a21\u578b\u4e2d\u5e94\u8be5\u8003\u8651\u4e2d\u5fc3\u6548\u5e94\u3002\u6240\u7528\u6a21\u578b\u5e94\u8be5\u80fd\u4f30\u8ba1\u4e0d\u540c\u4e2d\u5fc3\u7684\u6548\u5e94\uff0c\u53cd\u6620\u4e0d\u540c\u4e2d\u5fc3\u7684\u5b9e\u9645\u60c5\u51b5\uff0c\u5e76\u8bf4\u660e\u6765\u81ea\u4e0d\u540c\u4e2d\u5fc3\u7684\u8bd5\u9a8c\u6570\u636e\u662f\u5426\u53ef\u4ee5\u5408\u5e76\u8fdb\u884c\u5206\u6790\u3002<\/span><\/p>\n

\u5982\u679c\u5b58\u5728\u591a\u79cd\u53d7\u8bd5\u5236\u5242\u548c\/\u6216\u591a\u79cd\u53c2\u6bd4\u5236\u5242\uff0c\u901a\u5e38\u4f1a\u6709\u591a\u4e2a\u751f\u7269\u7b49\u6548\u7684\u5047\u8bbe\u68c0\u9a8c\u3002\u82e5\u591a\u4e2a\u5047\u8bbe\u68c0\u9a8c\u9700\u540c\u65f6\u6ee1\u8db3\uff0c\u5219\u65e0\u9700\u8fdb\u884cI\u7c7b\u9519\u8bef\u7684\u8c03\u6574\uff1b\u82e5\u4e0d\u8981\u6c42\u540c\u65f6\u6ee1\u8db3\uff0c\u5219\u9700\u5bf9I\u7c7b\u9519\u8bef\u8fdb\u884c\u8c03\u6574\uff0c\u8c03\u6574\u7684\u65b9\u6cd5\u6709Bonferroni\u6cd5\u3001Hochberg\u6cd5\u7b49\u3002<\/span><\/p>\n


<\/p>\n

\u56db\u3001\u7ed3\u679c\u62a5\u544a<\/span><\/strong><\/span><\/h1>\n

\u7ed3\u679c\u62a5\u544a\u4e2d\u5e94\u5bf9\u4ee5\u4e0b\u5185\u5bb9\u8fdb\u884c\u8be6\u7ec6\u8bf4\u660e\u3002<\/span><\/p>\n

\uff08\u4e00\uff09\u968f\u673a\u5316<\/span><\/p>\n

\u5e94\u5177\u4f53\u8bf4\u660e\u8bd5\u9a8c\u7528\u7684\u968f\u673a\u5316\u7cfb\u7edf\u548c\u968f\u673a\u5316\u65b9\u6848\uff0c\u5305\u62ec\u968f\u673a\u5316\u63a7\u5236\u7684\u56e0\u7d20\u3001\u533a\u7ec4\u3001\u79cd\u5b50\u6570\u7b49\uff0c\u5e76\u9644\u6709\u968f\u673a\u5316\u6570\u5b57\u8868\u3002<\/span><\/p>\n

\u968f\u673a\u5316\u7684\u7ed3\u679c\u5e94\u7528\u8868\u683c\u63cf\u8ff0\uff0c\u5176\u4e2d\u5305\u542b\u53d7\u8bd5\u8005\u7f16\u53f7\u3001\u6bcf\u4e00\u5468\u671f\u7684\u7528\u836f\u60c5\u51b5\uff0c\u4ee5\u53ca\u968f\u673a\u5316\u63a7\u5236\u7684\u56e0\u7d20\u7b49\u3002\u968f\u673a\u5316\u7ed3\u679c\u53ef\u5728\u9644\u5f55\u4e2d\u5c55\u73b0\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u7edf\u8ba1\u5b66\u65b9\u6cd5<\/span><\/p>\n

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\uff08\u4e09\uff09\u7edf\u8ba1\u5206\u6790\u7ed3\u679c<\/span><\/p>\n

\u5e94\u63d0\u4f9b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7ed9\u836f\u540e\u7684\u68c0\u6d4b\u6210\u5206\u6d53\u5ea6\u68c0\u6d4b\u7ed3\u679c\u3002\u5728\u9644\u5f55\u4e2d\u5e94\u540c\u65f6\u7ed9\u51fa\u7b97\u672f\u5750\u6807\u4ee5\u53ca\u5bf9\u6570\u5750\u6807\u4e0b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7ed9\u836f\u540e\u7684\u836f\u65f6\u66f2\u7ebf\u3001\u4e0d\u540c\u836f\u7269\u5236\u5242\u7684\u5e73\u5747\u836f\u65f6\u66f2\u7ebf\u3002<\/span><\/p>\n

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\u5e94\u63d0\u4f9b\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u51e0\u4f55\u5747\u503c\u6bd4\u53ca\u5176\u7f6e\u4fe1\u533a\u95f4\u4f30\u8ba1\u7ed3\u679c\u3002<\/span><\/p>\n


