{"id":66592,"date":"2018-11-06T01:00:00","date_gmt":"2018-12-07T04:03:20","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/2529a621d0\/"},"modified":"2018-12-07T12:03:26","modified_gmt":"2018-12-07T04:03:26","slug":"2529a621d0","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/66592\/","title":{"rendered":"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727"},"content":{"rendered":"
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\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n
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\u70b9\u51fb\u4e0a\u65b9\u84dd\u8272\u5b57\u4f53<\/span>\uff0c\u5173\u6ce8\u6211\u4eec<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
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\u6458\u8981:<\/strong><\/span>\u672c\u6587\u4ece\u8bd5\u9a8c\u8bbe\u8ba1\u3001\u6837\u672c\u542b\u91cf\u7684\u4f30\u8ba1\u3001\u53d7\u8bd5\u8005\u7684\u9009\u62e9\u4ee5\u53ca\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u65b9\u9762\u7efc\u8ff0\u4e86\u76ee\u524d\u56fd\u5185\u5916\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u73b0\u72b6, \u603b\u7ed3\u4e86\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u7684\u5404\u79cd\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5, \u5e76\u63d0\u51fa\u4e86\u4e00\u4e9b\u5b58\u5728\u95ee\u9898\u3002<\/p>\n

\u5173\u952e\u8bcd:<\/strong><\/span>\u751f\u7269\u7b49\u6548\u6027;\u8bd5\u9a8c\u8bbe\u8ba1 ;\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u751f\u7269\u7b49\u6548\u6027 [ 1] (bioequivalence)\u662f\u6307\u540c\u4e00\u79cd\u836f\u7269\u7684\u4e0d\u540c\u5236\u5242\u5728\u76f8\u540c\u5b9e\u9a8c\u6761\u4ef6\u4e0b , \u7ed9\u4e88\u76f8\u540c\u7684\u5242\u91cf, \u5176\u5438\u6536\u901f\u5ea6\u548c\u7a0b\u5ea6\u6ca1\u6709\u660e\u663e\u5dee\u5f02\u3002 \u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5728\u65b0\u836f\u5f00\u53d1\u548c\u65b0\u836f\u8bc4\u4ef7\u8fc7\u7a0b\u4e2d\u53d1\u6325\u7740\u975e\u5e38\u91cd\u8981\u7684\u4f5c\u7528\u3002\u5728\u5f00\u53d1\u5df2\u7ecf\u4e34\u5e8a\u8bd5\u9a8c\u8bc1\u5b9e\u7597\u6548\u548c\u5b89\u5168\u6027\u7684\u5df2\u4e0a\u5e02\u836f\u7269\u7684\u65b0\u5242\u578b\u3001\u8bc1\u660e\u65b0\u5242\u578b\u4e0e\u539f\u5242\u578b\u662f\u5426\u751f\u7269\u7b49\u6548;\u5728\u521b\u65b0\u836f\u4e13\u5229\u8fc7\u671f\u540e, \u5f00\u53d1\u5176\u4eff\u5236\u836f\u7269, \u8bc1\u660e\u4eff\u5236\u836f\u7269\u4e0e\u521b\u65b0\u836f\u7269\u662f\u5426\u5177\u6709\u7b49\u540c\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027;\u53e6\u5916, \u5728\u65b0\u836f\u83b7\u51c6\u4e0a\u5e02\u540e\u5176\u5236\u5242\u5305\u62ec\u5904\u65b9\u548c\u5de5\u827a\u53c8\u7ecf\u8fc7\u5927\u5e45\u5ea6\u6539\u53d8\u60c5\u51b5\u4e0b, \u5728\u6240\u6709\u8fd9\u4e9b\u60c5\u51b5\u4e0b, \u901a\u5e38\u5747\u4e0d\u9700\u8981\u91cd\u590d\u4e34\u5e8a\u8bd5\u9a8c\u53bb\u786e\u8ba4\u8bd5\u9a8c\u5236\u5242\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027, \u53ea\u9700\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c, \u901a\u8fc7\u6bd4\u8f83\u53d7\u8bd5\u836f\u54c1\u4e0e\u53c2\u6bd4\u836f\u54c1\u836f\u52a8\u5b66\u53c2\u6570\u7684\u7b49\u540c\u6027, \u63a8\u65ad\u4e24\u79cd\u836f\u54c1\u5c06\u4ea7\u751f\u7c7b\u4f3c\u7684\u6cbb\u7597\u6548\u679c \u3002\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u76ee\u6807\u662f\u8981\u8bc1\u5b9e\u7b49\u91cf\u540c\u79cd\u836f\u7269\u7684\u4e24\u79cd\u5236\u5242\u751f\u7269\u5229\u7528\u5ea6\u5b8c\u5168\u76f8\u540c, \u6700\u7ec8\u4f7f\u5f97\u5728\u66ff\u6362\u4f7f\u7528\u76f8\u5173\u7684\u4e24\u79cd\u5236\u5242\u65f6\u5177\u6709\u76f8\u540c\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002 \u672c\u6587\u9488\u5bf9\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u8bbe\u8ba1\u4e0e\u7edf\u8ba1\u548c\u4e00\u4e9b\u6709\u5f85\u89e3\u51b3\u7684\u95ee\u9898\u4f5c\u7b80\u8981\u6982\u8ff0\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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1 \u751f\u7269\u7b49\u6548\u6027\u7684\u5206\u7c7b<\/strong><\/p>\n<\/section>\n

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\u4ece\u7b49\u6548\u6027\u7684\u7a0b\u5ea6\u6765\u770b\u6709\u4e09\u79cd:\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027 (average bioequivalence,ABE), \u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027(populationbioequiva- lence,PBE), \u4e2a \u4f53 \u751f\u7269 \u7b49 \u6548 \u6027 (individualbioequivalence,IBE)\u3002<\/span><\/p>\n

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1.1 \u5e73\u5747\u751f\u7269\u7b49\u6548\u6027<\/strong><\/span> <\/span><\/strong><\/span>\u4eba\u7fa4\u4f7f\u7528 T\u836f\u7269\u4e0e\u4f7f\u7528 R\u836f\u7269\u6240\u5f97\u6548\u5e94, \u5176\u5e73\u5747\u503c\u76f8\u540c\u3002 ABE\u867d\u7136\u4fdd\u8bc1\u5e73\u5747\u6548\u5e94\u76f8\u540c, \u4f46\u4e0d\u4e00\u5b9a\u4fdd\u8bc1\u6548\u5e94\u7684\u53d8\u5f02\u5ea6\u76f8\u540c, \u5373\u4e24\u603b\u4f53\u7684\u5747\u503c\u76f8\u540c, \u4f46\u65b9\u5dee\u4e0d\u4e00\u5b9a\u76f8\u540c\u3002<\/p>\n

