{"id":85725,"date":"2019-04-15T00:00:50","date_gmt":"2019-04-18T07:51:51","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/85725\/"},"modified":"2019-04-18T15:51:53","modified_gmt":"2019-04-18T07:51:53","slug":"cae9b05a7c","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/85725\/","title":{"rendered":"FDA\uff1a\u6162\u6027\u4e59\u578b\u809d\u708e\u75c5\u6bd2\u611f\u67d3\u836f\u7269\u7814\u53d1\u6307\u5bfc\u610f\u89c1\uff08\u8349\u6848\uff09"},"content":{"rendered":"
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\u70b9\u51fb\u4e0a\u65b9\u7684  \u25b2 \u6dfb\u52a0\u5173\u6ce8<\/span><\/h1>\n


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1  \u5409\u6797\u5927\u5b66\u7b2c\u4e00\u533b\u9662<\/span><\/p>\n

2  \u4e0a\u6d77\u631a\u76df\u533b\u836f\u79d1\u6280\u6709\u9650\u516c\u53f8<\/span><\/p>\n


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\"FDA\uff1a\u6162\u6027\u4e59\u578b\u809d\u708e\u75c5\u6bd2\u611f\u67d3\u836f\u7269\u7814\u53d1\u6307\u5bfc\u610f\u89c1\uff08\u8349\u6848\uff09\"<\/p>\n


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\u7f8e\u56fd\u56fd\u5bb6\u98df\u54c1\u548c\u836f\u54c1\u76d1\u7ba1\u603b\u5c40<\/strong><\/span><\/p>\n

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Chronic Hepatitis B Virus Infection:<\/strong> Developing Drugs for Treatment <\/strong><\/span><\/p>\n

Guidance for Industry<\/span><\/p>\n

DRAFT GUIDANCE<\/span><\/p>\n

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A. \u4e00\u822c\u836f\u7269\u7814\u53d1\u7684\u8003\u8651\u4e8b\u9879<\/span><\/strong><\/p>\n


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1\u3001\u65e9\u671f\u7814\u53d1\u9636\u6bb5\u7684\u6ce8\u610f\u4e8b\u9879<\/span><\/strong><\/span><\/p>\n


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a. \u836f\u7406\u5b66\u548c\u6bd2\u7406\u5b66\u65b9\u9762\u5e94\u8003\u8651\u7684\u4e8b\u9879<\/span><\/strong><\/p>\n


<\/p>\n

\u5355\u4e2aHBV\u836f\u7269\u7684\u836f\u7406\u5b66\u548c\u6bd2\u7406\u5b66\u7814\u7a76\u5e94\u9075\u5faa\u73b0\u6709\u836f\u7269\u7814\u53d1\u6307\u5357\u4e2d\u6982\u8ff0\u7684\u65b9\u6cd5\u3002\u5c3d\u7ba1ICH\u884c\u4e1a\u6307\u5357M3<\/span>\uff08R2\uff09<\/span>\u300a\u62df\u652f\u6301\u4eba\u7c7b\u4e34\u5e8a\u8bd5\u9a8c\u7684\u975e\u4e34\u5e8a\u5b89\u5168\u8bd5\u9a8c\u548c\u836f\u7269\u5e02\u573a\u6388\u6743\u300b<\/span>\uff08ICH M3<\/span>\uff08R2\uff09<\/span>\uff09<\/span>\u5efa\u8bae\u5728\u975e\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u8fdb\u884c\u836f\u7269\u8054\u5408\u7814\u7a76\uff0c\u4ee5\u652f\u6301\u5728\u7814\u836f\u7269 <\/span>\uff08\u5728ICH M3(R2)\u4e2d\u79f0\u4e3a\u65e9\u671f\u5b9e\u4f53\uff09<\/span>\u5728\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u7684\u8054\u5408\u6cbb\u7597\u65b9\u6848\uff0c\u5f53\u8ba1\u5212\u628a\u65b0\u7684HBV\u5728\u7814\u836f\u7269\u8fdb\u884c\u7ec4\u5408\u65f6<\/span>\uff08\u5305\u62ec2\u79cd\u6216\u80052\u79cd\u4ee5\u4e0a\u7684\u65e9\u671f\u9636\u6bb5\u7684\u7814\u7a76\u836f\u7269\uff09<\/span>\uff0cFDA\u5efa\u8bae\u9879\u76ee\u7533\u529e\u65b9\u4e0eFDA\u8ba8\u8bba\u662f\u5426\u5e94\u5c06\u8054\u5408\u6bd2\u7406\u5b66\u7814\u7a76\u4f5c\u4e3a\u63d0\u4ea4\u65b0\u7a76\u7533\u8bf7<\/span>\uff08IND\uff09<\/span>\u7533\u62a5\u7684\u4e00\u90e8\u5206<\/span>\uff08\u5305\u62ec\u6b64\u7c7b\u7814\u7a76\u7684\u8bbe\u8ba1\uff09<\/span>\uff0c\u4ee5\u652f\u6301\u8054\u5408\u4e34\u5e8a\u8bd5\u9a8c\u3002\u5728\u8fdb\u884c\u8054\u5408\u6bd2\u7406\u5b66\u7814\u7a76\u65f6\uff0cFDA\u901a\u5e38\u4e0d\u5efa\u8bae\u5728\u4e00\u4e2a\u6bd2\u7406\u5b66\u7814\u7a76\u4e2d\u540c\u65f6\u6d4b\u5b9a\u8d85\u8fc7\u4e24\u79cd\u4ee5\u4e0a\u7684\u65e9\u671f\u836f\u7269\u3002<\/span><\/p>\n

\n

FDA\u4e00\u822c\u4e0d\u5efa\u8bae\u5c06\u5728\u7814\u836f\u7269\u548c\u5df2\u83b7\u6279\u51c6\u7684\u836f\u7269\u6216\u5df2\u83b7\u5f97\u8bb8\u53ef\u7684\u751f\u7269\u5236\u54c1\u8fdb\u884c\u975e\u4e34\u5e8a\u9636\u6bb5\u7684\u8054\u5408\u7814\u7a76\u3002\u6240\u4ee5\uff0c\u9664\u975e\u7814\u7a76\u836f\u7269\u7684\u975e\u4e34\u5e8a\u9636\u6bb5\u7814\u7a76\u6570\u636e\u8868\u660e\uff0c\u5728\u7814\u836f\u7269\u4e0e\u5df2\u6279\u51c6\u7684\u836f\u7269\u6216\u5df2\u83b7\u5f97\u8bb8\u53ef\u7684\u751f\u7269\u5236\u54c1\u53ef\u80fd\u5b58\u5728\u4e25\u91cd\u7684\u534f\u540c\u6bd2\u6027\uff0c\u5426\u5219\uff0cFDA\u4e0d\u8981\u6c42\u8fdb\u884c\u836f\u7269\u8054\u5408\u6bd2\u7406\u65b9\u9762\u7684\u7814\u7a76\u3002<\/span><\/p>\n


<\/p>\n

\u4e00\u822c\u5730\u8bb2\uff0c\u5982\u679c\u7533\u529e\u65b9\u7814\u53d1\u7684\u4e59\u809d\u836f\u7269\u7684\u670d\u836f\u6cbb\u7597\u65f6\u95f4\u8d85\u8fc76\u4e2a\u6708\uff0c\u5e94\u5bf9\u7814\u53d1\u836f\u7269\u7684\u81f4\u764c\u6027\u8fdb\u884c\u76f8\u5173\u7814\u7a76\u3002\u7533\u529e\u65b9\u5728\u8fdb\u884c\u751f\u7269\u5236\u54c1\u7814\u53d1\u7684\u8fc7\u7a0b\u4e2d\uff0c\u5e94\u9075\u5faa\u73b0\u6709ICH\u6307\u5357S6\u300a\u751f\u7269\u6280\u672f\u836f\u7269\u7684\u4e34\u5e8a\u524d\u5b89\u5168\u6027\u8bc4\u4ef7\u300b\u4e2d\u6982\u8ff0\u7684\u65b9\u6cd5\uff0c\u5e76\u4e0eFDA\u8ba8\u8bba\u4e34\u5e8a\u7814\u53d1\u8fc7\u7a0b\u4e2d\u81f4\u764c\u6027\u98ce\u9669\u8bc4\u4f30\u7684\u7814\u7a76\u65b9\u6848\uff0c\u4ee5\u5229\u4e8e\u5bf9\u5728\u7814\u751f\u7269\u5236\u54c1\u8fdb\u884c\u6700\u7ec8\u7684\u5b89\u5168\u8bc4\u4f30\u6765\u652f\u6301\u751f\u7269\u5236\u54c1\u836f\u7269\u4e0a\u5e02\u7533\u62a5<\/span>\uff08BLA\uff09<\/span>\u3002<\/span><\/p>\n

\n

\u7533\u529e\u65b9\u5e94\u5728\u63d0\u4ea4\u521d\u59cb\u7684\u65b0\u836f\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7<\/span>\uff08NDA\uff09<\/span>\u65f6\uff0c\u540c\u65f6\u63d0\u4ea4\u81f4\u764c\u6027\u7814\u7a76\u62a5\u544a\u3002\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0cFDA\u53ef\u4ee5\u8003\u8651\u5141\u8bb8\u7533\u529e\u65b9\u5728\u63d0\u4ea4NDA\u4e4b\u524d\u542f\u52a8\u81f4\u764c\u6027\u7814\u7a76<\/span>\uff08\u9700\u8981\u6709\u4e66\u9762\u540c\u610f\uff09<\/span>\uff0c\u5e76\u6839\u636eFDA\u76f8\u5173\u7ae0\u8282\u7684\u89c4\u5b9a\uff0c\u5728\u4e0a\u5e02\u540e\u63d0\u4ea4\u5df2\u5b8c\u6210\u7684\u7814\u7a76\u603b\u7ed3\u3002<\/span><\/p>\n

\n

\n

b. \u975e\u4e34\u5e8a\u9636\u6bb5\u75c5\u6bd2\u5b66\u7814\u7a76\u5e94\u8003\u8651\u7684\u4e8b\u9879<\/span><\/strong><\/p>\n


<\/p>\n

\u7533\u529e\u65b9\u5e94\u53c2\u8003\u884c\u4e1a\u6307\u5357\u300a\u6297\u75c5\u6bd2\u4ea7\u54c1\u7814\u53d1—\u75c5\u6bd2\u5b66\u7814\u7a76\u53ca\u5411FDA\u9012\u4ea4\u300b\u4e2d\u7684\u4e00\u822c\u6297\u75c5\u6bd2\u836f\u7269\u7814\u53d1\u5efa\u8bae\u3002\u7136\u800c\uff0c\u6cbb\u7597\u6162\u6027HBV\u611f\u67d3\u7684\u65b0\u578b\u836f\u7269\u53d1\u5c55\u8fc5\u901f\uff0c\u6211\u4eec\u5efa\u8bae\u7533\u529e\u65b9\u5229\u7528\u7814\u7a76\u6027\u65b0\u836f\u7533\u8bf7\u524d\u54a8\u8be2\u4f1a\u8bae<\/span>\uff08pre-IND\uff09<\/span>\u6765\u5f00\u5c55\u9488\u5bf9\u4ea7\u54c1\u548c\u7814\u53d1\u8ba1\u5212\u7684\u521d\u6b65\u8ba8\u8bba\u3002<\/span><\/p>\n


<\/p>\n

FDA\u9f13\u52b1\u901a\u8fc7\u8be6\u7ec6\u7684\u62a5\u544a\u6765\u63cf\u8ff0\u5728\u7814\u836f\u7269\u7684\u4f5c\u7528\u673a\u5236\u3001\u7ec6\u80de\u57f9\u517b\u4e2d\u7684\u6297\u75c5\u6bd2\u6d3b\u6027\u3001\u7ec6\u80de\u6bd2\u6027\u3001\u7ebf\u7c92\u4f53\u6bd2\u6027\u3001\u52a8\u7269\u6a21\u578b\u548c\u8010\u836f\u6027\u7814\u7a76\u3002\u6b64\u5916\uff0c\u5efa\u8bae\u7533\u529e\u65b9\u63d0\u4f9b\u4ee5\u4e0b\u9488\u5bf9\u6162\u6027\u4e59\u809d\u5728\u7814\u836f\u7269\u7684\u975e\u4e34\u5e8a\u75c5\u6bd2\u5b66\u7814\u7a76\u6570\u636e\u3002<\/span><\/p>\n

\n


<\/p>\n

\u258e\u8010\u836f\u4e0e\u4ea4\u53c9\u8010\u836f<\/span><\/strong><\/span><\/p>\n


<\/p>\n

\u5728\u7ec6\u80de\u57f9\u517b\u4e2d\uff0cHBV\u901a\u5e38\u4e0d\u80fd\u5f88\u597d\u7684\u751f\u957f\uff0c\u5f88\u96be\u7b5b\u9009\u6709\u8010\u836f\u6027\u7684\u75c5\u6bd2\u3002\u6211\u4eec\u5efa\u8bae\u5728\u6240\u6709\u7684\u52a8\u7269\u836f\u6548\u8bd5\u9a8c\u4e2d\u8fdb\u884c\u8010\u836f\u76f8\u5173\u8bc4\u4ef7\uff0c\u6765\u8bc4\u4f30\u5728\u7814\u836f\u7269\u5728\u611f\u67d3\u52a8\u7269\u4e2d\u7684\u8010\u836f\u6027\uff0c\u5e76\u5c06\u8010\u836f\u6027\u76d1\u6d4b\u8ba1\u5212\u52a0\u5165\u5230\u6240\u6709\u63a5\u53d7\u6cbb\u7597\u7684CHB\u60a3\u8005\u7684\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u4e2d\u3002<\/span><\/p>\n


<\/p>\n

    \n
  • \n

    \u901a\u8fc7\u5bf9\u836f\u7269\u9776\u70b9\u6d4b\u5e8f\u6765\u786e\u5b9a\u5bf9\u5728\u7814\u836f\u7269\u4ea7\u751f\u8010\u836f\u662f\u5426\u4e0e\u6c28\u57fa\u9178\u66ff\u4ee3\u6216\u6838\u82f7\u9178\u7a81\u53d8\u6709\u5173\uff0c\u5e76\u901a\u8fc7\u70b9\u7a81\u53d8\u7684\u65b9\u5f0f\u5c06\u4e0e\u8010\u836f\u76f8\u5173\u7684\u66ff\u4ee3\u6216\u7a81\u53d8\u5f15\u5165HBV\u57fa\u56e0\u7ec4\u6765\u8fdb\u884c\u9a8c\u8bc1\uff0c\u5e76\u786e\u5b9a\u8010\u836f\u6027\u589e\u52a0\u7684\u7a0b\u5ea6\u3002\u8fd9\u4e9b\u7814\u7a76\u7ed3\u679c\u6709\u52a9\u4e8e\u786e\u5b9a\u8010\u836f\u9014\u5f84\uff0c\u5e76\u652f\u6301\u5bfb\u627e\u9488\u5bf9\u836f\u7269\u63d0\u51fa\u7684\u4f5c\u7528\u673a\u5236\u3002\u82e5\u53d1\u73b0\u9488\u5bf9\u75c5\u6bd2\u7684\u654f\u611f\u6027\u6ca1\u6709\u53d8\u5316\uff0c\u5e76\u4e0d\u80fd\u6392\u9664\u5728\u591a\u4e2a\u72ec\u7acb\u7684\u67d0\u4e00\u7279\u5b9a\u7684\u6c28\u57fa\u9178\u66ff\u4ee3\u6216\u6838\u82f7\u9178\u7a81\u53d8\u51fa\u73b0\u65f6\u4e0d\u4f1a\u4ea7\u751f\u8010\u836f\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


    <\/p>\n

    \u5e94\u8bc4\u4f30\u4ea4\u53c9\u8010\u836f\u4ee5\u786e\u5b9a\u5bf9\u5df2\u6279\u51c6\u7684HBV\u836f\u7269\u8010\u836f\u7684\u75c5\u6bd2\u662f\u5426\u5bf9\u76ee\u524d\u7814\u53d1\u7684\u836f\u7269\u4e5f\u4ea7\u751f\u8010\u836f\uff0c\u53cd\u4e4b\u4ea6\u7136\u3002\u5efa\u8bae\u5bf9HBV\u75ab\u82d7\u6297\u539f\u8868\u4f4d\u4e4b\u95f4\u7684\u4ea4\u53c9\u8010\u836f\u8fdb\u884c\u8bc4\u4f30\u3002<\/span><\/p>\n


    <\/p>\n


    <\/p>\n

    \u258e\u53cd\u4e49\u5be1\u6838\u82f7\u9178\u548csiRNA\u7814\u53d1\u836f\u7269\u7684\u8003\u8651\u4e8b\u9879<\/span><\/strong><\/span><\/p>\n