<\/p>\n

\u4e94\u3001\u6570\u636e\u7ba1\u7406<\/span><\/strong><\/span><\/h1>\n

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\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u751f\u7269\u6837\u672c\u5206\u6790\u7b49\u6570\u636e\u4e3a\u5916\u90e8\u6570\u636e\uff0c\u5728\u6837\u672c\u5206\u6790\u53ca\u76f8\u5173\u6570\u636e\u4f20\u8f93\u8fc7\u7a0b\u4e2d\u5e94\u4fdd\u6301\u76f2\u6001\uff0c\u5e76\u6309\u7167\u63d0\u524d\u5236\u5b9a\u7684\u4f20\u8f93\u534f\u8bae\u8fdb\u884c\u6570\u636e\u4f20\u8f93\u3002\u8bd5\u9a8c\u6d89\u53ca\u5230\u7684\u751f\u7269\u6837\u672c\u5206\u6790\u3001\u6570\u636e\u4f20\u8f93\u548c\u7edf\u8ba1\u5206\u6790\u76f8\u5173\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u5e94\u7ecf\u8fc7\u9a8c\u8bc1\u5e76\u4fdd\u6301\u9a8c\u8bc1\u72b6\u6001\u3002<\/span><\/p>\n


<\/p>\n

\u516d\u3001\u53c2\u8003\u6587\u732e<\/span><\/strong><\/span><\/h1>\n

1.CFDA\uff1a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219. 2016\u5e743\u6708.<\/span><\/p>\n

2.CFDA\uff1a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219. 2016\u5e746\u6708.<\/span><\/p>\n

3.FDA\uff1aGuidance for Industry: Statistical Approaches to EstablishingBioequivalence. Jan 2001.<\/span><\/p>\n

4.EMA\uff1aGuideline on the Investigation of Bioequivalence. Aug 2010.<\/span><\/p>\n

5.EMA\uff1aQuestions & Answers: Positions on Specific Questions Addressedto the Pharmacokinetics Working Party. Nov 2015.<\/span><\/p>\n


<\/p>\n

\u4e03\u3001\u672f\u8bed\u8868<\/span><\/strong><\/span><\/p>\n

\"\u5b9a\u7a3f\uff01BE\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u548c\u9ad8\u53d8\u5f02\u836f\u7269BE\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u51fa\u6765\u4e86\"<\/p>\n


<\/p>\n

\u9644\u4ef62<\/span><\/strong><\/span><\/p>\n

 <\/span><\/p>\n

\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

 <\/span><\/p>\n

\u4e00\u3001\u6982\u8ff0<\/span><\/strong><\/span><\/h1>\n

\u5316\u5b66\u836f\u7269\u5236\u5242\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\uff0c\u901a\u5e38\u91c7\u7528\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\uff08Average bioequivalence,ABE\uff09\u65b9\u6cd5\uff0c\u7b49\u6548\u6807\u51c6\u4e3a\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u4e3b\u8981\u836f\u52a8\u5b66\u53c2\u6570\uff08AUC\u548cCmax<\/sub>\uff09\u51e0\u4f55\u5747\u503c\u6bd4\u768490%\u7f6e\u4fe1\u533a\u95f4\u843d\u572880.00%~125.00%\u8303\u56f4\u5185\u3002<\/span><\/p>\n