1.2 \u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027<\/strong><\/span> <\/span><\/span>\u4eba\u7fa4\u4f7f\u7528 T\u836f\u7269\u4e0e\u4f7f\u7528 R\u836f\u7269\u6240\u5f97\u6548\u5e94, \u4e0d\u4ec5\u5176\u5e73\u5747\u503c\u76f8\u540c, \u800c\u4e14\u6548\u5e94\u7684\u53d8\u5f02\u5ea6\u76f8\u540c, \u5373\u4e24\u603b\u4f53\u7684\u8fb9\u7f18\u5206\u5e03\u76f8\u540c\u3002 PBE\u867d\u4fdd\u8bc1\u5176\u8fb9\u7f18\u5206\u5e03\u76f8\u540c, \u4f46\u5bf9\u6bcf\u4e2a\u4e2a\u4f53\u800c\u8a00, \u4f7f\u7528 T\u836f\u7269\u4e0e\u4f7f\u7528 R\u836f\u7269\u6240\u5f97\u6548\u5e94\u4e0d\u4e00\u5b9a\u76f8\u540c\u3002 \u5373\u4e2a\u4f53\u4e0e\u836f\u7269\u95f4\u53ef\u80fd\u5b58\u5728\u4ea4\u4e92\u4f5c\u7528 (subject-by-formulationinter-action)\u3002<\/span><\/p>\n

1.3 \u4e2a\u4f53\u751f\u7269\u7b49\u6548\u6027<\/span><\/strong><\/span> <\/span>\u5bf9\u6bcf\u4e2a\u4e2a\u4f53\u800c\u8a00, \u4f7f\u7528 T\u836f\u7269\u4e0e\u4f7f\u7528R\u836f\u7269\u6240\u5f97\u6548\u5e94\u503c\u63a5\u8fd1\u3002 \u663e\u7136, \u5982\u679c\u4e2a\u4f53\u7b49\u6548, \u5219\u7fa4\u4f53\u7b49\u6548; \u5982\u679c\u7fa4\u4f53\u7b49\u6548, \u5219\u5e73\u5747\u7b49\u6548\u3002 \u53cd\u4e4b\u4e0d\u7136\u3002 \u4ece\u7b49\u6548\u7684\u7a0b\u5ea6\u6765\u8bb2,IBE\u6700\u5f3a, PBE\u5176\u6b21, ABE\u6700\u5f31\u3002 \u4ece\u5e94\u7528\u7684\u89d2\u5ea6\u6765\u8bb2, \u4e24\u4e2a\u5177\u6709\u4e2a\u4f53\u751f\u7269\u7b49\u6548\u6027\u7684\u836f\u7269, \u5177\u6709\u7528\u836f\u53ef\u4ea4\u66ff\u6027(switchability),\u5373\u67d0\u60a3\u8005\u5728\u670d\u7528\u67d0\u836f\u7269\u4e00\u6bb5\u65f6\u95f4\u540e, \u5982\u679c\u6539\u7528\u53e6\u4e00\u4e2a\u4e0e\u4e4b\u5177\u6709\u4e2a\u4f53\u7b49\u6548\u6027\u7684\u836f\u7269, \u53ef\u4ee5\u5f97\u5230\u540c\u6837\u7684\u6548\u679c;\u800c\u5177\u6709\u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027\u7684\u836f\u7269, \u5177\u6709\u5904\u65b9\u53ef\u9009\u62e9\u6027(prescribability), \u5373\u533b\u751f\u5728\u7ed9\u60a3\u8005\u521d\u6b21\u5f00\u836f\u65f6\u53ef\u4ee5\u4efb\u610f\u9009\u7528, \u8fd9\u5bf9\u4e8e\u8be5\u7c7b\u60a3\u8005\u7fa4\u4f53\u6765\u8bf4\u6548\u5e94\u662f\u76f8\u540c\u7684\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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2 \u751f\u7269\u7b49\u6548\u6027\u7684\u7814\u7a76\u8bbe\u8ba1<\/strong><\/p>\n<\/section>\n

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2.1 \u8bd5\u9a8c\u8bbe\u8ba1<\/strong><\/span><\/p>\n

2.1.1 \u975e\u91cd\u590d\u8bd5\u9a8c\u8bbe\u8ba1<\/strong>   \u7528\u4e8e ABE\u6216 PBE\u7814\u7a76\u3002<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
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2.1.2 \u91cd\u590d\u8bd5\u9a8c\u8bbe\u8ba1 [ 3] <\/span><\/strong> <\/span> \u4e09\u79cd\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u90fd\u53ef\u4ee5\u7528\u6b64\u79cd\u8bbe\u8ba1\u4f46 ABE\u6216 PBE\u7814\u7a76\u65f6\u4e0d\u4e00\u5b9a\u5fc5\u987b, \u800c IBE\u7814\u7a76\u65f6\u7531\u4e8e\u8981\u4f30\u8ba1\u4e2a\u4f53\u5185\u65b9\u5dee\u4ee5\u53ca\u4e2a\u4f53\u4e0e\u836f\u7269\u7684\u4ea4\u4e92\u4f5c\u7528, \u6240\u4ee5\u5fc5\u987b\u7528\u91cd\u590d\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
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2.2 \u6837\u672c\u542b\u91cf\u7684\u4f30\u8ba1[ 4, 5]<\/strong><\/span>    \u53d7\u8bd5\u8005\u4f8b\u6570\u5e94\u5f53\u7b26\u5408\u7edf\u8ba1\u5b66\u8981\u6c42, \u5bf9\u4e8e\u76ee\u524d\u7684\u7edf\u8ba1\u65b9\u6cd5, 18 \uff5e 24\u4f8b\u53ef\u6ee1\u8db3\u5927\u591a\u6570\u836f\u7269\u5bf9\u6837\u672c\u7684\u8981\u6c42, \u4f46\u5bf9\u4e8e\u67d0\u4e9b\u53d8\u5f02\u6027\u5927\u7684\u836f\u7269\u53ef\u80fd\u9700\u8981\u9002\u5f53\u589e\u52a0\u4f8b\u6570\u3002<\/p>\n