    <\/p>\n

    \u901a\u8fc7\u53cd\u4e49\u5be1\u6838\u82f7\u9178\u548c\u5c0f\u5e72\u6270RNA<\/span>\uff08siRNA\uff09<\/span>\u963b\u65ad\u75c5\u6bd2\u86cb\u767d\u8868\u8fbe\u662f\u6297\u75c5\u6bd2\u836f\u7269\u7814\u53d1\u4e2d\u7684\u4e00\u4e2a\u70ed\u95e8\u9886\u57df\u3002\u8fd9\u4e9b\u836f\u7269\uff0c\u5177\u6709\u6838\u9178\u9776\u70b9\uff0c\u53ef\u80fd\u4f1a\u4e0e\u5e8f\u5217\u53d1\u751f\u9519\u914d\uff0c\u800c\u4ea7\u751f\u6f5c\u5728\u7684\u975e\u9776\u5411\u6027\u7684\u7ed3\u5408<\/span>\uff08\u8131\u9776\u6548\u5e94\uff09<\/span>\uff0c\u901a\u8fc7\u4f20\u7edf\u7684\u6bd2\u7406\u5b66\u7814\u7a76\u65b9\u6cd5\uff0c\u53ef\u80fd\u65e0\u6cd5\u68c0\u6d4b\u5230\u8fd9\u79cd\u79cd\u5c5e\u7279\u5f02\u6027\u7684\u6bd2\u6027\u3002\u56e0\u6b64\uff0c\u6211\u4eec\u5efa\u8bae\u5728\u5e94\u7528\u4ee5\u6838\u9178\u4e3a\u9776\u70b9\u7684\u836f\u7269\u65f6\uff0c\u5e94\u8fdb\u884c\u4ee5\u4e0b\u65b9\u9762\u7684\u751f\u7269\u4fe1\u606f\u5b66\u7814\u7a76\u3002<\/span><\/p>\n


    <\/p>\n

    \u8fd9\u4e9b\u7814\u7a76\u5e94\u8be5\uff1a<\/span><\/strong><\/p>\n

    \n

      \n
    • \n

      \u4e0d\u7ba1\u5728\u7ec4\u7ec7\u4e2d\u7684\u8868\u8fbe\u5982\u4f55\uff0c\u9274\u522b\u5728\u4eba\u7c7b\u8f6c\u5f55\u7ec4\u4e2d\u6f5c\u5728\u7684\u975e\u9776\u5411\u7684\u5339\u914d\uff1b\u5bf9\u4e8e\u6bcf\u4e00\u7ec4\u975e\u7279\u5f02\u6027\u5339\u914d\uff0c\u90fd\u5e94\u8be5\u63d0\u4f9b\u73b0\u6709\u7684\u6709\u5173\u57fa\u56e0\u6572\u9664\u5c0f\u9f20\u548c\u4eba\u7c7b\u9057\u4f20\u75c5\u4fe1\u606f\u3002\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u4e2d\u5e94\u5305\u62ec\u76d1\u6d4b\u660e\u663e\u8131\u9776\u6548\u5e94\u7684\u8ba1\u5212\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

      \n

        \n
      • \n

        \u5728\u5c0f\u9f20\u57fa\u56e0\u4e0e\u5728\u7814\u836f\u7269\u4e4b\u95f4\u4e0d\u8d85\u8fc73\u4e2a\u9519\u914d\u78b1\u57fa\u65f6\uff0c\u786e\u5b9a\u5728\u7814\u836f\u7269\u8131\u9776\u4f4d\u70b9\u7684\u4eba\u7c7b\u57fa\u56e0\u4e0e\u5c0f\u9f20\u57fa\u56e0\u662f\u5426\u8db3\u591f\u4fdd\u5b88\u3002\u8fd9\u6837\u53ef\u4ee5\u9884\u6d4b\uff0c\u5982\u679c\u7814\u53d1\u836f\u7269\u51fa\u73b0\u4e86\u8131\u9776\uff0c\u8fd9\u4e9b\u6bd2\u6027\u4f1a\u6216\u8005\u4e0d\u4f1a\u5728\u5c0f\u9f20\u4e2d\u6709\u6240\u4f53\u73b0\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


        <\/p>\n

          \n
        • \n

          \u8bc6\u522b\u4eba\u7c7b\u7ebf\u7c92\u4f53\u8f6c\u5f55\u7ec4\u4e2d\u6f5c\u5728\u7684\u975e\u9776\u5411\u5339\u914d\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


          <\/p>\n

            \n
          • \n

            \u786e\u5b9a\u7f8e\u56fd\u4eba\u7fa4\u4e2d\u4e0d\u540c\u79cd\u65cf\u8f6c\u5f55\u7ec4\u4e2d\u7684\u975e\u9776\u5411\u6027\u5339\u914d\u7684\u53d8\u5f02\uff0c\u4ee5\u8bc4\u4f30\u79cd\u65cf\u7684\u5dee\u5f02\u662f\u5426\u4f1a\u5bfc\u81f4\u67d0\u4e9b\u79cd\u65cf\u4e0e\u5176\u4ed6\u79cd\u65cf\u76f8\u6bd4\uff0c\u66f4\u5bb9\u6613\u53d7\u5230\u975e\u9776\u5411\u6548\u5e94\u7684\u5f71\u54cd\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


            <\/p>\n

              \n
            • \n

              \u786e\u5b9a\u4e0d\u540c\u7c7b\u578b\u7684\u9519\u914d\u5bf9\u975e\u9776\u5411\u6548\u5e94\u7684\u5f71\u54cd(\u5373\uff0c\u6bd4\u8f83\u560c\u5464\u4e0e\u560c\u5464\u6216\u4e0e\u5176\u5b83\u78b1\u57fa\u9519\u914d)\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


              <\/p>\n


              <\/p>\n

              \u258e\u9776\u5411\u5bbf\u4e3b\u56e0\u7d20<\/span><\/strong><\/span><\/p>\n


              <\/p>\n

              \u5bf9\u4e8e\u9488\u5bf9\u5bbf\u4e3b\u7684\u836f\u7269\uff0c\u5e94\u8be5\u8bc4\u4ef7\u9776\u5e8f\u5217\u57fa\u56e0\u7f16\u7801\u533a\u7684\u591a\u6837\u6027\uff0c\u4ee5\u786e\u5b9a\u8be5\u836f\u7269\u5728\u4e0d\u540c\u4eba\u7fa4\u4e2d\uff0c\u662f\u5426\u6709\u7597\u6548\u7684\u589e\u52a0\u6216\u51cf\u5f31\u3002<\/span><\/p>\n

              \n

              \u5982\u679c\u975e\u4e34\u5e8a\u9636\u6bb5\u8bc4\u4ef7\u8be5\u836f\u7269\u662f\u6709\u6548\u7684\uff0c\u6b64\u65f6\u5efa\u8bae\u5e94\u8be5\u5bf9\u4ece\u7f8e\u56fd\u4e3b\u8981\u79cd\u65cf\u7fa4\u4f53\u4e2d\u6536\u96c6\u7684\u591a\u4e2a\u6837\u672c\u8fdb\u884c\u8bc4\u4f30\uff0c\u4ee5\u786e\u5b9a\u79cd\u65cf\u662f\u5426\u4e0e\u7597\u6548\u76f8\u5173\u3002\u5728\u4e34\u5e8a\u9636\u6bb5\u5e94\u6536\u96c6\u6837\u672c\uff0c\u786e\u5b9a\u5bf9\u4e8e\u6cbb\u7597\u5e94\u7b54\u4e0d\u4f73\u7684\u60a3\u8005\u7684\u75c5\u6bd2\u57fa\u56e0\u578b\u3002<\/span><\/p>\n

              \n


              <\/p>\n

              C. \u4e34\u5e8a\u836f\u7406\u5b66\u76f8\u5173\u7684\u6ce8\u610f\u4e8b\u9879<\/span><\/strong><\/p>\n


              <\/p>\n


              <\/p>\n

              \u65e9\u671f\u7597\u6548\u8bd5\u9a8c\u5242\u91cf\u7684\u9009\u62e9\u4e00\u822c\u5e94\u662f\u8840\u6d46\u836f\u7269\u66b4\u9732\u91cf\u8fbe\u5230\u836f\u7269\u5728\u7ec6\u80de\u57f9\u517b\u65f6\u9488\u5bf9\u76f8\u5173HBV\u57fa\u56e0\u578b\/\u4e9a\u578b\u6d4b\u5b9a\u7684\uff0c\u5e76\u5728\u7ed3\u5408\u86cb\u767d\u8c03\u6574\u540e\u7684EC50\u6570\u503c\u7684\u6570\u500d\u3002\u5242\u91cf\u9009\u62e9\u8fd8\u5e94\u8003\u8651\u524d\u671f\u7684I\u671f\u8bd5\u9a8c\u9636\u6bb5\u548c\u52a8\u7269\u7814\u7a76\u7684\u5b89\u5168\u6027\u6570\u636e\u3002<\/span><\/p>\n


              <\/p>\n

              \u7533\u529e\u65b9\u5e94\u53c2\u8003\u6709\u5173\u7684FDA\u4e3a\u5236\u836f\u884c\u4e1a\u5236\u5b9a\u7684\u4e34\u5e8a\u836f\u7406\u5b66\u6307\u5357\uff0c\u4ee5\u786e\u5b9a\u662f\u5426\u9700\u8981\u8fdb\u884c\u836f\u7269-\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u7684\u7814\u7a76\uff0c\u4ee5\u53ca\u5bf9\u80be\u810f\u6216\u809d\u810f\u529f\u80fd\u5f02\u5e38\u7684\u60a3\u8005\u7684\u836f\u7269\u4ee3\u8c22\u52a8\u529b\u5b66<\/span>\uff08PK\uff09<\/span>\u7684\u7814\u7a76\u3002\u5982\u679c\u9700\u8981\uff0c\u6211\u4eec\u9f13\u52b1\u7533\u529e\u65b9\u5728\u7814\u53d1\u65e9\u671f\u8fdb\u884c\u8fd9\u4e9b\u7814\u7a76\u3002<\/span><\/p>\n

              \n

              \u628a\u836f\u7269-\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u544a\u77e5\u836f\u7269\u76d1\u7ba1\u90e8\u95e8\uff0c\u5e76\u914c\u60c5\u8003\u8651\u5c06\u80be\u810f\u548c\u809d\u810f\u529f\u80fd\u5f02\u5e38\u7684\u60a3\u8005\u7eb3\u5165III\u671f\u8bd5\u9a8c\u3002<\/span>\uff08\u8be6\u89c1\u76f8\u5173\u7ae0\u8282\uff09<\/span><\/p>\n


              <\/p>\n


              <\/p>\n

              \u258e\u53d7\u8bd5\u4eba\u7fa4<\/span><\/strong><\/span><\/p>\n


              <\/p>\n

              \u6cbb\u7597\u65b9\u6848\u5e94\u9002\u7528\u4e8e\u5305\u62ec\u513f\u7ae5\u5728\u5185\u7684\u8303\u56f4\u5e7f\u6cdb\u7684CHB\u60a3\u8005\u3002<\/span><\/p>\n


              <\/p>\n

              \u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5e94\u4e3b\u8981\u96c6\u4e2d\u5728\u6ca1\u6709\u809d\u786c\u5316\u7684\u6210\u5e74\u4eba\u3002\u6700\u521d\u7684\u8bd5\u9a8c\u53ef\u4ee5\u5728\u672a\u7ecf\u6cbb\u7597\u7684\u4e59\u809d\u75c5\u6bd2e\u6297\u539f\u9633\u6027<\/span>\uff08HBeAg\u9633\u6027\uff09<\/span>\u7684\u3001\u5b58\u5728\u75be\u75c5\u6d3b\u52a8\u7684\u60a3\u8005\u4e2d\u8fdb\u884c\uff0c\u6216\u8005\u662f\u5728\u63a5\u53d7\u6838\u82f7<\/span>\uff08\u9178\uff09<\/span>\u7c7b\u4f3c\u7269<\/span>\uff08NUCs\uff09<\/span>\u6cbb\u7597\u540e, \u8fbe\u5230\u75c5\u6bd2\u5b66\u6291\u5236\u7684\u4e59\u809d\u75c5\u6bd2e\u6297\u539f<\/span>\uff08HBeAg\uff09<\/span>\u9633\u6027\u6216 HBeAg\u9634\u6027\u7684\u60a3\u8005\u4e2d\u8fdb\u884c\u3002<\/span><\/p>\n

              \n

              \u9664\u4e86\u5728\u7b2c\u4e09\u8282B.\u7ae0\u8282\u8ba8\u8bba\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ec8\u70b9\u5916\uff0c\u7533\u529e\u65b9\u8fd8\u53ef\u4ee5\u5728\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7814\u7a76\u4e00\u4e9b\u63a2\u7d22\u6027\u7684\u7597\u6548\u7ec8\u70b9\u3002\u8fd9\u4e9b\u6570\u636e\u53ef\u4ee5\u7528\u6765\u63d0\u4f9b\u6216\u662f\u652f\u6301\u5728\u540e\u671f\u8bd5\u9a8c\u9636\u6bb5\u7684\u67d0\u4e9b\u7597\u6548\u7ec8\u70b9\u7684\u9009\u62e9\uff0c\u7279\u522b\u662f\u90a3\u4e9b\u53ef\u4ee5\u7528\u6765\u8bc4\u4ef7\u6709\u9650\u7597\u7a0b\u7684\u6307\u6807\u3002<\/span><\/p>\n


              <\/p>\n

              \u8fd9\u4e9b\u63a2\u7d22\u6027\u7684\u7597\u6548\u7ec8\u70b9\u53ef\u4ee5\u5305\u62ec\u4ee5\u4e0b\u9879\u76ee\uff1a<\/span><\/strong><\/p>\n

              \n

                \n
              • \n

                \u5728\u6cbb\u7597\u8fc7\u7a0b\u4e2d\uff0c\u4e0d\u540c\u65f6\u95f4\u70b9\u7684HBsAg\uff08<\/span>qHBsAg\uff09<\/span>\u6ef4\u5ea6<\/span><\/p>\n<\/li>\n

              • \n

                HBeAg\u6ef4\u5ea6<\/span><\/p>\n<\/li>\n

              • \n

                HBV RNA<\/span><\/p>\n<\/li>\n

              • \n

                HBV\u6838\u5fc3\u76f8\u5173\u6297\u539f<\/span>\uff08HBcrAg\uff09<\/span><\/p>\n<\/li>\n

              • \n

                cccDNA\u5b9a\u91cf <\/span><\/p>\n<\/li>\n

              • \n

                HBsAg\u6784\u6210\u7247\u6bb5<\/span><\/p>\n<\/li>\n

              • \n

                HBsAg\u53caHBs\u6297\u4f53\u7684\u514d\u75ab\u590d\u5408\u7269<\/span><\/p>\n<\/li>\n<\/ul>\n


                <\/p>\n

                \u5e76\u4e14\u6839\u636e\u836f\u7269\u7684\u4f5c\u7528\u673a\u5236\uff0c\u5728\u201c\u6982\u5ff5\u6027\u8bc1\u660e\u201d\u7814\u7a76\u4e2d\uff0c\u809d\u6d3b\u68c0\u7ed3\u679c\u53ef\u4ee5\u7528\u4e8e\u786e\u8ba4\u65b0\u7684\u4f5c\u7528\u673a\u5236\uff0c\u6216\u4f5c\u4e3a\u9a8c\u8bc1\u6297\u75c5\u6bd2\u6d3b\u6027\u7684\u66ff\u4ee3\u6307\u6807\u3002<\/span><\/p>\n


                <\/p>\n

                \u6162\u6027\u4e59\u578b\u809d\u708e\u662f\u4e00\u79cd\u5168\u7403\u6027\u75be\u75c5\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u7ecf\u5e38\u5728\u591a\u4e2a\u56fd\u5bb6\u8fdb\u884c\u3002\u6839\u636e21CFR 312.120\u7684\u5efa\u8bae<\/span>\uff08\u6ce8\uff1a\u8fd9\u662f\u9488\u5bf9\u672a\u6309\u7167\u7814\u7a76\u6027\u65b0\u836f\u7533\u8bf7<\/span>\uff08IND\uff09<\/span>\u8fdb\u884c\u7684\u56fd\u5916\u4e34\u5e8a\u8bd5\u9a8c\uff09<\/span>\uff0c\u5982\u679c\u8bd5\u9a8c\u662f\u6309\u7167\u826f\u597d\u7684\u4e34\u5e8a\u5b9e\u8df5\u8fdb\u884c\u7684\u3001\u5e76\u4e14\u5728\u5fc5\u8981\u65f6\uff0cFDA\u80fd\u591f\u901a\u8fc7\u73b0\u573a\u68c0\u67e5\u6765\u9a8c\u8bc1\u8bd5\u9a8c\u6570\u636e\uff0cFDA\u53ef\u4ee5\u63a5\u6536\u4e00\u9879\u8bbe\u8ba1\u5b8c\u5584\u3001\u5b9e\u65bd\u826f\u597d\u3001\u975eIND\u7684\u56fd\u5916\u7814\u7a76\uff0c\u6765\u652f\u6301\u5176\u8fdb\u884cIND\u7533\u8bf7\u6216\u6279\u51c6\u5176\u4e0a\u5e02\u3002<\/span><\/p>\n