\u67d0\u4e9b\u836f\u7269\u7531\u4e8e\u751f\u7269\u5229\u7528\u5ea6\u8fc7\u4f4e\u3001\u9178\u4e0d\u7a33\u5b9a\u3001\u5438\u6536\u524d\u7684\u5e7f\u6cdb\u4ee3\u8c22\u7b49\u539f\u56e0\uff0c\u5bfc\u81f4\u4e00\u4e2a\u6216\u591a\u4e2a\u836f\u52a8\u5b66\u53c2\u6570\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\uff08Within-subject coefficient of variation,CVW<\/sub><\/em>%\uff09\u5927\u4e8e\u6216\u7b49\u4e8e30%\uff0c\u79f0\u4e3a\u9ad8\u53d8\u5f02\u836f\u7269\uff08Highly variable drug, HVD\uff09\u3002\u5728\u5176\u4ed6\u56e0\u7d20\u4e0d\u53d8\u7684\u60c5\u51b5\u4e0b\uff0c\u968f\u7740\u4e2a\u4f53\u5185\u53d8\u5f02\u589e\u52a0\uff0c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6240\u9700\u53d7\u8bd5\u8005\u6570\u91cf\u4e5f\u4f1a\u76f8\u5e94\u589e\u52a0\u3002\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\uff0c\u91c7\u7528\u5e38\u89c4\u6837\u672c\u91cf\u548c\u7b49\u6548\u6027\u5224\u5b9a\u6807\u51c6\uff0c\u6709\u65f6\u5373\u4f7f\u53c2\u6bd4\u5236\u5242\u4e0e\u81ea\u8eab\u76f8\u6bd4\u8f83\uff0c\u4e5f\u53ef\u80fd\u51fa\u73b0\u4e0d\u80fd\u8bc1\u660e\u5176\u751f\u7269\u7b49\u6548\u7684\u60c5\u51b5\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u5b89\u5168\u6027\u8f83\u597d\u3001\u6cbb\u7597\u7a97\u8f83\u5bbd\u7684\u9ad8\u53d8\u5f02\u836f\u7269\uff0c\u5728\u5145\u5206\u79d1\u5b66\u8bba\u8bc1\u7684\u57fa\u7840\u4e0a\u548c\u4fdd\u8bc1\u516c\u4f17\u7528\u836f\u5b89\u5168\u3001\u6709\u6548\u7684\u524d\u63d0\u4e0b\uff0c\u901a\u8fc7\u90e8\u5206\u91cd\u590d\u6216\u5b8c\u5168\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u6839\u636e\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\uff0c\u91c7\u7528\u53c2\u6bd4\u5236\u5242\u6807\u5ea6\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\uff08Reference-scaled average bioequivalence, RSABE\uff09\u65b9\u6cd5\uff0c\u5c06\u7b49\u6548\u6027\u5224\u5b9a\u6807\u51c6\u572880.00%~125.00%\u7684\u57fa\u7840\u4e0a\u9002\u5f53\u653e\u5bbd\uff0c\u53ef\u51cf\u5c11\u4e0d\u5fc5\u8981\u7684\u4eba\u7fa4\u66b4\u9732\uff0c\u8fbe\u5230\u79d1\u5b66\u8bc4\u4ef7\u4e0d\u540c\u5236\u5242\u662f\u5426\u751f\u7269\u7b49\u6548\u7684\u76ee\u7684\u3002<\/span><\/p>\n

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<\/p>\n

\u4e8c\u3001\u7814\u7a76\u603b\u4f53\u8bbe\u8ba1<\/span><\/strong><\/span><\/h1>\n

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\uff08\u4e00\uff09\u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/h2>\n

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1.\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/p>\n

\uff081\uff09\u975e\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/p>\n

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\uff082\uff09\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/p>\n

\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u53ef\u5206\u4e3a\u4e09\u5468\u671f\u90e8\u5206\u91cd\u590d\uff08\u4ec5\u91cd\u590d\u4f7f\u7528\u53c2\u6bd4\u5236\u5242\uff09\u548c\u56db\u5468\u671f\u5b8c\u5168\u91cd\u590d\uff08\u91cd\u590d\u4f7f\u7528\u53c2\u6bd4\u5236\u5242\u548c\u53d7\u8bd5\u5236\u5242\uff09\u4ea4\u53c9\u8bbe\u8ba1\u3002\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u53ef\u4fdd\u8bc1\u540c\u4e00\u53d7\u8bd5\u8005\u81f3\u5c11\u670d\u7528\u53c2\u6bd4\u5236\u5242\u4e24\u6b21\uff0c\u83b7\u5f97\u786e\u5207\u7684\u53c2\u6bd4\u5236\u5242\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\uff0c\u4ee5\u51b3\u5b9a\u662f\u5426\u91c7\u7528RSABE\u65b9\u6cd5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u3002\u5e38\u91c7\u7528\u7684\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u89c1\u88681\u548c\u88682\u3002<\/span><\/p>\n

\u88681  \u4e24\u5236\u5242\u3001\u4e09\u5e8f\u5217\u3001\u4e09\u5468\u671f\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/p>\n\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

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2<\/span><\/p>\n<\/td>\n

\n

3<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

3<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

\u88682  \u4e24\u5236\u5242\u3001\u4e24\u5e8f\u5217\u3001\u56db\u5468\u671f\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/p>\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

3<\/span><\/p>\n<\/td>\n

\n

4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

2.\u5e73\u884c\u7ec4\u8bbe\u8ba1<\/span><\/p>\n

\u7279\u6b8a\u60c5\u51b5\u4e0b\uff08\u4f8b\u5982\u957f\u534a\u8870\u671f\u836f\u7269\uff09\u53ef\u91c7\u7528\u5e73\u884c\u7ec4\u8bbe\u8ba1\u3002\u4e0e\u4ea4\u53c9\u8bbe\u8ba1\u76f8\u6bd4\uff0c\u5e73\u884c\u7ec4\u8bbe\u8ba1\u9700\u8981\u66f4\u5927\u7684\u6837\u672c\u91cf\u3002<\/span><\/p>\n