\u4e00\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4f8b\u6570\u591a\u5c11\u662f\u7531\u4e09\u4e2a\u57fa\u672c\u56e0\u7d20\u51b3\u5b9a\u7684[ 1] :(1)\u663e\u8457\u6027\u6c34\u5e73:\u5373 \u03b1\u503c\u7684\u5927\u5c0f, \u901a\u5e38\u53d6 0.05 \u6216 5  ;(2)\u628a\u63e1\u5ea6:\u5373 1 -\u03b2 \u503c\u7684\u5927\u5c0f, \u4e00\u822c\u5b9a\u4e3a\u4e0d\u5c0f\u4e8e 80  , \u5176\u4e2d \u03b2 \u662f\u72af\u7b2c I\u7c7b\u9519\u8bef\u7684\u6982\u7387, \u4e5f\u5c31\u662f\u628a\u5b9e\u9645\u6709\u6548\u8bef\u5224\u4e3a\u65e0\u6548\u7684\u6982\u7387;<\/span><\/p>\n

(3)\u53d8\u5f02\u6027(CV )\u548c\u5dee\u522b (\u03b8):\u4e24\u836f\u7b49\u6548\u6027\u68c0\u9a8c\u4e2d\u68c0\u6d4b\u6307\u6807\u7684\u53d8\u5f02\u6027\u548c\u5dee\u522b\u8d8a\u5927\u7684\u9700\u4f8b\u6570\u8d8a\u591a\u3002 \u5728\u8bd5\u9a8c\u524d\u5e76\u4e0d\u77e5\u9053 \u03b8\u548cCV , \u53ea\u80fd\u6839\u636e\u5df2\u6709\u7684\u53c2\u6bd4\u5236\u5242\u7684\u4e0a\u8ff0\u53c2\u6570\u6765\u4f30\u7b97\u6216\u8fdb\u884c\u9884\u8bd5\u9a8c\u3002 \u53e6\u5916, \u5f53\u4e00\u4e2a\u751f\u7269\u5229\u7528\u5ea6\u8bd5\u9a8c\u5b8c\u6210\u540e, \u53ef\u4ee5\u6839\u636e \u03b8\u3001CV \u548c\u628a\u63e1\u5ea6\u7b49\u53c2\u6570\u6765\u6c42 N\u503c, \u5e76\u4e0e\u8bd5\u9a8c\u6240\u9009\u62e9\u4f8b\u6570\u8fdb\u884c\u5bf9\u6bd4, \u68c0\u9a8c\u8bd5\u9a8c\u6240\u91c7\u7528\u4f8b\u6570\u662f\u5426\u5408\u9002\u3002<\/span><\/p>\n

2.2.1 ABE\u7814\u7a76\u7684\u6837\u672c\u542b\u91cf    <\/strong><\/span>\u6211\u56fd\u300a\u65b0\u836f\u5ba1\u6279\u529e\u6cd5\u300b(1999) \u548c 2002\u5e74\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b(\u8bd5\u884c )\u89c4\u5b9a\u8fdb\u884c ABE\u7814\u7a76\u65f6\u7684\u6837\u672c\u542b\u91cf\u4e00\u822c\u4e3a 18 \uff5e 24\u4f8b\u3002 \u5fc5\u8981\u65f6\u5e94\u6309\u7167\u7814\u7a76\u8bbe\u8ba1\u548c\u7edf\u8ba1\u539f\u7406\u8ba1\u7b97\u6240\u9700\u7684\u6837\u672c\u542b\u91cf\u3002<\/p>\n

2.2.2 PBE\u3001IBE\u7814\u7a76\u7684\u6837\u672c\u542b\u91cf<\/strong><\/span>  \u7531\u4e8e\u8bc4\u4ef7 PBE\u3001IBE\u7684\u7edf\u8ba1\u91cf\u662f\u7531\u6548\u5e94\u503c\u7684\u5747\u6570\u3001\u65b9\u5dee\u3001\u4e2a\u4f53\u5185\u7684\u65b9\u5dee\u4ee5\u53ca\u4e2a\u4f53\u4e0e\u836f\u7269\u7684\u4ea4\u4e92\u4f5c\u7528\u7ec4\u6210\u7684, \u56e0\u6b64\u6837\u672c\u542b\u91cf\u7684\u4f30\u8ba1\u662f\u57fa\u4e8e\u6a21\u62df\u6570\u636e\u4ea7\u751f\u7684\u3002 \u8be5\u6a21\u62df\u7cfb\u7edf\u6a21\u62df\u7684\u6570\u636e\u5176\u8bd5\u9a8c\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u5e73\u5747\u7b49\u6548\u6027\u5728\u65b9\u5dee\u548c\u836f\u7269\u4e0e\u4e2a\u4f53\u4e4b\u95f4\u7684\u4ea4\u4e92\u4f5c\u7528\u76f8\u540c\u7684\u60c5\u51b5\u4e0b, \u5176\u53d8\u5f02\u5ea6\u4e0d\u8d85\u8fc7 5 , \u8be5\u6837\u672c\u7684\u68c0\u9a8c\u6548\u80fd\u5e94\u8fbe\u5230 80\uff5e 90\u3002\u6837\u672c\u542b\u91cf\u8fd8\u4e0e\u53d8\u5f02\u5ea6\u7684\u5927\u5c0f\u4ee5\u53ca\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u6709\u5173\u3002 \u5728\u751f\u7269\u533b\u5b66\u6587\u732e\u548c \/\u6216\u521d\u6b65\u7814\u7a76\u4e2d\u53ef\u901a\u8fc7\u65b9\u5dee\u7684\u4f30\u7b97\u67e5\u627e\u67d0\u4e00\u836f\u7269\u53d7<\/span>\u8bd5\u8005\u7684\u4f8b\u6570\u3002<\/span><\/p>\n