                \n

                \u5f53\u7533\u529e\u65b9\u4f9d\u9760\u56fd\u5916\u7684\u6570\u636e\u65f6\uff0c\u8fd9\u4e9b\u6570\u636e\u5e94\u8be5\u9644\u6709\u8be5\u5730\u533a\u4e3b\u8981\u75c5\u6bd2\u57fa\u56e0\u578b\u548c\u4e9a\u578b\u7684\u4fe1\u606f\u3002\u7814\u53d1\u8ba1\u5212\u5e94\u5305\u62ec\u4e00\u5b9a\u6570\u76ee\u7684\u7f8e\u56fd\u60a3\u8005\uff0c\u4ee5\u786e\u4fdd\u6570\u636e\u9002\u7528\u4e8e\u7f8e\u56fd\u4eba\u7fa4\u3002FDA\u5f3a\u70c8\u9f13\u52b1\u7533\u529e\u65b9\u5728II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u540e\u7684\u6c9f\u901a\u4f1a\u4e2d\uff0c\u8ba8\u8bba\u5973\u6027\u53d7\u8bd5\u8005\u4eba\u6570\u548c\u79cd\u65cf\u7684\u4ee3\u8868\u6027\uff0c\u4ee5\u652f\u6301 NDA<\/span>\uff08\u65b0\u836f\u7533\u8bf7\uff09<\/span>\u6216BLA<\/span>\uff08\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7\uff09<\/span>\u3002<\/span><\/p>\n


                <\/p>\n


                <\/p>\n

                3\u3001\u5b89\u5168\u6027\u8003\u8651<\/span><\/strong><\/span><\/p>\n


                <\/p>\n

                \u901a\u5e38\uff0c\u6211\u4eec\u5efa\u8bae\u5728\u836f\u7269\u4e0a\u5e02\u521d\u671f\uff0c\u5bf9\u4e8e\u6cbb\u7597CHB\u7684\u836f\u7269\uff0c\u5e94\u8be5\u6709\u5927\u7ea6\u75311000\u81f31500\u4e2a\u63a5\u53d7\u6240\u5efa\u8bae\u6cbb\u7597\u5242\u91cf\u548c\u7597\u7a0b\u7684\u60a3\u8005\u6784\u6210\u7684\u5b89\u5168\u6570\u636e\u5e93\u3002\u6839\u636e\u836f\u7269\u5b89\u5168\u60c5\u51b5\u548c\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u786e\u5b9a\u7684\u5173\u6ce8\u70b9\uff0c\u53ef\u80fd\u9700\u8981\u66f4\u5927\u7684\u6570\u636e\u5e93\u6216\u957f\u671f\u7684\u6cbb\u7597\u540e\u968f\u8bbf\u3002<\/span><\/p>\n


                <\/p>\n

                \u9664\u4e86\u5e38\u89c4\u5b89\u5168\u76d1\u6d4b\u5916\uff0c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u4e2d\u5e94\u660e\u786e\u89c4\u5b9a\u76d1\u6d4b\u809d\u708e\u66b4\u53d1\u6216HBV\u518d\u6fc0\u6d3b\u7684\u5177\u4f53\u6807\u51c6\u3002\u4e34\u5e8a\u65b9\u6848\u5e94\u8be5\u5305\u62ec\u9884\u5148\u5b9a\u4e49\u597d\u7684\u3001\u5f53\u51fa\u73b0\u4e25\u91cd\u7684\u809d\u810f\u4e8b\u4ef6\u65f6\u7684\u6570\u636e\u6536\u96c6\u65b9\u6848\uff0c\u4ee5\u786e\u4fdd\u8fd9\u4e9b\u75c5\u4f8b\u7684\u76f8\u5173\u6570\u636e\u53ef\u7528\u4e8e\u8fdb\u4e00\u6b65\u8bc4\u4f30\u3001\u5224\u65ad\u548c\u533a\u5206\u6f5c\u5728\u7684\u75c5\u56e0\u3002\u5728\u4e34\u5e8a\u7814\u53d1\u7684\u8fc7\u7a0b\u4e2d\uff0c\u5e94\u7cfb\u7edf\u5730\u8bc4\u4f30\u6240\u6709\u4e25\u91cd\u809d\u810f\u76f8\u5173\u4e8b\u4ef6\u6240\u9020\u6210\u7684\u5371\u5bb3\uff0c\u9f13\u52b1\u72ec\u7acb\u5ba1\u5224\u59d4\u5458\u4f1a\u8fdb\u884c\u8bc4\u4f30\u3002<\/span><\/p>\n


                <\/p>\n

                \u88ab\u6279\u51c6\u7528\u4e8e\u975e\u809d\u786c\u5316\u6216\u4ee3\u507f\u671f\u809d\u786c\u5316\u60a3\u8005\u7684\u836f\u7269\uff0c\u82e5\u8ba1\u5212\u5411\u5931\u4ee3\u507f\u671f\u809d\u786c\u5316\u4eba\u7fa4\u4e2d\u63a8\u5e7f\u4f7f\u7528\u65f6\uff0c\u9700\u589e\u52a0\u7814\u7a76\u836f\u7269\u5728\u5931\u4ee3\u507f\u671f\u809d\u786c\u5316\u60a3\u8005\u4e2d\u4f7f\u7528\u7684\u5b89\u5168\u6027\u6570\u636e\u548c\u76ee\u6807\u4eba\u7fa4\u603b\u4f53\u7684\u98ce\u9669-\u83b7\u76ca\u60c5\u51b5\u3002<\/span><\/p>\n

                \n

                \u7c7b\u4f3c\u5730\uff0c\u5728\u5176\u4ed6\u4e9a\u7fa4\u4e2d<\/span>\uff08\u4f8b\u5982\u5728\u4e59\u578b\u809d\u708e\u4e0e\u4e01\u578b\u809d\u708e\u75c5\u6bd2<\/span>\uff08HDV\uff09<\/span>\u5171\u611f\u67d3\u7684\u60a3\u8005\u4e2d\uff09<\/span>\u83b7\u5f97\u7684\u5b89\u5168\u6027\u6570\u636e\uff0c\u5bf9\u4e8e\u67d0\u4e9b\u4e34\u5e8a\u7814\u53d1\u8ba1\u5212\u53ef\u80fd\u662f\u975e\u5e38\u91cd\u8981\u7684\u3002\u6211\u4eec\u9f13\u52b1\u7533\u529e\u65b9\u5728\u5f00\u59cbIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e4b\u524d\uff0c\u5c31\u5b89\u5168\u6027\u76f8\u5173\u7684\u8003\u8651 <\/span>\uff08\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u5b89\u5168\u6027\u6570\u636e\u5e93\u7684\u5927\u5c0f\uff09<\/span>\u4e0eFDA\u8fdb\u884c\u8ba8\u8bba\u3002<\/span><\/p>\n


                <\/p>\n


                <\/p>\n

                B. \u7b2c3\u9636\u6bb5\u7597\u6548\u8bd5\u9a8c\u7684\u8003\u8651\u4e8b\u9879<\/span><\/strong><\/p>\n<\/section>\n


                <\/section>\n

                <\/p>\n

                \u7533\u529e\u65b9\u53ef\u4ee5\u63d0\u4ea4NDA\/BLA\u7533\u8bf7\u4ee5\u652f\u6301\u5728\u5355\u4e00\u60a3\u8005\u7fa4\u4f53\u4e2d\u7684\u836f\u7269\u5e02\u573a\u5ba1\u6279\u3002\u8fd9\u79cd\u7533\u8bf7\u5e94\u8be5\u5305\u62ec\u81f3\u5c11\u4e24\u4e2a\u5728\u76ee\u6807\u4eba\u7fa4\u4e2d\u8fdb\u884c\u7684\u3001\u5b8c\u5584\u7684\u3001\u7ba1\u7406\u826f\u597d\u7684\u8bd5\u9a8c\u3002<\/span><\/p>\n

                \n

                \u7533\u529e\u65b9\u4e5f\u53ef\u4ee5\u9009\u62e9\u4e3a\u4e0d\u540c\u7684\u4eba\u7fa4\u5bfb\u6c42\u9002\u5e94\u75c7\uff0c\u5982\u5f00\u5c55\u4e00\u9879\u5728\u521d\u6cbb\u60a3\u8005\u4e2d\u7684\u8bd5\u9a8c\u65f6\uff0c\u5728\u63a5\u53d7NUCs\u6cbb\u7597\u540e\u5904\u4e8e\u75c5\u6bd2\u6291\u5236\u7684\u60a3\u8005\u4e2d\u5f00\u5c55\u7b2c\u4e8c\u9879\u8bd5\u9a8c\u3002\u5728\u8fd9\u4e9b\u60c5\u51b5\u4e0b\u7533\u8bf7NDA\u65f6\uff0c\u5e94\u8be5\u5728\u6bcf\u4e2a\u60a3\u8005\u7fa4\u4f53\u4e2d\u81f3\u5c11\u5305\u542b\u4e00\u4e2a\u6837\u672c\u5145\u8db3\u7684\u3001\u63a7\u5236\u826f\u597d\u7684\u8bd5\u9a8c\uff0c\u5e76\u6709\u8db3\u591f\u7684\u6570\u636e\u6765\u652f\u6301\u3002<\/span><\/p>\n


                <\/p>\n


                <\/p>\n

                1\u3001\u8bd5\u9a8c\u8bbe\u8ba1<\/span><\/strong><\/span><\/p>\n


                <\/p>\n

                \u7531\u4e8e\u6162\u6027\u4e59\u578b\u809d\u708e\u7684\u81ea\u7136\u75c5\u7a0b\u7684\u591a\u9636\u6bb5\u6027\uff0c\u56e0\u6b64\u5efa\u8bae\u8fdb\u884c\u968f\u673a\u5bf9\u7167\u8bd5\u9a8c\u4ee5\u786e\u5b9a\u7597\u6548\u3002<\/span><\/p>\n

                \n

                \u9002\u5f53\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u53d6\u51b3\u4e8e\u6cbb\u7597\u65b9\u6848\u662f\u8ba1\u5212\u7528\u4e8e\u6162\u6027\u6291\u5236\u6027\u6cbb\u7597\u8fd8\u662f\u6709\u9650\u65f6\u95f4\u7684\u6cbb\u7597\uff0c\u8be6\u89c1\u5982\u4e0b\u8ba8\u8bba\uff1a<\/strong><\/span><\/p>\n

                \n

                \n

                a. \u6162\u6027\u6291\u5236\u6027\u6cbb\u7597\u65b9\u6848<\/span><\/strong><\/p>\n


                <\/p>\n

                \u53ef\u4ee5\u5728HBeAg\u9633\u6027\u60a3\u8005\u548cHBeAg\u9634\u6027\u60a3\u8005\u4e2d\uff0c\u5f00\u5c55\u4e00\u9879\u968f\u673a\u5bf9\u7167\u8bd5\u9a8c\uff0c\u4f7f\u7528\u7ecf\u6279\u51c6\u7684\u836f\u7269\u4f5c\u4e3a\u9633\u6027\u5bf9\u7167\uff0c\u5176\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u4e3a\uff1a\u5728\u6cbb\u759748\u5468\u540e\u68c0\u6d4b\u4e0d\u5230HBV DNA<\/span>\uff08\u5b9a\u4e49\u4e3a\u4f4e\u4e8e\u68c0\u6d4b\u5b9a\u91cf\u4e0b\u9650\uff08LLOQ\uff09<\/span>\u3002<\/span><\/p>\n

                \n

                \u6709\u6548\u7684\u5bf9\u7167\u836f\u7269\u5e94\u8be5\u662f\u5728\u8bd5\u9a8c\u5f00\u59cb\u65f6\uff0c\u5df2\u7ecf\u88ab\u63a8\u8350\u7528\u4e8e\u6cbb\u7597\u6162\u6027\u4e59\u578b\u809d\u708e\u3001\u5e76\u5e94\u662f\u5f53\u65f6\u4e34\u5e8a\u63a8\u8350\u7684\u89c4\u8303\u836f\u7269\u3002\u75c5\u4eba\u53ef\u4ee5\u662f\u521d\u6cbb\u7684\u60a3\u8005\uff0c\u4e5f\u53ef\u4ee5\u662f\u4e4b\u524d\u63a5\u53d7\u8fc7\u6cbb\u7597\u3001\u4f46\u4ecd\u53ef\u68c0\u6d4b\u5230HBV DNA\u7684\u60a3\u8005\u3002<\/span><\/p>\n


                <\/p>\n


                <\/p>\n

                b. \u6709\u9650\u7597\u7a0b\u7684\u6cbb\u7597<\/span><\/strong><\/p>\n


                <\/p>\n

                \u6839\u636e\u60a3\u8005\u7fa4\u4f53\u548c\u8bc4\u4f30\u7684\u6cbb\u7597\u65b9\u6848\u5236\u5b9a\u5408\u9002\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u3002<\/span><\/p>\n


                <\/p>\n


                <\/p>\n

                \u258e\u75c5\u6bd2\u5df2\u88abNUCs\u6291\u5236\u7684\u60a3\u8005<\/span><\/strong><\/span><\/p>\n


                <\/p>\n

                \u5728\u63a5\u53d7\u6838\u82f7<\/span>\uff08\u9178\uff09<\/span>\u7c7b\u836f\u7269\u8fbe\u5230\u75c5\u6bd2\u5b66\u6291\u5236\u4f46\u5b58\u5728\u6d3b\u52a8\u6027\u75be\u75c5\u7684HBeAg\u9633\u6027\u6216HBeAg\u9634\u6027\u7684\u6162\u6027\u4e59\u578b\u809d\u708e\u60a3\u8005\u4e2d\uff0c\u5982\u679c\u4ee5\u505c\u836f\u540eHBV DNA\u6301\u7eed\u6291\u5236\u4ee5\u53ca\u4f34\u6709 HBsAg\u6e05\u9664\u4f5c\u4e3a\u4e3b\u8981\u7684\u7597\u6548\u7ec8\u70b9\uff0c\u7533\u529e\u65b9\u53ef\u4ee5\u8003\u8651\u628a\u76ee\u524d\u7684NUCs\u6cbb\u7597\u65b9\u6848\u4f5c\u4e3a\u4e00\u79cd\u80cc\u666f\u6cbb\u7597\uff0c\u4e0e\u5b89\u6170\u5242\u6bd4\u8f83\uff0c\u89c2\u5bdf\u9644\u52a0\u8bd5\u9a8c\u836f\u7269\u540e\u6709\u65e0\u4f18\u5316\u3002<\/span><\/p>\n

                \n

                \u4e3b\u8981\u7597\u6548\u7ec8\u70b9HBsAg\u6e05\u9664\u548c\u6301\u7eedHBV DNA\u6291\u5236\u5e94\u5728\u505c\u836f\u540e6\u4e2a\u6708\u8fdb\u884c\u8bc4\u4f30\u3002\u6b64\u5916\u8fd8\u9700\u8981\u8fdb\u884c\u989d\u5916\u7684\u968f\u8bbf\uff0c\u76d1\u6d4b\u6cbb\u7597\u5e94\u7b54\u7684\u6301\u4e45\u6027<\/span>\uff08\u5982\uff1a\u6301\u7eed\u7684HBV DNA\u6291\u5236\u548cHBsAg\u6e05\u9664\uff09<\/span>\u3002<\/span><\/p>\n


                <\/p>\n

                \u6216\u8005\uff0c\u901a\u8fc7\u4f18\u6548\u6027\u8bd5\u9a8c\u5bf9\u7814\u7a76\u836f\u7269\u4e0eNUCs\u7684\u8054\u5408\u65b9\u6848\u548cNUCs\u5355\u836f\u65b9\u6848\u8fdb\u884c\u6bd4\u8f83\uff0c\u5728\u6ca1\u6709HBsAg\u6e05\u9664\u7684\u60c5\u51b5\u4e0b\uff0c\u8bc4\u4ef7\u5728\u6709\u9650\u7684\u7597\u7a0b\u7ed3\u675f\u540e\uff0cHBV DNA\u6301\u7eed\u6291\u5236\u7684\u60c5\u51b5\u3002<\/span><\/p>\n