\u4e00\u822c\u5e94\u91c7\u7528\u5355\u6b21\u7ed9\u836f\u8fdb\u884c\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002\u82e5\u57fa\u4e8e\u5b89\u5168\u6027\u8003\u8651\uff0c\u9700\u5165\u9009\u6b63\u5728\u8fdb\u884c\u836f\u7269\u6cbb\u7597\u4e14\u6cbb\u7597\u4e0d\u53ef\u95f4\u65ad\u7684\u60a3\u8005\uff0c\u53ef\u5728\u591a\u6b21\u7ed9\u836f\u8fbe\u7a33\u6001\u540e\uff0c\u91c7\u7528ABE\u65b9\u6cd5\u8fdb\u884c\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u3002<\/span><\/p>\n

\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u5176\u4ed6\u8981\u6c42\u53ef\u53c2\u8003\u300a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\u53ca\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u6837\u672c\u91cf\u4f30\u8ba1<\/span><\/h2>\n

\u8bd5\u9a8c\u524d\u9700\u5145\u5206\u4f30\u8ba1\u6240\u9700\u7684\u6837\u672c\u91cf\uff0c\u4ee5\u4fdd\u8bc1\u8db3\u591f\u7684\u68c0\u9a8c\u6548\u80fd\u3002\u5bf9\u4e8eABE\u65b9\u6cd5\uff0c\u53ef\u7efc\u5408\u8003\u8651\u8bd5\u9a8c\u8bbe\u8ba1\u3001\u68c0\u9a8c\u6c34\u51c6\u3001\u68c0\u9a8c\u6548\u80fd\u3001\u5236\u5242\u95f4\u5e73\u5747\u751f\u7269\u5229\u7528\u5ea6\u53ef\u80fd\u7684\u5dee\u5f02\u3001\u53c2\u6bd4\u5236\u5242\u836f\u52a8\u5b66\u53c2\u6570\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\uff0c\u5efa\u8bae\u5145\u5206\u8003\u8651\u7814\u7a76\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u7684\u53d7\u8bd5\u8005\u8131\u843d\u7b49\u56e0\u7d20\uff0c\u8fdb\u884c\u6837\u672c\u91cf\u4f30\u8ba1\u3002\u5177\u4f53\u53c2\u89c1\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u3002<\/span><\/span><\/p>\n

RSABE\u65b9\u6cd5\u7684\u6837\u672c\u91cf\u4f30\u8ba1\u53ef\u901a\u8fc7\u8ba1\u7b97\u673a\u6a21\u62df\u7684\u65b9\u6cd5\uff1b\u4e5f\u53ef\u5c06\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u6807\u51c6\u5deeSWR<\/sub><\/em>\u89c6\u4e3a\u5e38\u6570\uff0c\u5148\u6c42\u5f97\u7ecf\u8c03\u6574\u7684\u7b49\u6548\u6027\u754c\u503c\uff0c\u518d\u4ee3\u5165\u5230\u76f8\u5e94\u8bbe\u8ba1\u4e0b\u57fa\u4e8eABE\u65b9\u6cd5\u7684\u8ba1\u7b97\u516c\u5f0f\u6c42\u7b97\uff0c\u5efa\u8bae\u9002\u5f53\u589e\u52a0\u6837\u672c\u91cf\u8fdb\u884c\u4fdd\u5b88\u4f30\u8ba1\u3002<\/span><\/p>\n


<\/p>\n

\u4e09\u3001\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5<\/span><\/strong><\/span><\/h1>\n

\u5e94\u5728\u7814\u7a76\u65b9\u6848\u548c\u7edf\u8ba1\u5206\u6790\u8ba1\u5212\u4e2d\u63d0\u524d\u5236\u5b9a\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u65b9\u6cd5\uff0c\u82e5\u9009\u62e9\u975e\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u6216\u5e73\u884c\u7ec4\u8bbe\u8ba1\uff0c\u5e94\u91c7\u7528ABE\u65b9\u6cd5\uff1b\u82e5\u9009\u62e9\u90e8\u5206\u91cd\u590d\u6216\u5b8c\u5168\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u5219\u53ef\u91c7\u7528ABE\u65b9\u6cd5\u6216RSABE\u65b9\u6cd5\u3002\u4e0eABE\u65b9\u6cd5\u76f8\u6bd4\uff0cRSABE\u65b9\u6cd5\u4f9d\u636e\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u9002\u5f53\u653e\u5bbd\u4e86\u7b49\u6548\u6027\u5224\u5b9a\u6807\u51c6\u3002<\/span><\/p>\n

\uff08\u4e00\uff09\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5<\/span><\/h2>\n

\u91c7\u7528ABE\u65b9\u6cd5\u8bc4\u4ef7\u65f6\uff0c\u5e94\u4ee5\u4e3b\u8981\u836f\u52a8\u5b66\u53c2\u6570\uff08AUC\u548cCmax<\/sub>\uff09\u51e0\u4f55\u5747\u503c\u6bd4\u768490%\u7f6e\u4fe1\u533a\u95f4\u843d\u572880.00%~125.00%\u7684\u8303\u56f4\u5185\u4e3a\u7b49\u6548\u6807\u51c6\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u53c2\u6bd4\u5236\u5242\u6807\u5ea6\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5<\/span><\/h2>\n