\u7814\u7a76\u8005\u5e94\u8be5\u7eb3\u5165\u8db3\u591f\u591a\u7684\u53d7\u8bd5\u8005\u4ee5\u514d\u53d1\u751f\u8131\u843d, \u56e0\u4e3a\u8bd5\u9a8c\u4e2d\u66ff\u4ee3\u53d7\u8bd5\u8005\u5c06\u4f1a\u4f7f\u7edf\u8ba1\u5206\u6790\u548c\u6a21\u578b\u590d\u6742\u5316, \u4e00\u822c\u6765\u8bf4\u8131\u843d\u53d7\u8bd5\u8005\u6700\u597d\u4e0d\u88ab\u66ff\u4ee3\u3002\u7814\u7a76\u8005\u5982\u679c\u5fc5\u987b\u8981\u7528\u65b0\u7684\u53d7\u8bd5\u8005\u66ff\u4ee3\u8131\u843d\u8005\u9700\u5728\u8bd5\u9a8c\u8bb0\u5f55\u4e2d\u89e3\u91ca\u539f\u56e0, \u5e76\u8981\u89e3\u91ca\u53d7\u8bd5\u8005\u6837\u672c\u662f\u5426\u6765\u81ea\u66ff\u4ee3\u8005, \u5982\u679c\u4e0d\u662f, \u8981\u6d4b\u5b9a\u8be5\u66ff\u4ee3\u6837\u672c\u3002 \u5982\u679c\u8131\u843d\u7387<\/span>\u9ad8, \u7814\u7a76\u8005\u9700\u52a0\u5165\u66f4\u591a\u7684\u53d7\u8bd5\u8005, \u5219\u9700\u4fee\u6539\u7edf\u8ba1\u65b9\u6848\u3002 \u5176\u4ed6\u53d7<\/span>\u8bd5\u8005\u4e0d\u5e94\u5728\u6570\u636e\u5206\u6790\u7ed3\u675f\u540e\u7eb3\u5165\u5206\u6790\u9664\u975e\u8bd5\u9a8c\u5f00\u59cb\u5373\u4e3a\u4e00\u4e2a\u5e8f\u5217\u7684\u6216\u6210\u7ec4\u5e8f\u5217\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span><\/p>\n

2.3    \u53d7\u8bd5\u8005\u7684\u9009\u62e9[ 7]  <\/span><\/strong><\/span>  \u5173\u4e8e\u53d7\u8bd5\u8005\u7684\u9009\u62e9, \u4e0d\u540c\u56fd\u5bb6\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6307\u5357\u4e2d\u5bf9\u62db\u52df\u53d7\u8bd5\u8005\u7684\u6761\u4ef6\u3001\u8981\u6c42\u5b58\u5728\u4e00\u5b9a\u5dee\u5f02, \u5982\u5728\u5e74\u9f84\u3001\u6027\u522b\u3001\u4f53\u91cd\u3001\u662f\u5426\u5438\u70df\u7b49\u65b9\u9762\u7684\u8981\u6c42\u4e0d\u540c, \u5bf9\u7814\u7a76\u7fa4\u4f53\u57fa\u56e0\u591a\u6001\u6027\u7684\u8003\u8651\u4e5f\u4e0d\u4e00\u81f4\u3002 \u4ece\u7ef4\u62a4\u53d7\u8bd5\u8005\u7684\u5b89\u5168\u89d2\u5ea6\u8003\u8651, \u6709\u4e9b\u56fd\u5bb6\u8981\u6c42\u5728\u8fdb\u884c\u5168\u65b0\u836f\u7269(NCEs)\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u65f6, \u5fc5\u987b\u6d4b\u5b9a\u53d7\u8bd5\u8005\u7684\u8868\u578b, \u5bf9\u4e8e\u4eff\u5236\u836f\u7269, \u5982\u679c\u5df2\u77e5\u8be5\u836f\u7269<\/span>\u4ee3\u8c22\u4e0d\u5b58\u5728\u57fa\u56e0\u591a\u6001\u6027, \u5219\u4e0d\u8981\u6c42\u6d4b\u5b9a\u5176\u8868\u578b, \u5982\u679c\u5df2\u77e5\u5176\u4ee3\u8c22\u5b58\u5728\u57fa\u56e0\u591a\u6001\u6027, \u5728\u8fdb\u884c\u5355\u5242\u91cf\u6216\u591a\u5242\u91cf\u7814\u7a76\u4e4b\u524d\u9700\u8981\u786e\u5b9a\u53d7\u8bd5\u8005\u7684\u8868\u578b, \u4ece\u4f26\u7406\u65b9\u9762\u8003\u8651, \u4e0d\u5e94\u62db\u52df\u5f31\u4ee3\u8c22\u8005\u53c2\u4e0e\u591a\u5242\u91cf\u7814\u7a76\u3002 \u53e6\u5916, \u4e3a\u4e86\u51cf\u5c11\u7814\u7a76\u7ed3\u679c\u7684\u53d8\u5f02\u6027, \u5bf9\u53d7\u8bd5\u8005\u7684\u8868\u578b\u4e5f\u5fc5\u987b\u4f5c\u51fa\u8981\u6c42\u3002 \u5173\u4e8e\u53d7\u8bd5\u8005\u7684\u6027\u522b, \u5728 WHO\u3001\u6b27\u76df\u3001\u7f8e\u56fd\u548c\u65e5\u672c\u7b49\u56fd\u5bb6\u5747\u8981\u6c42\u540c\u65f6\u9009\u62e9\u7537\u6027\u548c\u5973\u6027, \u5728\u6211\u56fd\u5219\u8981\u6c42\u53ea\u9009\u62e9\u7537\u6027\u3002 \u6709\u5173\u53d7\u8bd5\u8005\u7684\u4f8b\u6570, \u4e0d\u540c\u56fd\u5bb6\u4e5f\u6709\u4e0d\u540c\u8981\u6c42\u3002 \u76ee\u524d, \u6709\u5173\u53d7\u8bd5\u8005\u7684\u9009\u62e9\u8fd8\u7f3a\u4e4f\u56fd\u9645\u7684\u4e00\u81f4\u6027\u6807\u51c6\u3002<\/span><\/p>\n

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

2.3.1 \u5065\u5eb7\u53d7\u8bd5\u8005[ 1] <\/strong><\/span> <\/span>  \u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u53d7\u8bd5\u4eba\u7fa4\u7684\u9009\u62e9\u5e94\u5c3d\u53ef\u80fd\u4e00\u81f4, \u901a\u5e38\u9009\u62e9\u5065\u5eb7\u53d7\u8bd5\u8005\u4ee5\u51cf\u5c11\u975e\u53d7\u8bd5\u836f\u7269\u5f15\u8d77\u7684\u53d8\u5f02\u3001\u5e94\u5236\u5b9a\u660e\u786e\u7684\u5165\u9009 \/\u5254\u9664\u6807\u51c6, \u4e00\u822c\u5e94\u9009\u7528\u7537\u6027\u53d7\u8bd5\u8005\u3002\u5e74\u9f84\u5728 18 \uff5e 40 \u5468\u5c81\u3002 \u540c\u4e00\u6279\u53d7\u8bd5\u8005\u5e74\u9f84\u4e0d\u5b9c\u76f8\u5dee 10\u5c81\u4ee5\u4e0a\u3002 \u4f53\u91cd\u5e94\u5728\u6807\u51c6\u8303\u56f4\u5185, \u4e14\u540c\u4e00\u6279\u53d7\u8bd5\u8005\u4f53\u91cd (\u516c\u65a4)\u4e0d\u5b9c\u60ac\u6b8a\u8fc7\u5927\u3002 \u56e0\u8bd5\u9a8c\u4e2d\u4e0d\u540c\u53d7\u8bd5\u8005\u670d\u7528\u836f\u7269\u5242\u91cf\u76f8\u540c \u3002<\/span><\/p>\n