                <\/p>\n

                \u7533\u529e\u65b9\u5728\u76d1\u6d4b\u671f\u7ed3\u675f\u65f6\uff0c\u5e94\u4f7f\u7528\u4e0b\u5217\u6807\u51c6\u6765\u51b3\u5b9a\u662f\u5426\u505c\u6b62NUCs\u6cbb\u7597\uff1a<\/span><\/p>\n

                \n

                \uff081\uff09\u65e0\u504f\u5411\u5730\u9002\u7528\u4e8e\u6240\u6709\u4e34\u5e8a\u6cbb\u7597\u961f\u5217\uff1b<\/span><\/p>\n

                \n

                \uff082\uff09\u5728\u4e34\u5e8a\u65b9\u6848\u4e2d\u5df2\u7ecf\u5b9a\u4e49\u6e05\u6670\uff1b<\/span><\/p>\n

                \n

                \uff083\uff09\u4e25\u683c\u7684\u6807\u51c6\uff0c\u5982\u5728II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u51fa\u73b0\u8bf8\u5982HBsAg\u6d88\u5931\u6216\u6301\u7eed\u7684HBsAg\u663e\u8457\u4e0b\u964d\u6216\u5176\u4ed6\u91cd\u8981\u7684\u751f\u7269\u5b66\u6807\u5fd7\u7269\u7684\u663e\u8457\u4e0b\u964d\u3002\u5728\u5b89\u6170\u5242\u7ec4\u4e2d\u5e94\u6709\u5f88\u5c11\u60a3\u8005\u8fbe\u5230\u8fd9\u6837\u7684\u6807\u51c6\u3002\u5982\u679c\u62df\u91c7\u7528\u751f\u7269\u6807\u8bb0\u7269\u4f5c\u4e3a\u6cbb\u7597\u7ec8\u6b62\u7684\u6307\u6807\uff0c\u5728\u8bd5\u9a8c\u5f00\u59cb\u4e4b\u524d\u5e94\u5f53\u4e0eFDA\u8fdb\u884c\u8ba8\u8bba\u3002<\/span><\/p>\n

                \n


                <\/p>\n

                \u258e\u521d\u6cbb\u60a3\u8005<\/span><\/strong><\/span><\/p>\n


                <\/p>\n

                \u5bf9\u4e8e\u6307\u5357\u4e2d\u6682\u65f6\u672a\u5efa\u8bae\u63a5\u53d7\u6cbb\u7597\u7684\u521d\u6cbb\u60a3\u8005\uff0c\u53ef\u4ee5\u7528\u505c\u836f\u540eHBV DNA\u7684\u6301\u7eed\u6291\u5236\u4f34\u6709HBsAg\u7684\u6e05\u9664\u6765\u663e\u793a\u7814\u7a76\u836f\u7269\u8f83\u9633\u6027\u5bf9\u7167\u6216\u8005\u5b89\u6170\u5242\u66f4\u6709\u4f18\u52bf\u3002<\/span><\/p>\n

                \n

                \u5728\u67d0\u4e9b\u60a3\u8005\u7fa4\u4f53\u4e2d<\/span>\uff08\u5982\uff0c\u5904\u4e8e\u514d\u75ab\u8010\u53d7\u671f\u4f34\u6709\u8f7b\u5ea6\u708e\u75c7\u574f\u6b7b\u6216\u7ea4\u7ef4\u5316\u7684\u60a3\u8005\uff09<\/span>\uff0c\u4e0e\u5b89\u6170\u5242\u8fdb\u884c\u6bd4\u8f83\u53ef\u80fd\u662f\u53ef\u884c\u7684\uff0c\u56e0\u4e3a\u5728\u76ee\u524d\u7684\u6cbb\u7597\u6307\u5357\u4e2d\uff0c\u6682\u672a\u5efa\u8bae\u5bf9\u8fd9\u4e9b\u60a3\u8005\u8fdb\u884c\u6cbb\u7597\u3002<\/span><\/p>\n


                <\/p>\n

                \u5728\u4efb\u4f55\u8bd5\u9a8c\u8bbe\u8ba1\u65b9\u6848\u4e2d\uff0c\u5728\u8bd5\u9a8c\u5b8c\u6210\u4e4b\u524d<\/span>\uff08\u4f8b\u5982\uff0c\u5728\u9884\u5148\u6307\u5b9a\u7684\u4e2d\u671f\u5206\u6790\u65f6\uff09<\/span>\uff0c\u5c06\u60a3\u8005\u4ece\u5b89\u6170\u5242\u7ec4\u8f6c\u5230\u6709\u6cbb\u7597\u6548\u679c\u7684\u7814\u7a76\u836f\u7269\u7ec4\u5e94\u8be5\u662f\u53ef\u4ee5\u8003\u8651\u7684\u3002\u8fd9\u5e94\u8be5\u4e0eFDA\u5728\u8bd5\u9a8c\u62db\u52df\u524d\u8fdb\u884c\u8ba8\u8bba\u3002<\/span><\/p>\n


                <\/p>\n

                \u7533\u529e\u65b9\u5728\u8003\u8651\u975e\u52a3\u6027<\/span>\uff08NI\uff09<\/span>\u8bd5\u9a8c\u8bbe\u8ba1\u65f6\uff0c\u5e94\u6839\u636e\u9633\u6027\u5bf9\u7167\u6cbb\u7597\u6548\u679c\u7684\u65e2\u5f80\u60c5\u51b5\uff0c\u63d0\u524d\u4e0eFDA\u8ba8\u8bba\u5176\u8bd5\u9a8c\u8bbe\u8ba1\u53ca\u62df\u5236\u5b9a\u7684\u975e\u52a3\u6027<\/span>\uff08<\/span>NI\uff09<\/span><\/span>\u754c\u9650\u503c\u7684\u5408\u7406\u6027\u3002<\/span><\/p>\n

                \n

                \u4e00\u822c\u6765\u8bf4\uff0cNI\u8bd5\u9a8c\u4e2d\u7684\u6709\u6548\u53c2\u7167\u7269\u5e94\u8be5\u662f\u4e00\u6b3eFDA\u6279\u51c6\u7684\u9488\u5bf9\u9002\u5e94\u75c7\u548c\u5373\u5c06\u63a5\u53d7\u7814\u7a76\u7684\u4eba\u7fa4\u7279\u5f02\u7684\u6807\u51c6\u836f\u7269\u3002\u7533\u529e\u65b9\u5e94\u8be5\u63d0\u4ea4\u4e00\u4efd\u8be6\u7ec6\u7684\u4e34\u5e8a\u7814\u7a76\u65b9\u6848\u548c\u7edf\u8ba1\u5206\u6790\u8ba1\u5212<\/span>\uff08SAP\uff09<\/span>\u4ee5\u4f9b\u5ba1\u67e5\u3002<\/span><\/p>\n


                <\/p>\n


                <\/p>\n

                2\u3001\u8bd5\u9a8c\u4eba\u7fa4<\/span><\/strong><\/span><\/p>\n


                <\/p>\n

                \u7b26\u5408\u4ee5\u4e0b\u4e24\u4e2a\u6807\u51c6\u4e4b\u4e00\u7684CHB\u60a3\u8005\u5e94\u8003\u8651\u88ab\u7eb3\u5165<\/span>\uff08\u7f8e\u56fd\u56fd\u5bb6\u75be\u75c5\u63a7\u5236\u548c\u9884\u9632\u4e2d\u5fc3 2012\uff09<\/span>\uff1a<\/span><\/p>\n


                <\/p>\n

                \uff081\uff09<\/span><\/strong>HBV\u6838\u5fc3\u6297\u539f\u514d\u75ab\u7403\u86cb\u767dM<\/span>\uff08<\/span>IgM\uff09<\/span><\/span>\u6297\u4f53<\/span>\uff08\u6297-HBc IgM\uff09<\/span>\u9634\u6027\uff0c\u540c\u65f6\u6709\u4e0b\u5217\u68c0\u6d4b\u4e4b\u4e00\u9633\u6027\uff1aHBV\u8868\u9762\u6297\u539f<\/span>\uff08HBsAg\uff09<\/span>\u3001 HBV e\u6297\u539f<\/span>\uff08HBeAg\uff09<\/span>\u6216\u4e59\u578b\u809d\u708e\u75c5\u6bd2DNA\u6838\u9178\u68c0\u6d4b<\/span>\uff08\u5305\u62ec\u5b9a\u6027\u3001\u5b9a\u91cf\u548c\u57fa\u56e0\u578b\u68c0\u6d4b\uff09<\/span>\uff1b<\/span><\/p>\n


                <\/p>\n

                \uff082\uff09<\/span><\/strong>HBsAg\u9633\u6027\u6216HBV DNA\u6838\u9178\u68c0\u6d4b\u9633\u6027<\/span>\uff08<\/span>\u5305\u62ec\u5b9a\u6027\u3001\u5b9a\u91cf\u548c\u57fa\u56e0\u578b\u68c0\u6d4b\uff09<\/span><\/span>\u6216\u81f3\u5c11\u5728\u95f4\u96946\u4e2a\u6708\u7684\u60c5\u51b5\u4e0b\uff0c\u968f\u673a\u68c0\u6d4b\u4e24\u6b21HBeAg\uff0c\u7ed3\u679c\u5747\u5448\u9633\u6027<\/span>\uff08\u4e0a\u8ff0\u68c0\u6d4b\uff0c\u5728\u95f4\u96946\u4e2a\u6708\u4ee5\u4e0a\u7684\u4efb\u4f55\u7ec4\u5408\u90fd\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\uff09<\/span>\u3002<\/span><\/p>\n


                <\/p>\n

                \u7533\u529e\u65b9\u5e94\u8003\u8651\u5728\u51e0\u7c7b\u91cd\u8981\u7684CHB\u4eba\u7fa4\u4e9a\u7ec4\u4e2d\u8bc4\u4f30\u836f\u7269\u7597\u6548\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a<\/span><\/p>\n

                \n

                  \n
                • \n

                  HBeAg\u9633\u6027\u548cHBeAg\u9634\u6027\u7684\u60a3\u8005<\/span><\/p>\n<\/li>\n

                • \n

                  \u6709\u809d\u786c\u5316\u7684\u60a3\u8005<\/span><\/p>\n<\/li>\n

                • \n

                  \u6709\u5931\u4ee3\u507f\u671f\u809d\u75c5\u7684\u60a3\u8005<\/span><\/p>\n<\/li>\n<\/ul>\n


                  <\/p>\n


                  <\/p>\n

                  3\u3001\u7eb3\u5165\u6807\u51c6<\/span><\/strong><\/span><\/p>\n


                  <\/p>\n

                  \u5728\u7814\u7a76\u5f00\u59cb\u65f6, \u662f\u5426\u5b58\u5728\u809d\u786c\u5316\u5e94\u8bb0\u5f55\u5728\u6848\u3002\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\uff0c\u5982\u4f7f\u7528\u975e\u4fb5\u5165\u6027\u624b\u6bb5\u6765\u5b9a\u4e49\u662f\u5426\u5b58\u5728\u809d\u786c\u5316\uff0c\u5e94\u8be5\u6709\u6587\u732e\u7684\u652f\u6301\u3002\u8fd9\u4e9b\u6587\u732e\u8981\u7ed9\u51fa\u7528\u4e8e\u8bc6\u522b\u809d\u786c\u5316\u60a3\u8005\u7684\u65e0\u521b\u65b9\u6cd5\u7684\u4e34\u5e8a\u7279\u5f81\u3001\u654f\u611f\u6027\u548c\u7279\u5f02\u6027\u3002\u5e94\u6392\u9664\u65e2\u5f80\u60a3\u6709\u809d\u764c\u6216\u76ee\u524d\u5b58\u5728\u809d\u764c\u8bc1\u636e\u7684\u60a3\u8005\u3002<\/span><\/p>\n


                  <\/p>\n


                  <\/p>\n

                  4\u3001\u968f\u673a\u5316\u3001\u5206\u5c42\u548c\u8bbe\u76f2<\/span><\/strong><\/span><\/p>\n


                  <\/p>\n

                  \u7533\u529e\u65b9\u5e94\u5c3d\u53ef\u80fd\u8fdb\u884c\u968f\u673a\u3001\u53cc\u76f2\u8bd5\u9a8c\uff0c\u4ee5\u51cf\u5c11\u6f5c\u5728\u7684\u504f\u501a\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u8bd5\u9a8c\u5e94\u8be5\u5728\u6709\u91cd\u8981\u75be\u75c5\u7279\u5f81\u7684\u60a3\u8005\u4e2d\u8bc4\u4ef7\u5176\u8bd5\u9a8c\u6027\u6cbb\u7597\u836f\u7269\u7684\u6548\u679c\u3002\u5982\u679c\u53ef\u4ee5\u7684\u8bdd\uff0c\u60a3\u8005\u4eba\u7fa4\u7684\u4e9a\u7ec4\u8fd8\u5e94\u8be5\u88ab\u5355\u72ec\u8fdb\u884c\u7814\u7a76\u3002<\/span><\/p>\n

                  \n

                  \u5982\u679c\u540c\u4e00\u8bd5\u9a8c\u4e2d\uff0c\u5305\u62ec\u591a\u4e2a\u60a3\u8005\u7fa4\u4f53\uff0c\u5219\u5e94\u8003\u8651\u57fa\u4e8e\u4e0d\u540c\u6307\u6807\u7684\u968f\u673a\u5206\u5c42\u5206\u7ec4\uff0c\u5982\u6839\u636eHBeAg\u8840\u6e05\u5b66\u9636\u6bb5\u3001HBsAg\u6c34\u5e73\u3001\u662f\u5426\u5b58\u5728\u809d\u786c\u5316\u3001HBV DNA\u6c34\u5e73\u3001\u65e2\u5f80\u6cbb\u7597\u53f2\u6216HBV\u57fa\u56e0\u578b\u7b49\u8fdb\u884c\u5206\u7ec4\uff1b\u4fdd\u8bc1\u6bcf\u4e2a\u5206\u7ec4\u6709\u8db3\u591f\u7684\u75c5\u4eba\uff0c\u53ef\u4ee5\u63d0\u4f9b\u7fd4\u5b9e\u7684\u6570\u636e\u3002<\/span><\/p>\n


                  <\/p>\n


                  <\/p>\n

                  5\u3001\u7279\u6b8a\u4eba\u7fa4<\/span><\/strong><\/span><\/p>\n


                  <\/p>\n


                  <\/p>\n

                  a. HBV\/HIV-1\u5408\u5e76\u611f\u67d3\u8005<\/span><\/strong><\/p>\n


                  <\/p>\n

                  HBV\/HIV\u5171\u611f\u67d3\u60a3\u8005\u7684\u603b\u4f53\u6cbb\u7597\u76ee\u6807\u4e0e\u9488\u5bf9HBV\u5355\u72ec\u611f\u67d3\u4eba\u7fa4\u7684\u76ee\u6807\u76f8\u540c\u3002\u5728\u6709\u9650\u7597\u7a0b\u7684HBV\u6cbb\u7597\u65b9\u6848\u4e2d\uff0c\u540c\u65f6\u4f7f\u7528\u5bf9HBV\u4e5f\u6709\u6548\u7684\u6297HIV\u9006\u8f6c\u5f55\u75c5\u6bd2\u836f\u7269\uff0c\u4f1a\u5bf9HBV\u7814\u7a76\u836f\u7269\u7684\u7597\u7a0b\u4ea7\u751f\u5f71\u54cd\uff0c\u4e5f\u53ef\u80fd\u4f1a\u6df7\u6dc6\u5bf9\u7597\u6548\u7ed3\u679c\u7684\u89e3\u91ca\u3002<\/span><\/p>\n

                  \n

                  \u7531\u4e8eHIV\u548cHBV\u6cbb\u7597\u4e4b\u95f4\u7684\u5404\u79cd\u76f8\u4e92\u4f5c\u7528\uff0c\u6211\u4eec\u5efa\u8bae\u7533\u529e\u65b9\u4e0eFDA\u8ba8\u8bba\u4ed6\u4eec\u7684\u7814\u7a76\u8ba1\u5212\uff0c\u5e76\u83b7\u5f97\u6709\u5173\u5171\u611f\u67d3\u4eba\u7fa4\u8bd5\u9a8c\u7684\u53cd\u9988\u3002<\/span><\/p>\n


                  <\/p>\n


                  <\/p>\n

                  b. HBV\/HDV\u5408\u5e76\u611f\u67d3\u8005<\/span><\/strong><\/p>\n


                  <\/p>\n

                  HDV\u611f\u67d3\u4ec5\u53d1\u751f\u5728\u4e0eHBV\u5171\u540c\u611f\u67d3\u7684\u60c5\u51b5\u4e0b<\/span>\uff08<\/span>Wranke\u548cWedemeyer, 2016\uff09<\/span><\/span>\u3002 \u5168\u4e16\u754c\u5927\u7ea6\u67091500\u4e07\u4eba\u60a3\u6709HBV\/HDV\u5171\u611f\u67d3<\/span>\uff08\u4e16\u754c\u536b\u751f\u7ec4\u7ec72017\uff09<\/span>\u3002<\/span><\/p>\n