RSABE\u6cd5\u4e3b\u8981\u5206\u4e3a\u4e0b\u5217\u4e09\u6b65\uff1a<\/span><\/p>\n

1.\u8ba1\u7b97\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u6807\u51c6\u5dee\uff08SWR<\/sub><\/em>\uff09<\/span><\/p>\n

\u91c7\u7528\u90e8\u5206\u91cd\u590d\u6216\u5b8c\u5168\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u53ef\u83b7\u5f97\u53d7\u8bd5\u8005\u4e24\u6b21\u670d\u7528\u53c2\u6bd4\u5236\u5242\u540e\uff0c\u4e3b\u8981\u836f\u52a8\u5b66\u53c2\u6570\u7684\u4e2a\u4f53\u5185\u6807\u51c6\u5dee\uff08SWR<\/sub><\/em>\uff09\uff0cSWR<\/sub><\/em>\u53ef\u901a\u8fc7\u516c\u5f0f1\u8ba1\u7b97\uff1a<\/span><\/p>\n

<\/span>          \uff08\u516c\u5f0f1\uff09<\/span><\/p>\n

\u5176\u4e2d\uff0ci<\/em>\u4e3a\u7814\u7a76\u4e2d\u7684\u5e8f\u5217\u7f16\u53f7\uff08m<\/em>\u5728\u90e8\u5206\u91cd\u590d\u548c\u5b8c\u5168\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u4e2d\u5206\u522b\u4e3a3\u548c2\uff0cni<\/sub><\/em>\u4e3a\u7b2ci<\/em>\u4e2a\u5e8f\u5217\u4e2d\u53d7\u8bd5\u8005\u4eba\u6570\uff09\uff1bj<\/em>\u4e3a\u5e8f\u5217\u5185\u53d7\u8bd5\u8005\u7f16\u53f7\uff1bDij<\/sub>\uff08Rij1<\/sub>-Rij2<\/sub>\uff09<\/em>\u4ee3\u8868\u53c2\u6bd4\u5236\u5242\u4e24\u6b21\u7ed9\u836f\u540e\u81ea\u7136\u5bf9\u6570\u8f6c\u5316\u540e\u836f\u52a8\u5b66\u53c2\u6570\u7684\u5dee\u503c\uff1b<\/span>\uff1bn<\/em>\u4e3a\u7814\u7a76\u4e2d\u53d7\u8bd5\u8005\u603b\u4eba\u6570\u3002\u4e0d\u540c\u836f\u52a8\u5b66\u53c2\u6570\u7684SWR<\/sub><\/em>\u9700\u5206\u522b\u8ba1\u7b97\u3002<\/span><\/p>\n

SWR<\/sub><\/span><\/em>\u4e0eCVW<\/sub>%<\/em>\u5b58\u5728\u4ee5\u4e0b\u6362\u7b97\u5173\u7cfb\uff1a<\/span><\/span><\/p>\n

<\/span>             \uff08\u516c\u5f0f2\uff09<\/span><\/span><\/p>\n

\u82e5SWR<\/sub><\/em>\u22650.294\uff0c\u5373CVW<\/sub>%<\/em>\u226530%\uff0c\u53ef\u91c7\u7528RSABE\u65b9\u6cd5\u8fdb\u884c\u7b49\u6548\u6027\u8bc4\u4ef7\uff08\u5e94\u7528\u4e8eAUC\u3001Cmax<\/sub>\u4e24\u8005\u4e4b\u4e2d\u4efb\u610f\u4e00\u4e2a\u6216\u5168\u90e8\u91c7\u7528\uff09\u3002\u82e5SWR<\/sub><\/em>\uff1c0.294\uff0c\u5373CVW<\/sub>%<\/em>\uff1c30%\uff0c\u5219\u5e94\u91c7\u7528ABE\u65b9\u6cd5\u8bc4\u4ef7\u751f\u7269\u7b49\u6548\u6027\u3002<\/span><\/p>\n

2.\u8ba1\u7b97\u4ee5\u4e0b\u7b97\u5f0f\u7684\u5355\u4fa795%\u7f6e\u4fe1\u533a\u95f4\u4e0a\u9650\uff08Upper bound of 95% confidence interval\uff09<\/span><\/p>\n

<\/span><\/p>\n

\u8fd0\u7528Howe\u4e00\u9636\u903c\u8fd1\u6cd5\u6765\u786e\u5b9a<\/span>\u7684\u5355\u4fa795%\u7f6e\u4fe1\u533a\u95f4\u4e0a\u9650\u3002\u5f0f\u4e2d<\/span><\/span>\u548c<\/span>\u5206\u522b\u8868\u793a\u5728\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u5206\u522b\u83b7\u5f97\u7684\u81ea\u7136\u5bf9\u6570\u8f6c\u6362\u7684AUC\u6216Cmax<\/sub>\u7684\u5747\u503c\u3002<\/span><\/span><\/p>\n