\u6807\u51c6\u4f53\u91cd =[ \u8eab\u9ad8(cm)-80] \u00d70.7 \u6216[ \u8eab\u9ad8 (cm)-170] \u00d70.6 +62, \u4e00\u822c\u8981\u6c42\u5728\u6807\u51c6\u4f53\u91cd \u00b110\u8303\u56f4\u5185\u3002<\/span><\/p>\n

2.3.2 \u6709\u9002\u5e94\u8bc1\u7684\u60a3\u8005    <\/span><\/span><\/strong>\u5982\u679c\u7531\u4e8e\u6d3b\u6027\u836f\u7269\u5df2\u77e5\u7684\u4e0d\u826f\u53cd\u5e94\u53ef\u80fd\u5bf9\u5065\u5eb7\u4eba\u4ea7\u751f\u96be\u4ee5\u63a5\u53d7\u7684\u836f\u7406\u5b66\u53cd\u5e94\u548c\u5371\u9669, \u6709\u5fc5\u8981\u4f7f\u7528\u6cbb\u7597\u4e2d\u7684\u75c5\u4eba\u8fdb\u884c\u8bd5\u9a8c, \u8fd9\u79cd\u6539\u53d8\u5e94\u7531\u7533\u529e\u4eba\u4e88\u4ee5\u89e3\u91ca\u3002<\/p>\n

2.3.3 \u9057\u4f20\u8868\u578b <\/strong><\/span> <\/span>  \u4e3a\u5b89\u5168\u8d77\u89c1, \u5e94\u8003\u8651\u53d7\u8bd5\u8005\u7684\u9057\u4f20\u8868\u578b\u548c \/\u6216\u9057\u4f20\u578b, \u5e76\u63a2\u7d22\u53d7\u8bd5\u8005\u95f4\u7684\u4e3b\u8981\u5dee\u5f02\u3002<\/p>\n

2.3 \u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u7684\u53c2\u6570<\/span><\/strong><\/span>    FDA\u8981\u6c42\u4ee5\u751f\u7269\u5229\u7528\u5ea6\u8bd5\u9a8c\u83b7\u5f97\u7684\u5236\u5242\u7684 AUC(\u836f\u65f6\u66f2\u7ebf\u4e0b\u9762\u79ef)\u3001Cmax(\u5cf0\u6d53\u5ea6 )\u3001tmax(\u8fbe\u5cf0\u65f6\u95f4 )\u3001t1\/2 (\u534a\u8870\u671f)\u7b49\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6765\u4f30\u8ba1\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027, \u5176\u4e2d AUC\u53cd\u6620\u836f\u7269\u7684\u5438\u6536\u91cf, \u5b83\u662f\u4f30\u8ba1\u5176\u4ed6\u53c2\u6570\u7684\u57fa\u7840;Cmax\u3001tmax\u53cd\u6620\u836f\u7269\u7684\u5438\u6536\u901f\u7387;t1\/2\u53cd\u6620\u836f\u7269\u7684\u4ee3\u8c22\u60c5\u51b5\u3002 \u968f\u7740\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u7684\u53d1\u5c55, \u73b0\u5df2\u6709\u4eba\u5bf9\u8fd9\u4e9b\u53c2\u6570\u63d0\u51fa\u5f02\u8bae, \u5e76\u63d0\u51fa\u4e86\u4e00\u4e9b\u65b0\u7684\u8bc4\u4ef7\u751f\u7269\u7b49\u6548\u6027\u7684\u53c2\u6570 \u3002<\/span><\/p>\n

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

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3 \u5404\u79cd\u751f\u7269\u7b49\u6548\u6027\u7684\u8bc4\u4ef7\u7684\u7edf\u8ba1\u65b9\u6cd5<\/strong><\/p>\n<\/section>\n

<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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3.1   \u8bc4\u4ef7\u601d\u8def   \u8bc4\u4ef7\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u5373\u662f\u6bd4\u8f83\u6548\u5e94\u503c\u7684\u5e73\u5747\u6c34\u5e73\u662f\u5426\u63a5\u8fd1\u3002 \u5176\u8bc4\u4ef7\u51c6\u5219\u4e3a<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
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\u5728\u8bc4\u4ef7\u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027\u65f6, \u65e2\u8981\u8003\u8651 T\u548c R\u7684\u5e73\u5747\u6548\u5e94, \u53c8\u8981\u8003\u8651 T\u548c R\u6548\u5e94\u503c\u7684\u65b9\u5dee\u3002 \u5176\u8bc4\u4ef7\u51c6\u5219\u4e3a:<\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
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\u5728\u8bc4\u4ef7\u4e2a\u4f53\u751f\u7269\u7b49\u6548\u6027\u65f6, \u9664\u4e86\u8003\u8651\u4e0a\u8ff0 T\u548c R\u7684\u5e73\u5747\u6548\u5e94\u53ca\u65b9\u5dee, \u8fd8\u8981\u8003\u8651\u4e2a\u4f53\u4e0e\u836f\u7269\u95f4\u7684\u4ea4\u4e92\u4f5c\u7528\u3002 \u5176\u8bc4\u4ef7\u51c6\u5219\u4e3a:<\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
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\u7531\u4e0a\u53ef\u89c1, \u4e0d\u540c\u7684\u751f\u7269\u7b49\u6548\u6027\u8981\u6c42\u4e0d\u540c, \u8003\u8651\u95ee\u9898\u7684\u89d2\u5ea6\u4e0d\u540c, \u56e0\u6b64, \u8bc4\u4ef7\u65f6\u8003\u8651\u7684\u56e0\u7d20\u4ea6\u4e0d\u76f8\u540c\u3002\u4e0a\u8ff0\u5f0f1\uff5e 3\u4e2d, \u65b9\u7a0b\u7684\u5de6\u8fb9\u53ef\u4ee5\u6839\u636e\u6837\u672c\u4f30\u8ba1, \u800c\u65b9\u7a0b\u53f3\u8fb9\u7684\u7b49\u6548\u9650\u9700\u8981\u4e8b\u5148\u7ed9\u51fa\u3002\u4e0d\u540c\u7684\u601d\u7ef4\u6216\u6307\u5bfc\u601d\u60f3\u786e\u5b9a\u7684\u7b49\u6548\u503c, \u5c31\u5f62\u6210\u4e86\u4e0d\u540c\u7684\u65b9\u6cd5\u3002<\/p>\n