                  \n

                  \u4e0eHBV\u5355\u72ec\u611f\u67d3\u76f8\u6bd4\uff0cHBV\/HDV\u5171\u611f\u67d3\u4f1a\u5bfc\u81f4\u66f4\u4e3a\u4e25\u91cd\u7684\u809d\u810f\u75be\u75c5\uff0c\u6709\u66f4\u9ad8\u7684\u98ce\u9669\u8fdb\u5c55\u4e3a\u809d\u786c\u5316\u3001HCC\u548c\u5931\u4ee3\u507f\u671f\u809d\u75c5\/\u809d\u8870\u7aed\u3002<\/span><\/p>\n


                  <\/p>\n

                  \u6cbb\u7597HBV\/HDV\u5171\u611f\u67d3\u60a3\u8005\u7684\u6700\u7ec8\u76ee\u6807\u662f\u6e05\u9664\u6216\u957f\u671f\u6291\u5236\u8fd9\u4e24\u79cd\u75c5\u6bd2\u3002\u6e05\u9664HBsAg\u7684CHB\u6cbb\u7597\u53ef\u80fd\u6700\u7ec8\u4e5f\u4f1a\u4f7fHDV\u611f\u67d3\u6e05\u9664<\/span>\uff08<\/span>Wranke\u548cWedemeyer, 2016\uff09<\/span><\/span>\u3002<\/span><\/p>\n

                  \n

                  HDV\u611f\u67d3\u5e38\u5e38\u5bfc\u81f4HBV\u7684\u81ea\u53d1\u6027\u6291\u5236<\/span>\uff08Huang\u548cLo 2014\uff09<\/span>\uff0c\u7279\u5f02\u6027\u7684\u9488\u5bf9HBV\u7684\u6cbb\u7597\u836f\u7269\u5bf9\u4e24\u79cd\u75c5\u6bd2\u4e4b\u95f4\u76f8\u4e92\u4f5c\u7528\u7684\u5f71\u54cd\u5f88\u96be\u9884\u6d4b\u3002\u5173\u4e8eHBV\/HDV\u5171\u611f\u67d3\u7684\u7814\u7a76\u8d85\u51fa\u4e86\u672c\u6307\u5357\u7684\u8303\u56f4\uff0c\u5efa\u8bae\u76f4\u63a5\u4e0eFDA\u8ba8\u8bba\u7814\u53d1\u8ba1\u5212\u3002<\/span><\/p>\n

                  \n

                  \n

                  C. \u513f\u7ae5\u60a3\u8005<\/span><\/strong><\/p>\n


                  <\/p>\n


                  <\/p>\n

                  \u300aFD&C\u6cd5\u300b\u7b2c505B\u6761\u8981\u6c42\u6574\u4e2a\u836f\u7269\u7814\u53d1\u8ba1\u5212\u5e94\u5305\u62ec\u5728\u513f\u7ae5\u60a3\u8005\u4e2d\u8bc4\u4f30 \u201c\u65b0\u6d3b\u6027\u6210\u5206\u3001\u65b0\u9002\u5e94\u75c7\u3001\u65b0\u5242\u578b\u3001\u65b0\u7ed9\u836f\u65b9\u6848\u6216\u65b0\u7ed9\u836f\u9014\u5f84\u201d\uff0c\u9664\u975e\u8fd9\u4e9b\u8bc4\u4f30\u5728\u300aFD&C \u6cd5\u300b\u7b2c505B (a) (5) \u4e2d\u88ab\u514d\u9664\u3002\u7533\u529e\u65b9\u5fc5\u987b\u5728\u201cII\u671f\u4e34\u5e8a\u7ed3\u675f\u4f1a\u8bae\u201d\u540e60\u5929\u5185\u6216\u5728FDA\u4e0e\u7533\u529e\u65b9\u5546\u5b9a\u7684\u5176\u5b83\u65f6\u95f4\u63d0\u4ea4\u9488\u5bf9\u513f\u7ae5\u7684\u7814\u7a76\u8ba1\u5212\u3002<\/span><\/p>\n


                  <\/p>\n

                  \u5982\u679c\u5728\u6210\u4eba\u8bd5\u9a8c\u4e2d\u6ca1\u6709\u51fa\u73b0\u4e25\u91cd\u7684\u5b89\u5168\u4e8b\u4ef6\uff0c\u5728III\u671f\u8bd5\u9a8c\u9636\u6bb5\uff0c\u7533\u529e\u65b9\u53ef\u5728\u62db\u52df\u6210\u4eba\u65f6\uff0c\u540c\u65f6\u62db\u52df\u9752\u5c11\u5e74<\/span>\uff08\u5c31\u672c\u6307\u5357\u7684\u76ee\u7684\u800c\u8a00\uff0c\u630712\u81f318\u5c81\u4e4b\u95f4\uff09<\/span>\uff0c\u5e76\u5c3d\u91cf\u5728\u8be5\u5e74\u9f84\u7ec4\u7684\u961f\u5217\u4e2d\u83b7\u5f97\u9a8c\u8bc1\u6027\u7684PK\u548c\u5b89\u5168\u6027\u6570\u636e\uff0c\u5e76\u5728\u63d0\u4ea4\u6700\u521dNDA\/BLA\u65f6\uff0c\u5e94\u5305\u62ec\u8fd9\u90e8\u5206\u6570\u636e\u3002<\/span><\/p>\n

                  \n

                  \u7531\u4e8e\u8fdb\u5c55\u6027\u7684\u809d\u810f\u75be\u75c5\u5728\u4e59\u809d\u75c5\u6bd2\u611f\u67d3\u7684\u5e7c\u513f\u4e2d\u5e76\u4e0d\u5e38\u89c1\uff0c\u56e0\u6b64\u5728\u5927\u591a\u6570\u7814\u53d1\u8ba1\u5212\u4e2d\uff0c\u4e00\u822c\u4e0d\u4f1a\u5efa\u8bae\u5305\u62ec2\u5c81\u4ee5\u4e0b\u7684\u60a3\u513f\u3002\u6b64\u5916\uff0c\u6839\u636e\u76ee\u524d\u7684\u6cbb\u7597\u6307\u5357\uff0c\u4e00\u822c\u4e5f\u4e0d\u5efa\u8bae\u6cbb\u75972\u5c81\u4ee5\u4e0b\u7684\u513f\u7ae5<\/span>\uff08<\/span>Terrault\u7b49\u4eba\uff0c2016\uff09<\/span><\/span>\u3002<\/span><\/p>\n

                  \n

                   \u7533\u529e\u65b9\u5e94\u4e0e\u8bc4\u5ba1\u90e8\u95e8\u8ba8\u8bba\u5176\u513f\u7ae5\u8bc4\u4f30\u8ba1\u5212\uff0c\u5e76\u4e86\u89e3FD&C\u6cd5\u6848\u7b2c505B<\/span>\uff08e\uff09<\/span>\u6761\u89c4\u5b9a\u7684\u513f\u7ae5\u7814\u7a76\u8ba1\u5212\u5b9e\u65bd\u7684\u65f6\u95f4\u548c\u5185\u5bb9\u8981\u6c42\u3002<\/span><\/p>\n


                  <\/p>\n

                  \u4e00\u822c\u6765\u8bf4\uff0c\u513f\u7ae5\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u4ee5\u5728\u83b7\u5f97\u6210\u4ebaII\u671f\u4e34\u5e8a\u6570\u636e\u540e\u5f00\u59cb\uff0c\u8fd9\u4e9b\u6570\u636e\u63d0\u4f9b\u4e86\u5b89\u5168\u6027\u7279\u5f81\u4ee5\u53ca\u7597\u6548\u7684\u521d\u6b65\u8bc1\u636e\u3002\u901a\u5e38\uff0c\u975e\u9752\u5c11\u5e74\u513f\u7ae5<\/span>\uff08\u5c31\u672c\u6307\u5357\u7684\u76ee\u7684\u800c\u8a00\uff0c\u6307 2\u81f312\u5c81\u4ee5\u4e0b\uff09<\/span>\uff0c\u5e94\u6839\u636e\u5e74\u9f84\u6216\u4f53\u91cd\u5206\u6210\u82e5\u5e72\u7ec4\u6216\u961f\u5217\u8fdb\u884c\u8bd5\u9a8c\u3002<\/span><\/p>\n

                  \n

                  \u4f53\u91cd\uff0c\u800c\u4e0d\u662f\u5e74\u9f84\uff0c\u5e94\u8be5\u662f\u5165\u7ec4\u7684\u9996\u9009\u6807\u51c6\uff0c\u8fd9\u662f\u56e0\u4e3a\u5927\u591a\u6570\u6297\u75c5\u6bd2\u836f\u7269\u7684\u5242\u91cf\u5efa\u8bae\u662f\u57fa\u4e8e\u4f53\u91cd\u7684\u3002\u6b64\u5916\uff0c\u5728\u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u7533\u529e\u65b9\u5e94\u8be5\u5e73\u884c\u5730\u62db\u52df\u961f\u5217\u800c\u4e0d\u662f\u9010\u6b65\u7684\u62db\u52df\u8fd9\u4e9b\u961f\u5217\uff0c\u9664\u975e\u56e0\u836f\u7269\u6709\u7279\u5b9a\u7684\u4e0e\u5b89\u5168\u6027\u76f8\u5173\u7684\u6216\u4e0e\u836f\u7269\u5904\u7f6e\u76f8\u5173\u7684\u56e0\u7d20\uff0c\u9700\u8981\u91c7\u53d6\u4e0d\u540c\u7684\u65b9\u6cd5\u3002<\/span><\/p>\n


                  <\/p>\n

                  \u7533\u529e\u65b9\u5728\u9009\u62e9\u513f\u7ae5\u6cbb\u7597\u8bd5\u9a8c\u5242\u91cf\u4e4b\u524d\uff0c\u5e94\u4e0eFDA\u8ba8\u8bba\u539f\u59cb\u7684\u513f\u7ae5PK\u6570\u636e\u548c\u53ef\u7528\u7684\u5efa\u6a21\u65b9\u6cd5\u548c\u6a21\u5f0f\u3002\u7531\u4e8e\u5728\u6210\u4eba\u548c\u513f\u7ae5\u4eba\u7fa4\u4e2d\u6297\u75c5\u6bd2\u6548\u679c\u5145\u5206\u76f8\u4f3c\uff0c\u5728HBV\u836f\u7269\u7814\u53d1\u7684\u8fc7\u7a0b\u4e2d\uff0c\u57fa\u4e8e\u6210\u4eba\u6570\u636e\u7684\u7597\u6548\u63a8\u7b97\u51fa\u6765\u7684\u9488\u5bf9\u513f\u7ae5\u7684\u7528\u836f\u5242\u91cf\u662f\u53ef\u4ee5\u8003\u8651\u63a5\u53d7\u7684\u3002<\/span><\/p>\n

                  \n

                  \u56e0\u6b64\uff0c\u5728\u4ece\u6210\u4eba\u6570\u636e\u4e2d\u83b7\u5f97\u836f\u7269\u7684\u5173\u952e\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u540e\uff0c\u513f\u7ae5\u7814\u53d1\u8ba1\u5212\u53ef\u4ee5\u6839\u636e\u5339\u914d\u76f8\u5173\u7684\u513f\u7ae5\u548c\u6210\u4eba\u66b4\u9732\u53c2\u6570\u6765\u8bf4\u660e\u6cbb\u7597\u5728\u513f\u7ae5\u60a3\u8005\u4e2d\u4f1a\u6709\u6548\u3002\u7533\u529e\u65b9\u5e94\u83b7\u5f97\u989d\u5916\u7684\u6570\u636e\u7528\u6765\u8bc4\u4f30\u836f\u7269\u662f\u5426\u6709\u4e0e\u5728\u6210\u4eba\u60a3\u8005\u4e2d\u7c7b\u4f3c\u7684\u6297\u75c5\u6bd2\u6d3b\u6027\u3002<\/span><\/p>\n


                  <\/p>\n

                  \u513f\u7ae5\u8bd5\u9a8c\u8fd8\u5e94\u83b7\u5f97\u6570\u636e\u4ee5\u652f\u6301\u5728\u513f\u7ae5\u4e2d\u5e94\u7528\u7684\u5b89\u5168\u6027\uff1b\u901a\u5e38\u662f\u5efa\u7acb\u4e00\u4e2a\u5b89\u5168\u6027\u6570\u636e\u5e93\uff0c\u7eb3\u5165\u5927\u7ea6100\u540d\u63a5\u53d7\u5efa\u8bae\u5242\u91cf\u3001\u6cbb\u7597\u65f6\u95f4\u81f3\u5c11\u572848\u5468\u7684\u60a3\u513f\uff0c\u6216\u8005\u9884\u5148\u786e\u5b9a\u7684\u7597\u7a0b\u3002<\/span><\/p>\n

                  \n

                  \u6570\u636e\u5e93\u4e2d\u7684\u60a3\u513f\u5e94\u9002\u5f53\u5730\u5206\u5e03\u5728\u8be5\u9879\u7814\u7a76\u6240\u5e94\u5305\u542b\u7684\u6574\u4e2a\u513f\u7ae5\u7fa4\u4f53\u4e2d<\/span>\uff08\u6ca1\u6709\u88ab\u514d\u9664\u6216\u63a8\u8fdf\uff09<\/span>\u3002\u5982\u679c\u6210\u4eba\u4e34\u5e8a\u8bd5\u9a8c\u8868\u660e\uff0c\u5728\u4e0d\u540c\u809d\u7ea4\u7ef4\u5316\u9636\u6bb5\uff0c\u5b89\u5168\u6027\u6216\u5242\u91cf\u5b58\u5728\u5dee\u5f02\uff0c\u6bcf\u4e2a\u7814\u7a76\u4e2d\u5fc3\u4e5f\u5e94\u8be5\u4f7f\u7528\u6700\u5408\u9002\u7684\u65b9\u5f0f\u8bc4\u4f30\u513f\u7ae5\u60a3\u8005\u662f\u5426\u5b58\u5728\u809d\u786c\u5316\u3002<\/span><\/p>\n


                  <\/p>\n

                  \u300aFD&C\u6cd5\u300b\u7b2c505B\u6761\u8fd8\u89c4\u5b9a\uff1a\u5728\u5bf9\u513f\u7ae5\u60a3\u8005\u8fdb\u884c\u836f\u7269\u8bc4\u4f30\u65f6\uff0c\u5fc5\u987b\u4f7f\u7528\u513f\u7ae5\u7ec4\u522b\u80fd\u591f\u63a5\u53d7\u7684\u836f\u7269\u5242\u578b<\/span>\uff08\u4e0d\u540c\u7684\u513f\u7ae5\u7ec4\u522b\u53ef\u80fd\u9700\u8981\u91c7\u7528\u4e0d\u540c\u7684\u836f\u7269\u5242\u578b\uff09<\/span>\u3002\u6210\u4eba\u5242\u578b\u901a\u5e38\u88ab\u8ba4\u4e3a\u9002\u5408\u4e8e\u9752\u5c11\u5e74\u60a3\u8005<\/span>\uff08\u5927\u7ea612\u81f318\u5c81\uff09\uff08Momper\u7b49. 2013\uff09<\/span>\uff0c\u4f46\u66f4\u5c0f\u7684\u60a3\u513f\u53ef\u80fd\u4e0d\u80fd\u541e\u54bd\u836f\u7247\uff0c\u53ef\u80fd\u9700\u8981\u4e0d\u540c\u7684\u914d\u65b9\u3002\u56e0\u6b64\uff0c\u513f\u7ae5\u5236\u5242\u7684\u7814\u53d1\u5e94\u8be5\u5c3d\u65e9\u5f00\u59cb\uff0c\u4ee5\u4fbf\u80fd\u591f\u5f00\u53d1\u51fa\u8be5\u7814\u7a76\u836f\u7269\u5408\u9002\u7684\u513f\u7ae5\u5242\u578b\u3002<\/span><\/p>\n


                  <\/p>\n


                  <\/p>\n

                  6\u3001\u5242\u91cf\u9009\u62e9<\/span><\/strong><\/span><\/p>\n


                  <\/p>\n

                  FDA\u9f13\u52b1\u7533\u529e\u65b9\u4f7f\u7528\u91cf\u5316\u4e34\u5e8a\u836f\u7406\u5b66\u65b9\u6cd5\uff0c\u5229\u7528\u5148\u524d\u7684\u4fe1\u606f\u4e3aII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u63d0\u4f9b\u5242\u91cf\u9009\u62e9\u7684\u4f9d\u636e\uff0c\u5e76\u9009\u51fa\u6700\u4f73\u5242\u91cf\u7528\u4e8eIII\u671f\u8bd5\u9a8c\u3002\u6982\u5ff5\u9a8c\u8bc1\u6027\u6297\u75c5\u6bd2\u8bd5\u9a8c\u7684\u7ed3\u679c\u5e94\u7528\u4e8e\u6307\u5bfc\u5728III\u671f\u8bd5\u9a8c\u4e2d\u5242\u91cf\u8303\u56f4\u7684\u8bc4\u4f30\u3002<\/span><\/p>\n