<\/span>              \uff08\u516c\u5f0f3\uff09<\/span><\/span><\/p>\n

\u03c3w0<\/sub>\u4e3a\u6cd5\u89c4\u9650\u5ea6\uff08Regulatory limit, \u4e00\u822c\u53d6\u03c3w0<\/sub>=0.25\uff09\u3002<\/span><\/p>\n

3.\u7b49\u6548\u6027\u5224\u65ad\u6807\u51c6<\/span><\/p>\n

\u82e5<\/span><\/span>\u7684\u5355\u4fa795%\u7f6e\u4fe1\u533a\u95f4\u4e0a\u9650\u5c0f\u4e8e\u7b49\u4e8e\u96f6\uff0c\u540c\u65f6\uff0c\u5236\u5242\u95f4\u4e3b\u8981\u836f\u52a8\u5b66\u53c2\u6570\u7684\u51e0\u4f55\u5747\u503c\u6bd4\uff08Geometricmean ratio, GMR\uff09\u7684\u70b9\u4f30\u8ba1\u503c\u572880.00%~125.00%\u8303\u56f4\u5185\uff0c\u53ef\u5224\u5b9a\u53d7\u8bd5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u836f\u52a8\u5b66\u8bc4\u4ef7\u6307\u6807\uff08AUC\u6216Cmax<\/sub>\uff09\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002\u53ea\u6709AUC\u548cCmax<\/sub>\u5747\u5224\u5b9a\u7b49\u6548\u624d\u53ef\u7533\u660e\u8be5\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u56db\u3001\u62a5\u544a\u603b\u7ed3\u4e0e\u8ba8\u8bba<\/span><\/strong><\/span><\/h1>\n

\u7814\u7a76\u62a5\u544a\u64b0\u5199\u5185\u5bb9\u9664\u5e94\u7b26\u5408\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u4e00\u822c\u6280\u672f\u8981\u6c42\u5916\uff0c\u8fd8\u5e94\u91cd\u70b9\u8fdb\u884c\u9ad8\u53d8\u5f02\u836f\u7269\u7279\u5f81\u8bba\u8bc1\u3001\u98ce\u9669\u8bc4\u4f30\u53ca\u76f8\u5e94\u7684\u6570\u636e\u5206\u6790\u62a5\u544a\u3002<\/span><\/p>\n

\uff08\u4e00\uff09\u9ad8\u53d8\u5f02\u7279\u5f81\u8bba\u8bc1<\/span><\/h2>\n

\u901a\u5e38\u60c5\u51b5\u4e0b\uff0c\u5bfc\u81f4\u836f\u7269\u4e2a\u4f53\u5185\u9ad8\u53d8\u5f02\u7279\u5f81\u7684\u6f5c\u5728\u56e0\u7d20\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a\uff081\uff09\u80c3\u80a0\u9053pH\u503c\u3001\u80c3\u80a0\u52a8\u529b\u3001\u80c3\u6392\u7a7a\u3001\u5c0f\u80a0\u8f6c\u8fd0\u548c\u7ed3\u80a0\u9a7b\u7559\u65f6\u95f4\u7b49\u5f71\u54cd\u751f\u7269\u5229\u7528\u5ea6\u7684\u751f\u7406\u56e0\u7d20\uff1b\uff082\uff09\u836f\u7269\u5206\u5e03\u3001\u9996\u8fc7\u4ee3\u8c22\u3001\u5168\u8eab\u4ee3\u8c22\u548c\u6e05\u9664\u7b49\u836f\u7269\u56fa\u6709\u6027\u8d28\uff1b\uff083\uff09\u6eb6\u89e3\u6027\u7b49\u539f\u6599\u836f\u7684\u7406\u5316\u6027\u8d28\uff1b\uff084\uff09\u836f\u7269\u6eb6\u51fa\u7b49\u5236\u5242\u7684\u5904\u65b9\u56e0\u7d20\uff1b\uff085\uff09\u996e\u98df\u7b49\u5176\u4ed6\u56e0\u7d20\u3002<\/span><\/p>\n

\u91c7\u7528RSABE\u65b9\u6cd5\u524d\uff0c\u5e94\u57fa\u4e8e\u5df2\u6709\u7684\u6587\u732e\u8d44\u6599\u3001\u9884\u8bd5\u9a8c\u7ed3\u679c\u7b49\uff0c\u5145\u5206\u5206\u6790\u53c2\u6bd4\u5236\u5242\u751f\u7269\u836f\u5242\u5b66\u7279\u5f81\u548c\u4f53\u5185\u8fc7\u7a0b\uff0c\u4f30\u7b97\u4e3b\u8981\u836f\u52a8\u5b66\u53c2\u6570\uff08AUC\u548c\/\u6216Cmax<\/sub>\uff09\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\uff0c\u5145\u5206\u8bba\u8bc1\u91c7\u7528RSABE\u65b9\u6cd5\u7684\u9002\u7528\u6027\u3002\u5fc5\u8981\u65f6\uff0c\u8fd8\u9700\u901a\u8fc7\u8865\u5145\u76f8\u5173\u8bd5\u9a8c\u52a0\u4ee5\u8bba\u8bc1\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u98ce\u9669\u8bc4\u4f30<\/span><\/h2>\n