3.2 \u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u65b9\u6cd5 <\/strong><\/span><\/p>\n

3.2.1 \u65b9\u5dee\u5206\u6790\u6cd5 <\/span><\/strong><\/span> <\/span>  \u8fd9\u662f\u4e00\u79cd\u6bd4\u8f83\u4f20\u7edf\u7684\u5206\u6790\u65b9\u6cd5, \u56e0\u4e3a\u5176\u68c0\u9a8c\u7ed3\u679c\u53ea\u80fd\u6ee1\u8db3\u201c \u662f\u201d\u4e0e\u201c \u5426\u201d, \u6837\u672c\u5bb9\u91cf\u4e5f\u8f83\u5c11, \u6240\u4ee5\u4e0d\u80fd\u6ee1\u8db3\u9700\u8981\u3002 \u4f46\u662f, \u65b9\u5dee\u5206\u6790\u6cd5\u53ef\u83b7\u5f97\u751f\u7269\u7b49\u6548\u6027\u7684\u521d\u6b65\u8bc4\u4ef7, \u4e14\u662f Westlake\u6cd5\u3001Bayesian\u7b49\u6cd5\u68c0\u9a8c\u65b9\u6cd5\u7684\u57fa\u7840, \u56e0\u4e3a\u5b83\u4eec\u90fd\u8981\u7528\u5230\u65b9\u5dee\u5206\u6790\u4e2d\u7b97\u51fa\u7684\u6807\u51c6\u5dee\u3002<\/span><\/p>\n

3.2.2 Westlake\u6cd5    <\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
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3.2.3 Bayesian\u6cd5<\/strong><\/p>\n

<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

Bayesian\u6cd5 Westlake\u6cd5\u4e4b\u95f4\u7684\u5173\u7cfb:\u5f53 P>1-a, \u610f\u5473\u7740(1-a)\u7684 Westlake\u7f6e\u4fe1\u533a\u95f4\u5728(r1, r2)\u4e4b\u5185, \u4e3a\u7f6e\u4fe1\u6c34\u5e73\u3002<\/span><\/p>\n

3.2.4 \u53cc\u5355\u4fa7 t\u68c0\u9a8c\u6cd5<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

3.2.5 (1-2\u03b1) \u7f6e\u4fe1\u533a\u95f4\u6cd5<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
\n
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3.3    \u7fa4\u4f53\u53ca\u4e2a\u4f53\u7b49\u6548\u754c\u503c\u53ca\u76f8\u5173\u53c2\u6570\u7684\u786e\u5b9a<\/strong><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027<\/span>\u7684\u8bc4\u4ef7\u662f\u57fa\u4e8e\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570 AUC\u3001Cmax\u3001tmax\u7684, \u7531\u4e8e\u8fd9\u4e9b\u53c2\u6570\u7684\u89c2\u5bdf\u503c\u5206\u5e03\u4e3a\u975e\u6b63\u6001\u5206\u6790, \u6545 FDA\u5efa\u8bae, \u5728\u8fdb\u884c\u5206\u6790\u524d\u5148\u5bf9 AUC\u3001Cmax\u7b49\u4f5c\u5bf9\u6570\u53d8\u6362, \u518d\u5bf9\u53d8\u6362\u540e\u6570\u636e\u8fdb\u884c\u5206\u6790\u3002 \u4e3a<\/span>\u65b9\u4fbf\u8d77\u89c1, \u4e0b\u6807 T\u548c R\u5206\u522b\u8868\u793a T\u548c R\u7684\u6548\u5e94\u3002<\/span><\/p>\n

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

3.3.1 \u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027\u7b49\u6548\u754c\u503c\u7684\u786e\u5b9a <\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

3.3.2 \u4e2a\u4f53\u751f\u7269\u7b49\u6548\u6027\u7b49\u6548\u754c\u503c\u7684\u786e\u5b9a<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

3.4 \u6570\u636e\u53d8\u6362<\/strong><\/span>    FDA(2001)\u5efa\u8bae, AUC\u7b49\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u5e94\u5728\u5bf9\u6570\u5c3a\u5ea6\u4e0b\u8fdb\u884c\u3002 \u56e0\u4e3a :(1)\u901a\u5e38\u60c5\u51b5\u4e0b, AUC\u6216 Cmax\u5448\u6b63\u504f\u5206\u5e03\u4e14\u65b9\u5dee\u4e0d\u9f50, \u5bf9\u5176\u4f5c\u5bf9\u6570\u53d8\u6362\u53ef\u4ee5\u6539\u5584\u5176\u5206\u5e03\u7684\u504f\u6027, \u7f29\u5c0f\u65b9\u5dee\u95f4\u7684\u5dee\u5f02;(2)\u836f\u4ee3\u52a8\u529b\u5b66\u8fdb<\/span>\u884c\u5bf9\u6570\u53d8\u6362\u7684\u7406\u8bba\u57fa\u7840\u4e3a:\u8f6c\u6362\u540e\u7684\u6570\u636e\u53ef\u4ee5\u7528\u52a0\u6cd5\u6a21\u578b\u8fdb\u884c\u5904\u7406\u3002 \u4f8b\u5982, \u82e5\u53d1\u751f\u4e2d\u592e\u5ba4\u4e00\u7ea7\u6392\u9664, \u65b9\u7a0b\u4e3a:lnAUC0-\u221e  = lnF+lnD-lnV-lnKe(F\u4e3a\u5438\u6536\u5206\u6570;D\u4e3a\u5438\u6536\u91cf;V\u4e3a\u8868\u89c2\u5206\u5e03;Ke\u4e3a\u6392\u9664\u7387\u5e38\u6570)\u3002<\/span><\/p>\n