                  \n

                  \u9009\u62e9\u5242\u91cf\u65f6\u8fd8\u5e94\u8003\u8651\u907f\u514d\u51fa\u73b0\u75c5\u6bd2\u8010\u836f\uff0c\u6216\u662f\u56e0\u4e9a\u6cbb\u7597\u5242\u91cf\u7684\u66b4\u9732\u53ef\u80fd\u5bfc\u81f4\u7684\u6cbb\u7597\u5931\u8d25\u3002\u4e3a\u4e86\u4f18\u5316II\u671f\u8bd5\u9a8c\u7684\u5242\u91cf\u9009\u62e9\uff0c\u53ef\u5728\u7814\u7a76\u8ba1\u5212\u4e2d\u4f7f\u7528\u91cf\u5316\u4e34\u5e8a\u836f\u7406\u5b66\u65b9\u6cd5\u9884\u6d4bHBV DNA\u7684\u51cf\u5c11\u3002\u5bf9\u53ef\u80fd\u7531\u8be5\u836f\u7269\u5f15\u8d77\u7684\u6b7b\u4ea1\u4e8b\u4ef6\u548c\u4e34\u5e8a\u610f\u4e49\u4e0a\u7684\u6bd2\u526f\u4f5c\u7528\u4e8b\u4ef6\uff0c\u8981\u5bf9\u836f\u7269\u66b4\u9732\u91cf-\u5b89\u5168\u6027\u4e4b\u95f4\u7684\u5173\u7cfb\u8fdb\u884c\u5206\u6790\u3002<\/span><\/p>\n


                  <\/p>\n


                  <\/p>\n

                  7\u3001\u7597\u6548\u7ec8\u70b9<\/span><\/strong><\/span><\/p>\n


                  <\/p>\n

                  \u65b0\u7684\u6cbb\u7597\u65b9\u6cd5\u53ef\u4ee5\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4f7f\u7528\u4ee5\u4e0b\u4efb\u4e00\u4e2a\u7597\u6548\u7ec8\u70b9\u8fdb\u884c\u8bc4\u4f30\uff1a<\/span><\/p>\n


                  <\/p>\n

                    \n
                  • \n

                    \u6cbb\u7597\u8fc7\u7a0b\u4e2d\u5bf9HBV DNA\u7684\u6291\u5236<\/span>\uff08\u5b9a\u4e49\u4e3a\u5c0f\u4e8eLLOQ\uff0cTND\uff09<\/span>-\u7c7b\u4f3c\u4e8e\u76ee\u524d\u5e94\u7528\u7684\u957f\u671fNUCs\u6cbb\u7597\u65b9\u6848<\/span><\/p>\n<\/li>\n<\/ul>\n

                    \n

                      \n
                    • \n

                      \u5728\u4e00\u4e2a\u6709\u9650\u7684\u7597\u7a0b\u7ed3\u675f\u540e\uff0cHBV DNA<\/span>\uff08\u5c0f\u4e8eLLQ\u3001TND\uff09<\/span>\u7684\u6301\u7eed\u6291\u5236<\/span>\uff086\u4e2a\u6708\u4ee5\u4e0a\uff09<\/span><\/p>\n<\/li>\n<\/ul>\n

                      \n

                        \n
                      • \n

                        \u5728\u6709\u9650\u7684\u7597\u7a0b\u540e\uff0cHBV DNA<\/span>\uff08\u5c0f\u4e8eLLQ\u3001TND\uff09<\/span>\u7684\u6301\u7eed\u6291\u5236<\/span>\uff086\u4e2a\u6708\u4ee5\u4e0a\uff09<\/span>\u5e76\u4f34\u6709HBsAg\u6e05\u9664<\/span>\uff08\u5c0f\u4e8e0.05\u56fd\u9645\u5355\u4f4d\/\u6beb\u5347<\/span>(IU\/mL)<\/span>\uff09<\/span>\uff0c\u4f34\u6216\u4e0d\u4f34HBsAb\u7684\u8840\u6e05\u5b66\u8f6c\u5316<\/span><\/p>\n<\/li>\n<\/ul>\n


                        <\/p>\n

                        \u7531\u4e8eHBsAg\u5b9a\u91cf\u4e0e\u4e34\u5e8a\u5e94\u7b54\u4e4b\u95f4\u7684\u76f8\u5173\u6027\u4e0d\u5b8c\u5168\u4e00\u81f4<\/span>\uff08Hu et al. 2018; Thompson et al. 2010; Chan et al. 2011\uff09<\/span>\uff0c\u76ee\u524d\uff0c\u5229\u7528HBsAg\u8f83\u57fa\u7ebf\u503c\u7684\u4e0b\u964d<\/span>\uff08<\/span>\u672a\u5b8c\u5168\u6e05\u9664\uff09<\/span><\/span>\u6765\u8bc4\u4f30\u5bf9CHB\u6cbb\u7597\u7684\u5e94\u7b54\u5c1a\u4e0d\u660e\u786e\u3002<\/span><\/p>\n


                        <\/p>\n

                        \u5e94\u8be5\u5bf9\u4e00\u5b9a\u6570\u91cf\u7684\u6b21\u8981\u7ec8\u70b9<\/span>\uff08<\/span>\u4f8b\u5982\uff0cHBeAg\u6d88\u5931\u3001HBeAg\u9633\u6027\u60a3\u8005\u7684HBe\u6297\u4f53\u7684\u8840\u6e05\u5b66\u8f6c\u6362\u3001ALT\u6b63\u5e38\uff09<\/span><\/span>\u5229\u7528\u5408\u7406\u7684\u7edf\u8ba1\u5b66\u65b9\u6cd5\u8fdb\u884c\u8bc4\u4ef7\u3002\u8840\u6e05\u751f\u5316\u6807\u5fd7\u7269\uff0c\u5982\uff1aALT\u503c\uff0c\u5728\u4e0d\u540c\u5b9e\u9a8c\u5ba4\u4e4b\u95f4\u6709\u6240\u5dee\u5f02\uff1bALT\u5f02\u5e38\u4e5f\u5e38\u89c1\u4e8e\u5176\u5b83\u6162\u6027\u809d\u75c5\uff0c\u5982\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u75c5\u3002<\/span><\/p>\n


                        <\/p>\n


                        <\/p>\n

                        \u5176\u4ed6\u91cd\u8981\u7ec8\u70b9\uff1a\u8bc4\u4f30\u809d\u810f\u75be\u75c5\u7684\u8fdb\u5c55<\/span><\/strong><\/p>\n


                        <\/p>\n


                        <\/p>\n

                        \u9664\u4e86\u7ec8\u672b\u671f\u6216\u5931\u4ee3\u507f\u671f\u809d\u786c\u5316\u60a3\u8005\uff0c\u5bf9\u809d\u810f\u75be\u75c5\u8fdb\u5c55\u7684\u7ec8\u70b9\u8fdb\u884c\u7edf\u8ba1\u5b66\u610f\u4e49\u4e0a\u4e25\u683c\u7684\u8bc4\u4f30\u53ef\u80fd\u662f\u975e\u5e38\u5177\u6709\u6311\u6218\u6027\u7684\uff0c\u56e0\u4e3a\u5728CHB\u75c5\u7a0b\u5230\u8fbe\u665a\u671f\u4e4b\u524d\uff0c\u8fd9\u4e9b\u4e8b\u4ef6\u5f88\u5c11\u53d1\u751f\u3002<\/span><\/p>\n

                        \n

                        \u7136\u800c\uff0c\u5bf9\u8fd9\u4e9b\u7ec8\u70b9\u7684\u6cbb\u7597\u6548\u679c\u53ef\u4ee5\u63d0\u4f9b\u6709\u7528\u7684\u4e34\u5e8a\u4fe1\u606f\uff0c\u8bc4\u4f30\u75be\u75c5\u8fdb\u5c55\u7ec8\u70b9\u7684\u8bd5\u9a8c\u53ef\u7528\u4e8e\u6269\u5927\u6cbb\u7597\u6307\u5f81\u6216\u6269\u5c55\u60a3\u8005\u7fa4\u4f53\uff0c\u5e76\u4e14\u53ef\u4ee5\u5728\u836f\u54c1\u6807\u7b7e\u7684\u9002\u5f53\u90e8\u5206\u8fdb\u884c\u6982\u8ff0\u3002<\/span><\/p>\n


                        <\/p>\n

                        \u7533\u529e\u65b9\u53ef\u4ee5\u8003\u8651\u4ee5\u4e0b\u7684\u4e00\u4e9b\u53c2\u6570\u6216\u4e34\u5e8a\u7ed3\u679c\uff1a<\/span><\/strong><\/p>\n


                        <\/p>\n

                          \n
                        • \n

                          \u7ec8\u672b\u671f\u809d\u75c5\u8bc4\u5206\u6a21\u578b<\/span>\uff08MELD\uff09<\/span>\u7684\u53d8\u5316<\/span><\/p>\n<\/li>\n

                        • \n

                          Child-Turcotte-Pugh\u8bc4\u5206\u7684\u53d8\u5316<\/span><\/p>\n<\/li>\n

                        • \n

                          \u8fdb\u5c55\u5230\u56e0\u809d\u8870\u7aed\u9700\u8981\u8fdb\u884c\u809d\u79fb\u690d\u6216\u75be\u75c5\u76f8\u5173\u6b7b\u4ea1<\/span><\/p>\n<\/li>\n

                        • \n

                          \u809d\u7ec6\u80de\u764c\u7684\u53d1\u751f<\/span><\/p>\n<\/li>\n<\/ul>\n


                          <\/p>\n

                          \u901a\u8fc7\u809d\u6d3b\u68c0\u6216\u65e0\u521b\u6027\u8bc4\u4f30\u624b\u6bb5\u6765\u8bc4\u4ef7\u6cbb\u7597\u76f8\u5173\u7684\u809d\u7ea4\u7ef4\u5316\u6216\u809d\u786c\u5316\u7684\u9006\u8f6c\uff0c\u4e5f\u53ef\u5728\u836f\u54c1\u6807\u7b7e\u4e2d\u8fdb\u884c\u8bf4\u660e\uff0c\u5e76\u4e14\u5728\u8bbe\u8ba1\u8bc4\u4f30\u8fd9\u4e9b\u7ec8\u70b9\u7684\u7814\u7a76\u65b9\u6848\u65f6\uff0c\u5e94\u8be5\u4e0eFDA\u76f8\u5173\u90e8\u95e8\u8fdb\u884c\u8ba8\u8bba\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          8\u3001\u8bd5\u9a8c\u6d41\u7a0b\u548c\u8bc4\u4f30\u7684\u65f6\u673a<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          \u751f\u5316\u5b66\u3001\u8840\u6e05\u5b66\u3001\u75c5\u6bd2\u5b66\u548c\u7ec4\u7ec7\u5b66\u7ec8\u70b9\u53ef\u7528\u4e8e\u8bc4\u4f30\u6cbb\u7597\u6548\u679c\u3002\u5bf9\u4e8e\u5177\u6709\u6709\u671f\u9650\u7597\u7a0b\u7684\u836f\u7269\uff0c\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u2014\u75c5\u6bd2\u5b66\u6301\u7eed\u6027\u5e94\u7b54\u7684\u6700\u4f73\u8bc4\u4ef7\u65f6\u95f4\u662f\u505c\u6b62\u6cbb\u7597\u540e\u76846\u4e2a\u6708\u6216\u66f4\u957f\u65f6\u95f4\u3002<\/span>\u6b64\u5916\uff0c\u8bc4\u4f30\u7597\u6548\u7ec8\u70b9\u7684\u6700\u5408\u9002\u65f6\u95f4\u70b9\u53d6\u51b3\u4e8e\u836f\u7269\u7684\u4f5c\u7528\u673a\u5236\u548c\u534a\u8870\u671f\u3002<\/span><\/p>\n

                          \n

                          \u76f8\u5bf9\u957f\u671f\u7684\u968f\u8bbf\u53ef\u80fd\u6709\u52a9\u4e8e\u786e\u8ba4\u6cbb\u7597\u5e94\u7b54\u7684\u6301\u4e45\u6027\u548c\u8bc4\u4f30\u4e34\u5e8a\u9884\u540e\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          9\u3001\u7edf\u8ba1\u65b9\u9762\u7684\u8003\u8651\u4e8b\u9879<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          \u4e00\u822c\u6765\u8bf4\uff0c\u5728\u8bd5\u9a8c\u5f00\u59cb\u4e4b\u524d\uff0c\u5e94\u5411\u6297\u75c5\u6bd2\u836f\u54c1\u5904<\/span>\uff08DAVP\uff09<\/span>\u63d0\u4f9b\u8be6\u7ec6\u7684\u7814\u7a76\u65b9\u6848\uff0c\u5728\u7edf\u8ba1\u5206\u6790\u8ba1\u5212<\/span>\uff08SAP\uff09<\/span>\u4e2d\u5bf9\u8bd5\u9a8c\u5047\u8bbe\u3001\u5206\u6790\u65b9\u6cd5\u4ee5\u53ca\u5176\u5b83\u76f8\u5173\u7ec6\u8282\u8fdb\u884c\u9648\u8ff0\u3002\u6709\u5173\u7edf\u8ba1\u5206\u6790\u7684\u65b9\u6cd5\u548c\u95ee\u9898\uff0c\u8bf7\u53c2\u9605FDA\u7684\u884c\u4e1a\u6307\u5357\uff1a\u300a\u4eba\u7528\u836f\u54c1\u548c\u751f\u7269\u5236\u54c1\u6709\u6548\u6027\u4e34\u5e8a\u8bc1\u636e\u63d0\u4ea4\u548c\u975e\u52a3\u6548\u4e34\u5e8a\u8bd5\u9a8c\u786e\u7acb\u6709\u6548\u6027\u300b\u4ee5\u53ca\u300aFDA\u767d\u76ae\u4e66\uff1a\u4e34\u5e8a\u8bd5\u9a8c\u4e9a\u7ec4\u5206\u6790\u7684\u7edf\u8ba1\u5b66\u8003\u8651\u300b<\/span>\uff08ALOSH\u7b49\uff0c2015\uff09<\/span>\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          a. \u5206\u6790\u4eba\u7fa4<\/span><\/strong><\/p>\n


                          <\/p>\n

                          \u6240\u6709\u53c2\u52a0\u968f\u673a\u5217\u961f\u5e76\u4e14\u5728\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u63a5\u53d7\u81f3\u5c11\u4e00\u6b21\u6307\u5b9a\u6cbb\u7597\u7684\u60a3\u8005\u90fd\u5e94\u8be5\u88ab\u5305\u62ec\u5728\u57fa\u672c\u7597\u6548\u5206\u6790\u4e2d\u3002\u5728\u4efb\u4f55\u4e00\u7ec4\u4e2d\uff0c\u7ecf\u8fc7\u968f\u673a\u5316\u3001\u4f46\u672a\u63a5\u53d7\u6cbb\u7597\u7684\u60a3\u8005\u7684\u53ef\u80fd\u6027\u90fd\u5e94\u63a7\u5236\u5728\u6700\u5c0f\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          b. \u7597\u6548\u5206\u6790<\/span><\/strong><\/p>\n


                          <\/p>\n

                          \u57fa\u672c\u7684\u5206\u6790\u5e94\u8be5\u6bd4\u8f83\u6cbb\u7597\u8bd5\u9a8c\u961f\u5217\u4e4b\u95f4\u5e94\u7b54\u8005\u7684\u6bd4\u4f8b\uff0c\u8fd9\u4e00\u5206\u6790\u51b3\u5b9a\u4e86\u6709\u6548\u6027\u662f\u5426\u5df2\u7ecf\u88ab\u8bc1\u660e\u3002<\/span><\/p>\n