\u901a\u5e38\u60c5\u51b5\u4e0b\uff0c\u53ea\u6709\u5b89\u5168\u6027\u8f83\u597d\u3001\u6cbb\u7597\u7a97\u8f83\u5bbd\u7684\u9ad8\u53d8\u5f02\u836f\u7269\u624d\u53ef\u91c7\u7528RSABE\u65b9\u6cd5\u8fdb\u884c\u4e0d\u540c\u5236\u5242\u7684\u751f\u7269\u7b49\u6548\u6027\u7684\u8bc4\u4ef7\u3002\u7531\u836f\u7269\u7684\u56fa\u6709\u5c5e\u6027\u3001\u673a\u4f53\u751f\u7406\u56e0\u7d20\u7b49\u5f15\u8d77\u7684\u9ad8\u53d8\u5f02\u6027\u4e00\u822c\u65e0\u6cd5\u901a\u8fc7\u63d0\u9ad8\u5236\u5242\u548c\u8bd5\u9a8c\u8d28\u91cf\u800c\u6d88\u9664\uff0c\u7531\u4e8e\u5b58\u5728\u8fd9\u79cd\u7279\u6027\u7684\u53c2\u6bd4\u5236\u5242\u4e0a\u5e02\u8fc7\u7a0b\u4e2d\u5df2\u5f97\u5230\u5145\u5206\u66b4\u9732\u5e76\u7ecf\u8fc7\u4e34\u5e8a\u7814\u7a76\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8bc1\u660e\uff0c\u6b64\u65f6\uff0c\u91c7\u7528RSABE\u65b9\u6cd5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u662f\u53ef\u63a5\u53d7\u7684\u3002<\/span><\/p>\n

\u91c7\u7528RSABE\u65b9\u6cd5\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\uff0c\u5e94\u8fdb\u884c\u4e25\u683c\u79d1\u5b66\u7684\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u8bd5\u9a8c\u901a\u5e38\u5e94\u5728\u540c\u4e00\u4e2d\u5fc3\u5b8c\u6210\uff0c\u5e76\u5e94\u907f\u514d\u8bd5\u9a8c\u8d28\u91cf\u5bf9\u4e2a\u4f53\u5185\u53d8\u5f02\u7684\u4f30\u8ba1\u5f15\u5165\u504f\u501a\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u7531\u5236\u5242\u8d28\u91cf\u6216\u8bd5\u9a8c\u64cd\u4f5c\u4e0d\u5f53\u7b49\u539f\u56e0\u5f15\u8d77\u7684\u9ad8\u53d8\u5f02\uff0c\u4e0d\u9002\u5408\u91c7\u7528RSABE\u65b9\u6cd5\u3002\u7533\u529e\u8005\u5e94\u786e\u4fdd\u5236\u5242\u8d28\u91cf\u7684\u5747\u4e00\u6027\u53ca\u53ef\u63a7\u6027\uff0c\u52a0\u5f3a\u7814\u7a76\u8fc7\u7a0b\u4e2d\u7684\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\uff0c\u5e76\u5728\u7814\u7a76\u62a5\u544a\u4e2d\u6bd4\u8f83\u4e34\u5e8a\u7814\u7a76\u6240\u83b7\u5f97\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u4e0e\u6587\u732e\u6570\u636e\u7684\u5dee\u5f02\uff0c\u907f\u514d\u751f\u7269\u7b49\u6548\u6027\u5224\u5b9a\u6807\u51c6\u7684\u4e0d\u5f53\u653e\u5bbd\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u7ed3\u679c\u62a5\u544a<\/span><\/h2>\n

\u6839\u636e\u6587\u732e\u6216\u9884\u8bd5\u9a8c\u7684\u7814\u7a76\u7ed3\u679c\uff0c\u660e\u786e\u6b63\u5f0f\u8bd5\u9a8c\u6240\u9009\u62e9\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u7c7b\u578b\u548c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u65b9\u6cd5\uff0c\u5176\u4e2d\u5305\u62ec\u4e2a\u4f53\u5185\u53d8\u5f02\u7ed3\u679c\u4e0e\u9884\u671f\u6709\u5dee\u5f02\u65f6\u7684\u5907\u9009\u7edf\u8ba1\u65b9\u6cd5\u3002\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u62a5\u544a\u9664\u5e94\u7b26\u5408\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u548c\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u76f8\u5173\u6280\u672f\u8981\u6c42\u4ee5\u5916\uff0c\u82e5\u91c7\u7528RSABE\u65b9\u6cd5\uff0c\u8fd8\u5e94\u63d0\u4f9b\u5982\u4e0b\u4fe1\u606f\uff1a<\/span><\/p>\n