3.5   \u53c2\u6570\u7684\u4f30\u8ba1 [ 6]  <\/span><\/strong><\/span>  \u7b49\u6548\u6027\u8bc4\u4ef7\u4e2d, \u5404\u65b9\u5dee\u5206\u91cf\u7684\u4f30\u8ba1, FDA\u63a8\u8350\u91c7\u7528\u77e9\u6cd5(Method of Moments);\u5728\u6709\u7f3a\u5931\u6570\u636e\u65f6, \u63a8\u8350\u91c7\u7528\u9650\u5236\u6027\u6781\u5927\u4f3c\u7136\u6cd5(RestrictedMaximum LikelihodMethod)\u4f30\u8ba1\u3002 FDA\u5728\u5176\u516c\u5e03\u7684\u6307\u5bfc\u539f\u5219\u4e2d\u4e13\u95e8\u4ecb\u7ecd\u4e86\u4f30\u8ba1\u65b9\u6cd5\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
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4 \u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u7684\u5176\u4ed6\u95ee\u9898<\/strong><\/p>\n<\/section>\n

<\/section>\n
<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
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<\/section>\n<\/section>\n
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4.1 \u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u7684\u7acb\u4f53\u5f02\u6784\u95ee\u9898 <\/strong><\/span> <\/span>  \u636e\u4f30\u8ba1, \u5728\u76ee\u524d\u4e34\u5e8a\u4f7f\u7528\u7684\u836f\u7269\u4e2d\u8d85\u8fc7  1\/4\u4ee5\u4e0a\u7684\u836f\u7269\u4e3a\u624b\u6027\u836f\u7269,  \u5176\u4e2d\u4ee5\u5355\u4e00\u5bf9\u6620\u4f53\u4e0a\u5e02\u7684\u836f\u7269\u5f88\u5c11, \u591a\u6570\u836f\u7269\u5219\u662f\u4ee5\u5916\u6d88\u65cb\u4f53\u5f62\u5f0f\u7ed9 \u836f.\u5728\u4e0d\u540c\u836f\u7269\u7684\u5916\u6d88\u65cb\u4f53\u4e2d\u5176\u5bf9\u6620\u5f02\u6784\u4f53\u7684\u836f\u7406\u6d3b\u6027\u53ef\u80fd\u5b58\u5728\u663e\u8457\u5dee\u5f02,  \u4f7f\u7528\u5e38\u89c4\u7684\u975e\u7acb\u4f53\u4e13\u5c5e\u6027\u65b9\u6cd5\u8bc4\u4f30\u751f\u7269\u7b49\u6548\u6027\u96be\u4ee5\u4fdd\u8bc1\u5b9e\u9a8c\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5728\u6cbb\u7597\u4e0a\u7b49\u6548.\u7acb\u4f53\u5f02\u6784\u5728\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u5e94\u53d7\u5230\u8db3\u591f\u91cd\u89c6 .\u57281992 \u5e74\u751f\u7269\u7b49\u6548\u6027\u56fd\u9645\u4f1a\u8bae\u7684\u62a5\u544a[  18]  \u4e2d\u58f0\u660e,  \u5982\u679c\u4e24\u79cd\u5bf9\u6620\u4f53\u7684\u5168\u8eab\u5229\u7528\u5ea6\u548c\u5168\u8eab\u6e05\u9664\u7387\u5df2\u6709\u8d44\u6599\u8bc1\u5b9e\u65e0\u5dee\u5f02, \u53ef\u4f7f\u7528\u975e\u7acb\u4f53\u4e13\u5c5e\u6027\u65b9\u6cd5\u8bc4\u4ef7, \u5426\u5219, \u5e94\u4f7f\u7528\u7acb\u4f53\u4e13\u5c5e\u6027\u65b9\u6cd5.SrinivasNR\u7b49 [ 19] \u5bf9 \u03b2 -\u80be\u4e0a\u817a\u7d20\u53d7\u4f53\u963b\u65ad\u5242 nadolol\u7684\u4e24\u79cd\u5236\u5242\u8fdb\u884c\u4e86\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76, \u8be5\u836f\u7269\u5177\u6709\u4e24\u4e2a\u624b\u6027\u4e2d\u5fc3\u53ca 4\u4e2a\u5149\u5b66\u5f02\u6784\u4f53, \u5b83\u4eec\u4e0e\u819c\u8868\u8fbe\u7684 \u03b2-\u80be\u4e0a\u817a\u7d20\u53d7\u4f53\u7ed3\u5408\u7684\u4eb2\u548c\u529b\u4e0d\u540c,\u5728\u7ed9\u4e88 nadolol\u5355\u5242\u91cf\u548c\u8fbe\u7a33\u6001\u540e\u8fdb\u884c\u7acb\u4f53\u9009\u62e9\u6027\u548c\u975e\u7acb\u4f53\u9009\u62e9\u6027\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76, \u4ee5 lnCmax\u548c lnAUC\u4e3a\u751f\u7269\u7b49\u6548\u6027\u8003\u6838\u6307\u6807, \u62a5\u9053\u5728\u5355\u5242\u91cf\u60c5\u51b5\u4e0b, \u6309\u603b\u7684\u836f\u7269\u53ca\u5149\u5b66\u5f02\u6784\u4f53\u4e4b\u4e00SQ12150\u8bc4\u4f30\u4e3a\u751f\u7269\u7b49\u6548, \u800c\u6309\u5176\u5b83\u4e09\u79cd\u5149\u5b66\u5f02\u6784\u4f53\u8bc4\u4f30\u5747\u4e0d\u7b49\u6548, \u5728\u7a33\u6001\u60c5\u51b5\u4e0b, \u6309\u603b\u7684\u836f\u7269\u8bc4\u4f30\u4e3a\u751f\u7269\u7b49\u6548, \u800c\u4f7f\u7528\u7acb\u4f53\u9009\u62e9\u6027\u65b9\u6cd5\u8bc4\u4f30\u5219\u672a\u80fd\u83b7\u5f97\u7b49\u6548\u7ed3\u679c\u3002 \u8fd9\u7bc7\u62a5\u9053\u9996\u6b21\u63d0\u4f9b\u8bc1\u636e\u8bc1\u660e\u5bf9\u4e8e\u624b\u6027\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u5e94\u8be5\u4f7f\u7528\u7acb\u4f53\u9009\u62e9\u6027\u65b9\u6cd5\u3002<\/span><\/p>\n