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

                          \u5bf9\u4e8e\u4e9a\u7ec4\uff0c\u57fa\u672c\u7597\u6548\u7ec8\u70b9\u7684\u5206\u6790\u5e94\u8003\u8651\u5230\u91cd\u8981\u7684\u4eba\u53e3\u5b66\u548c\u57fa\u7ebf\u7279\u5f81<\/span>\uff08\u4f8b\u5982\uff0c\u5730\u7406\u533a\u57df\u3001\u6027\u522b\u3001\u79cd\u65cf\u3001\u4e0d\u540c\u5e74\u9f84\u7ec4\uff0cHBV\u57fa\u56e0\u578b\uff0cHBeAg\u8840\u6e05\u5b66\u72b6\u6001\uff0cHBV DNA\u76d1\u6d4b\uff0c\u57fa\u7ebf\u4f53\u91cd\uff0c\u4f53\u91cd\u6307\u6570\uff0c\u57fa\u7ebfALT\uff0c\u57fa\u7ebf\u7ea4\u7ef4\u5316\/\u809d\u786c\u5316\uff0c\u5bf9\u5148\u524d\u6cbb\u7597\u65b9\u6848\u7684\u5e94\u7b54<\/span>\uff08\u5982\u679c\u9002\u7528\u7684\u8bdd\uff09<\/span>\uff09<\/span>\u3002\u8fd9\u4e9b\u5206\u6790\u7684\u76ee\u7684\u662f\u63a2\u7d22\u57fa\u672c\u7597\u6548\u7ec8\u70b9\u7ed3\u679c\u5728\u8fd9\u4e9b\u4e9a\u7ec4\u4e4b\u95f4\u662f\u5426\u5177\u6709\u4e00\u81f4\u6027\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u5e94\u8c03\u67e5\u548c\u62a5\u544a\u4e0d\u540c\u533a\u57df\u7684\u6cbb\u7597\u7ed3\u679c\uff0c\u4ee5\u8bc4\u4f30\u7597\u6548\u7ed3\u679c\u7684\u4e00\u81f4\u6027\u3002\u5982\u679cHBeAg\u9633\u6027\u548cHBeAg\u9634\u6027\u60a3\u8005\u88ab\u7eb3\u5165\u8bd5\u9a8c\uff0c\u8fd8\u5e94\u5206\u6790HBeAg\u72b6\u6001\u5bf9\u6cbb\u7597\u7ed3\u679c\u7684\u5f71\u54cd\u3002<\/span><\/p>\n


                          <\/p>\n

                          \n

                          c. \u5904\u7406\u7f3a\u5931\u6570\u636e<\/span><\/strong><\/p>\n


                          <\/p>\n

                          \u7533\u529e\u65b9\u5e94\u5c3d\u91cf\u9650\u5236\u60a3\u8005\u4e2d\u65ad\u8bd5\u9a8c\u3002\u5f53\u60a3\u8005\u6d41\u5931\u96be\u4ee5\u907f\u514d\u65f6\uff0c\u7533\u529e\u65b9\u5e94\u89e3\u91ca\u7f3a\u5931\u6570\u636e\u7684\u539f\u56e0\uff0c\u5e76\u8bd5\u56fe\u786e\u5b9a\u672a\u5b8c\u6210\u8bd5\u9a8c\u65b9\u6848\u60a3\u8005\u7684\u6700\u7ec8\u72b6\u6001\u3002\u60a3\u8005\u6570\u636e\u7f3a\u5931\u6216\u5176\u5b83\u6cbb\u7597\u7ed3\u679c\u7f3a\u5931\u4f1a\u7ed9\u5206\u6790\u9020\u6210\u504f\u5dee\uff0c\u56e0\u4e3a\u672a\u5b8c\u6210\u8bd5\u9a8c\u7684\u60a3\u8005\u4e0e\u7559\u5728\u8bd5\u9a8c\u4e2d\u7684\u60a3\u8005\uff0c\u5728\u6d4b\u91cf\u5230\u7684\u548c\u672a\u6d4b\u91cf\u5230\u7684\u6307\u6807\u4e0a\u53ef\u80fd\u5b58\u5728\u663e\u8457\u7684\u5dee\u5f02\u3002<\/span><\/p>\n

                          \n

                          \u5e94\u5728\u65b9\u6848\u6216SAP\u4e2d\u9884\u5148\u786e\u5b9a\u5206\u6790\u4e2d\u5904\u7406\u4e22\u5931\u6570\u636e\u7684\u57fa\u672c\u65b9\u6cd5\u3002\u654f\u611f\u6027\u5206\u6790\u5e94\u8bc1\u660e\u57fa\u672c\u7684\u836f\u6548\u5206\u6790\u7ed3\u679c\u5bf9\u5173\u4e8e\u7f3a\u5931\u6570\u636e\u7684\u5047\u8bbe\u662f\u7a33\u5b9a\u53ef\u4fe1\u7684\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          10\u3001\u5feb\u901f\u5ba1\u6279(Subpart H)\u7684\u76f8\u5173\u4e8b\u5b9c<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          \u5bf9\u4e8eCHB\uff0cHBV DNA\u75c5\u6bd2\u5b66\u6291\u5236\u4f34\u6216\u4e0d\u4f34\u6709HBsAg\u6e05\u9664\u88ab\u8ba4\u4e3a\u662f\u5df2\u8bc1\u5b9e\u7684\u3001\u53ef\u4ee5\u9884\u6d4b\u4e34\u5e8a\u7ed3\u5c40\u7684\u66ff\u4ee3\u7ec8\u70b9\uff0c\u5e76\u4e14\u8be5\u7ec8\u70b9\u4e5f\u7528\u4e8e\u652f\u6301\u4f20\u7edf\u7684\u5ba1\u6279\u3002<\/span><\/p>\n

                          \n

                          \u7533\u529e\u65b9\u5e94\u8ba8\u8bba\u4f7f\u7528\u5408\u7406\u7684\u3001\u80fd\u591f\u9884\u6d4b\u4e34\u5e8a\u6548\u76ca\u7684\u4efb\u4f55\u66ff\u4ee3\u7ec8\u70b9\uff0c\u6765\u652f\u6301FDA\u7684\u5feb\u901f\u5ba1\u6279\u3002\u5728\u5feb\u901f\u5ba1\u6279\u540e\uff0c\u6309\u7167\u8981\u6c42\u8fdb\u884c\u4e0a\u5e02\u540e\u7684\u786e\u8ba4\u8bd5\u9a8c\uff0c\u4ee5\u9a8c\u8bc1\u548c\u63cf\u8ff0\u5bf9\u4e0d\u53ef\u9006\u8f6c\u7684\u53d1\u75c5\u7387\u6216\u6b7b\u4ea1\u7387\u6216\u5176\u5b83\u4e34\u5e8a\u83b7\u76ca\u7684\u9884\u671f\u5f71\u54cd\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          11\u3001\u6548\u76ca-\u98ce\u9669\u8bc4\u4f30\u7684\u76f8\u5173\u4e8b\u5b9c<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          \u8fdb\u884c\u8be6\u7ec6\u800c\u5168\u9762\u7684\u6548\u76ca\u2014\u98ce\u9669\u8bc4\u4f30\u6765\u786e\u4fdd\u53d7\u8bd5\u4eba\u7fa4\u7684\u5229\u76ca\u5927\u4e8e\u6f5c\u5728\u7684\u98ce\u9669\u3002\u4ee5\u6b64\u75be\u75c5\u7ed9\u60a3\u8005\u5e26\u6765\u7684\u5371\u5bb3\u548c\u73b0\u6709\u7684\u53ef\u9009\u62e9\u7684\u6cbb\u7597\u65b9\u6848\u4e3a\u80cc\u666f\uff0c\u6548\u76ca-\u98ce\u9669\u8bc4\u4f30\u9700\u8981\u8003\u8651\u65b0\u836f\u5df2\u8bc1\u5b9e\u7684\u6cbb\u7597\u6548\u679c\u3001\u548c\u89c2\u5bdf\u5230\u7684\u5b89\u5168\u6027\u3002<\/span><\/p>\n

                          \n

                          \n

                          C. \u5176\u4ed6\u8003\u8651\u4e8b\u9879<\/span><\/strong><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          1\u3001\u4e34\u5e8a\u75c5\u6bd2\u5b66\u7684\u8003\u8651\u4e8b\u9879<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          \u7528\u4e8eHBV\u5b9a\u91cf\u6d4b\u5b9a\u3001\u57fa\u56e0\u578b\u548c\u8868\u578b\u5206\u6790\u7684\u6837\u54c1\u5e94\u5728\u6cbb\u7597\u548c\u968f\u8bbf\u671f\u95f4\u7684\u4e0d\u540c\u65f6\u95f4\u70b9\u83b7\u5f97\u3002\u6837\u672c\u6536\u96c6\u7684\u65f6\u95f4\u5e94\u8be5\u6839\u636e\u7597\u6548\u7684\u521d\u6b65\u89c2\u5bdf\u3001\u6cbb\u7597\u7684\u6301\u7eed\u65f6\u95f4\u4ee5\u53ca\u505c\u836f\u540e\u7684\u6301\u4e45\u6027\u786e\u5b9a\u3002<\/span><\/p>\n

                          \n

                          \u5e94\u786e\u5b9a\u57fa\u7ebf\u548c\u75c5\u6bd2\u5b66\u5931\u8d25\u6837\u672c\u7684\u75c5\u6bd2\u57fa\u56e0\u578b\u548c\u8868\u578b<\/span>\uff08\u75c5\u6bd2\u5b66\u5931\u8d25\u7684\u5b9a\u4e49\u4e3a\uff1a\u4e0eHBV DNA\u7684\u6700\u4f4e\u503c\u76f8\u6bd4\uff0cHBV DNA\u4e0a\u5347\u5927\u4e8e\u6216\u7b49\u4e8e1log10\u62f7\u8d1d\/mL\u3001\u6216\u5728HBV DNA\u4f4e\u4e8eLLOQ\u540e\uff0c\u53c8\u53cd\u5f39\u5230\u53ef\u88ab\u68c0\u6d4b\u5230\uff0c\u6216\u68c0\u6d4b\u503c\u4ece\u672a\u8fbe\u5230\u4f4e\u4e8eHBV DNA\u7684\u68c0\u6d4b\u6c34\u5e73\uff09<\/span>\u3002<\/span><\/p>\n

                          \n

                          \u5e94\u6bd4\u8f83\u57fa\u7ebf\u548c\u6cbb\u7597\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u75c5\u6bd2\u5b66\u5931\u8d25\u6837\u672c\u4e2d\u6240\u5206\u79bb\u51fa\u7684\u57fa\u56e0\u578b\uff0c\u5e76\u9274\u5b9a\u65b0\u51fa\u73b0\u7684\u4e0e\u8010\u836f\u76f8\u5173\u7684\u78b1\u57fa\u66ff\u6362\/\u7a81\u53d8\u3002\u5e94\u628a\u6765\u81ea\u5bf9\u7814\u7a76\u836f\u7269\u5177\u6709\u8010\u836f\u7684\u60a3\u8005\u7684HBV DNA\u514b\u9686\u5230\u654f\u611f\u578bHBV\u57fa\u56e0\u7ec4\u6846\u67b6\u5185\uff0c\u786e\u5b9a\u5176\u5bf9\u7814\u7a76\u836f\u7269\u7684\u654f\u611f\u6027\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u76ee\u524dHBV\u53ef\u88ab\u9274\u522b\u7684\u57fa\u56e0\u578b\u670910\u79cd<\/span>\uff08\u57fa\u56e0\u578bA\u5230H\uff09<\/span>\uff0c\u53e6\u6709A\u5230F\u57fa\u56e0\u578b\u4e0b\u7684\u4e9a\u578b\u3002\u4e0d\u540c\u7684HBV\u57fa\u56e0\u578b\/\u4e9a\u578b\u7f16\u7801\u53d8\u5f02\u7684\u75c5\u6bd2\u86cb\u767d\uff0c\u5e76\u4e14\u53ef\u80fd\u5bf9\u7814\u7a76\u836f\u7269\u4ea7\u751f\u4e0d\u540c\u7684\u5e94\u7b54\u3002\u5982\u679c\u7814\u7a76\u836f\u7269\u4ec5\u5bf9\u67d0\u4e9b\u57fa\u56e0\u578b\/\u4e9a\u578b\u6709\u6548\uff0c\u90a3\u4e48\u4f1a\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5bf9\u836f\u7269\u7684\u7597\u6548\u4ea7\u751f\u5f71\u54cd\u3002<\/span><\/p>\n

                          \n

                          \u56e0\u6b64\uff0c\u6211\u4eec\u5efa\u8bae\u5728\u57fa\u7ebf\u65f6\uff0c\u786e\u5b9aHBV\u611f\u67d3\u7684\u57fa\u56e0\u578b\/\u4e9a\u578b\uff0c\u4ee5\u786e\u5b9a\u7814\u7a76\u836f\u7269\u662f\u5426\u9488\u5bf9\u6240\u6709HBV\u57fa\u56e0\u578b\/\u4e9a\u578b\u90fd\u6709\u6297\u75c5\u6bd2\u6d3b\u6027\u3002\u5bf9\u5165\u7ec4\u60a3\u8005\u7684HBV\u6837\u672c\u8fdb\u884c\u57fa\u56e0\u5206\u578b\u7684\u68c0\u6d4b<\/span>\uff08\u5305\u62ec\u68c0\u6d4b\u65b9\u6cd5\u7684\u6027\u80fd\u7279\u5f81\uff09<\/span>\u5e94\u5305\u542b\u5728\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u4e2d\u3002\u901a\u8fc7\u7cfb\u7edf\u8fdb\u5316\u5206\u6790\u786e\u5b9a\u57fa\u56e0\u578b\/\u4e9a\u578b\u53ef\u80fd\u5177\u6709\u91cd\u8981\u610f\u4e49\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u5bf9\u4e8e\u8010\u836f\u6027\u5206\u6790\uff0c\u5728\u6cbb\u7597\u4e2d\u6216\u968f\u8bbf\u9636\u6bb5<\/span>\uff08\u4e0d\u5305\u62ec\u57fa\u7ebf\u65f6\uff09<\/span>\uff0c\u51fa\u73b0\u7684\u9776\u86cb\u767d\u7684\u6c28\u57fa\u9178\u5e8f\u5217\u6216\u57fa\u56e0\u7ec4\u9776\u5411\u836f\u7269\u7684DNA\u5e8f\u5217\u7684\u4efb\u4f55\u6539\u53d8<\/span>\uff08\u5305\u62ec\u6df7\u5408\u7684\u53d8\u5316\uff09<\/span>\uff0c\u5747\u53ef\u88ab\u62a5\u544a\u4e3a\u5728\u6cbb\u7597\u671f\u95f4\u6240\u51fa\u73b0\u7684\u8010\u836f\u3002\u6b64\u5916\uff0c\u5e94\u8be5\u5728\u57fa\u7ebf\u65f6\uff0c\u5bf9\u6837\u672c\u8fdb\u884c\u5206\u6790\uff0c\u4ee5\u8bc6\u522b\u4e0e\u7814\u7a76\u836f\u7269\u6297\u75c5\u6bd2\u6d3b\u6027\u76f8\u5173\u7684HBV\u57fa\u56e0\u7684\u591a\u6837\u6027\u3002\u7533\u529e\u65b9\u5e94\u5c3d\u65e9\u5411FDA\u54a8\u8be2\u8010\u836f\u76f8\u5173\u6570\u636e\u63d0\u4ea4\u7684\u6700\u65b0\u683c\u5f0f\uff0c\u4ee5\u53ca\u662f\u5426\u4f7f\u7528\u4e0b\u4e00\u4ee3\u6d4b\u5e8f<\/span>\uff08NGS\uff09<\/span>\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u5728HIV\u548cHBV\u540c\u65f6\u611f\u67d3\u7684\u60a3\u8005\u4e2d\uff0c\u67d0\u79cd\u6297\u75c5\u6bd2\u836f\u7269\u53ef\u80fd\u4f1a\u4f5c\u7528\u4e8e\u4e24\u79cd\u4e0d\u540c\u75c5\u6bd2\u4e2d\u7c7b\u4f3c\u7684\u75c5\u6bd2\u86cb\u767d\uff0c\u56e0\u800c\u6709\u5b58\u5728\u51fa\u73b0\u8010\u836f\u7684\u98ce\u9669\u3002\u9274\u4e8e\u8fd9\u79cd\u98ce\u9669\u7684\u5b58\u5728\uff0c\u6211\u4eec\u5efa\u8bae\u5728\u6070\u5f53\u7684\u65f6\u673a\uff0c\u5bf9HIV-1\u548cHBV\u75c5\u6bd2\u86cb\u767d\u7684\u8010\u836f\u548c\u4ea4\u53c9\u8010\u836f\u8fdb\u884c\u8bc4\u4f30\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u5bf9\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u6240\u6709\u75c5\u6bd2\u5b66\u8bc4\u4f30\uff0c\u5982\u679c\u53ef\u80fd\u7684\u8bdd\uff0c\u6211\u4eec\u5efa\u8bae\u4f7f\u7528\u7ecfFDA\u6279\u51c6\u6216\u901a\u8fc7\u7684\u68c0\u6d4b\u65b9\u6cd5\uff0c\u5e76\u5728\u540c\u4e00\u4e2a\u4e2d\u5fc3\u5b9e\u9a8c\u5ba4\u5b8c\u6210\u8fd9\u4e9b\u8bc4\u4f30\u3002\u7533\u529e\u65b9\u53ef\u4ee5\u4ece\u5f53\u5730\u7684\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u4e2d\u6536\u96c6\u7ed3\u679c\uff0c\u4f46\u8981\u786e\u5b9a\u6240\u4f7f\u7528\u7684\u68c0\u6d4b\u65b9\u6cd5\u3002<\/span><\/p>\n