1\uff0e\u836f\u52a8\u5b66\u53c2\u6570AUC0-t<\/sub>\u3001AUC0-\u221e<\/sub>\u548cCmax<\/sub>\u7684\u4e2a\u4f53\u5185\u6807\u51c6\u5dee\uff08SWR<\/sub><\/em>\uff09\uff1b<\/span><\/p>\n

2.AUC0-t<\/sub>\u3001AUC0-\u221e<\/sub>\u548cCmax<\/sub>\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\uff08CVW<\/sub>%<\/em>\uff09\u53ca\u4e0e\u6587\u732e\u76f8\u5e94\u6570\u636e\u7684\u6bd4\u8f83\uff1b<\/span><\/p>\n

3..<\/span>\u7684\u5355\u4fa795%\u7f6e\u4fe1\u533a\u95f4\u4e0a\u9650\uff1b<\/span><\/p>\n

4.AUC0-t<\/sub>\u3001AUC0-\u221e<\/sub>\u548cCmax<\/sub>\u7684\u51e0\u4f55\u5747\u503c\u6bd4\u7684\u70b9\u4f30\u8ba1\u503c\u3002<\/span><\/p>\n


<\/p>\n

\u4e94\u3001\u7279\u6b8a\u8003\u8651<\/span><\/strong><\/span><\/h1>\n

\u5bf9\u4e8e\u66b4\u9732\u91cf-\u6548\u5e94\u66f2\u7ebf\u4e0d\u5e73\u7f13\u751a\u81f3\u9661\u5ced\u7684\u836f\u7269\uff0c\u5982\u66ff\u683c\u745e\u6d1b\u3001\u8fbe\u6bd4\u52a0\u7fa4\u7b49\uff0c\u5373\u4f7f\u4e2a\u4f53\u5185\u53d8\u5f02\u7cfb\u6570\u5927\u4e8e30%\uff0c\u4e5f\u4e0d\u5efa\u8bae\u91c7\u7528RSABE\u65b9\u6cd5\u653e\u5bbd\u7b49\u6548\u6027\u5224\u65ad\u6807\u51c6\uff0c\u4ee5\u907f\u514d\u67d0\u4e9b\u60a3\u8005\u53ef\u80fd\u7531\u4e8e\u66b4\u9732\u91cf\u589e\u52a0\u51fa\u73b0\u5b89\u5168\u6027\u98ce\u9669\u3002<\/span><\/p>\n

\u542b\u6709\u9ad8\u53d8\u5f02\u836f\u7269\u7684\u590d\u65b9\u5236\u5242\uff08\u4f8b\u5982\u7f2c\u6c99\u5766\u6c28\u6c2f\u5730\u5e73\u7247\uff09\u5728\u8bd5\u9a8c\u8bbe\u8ba1\u65f6\u5e94\u5145\u5206\u8003\u8651\u5355\u4e2a\u836f\u7269\u7684\u751f\u7269\u836f\u5242\u5b66\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u70b9\uff0c\u6839\u636e\u5176\u4e2d\u4e2a\u4f53\u5185\u53d8\u5f02\u8f83\u9ad8\u7684\u836f\u7269\u8fdb\u884c\u76f8\u5e94\u6837\u672c\u91cf\u4f30\u8ba1\uff0c\u5404\u7ec4\u6210\u836f\u7269\u5219\u5e94\u5206\u522b\u9009\u62e9\u9002\u5b9c\u7684\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u3002<\/span><\/p>\n


<\/p>\n

\u516d\u3001\u53c2\u8003\u6587\u732e<\/span><\/strong><\/span><\/h1>\n

1. CFDA\uff1a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219. 2016\u5e743\u6708.<\/span><\/p>\n

2. CFDA\uff1a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219. 2016\u5e746\u6708.<\/span><\/p>\n

3. FDA\uff1aDraft Guidance on Progesterone. Feb 2011.<\/span><\/p>\n

4. Lawrence X. Yu, Bing V. Li. FDA Bioequivalence Standards. Jul 2014.<\/span><\/p>\n

5. FDA\uff1aDraft Guidance on Dabigatran Etexilate Mesylate. Jul 2017.<\/span><\/p>\n


<\/p>\n

\u9644\u5f55<\/span><\/strong><\/span><\/p>\n

\u9644\u5f551   \u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u51b3\u7b56\u6811<\/span><\/h3>\n


<\/p>\n

 <\/span><\/p>\n

\"\u5b9a\u7a3f\uff01BE\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u548c\u9ad8\u53d8\u5f02\u836f\u7269BE\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u51fa\u6765\u4e86\"<\/p>\n

 
<\/span><\/p>\n

 <\/span><\/p>\n

\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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