4.2 \u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u5728\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4f30\u4e2d\u7684\u4f5c\u7528<\/strong><\/span>     \u751f\u7269\u7b49\u6548\u6027\u8bc4\u4f30\u901a\u5e38\u8981\u6c42\u5fc5\u987b\u901a\u8fc7\u4eba\u4f53\u8bd5\u9a8c\u8fdb\u884c\u4f46\u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u5728\u751f   \u7269\u7b49\u6548\u6027\u8bc4\u4f30\u4e2d\u4e5f\u5177\u6709\u4e00\u5b9a\u4f5c\u7528\u3002  WHO\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6307\u5357[ 20] \u5141\u8bb8\u5229\u5ddd\u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u8bc4\u4f30\u67d0\u4e9b\u836f\u7269\u7684\u751f\u7269\u7b49\u6548\u6027, \u8be5\u6307\u5357\u4e2d\u89c4\u5b9a, \u5f53\u4f53\u5916\u548c\u4f53\u5185\u76f8\u5173\u6027\u80fd\u591f\u88ab\u8bc1\u5b9e, \u7279\u522b\u662f\u5f53\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5728\u4f53\u5916\u7684\u6eb6\u51fa\u901f\u5ea6\u5f88\u5feb(15min\u5185\u6eb6\u51fa\u5ea6\u4e0d\u4f4e\u5e72 80  )\u7684\u60c5\u51b5\u4e0b,   \u53ef\u4ee5\u5229\u7528\u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u7ed3\u679c\u6765\u63a8\u6d4b\u836f\u7269\u5728\u4f53\u5185\u7684\u751f\u7269\u7b49\u6548\u6027, \u4f46\u8be5\u6307\u5357\u4e5f\u6307\u51fa,  \u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u5728\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4f30\u65b9\u9762\u5e94\u5c3d\u91cf\u5c11\u7528\u3002\u5728\u65e5\u672c\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6307\u5357\u4e2d, \u5c06\u4f53\u5916\u6eb6\u51fa\u8bd5\u9a8c\u7528\u4e8e\u9009\u62e9\u53d7\u8bd5\u8005\u3001\u8bd5\u9a8c\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242,   \u53e6\u5916\u8fd8\u5c06\u5176\u7528\u4e8e\u4e2a\u4f53\u5185\u53d8\u5f02\u5f88\u5927\u7684\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7684\u8bc4\u4f30\u3002<\/p>\n

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4.3 \u98df\u7269\u6548\u5e94\u95ee\u9898<\/strong><\/span>    \u8003\u8651\u5230\u591a\u6570\u836f\u7269\u90fd\u662f\u5728\u9910\u540e\u7ed9\u836f\u7684\u5b9e\u9645\u60c5\u51b5\u4ee5\u53ca\u836f\u54c1\u751f\u7269\u5229\u7528\u5ea6\u7684\u98df\u7269\u6548\u5e94, \u5728\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u9610\u660e\u751f\u7269\u5229\u7528\u5ea6\u7684\u98df\u7269\u6548\u5e94\u662f\u6781\u4e3a\u91cd\u8981\u7684.\u5728\u7814\u7a76\u65b9\u6cd5\u4e0a,\u901a\u5e38\u662f\u5c06\u5b9e\u9a8c\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5728\u76f8\u540c\u7684\u6761\u4ef6\u4e0b\u6309\u5355\u5242\u91cf\u7ed9\u836f\u8fdb\u884c\u7814\u7a76, \u53ef\u4ee5\u91c7\u7528\u56db\u671f\u4ea4\u53c9\u8bbe\u8ba1\u65b9\u6cd5\u5bf9\u4e24\u79cd\u5236\u5242\u5728\u7981\u9910\u548c\u9910\u540e\u5206\u522b\u7ed9\u836f\u8fdb\u884c\u7814\u7a76,  \u53e6\u5916, \u4e5f\u53ef\u4ee5\u8fdb\u884c\u4e24\u9879\u72ec\u7acb\u7684\u4e24\u671f\u4ea4\u53c9\u7814\u7a76, \u5373\u5728\u7981\u9910\u548c\u9910\u540e\u5bf9\u4e24\u79cd\u836f\u54c1\u5206\u522b\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4f30.\u76ee\u524d\u5404\u4e2a\u56fd\u5bb6\u5728\u5efa\u8bae\u8981\u6c42\u8fdb\u884c\u9910\u540e\u7ed9\u7a76\u7684\u5236\u5242\u7c7b\u522b\u53ca\u9910\u540e\u7ed9\u7a76\u7684\u65b9\u6cd5\u4e0a\u8fd8\u5b58\u5728\u5dee\u5f02\u3002FDA\u53d1\u8868\u4e86\u5173\u4e8e\u751f\u7269\u5229\u7528\u5ea6\u548c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u98df\u7269\u6548\u5e94\u7814\u7a76\u7684\u8349\u6848\u6307  \u5357 [ 21] , \u5176\u4e2d\u89c4\u5b9a\u4e86\u8bc4\u4f30\u98df\u7269\u6548\u5e94\u7684\u7814\u7a76\u65b9\u6cd5, \u4ee5\u53ca\u901f\u91ca\u7247\u548c\u7f13\u91ca\u7247\u9700\u8981\u8fdb\u884c\u98df\u7269\u6548\u5e94\u7814\u7a76\u7684\u60c5\u51b5:\u65b0\u836f\u7684\u5f00\u53d1\u8fc7\u7a0b\u3001\u65b0\u836f\u83b7\u6279\u51c6\u540e\u7684\u6539\u53d8\u4ee5\u53ca\u4eff\u5236\u836f\u54c1\u7684\u6279\u51c6\u7533\u6e05, \u89c4\u5b9a\u5728\u8fd9\u4e9b\u60c5\u51b5\u4e0b\u5fc5\u987b\u8fdb\u884c\u98df\u7269\u6548\u5e94\u7814\u7a76\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u3010\u8f6c\u81ea\uff1a\u534e\u666e\u533b\u836f\u3011<\/strong><\/span><\/p>\n

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\"\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u73b0\u72b6\u6982\u8ff0\u2014\u2014\u57f9\u4f18BE\u7cfb\u521727\"
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\u70b9\u51fb\u4e0a\u65b9\u84dd\u8272\u5b57\u4f53\uff0c\u5173\u6ce8\u6211\u4eec \u6458\u8981:\u672c\u6587\u4ece\u8bd5\u9a8c\u8bbe\u8ba1\u3001\u6837\u672c\u542b\u91cf\u7684\u4f30\u8ba1\u3001\u53d7\u8bd5\u8005\u7684\u9009\u62e9\u4ee5\u53ca\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u65b9\u9762\u7efc\u8ff0\u4e86\u76ee\u524d […]<\/p>\n","protected":false},"author":1,"featured_media":66593,"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\/66592"}],"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=66592"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66592\/revisions"}],"predecessor-version":[{"id":66609,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66592\/revisions\/66609"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/66593"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=66592"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=66592"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=66592"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}