                          \n

                          \u5982\u679c\u4f7f\u7528\u5b9e\u9a8c\u6027\u5206\u6790\u65b9\u6cd5\uff0c\u9664\u4e86\u63d0\u4f9b\u65b9\u6cd5\u5b66\u7684\u8be6\u7ec6\u63cf\u8ff0\u4e4b\u5916\uff0c\u8fd8\u5e94\u63d0\u4f9b\u7528\u4e0d\u540c\u65f6\u95f4\u548c\u4e0d\u540c\u5730\u57df\u6536\u96c6\u6765\u7684\u75c5\u6bd2\u682a\u8fdb\u884c\u6d4b\u5b9a\u65f6\u8be5\u5206\u6790\u65b9\u6cd5\u6240\u8868\u73b0\u7684\u6027\u80fd\u7279\u5f81\u3002\u5bf9\u4e8e\u9700\u8981\u901a\u8fc7\u5316\u9a8c\u4ee5\u786e\u5b9a\u611f\u67d3\u4eba\u7fa4<\/span>\uff08\u4f8b\u5982\uff0c\u7279\u5b9a\u57fa\u56e0\u578b\u6216\u8010\u836f\u4eba\u7fa4\uff09<\/span>\u662f\u5426\u53d7\u76ca\u7684\u836f\u7269\uff0c\u53ef\u80fd\u9700\u8981\u4e00\u4e9b\u4f34\u968f\u7684\u68c0\u6d4b\u8bca\u65ad\u3002\u5176\u5b83\u5efa\u8bae\u53ef\u4ee5\u5728\u4f9b\u4f01\u4e1a\u548cFDA\u5de5\u4f5c\u4eba\u5458\u53c2\u8003\u7684\u300a\u6cbb\u7597\u6027\u4ea7\u54c1\u7684\u4f53\u5916\u4f34\u968f\u8bca\u65ad\u6027\u5668\u6750\u7684\u5171\u540c\u7814\u53d1\u7684\u539f\u5219\u300b\u4e2d\u627e\u5230\u3002<\/span><\/p>\n


                          <\/p>\n

                          FDA\u9f13\u52b1\u7533\u529e\u65b9\u5728\u7814\u53d1\u521d\u671f\u63d0\u4ea4\u8010\u836f\u76d1\u6d4b\u8ba1\u5212\u3002\u5982\u679c\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u8010\u836f\u6027\u8bc4\u4f30\u6d89\u53ca\u4e0b\u4e00\u4ee3\u6d4b\u5e8f<\/span>\uff08NGS\uff09<\/span>\uff0c\u6211\u4eec\u5efa\u8bae\u7533\u529e\u65b9\u4e0eFDA\u8ba8\u8bbaNGS\u65b9\u6cd5\u7684\u7ec6\u8282\u3002\u975e\u5e38\u9f13\u52b1NGS\u6570\u636e\u4ee5fastq\u683c\u5f0f\u63d0\u4ea4\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u5728\u957f\u671f\u968f\u8bbf\u4e2d\u4e00\u65e6\u68c0\u6d4b\u5230HBV DNA, \u90fd\u5e94\u8fdb\u884c\u57fa\u56e0\u5206\u578b\uff0c\u4ee5\u786e\u5b9a\u68c0\u6d4b\u5230\u7684HBV DNA\u662f\u590d\u53d1\u8fd8\u662f\u518d\u611f\u67d3\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          2\u3001\u836f\u4ee3\u52a8\u529b\u5b66\/\u836f\u6548\u5b66\u65b9\u9762\u7684\u8003\u8651\u4e8b\u9879<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          \u5728HBV\u611f\u67d3\u60a3\u8005\u4e2d\u8fdb\u884c\u7684\u8bd5\u9a8c\uff0c\u5e94\u8be5\u5305\u62ec\u836f\u7269\u52a8\u529b\u5b66\u4ee5\u53ca\u75c5\u6bd2\u5b66\u7597\u6548\u548c\u6bd2\u6027\u4e0e\u836f\u7269\u66b4\u9732\u91cf\u4e4b\u95f4\u7684\u5173\u7cfb<\/span>\uff08\u4f8b\u5982\uff0c\u6700\u5c0f\u6216\u6700\u5927\u8840\u836f\u6d53\u5ea6<\/span>(Cmin\u6216Cmax)<\/span>\uff0c\u66f2\u7ebf\u4e0b\u7684\u9762\u79ef\u7b49\uff09<\/span>\u7684\u8bc4\u4f30\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u7533\u529e\u65b9\u53ef\u4ee5\u5728\u6574\u4e2a\u7814\u53d1\u8fc7\u7a0b\u4e2d\u91c7\u7528\u5bc6\u96c6\u548c\u7a00\u758f\u62bd\u6837\u76f8\u7ed3\u5408\u7684\u65b9\u5f0f\u6765\u7814\u7a76\u5728\u7814\u836f\u7269\u7684\u836f\u7269\u52a8\u529b\u5b66\u3002\u4f8b\u5982\uff0c\u7533\u529e\u65b9\u5e94\u8be5\u5728\u65e9\u671f\u5355\u836f\u8bd5\u9a8c\u4e2d\u5b9e\u65bd\u5f3a\u5316\u62bd\u6837\u65b9\u6848\u3002\u5728\u957f\u671f\u8bd5\u9a8c\u4e2d\uff0c\u5f3a\u5316\u62bd\u6837\u8ba1\u5212\u53ef\u80fd\u662f\u4e0d\u53ef\u884c\u7684\u3002\u7533\u529e\u65b9\u4e5f\u53ef\u4ee5\u5c06\u4e2d\u540e\u671f\u7a00\u758f\u62bd\u6837\u4e0e\u65e9\u671f\u8bd5\u9a8c\u4e2d\u5bc6\u96c6\u7684PK\u6570\u636e\u7ed3\u5408\u8d77\u6765\u8fdb\u884c\u7fa4\u4f53PK\u5206\u6790\u3002\u7533\u529e\u65b9\u5e94\u4ece\u5c3d\u53ef\u80fd\u591a\u7684\u60a3\u8005\u4e2d\u83b7\u53d6\u591a\u4e2a\u96f6\u6563\u7684PK\u6837\u672c\uff0c\u5305\u62ec\u5728\u8fdb\u884c\u5173\u952e\u75c5\u6bd2\u5b66\u8bc4\u4f30\u65f6\u83b7\u53d6\u7684PK\u6837\u672c\u3002\u8bb0\u5f55\u7ed9\u836f\u65f6\u95f4\u548c\u91c7\u53d6\u8840\u6837\u7684\u65f6\u95f4\u662f\u5f88\u91cd\u8981\u7684\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u6839\u636e\u4e0d\u540c\u7684\u7814\u53d1\u9636\u6bb5\u548c\u7814\u53d1\u76ee\u7684\uff0c\u7533\u529e\u65b9\u53ef\u4ee5\u4f7f\u7528\u4ee5\u4e0b\u4e24\u79cd\u5e38\u7528\u7684\u65b9\u6cd5\u6765\u63cf\u8ff0\u836f\u7269\u66b4\u9732\u91cf\u4e0e\u75c5\u6bd2\u52a8\u6001\u53d8\u5316<\/span>\uff08\u6216\u7814\u7a76\u836f\u7269\u7684\u75c5\u6bd2\u5b66\u6291\u5236\uff09<\/span>\u4e4b\u95f4\u7684\u5173\u7cfb\uff0c\u8fd9\u4e24\u79cd\u65b9\u6cd5\u90fd\u5141\u8bb8\u5bf9\u76f8\u5173\u53d8\u91cf\u8fdb\u884c\u63a2\u7d22\u3002<\/span><\/p>\n


                          <\/p>\n

                          \uff081\uff09\u4e3a\u4e86\u5229\u4e8eIIb\u671f\u6216III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8bbe\u8ba1\uff0c\u5728\u9009\u62e9\u5242\u91cf\u65b9\u6848\u65f6\uff0c\u5e94\u8003\u8651\u91c7\u7528\u5c06\u836f\u7269\u6d53\u5ea6\u548c\u75c5\u6bd2\u52a8\u529b\u5b66\u8054\u7cfb\u8d77\u6765\u7684\u673a\u68b0\u5efa\u6a21\u65b9\u6cd5\u3002\u673a\u68b0\u5efa\u6a21\u65b9\u6cd5\u8fd8\u5e94\u8be5\u8003\u8651\u5230\u7814\u7a76\u836f\u7269\u8010\u836f\u6027\u7684\u4ea7\u751f\u548c\u9884\u671f\u60a3\u8005\u7fa4\u4f53\u7684\u7279\u5f81\u3002\u5bf9\u4e8e\u8054\u5408\u6cbb\u7597\uff0c\u53ef\u4ee5\u628a\u6f5c\u5728\u7684\u7d2f\u52a0\u6216\u534f\u540c\u6297\u75c5\u6bd2\u6548\u679c\u6574\u5408\u5728\u6a21\u578b\u4e2d\u4ee5\u8fbe\u5230\u5bf9\u5242\u91cf\u7ec4\u5408\u8fdb\u884c\u4f18\u5316\u3002<\/span><\/p>\n


                          <\/p>\n

                          \uff082\uff09\u75c5\u6bd2\u5b66\u6291\u5236<\/span>\uff08\u6216\u75c5\u6bd2\u5b66\u5931\u8d25\uff09<\/span>\u60a3\u8005\u7684\u6bd4\u4f8b\u4e0e\u9002\u5f53\u7684\u66b4\u9732\u91cf\u53c2\u6570(\u4f8b\u5982\uff0c\u6700\u4f4e\u8840\u836f\u6d53\u5ea6\u4e0e\u836f\u7269\u6d53\u5ea6\u65f6\u95f4\u66f2\u7ebf\u4e0b\u9762\u79ef)\u4e4b\u95f4\u7684\u5173\u7cfb\u7684\u7b80\u5355\u5730\u5206\u6790\u7ed3\u679c\uff0c\u4e5f\u53ef\u4f5c\u4e3a\u836f\u7269\u6d3b\u6027\u7684\u8bc1\u636e\uff0c\u5e2e\u52a9\u9009\u62e9\u5242\u91cf\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u5206\u6790\u66b4\u9732\u91cf\u4e0e\u5b89\u5168\u6027\u4e4b\u95f4\u7684\u5173\u7cfb\u65f6\uff0c\u5e94\u8003\u8651\u5230\u7531\u7814\u7a76\u836f\u7269\u4f5c\u7528\u673a\u5236\u5f15\u8d77\u7684\u4e2d\u9776\u548c\u8131\u9776\u6548\u5e94\uff0c\u4ee5\u53ca\u7814\u7a76\u836f\u7269\u961f\u5217\u4e2d\u51fa\u73b0\u7684\u66f4\u4e3a\u9891\u7e41\u7684\u4e0d\u826f\u4e8b\u4ef6\u3002\u6070\u5f53\u7684\u66b4\u9732\u53c2\u6570\u548c\u5efa\u6a21\u65b9\u6cd5\u53d6\u51b3\u4e8e\u7814\u7a76\u7684\u836f\u7269\u548c\u53ca\u5176\u6bd2\u6027\u3002<\/span><\/p>\n


                          <\/p>\n


                          <\/p>\n

                          3\u3001\u836f\u54c1\u8bf4\u660e\u4e66\u7684\u76f8\u5173\u4e8b\u9879<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          \u5728\u505c\u6b62\u6297HBV\u6cbb\u7597\u540e\uff0c\u53ef\u80fd\u51fa\u73b0\u4e25\u91cd\u7684HBV\u611f\u67d3\u7684\u6025\u6027\u53d1\u4f5c\u3002\u5bf9\u4e8e\u505c\u6b62\u6297HBV\u6cbb\u7597\u7684\u60a3\u8005\uff0c\u5e94\u5bc6\u5207\u76d1\u6d4b\u809d\u529f\u80fd\uff0c\u540c\u65f6\u8fdb\u884c\u81f3\u5c11\u51e0\u4e2a\u6708\u7684\u4e34\u5e8a\u548c\u5b9e\u9a8c\u5ba4\u968f\u8bbf\u3002\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u53ef\u80fd\u9700\u8981\u91cd\u65b0\u542f\u52a8\u6297HBV\u6cbb\u7597\u3002\u8fd9\u4e9b\u9700\u8981\u5173\u6ce8\u7684\u4fe1\u606f\u5e94\u8be5\u5728\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\u6709\u660e\u786e\u7684\u4f53\u73b0\u3002<\/span><\/p>\n


                          <\/p>\n

                          \u6709\u6297HIV-1\u6d3b\u6027\u7684\u6297HBV\u836f\u7269\u53ef\u80fd\u4ea7\u751f\u9488\u5bf9HIV-1\u7684\u8010\u836f\u3002\u6b64\u6f5c\u5728\u7684\u98ce\u9669\uff0c\u9700\u8981\u5728\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\u660e\u786e\u7684\u4f53\u73b0\u3002<\/span><\/p>\n

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

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                          \n

                          \u6587\u7ae0\u4fe1\u606f<\/span>\u6e90\u4e8e<\/span>\u516c\u4f17\u53f7<\/span>\u540c\u5199\u610f<\/span>\uff0c\u767b\u8f7d\u8be5\u6587\u7ae0\u76ee\u7684\u4e3a\u66f4\u5e7f\u6cdb\u7684\u4f20\u9012\u884c\u4e1a\u4fe1\u606f\uff0c\u4e0d\u4ee3\u8868\u8d5e\u540c\u5176\u89c2\u70b9\u6216\u5bf9\u5176\u771f\u5b9e\u6027\u8d1f\u8d23\u3002<\/span>\u6587\u7ae0\u7248<\/span>\u6743\u5f52\u539f\u4f5c\u8005\u53ca\u539f\u51fa\u5904\u6240\u6709\uff0c\u6587\u7ae0\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\u3002\u672c\u7f51\u62e5\u6709\u5bf9\u6b64\u58f0\u660e\u7684\u6700\u7ec8\u89e3\u91ca\u6743\uff0c\u82e5\u65e0\u610f\u4fb5\u72af\u7248\u6743\uff0c\u8bf7\u8054\u7cfb\u5c0f\u7f16\u5220\u9664\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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                          <\/p>\n

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                          <\/section>\n<\/section>\n<\/section>\n<\/section>\n
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                          <\/section>\n<\/section>\n<\/section>\n<\/section>\n
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                          <\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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                          \u5b66\u5982\u9006\u6c34\u884c\u821f\uff0c\u4e0d\u8fdb\u5219\u9000\uff1b<\/span><\/p>\n

                          \u5fc3\u4f3c\u5e73\u539f\u8d70\u9a6c\uff0c\u6613\u653e\u96be\u6536\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

                          \n
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                          <\/section>\n<\/section>\n<\/section>\n<\/section>\n
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                          <\/section>\n<\/section>\n<\/section>\n
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                          <\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


                          <\/p>\n

                          \"FDA\uff1a\u6162\u6027\u4e59\u578b\u809d\u708e\u75c5\u6bd2\u611f\u67d3\u836f\u7269\u7814\u53d1\u6307\u5bfc\u610f\u89c1\uff08\u8349\u6848\uff09\"<\/p>\n


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

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                          \u6bcf\u65e5\u66f4\u65b0 \u6b22\u8fce\u8ba2\u9605+<\/span><\/p>\n

                          \n


                          <\/p>\n

                          \"FDA\uff1a\u6162\u6027\u4e59\u578b\u809d\u708e\u75c5\u6bd2\u611f\u67d3\u836f\u7269\u7814\u53d1\u6307\u5bfc\u610f\u89c1\uff08\u8349\u6848\uff09\"<\/p>\n<\/section>\n


                          <\/p>\n

                          \u533b\u836f\u5927\u6570\u636e|\u884c\u4e1a\u52a8\u6001|\u653f\u7b56\u89e3\u8bfb<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

                          \u70b9\u51fb\u4e0a\u65b9\u7684  \u25b2 \u6dfb\u52a0\u5173\u6ce8 \u5f20\u660e\u5a9b1\u3001\u5b54\u83f21\uff08\u8bd1\uff09\uff1b\u5f20\u5fd7\u519b2\u3001\u725b\u4fca\u59471\uff08\u5ba1\u6821\uff09 […]<\/p>\n","protected":false},"author":1,"featured_media":85726,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/85725"}],"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=85725"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/85725\/revisions"}],"predecessor-version":[{"id":85731,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/85725\/revisions\/85731"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/85726"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=85725"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=85725"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=85725"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}