{"id":122036,"date":"2019-12-22T14:19:31","date_gmt":"2020-04-21T00:56:57","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/122036\/"},"modified":"2020-04-21T08:56:59","modified_gmt":"2020-04-21T00:56:59","slug":"230674deee","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/122036\/","title":{"rendered":"\u5438\u5165\u6027\u836f\u7269\u4e00\u81f4\u6027\u8bc4\u4ef7\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8"},"content":{"rendered":"
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\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/p>\n

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\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/p>\n
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\u6765\u6e90<\/strong><\/p>\n<\/section>\n

\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/section>\n

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\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/p>\n
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\u4f5c\u8005<\/strong><\/p>\n<\/section>\n

\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/section>\n

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\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/p>\n
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\u6458\u8981<\/strong><\/p>\n<\/section>\n

\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/section>\n

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\u4e0e\u4f20\u7edf\u7ed9\u836f\u65b9\u5f0f\u76f8\u6bd4\uff0cOIDPs \u7684\u836f\u4ee3\u52a8\u529b\u5b66( PK) \u884c\u4e3a\u66f4\u52a0\u590d\u6742\uff0c\u8bc4\u4f30\u5438\u5165\u6027\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7684PK \u7814\u7a76\u5e38\u4e0d\u8db3\u4ee5\u8bc1\u660eOIDPs \u7684\u7b49\u6548\u6027\u3002<\/section>\n
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\n
\"\u5438\u5165\u6027\u4e2d\u6709\u5173\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7684\u63a2\u8ba8\"<\/p>\n
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\u5173\u952e\u8bcd<\/strong><\/p>\n<\/section>\n

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\u6b63\u6587<\/strong><\/section>\n<\/section>\n<\/td>\n

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1<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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OIDPs \u7684PK \u5b66\u7279\u70b9<\/strong><\/p>\n<\/section>\n<\/section>\n

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\n
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2<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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PK \u7814\u7a76\u5728OIDPs \u4e00\u81f4\u6027\u8bc4\u4ef7\u4e2d\u7684\u5730\u4f4d<\/strong><\/p>\n<\/section>\n<\/section>\n

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\u53e6\u5916\uff0c\u5f53\u836f\u7269\u7684\u91ca\u653e\u548c\u5438\u6536\u6e38\u79bb\u4e8e\u8840\u6db2\u5faa\u73af\u4e4b\u5916\u65f6\uff0c\u836f\u7269\u5728\u4f53\u5185\u7684\u5438\u6536\u7a0b\u5ea6\u548c\u901f\u5ea6\u5e76\u4e0d\u80fd\u7b80\u5355\u7684\u901a\u8fc7PK \u53c2\u6570\u505a\u51fa\u5224\u65ad\uff0c\u5355\u7eaf\u8bc4\u4ef7\u8840\u6db2\u5faa\u73af\u836f\u7269\u6d53\u5ea6\u5e76\u4e0d\u8db3\u4ee5\u8bf4\u660e\u4eff\u5236\u836f\u7269\u4e0e\u539f\u7814\u836f\u7b49\u6548\u3002<\/section>\n
\u6545\u8bc4\u4f30\u53e3\u670d\u5242\u578b\u836f\u7269BE \u7684PK \u6cd5\u5f80\u5f80\u4e0d\u8db3\u4ee5\u5efa\u7acb\u5c40\u90e8\u4f5c\u7528\u7684OIDPs \u7684\u7b49\u6548\u6027\uff0c\u7528\u4e8e\u53e3\u670d\u5242\u578b\u7684\u7cfb\u7edf\u6027\u8bc4\u4f30\u4e5f\u53ef\u80fd\u4e0d\u9002\u7528\u4e8e\u5177\u6709\u5c40\u90e8\u4f5c\u7528\u9776\u70b9\u7684\u836f\u7269\uff3b2\uff0c4\uff3d\u3002<\/section>\n
\u5c3d\u7ba1\u5982\u6b64\uff0c\u76f8\u6bd4\u836f\u6548\u5b66( PD) \u53ca\u4e34\u5e8a\u7ec8\u70b9( CE) \u7814\u7a76\uff0cPK \u7814\u7a76\u4ecd\u7136\u662f\u6bd4\u8f832 \u79cdOIDPs \u5dee\u5f02\u6027\u66f4\u7b80\u5355\u3001\u66f4\u654f\u611f\u7684\u65b9\u6cd5\u3002<\/section>\n
\u503c\u5f97\u5173\u6ce8\u7684\u662f\uff0c\u76ee\u524d\u5728\u6b27\u76df\u5927\u90e8\u5206\u5438\u5165\u6027\u836f\u7269\u662f\u4ee5PK \u7814\u7a76\u4e3a\u57fa\u7840\u83b7\u6279\u7684\uff0c\u8fd9\u4e5f\u5145\u5206\u8bf4\u660e\u4e86PK \u7814\u7a76\u5728\u5438\u5165\u5236\u5242BE \u65b9\u9762\u7684\u91cd\u8981\u5730\u4f4d\uff3b5\uff3d\u3002<\/section>\n<\/section>\n
\n
\n
\n
\n
\n

3<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

\u56fd\u9645\u4e0a\u6307\u5357\u5bf9OIDPs \u4e00\u81f4\u6027\u8bc4\u4ef7\u4e2dPK \u7814\u7a76\u7684\u8981\u6c42<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n
\n
\n
\u9488\u5bf9\u5438\u5165\u5236\u5242\u7684\u4e00\u81f4\u6027\u8bc4\u4ef7\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40( FDA) \u3001\u6b27\u6d32\u836f\u7269\u7ba1\u7406\u5c40( EMA) \u3001\u52a0\u62ff\u5927\u536b\u751f\u90e8( HC) \u548c\u6fb3\u5927\u5229\u4e9a\u7b49\u90fd\u9881\u5e03\u4e86\u76f8\u5e94\u6cd5\u89c4\u548c\u6307\u5bfc\u539f\u5219\uff3b2 \uff0d 6\uff3d\u3002<\/section>\n
FDA \u63d0\u51fa\u4e86\u96c6\u5408\u8bc1\u636e\u52a0\u6743\u6cd5\u7efc\u5408\u8bc4\u4ef7\u5236\u5242\u7684\u5168\u8eab\u5438\u6536\u91cf\u548c\u6548\u5e94\/\u6bd2\u6027\u5668\u5b98BE\u3002<\/section>\n
\u8be5\u6cd5\u5305\u62ec3 \u4e2a\u65b9\u9762: \u4f53\u5916\u7814\u7a76\u3001PK \u7b49\u6548\u6027\u7814\u7a76\u4ee5\u53caPD \u6216CE \u7814\u7a76\u3002<\/section>\n
FDA \u7684\u8981\u6c42\u6bd4\u8f83\u4e25\u683c\uff0c\u8981\u6c42\u5728\u5404\u4e2a\u65b9\u9762\u5747\u7b49\u6548\uff0c\u5305\u62ec:\u2460\u60a3\u8005\u5bf9\u88c5\u7f6e\u7684\u4f7f\u7528; \u2461\u4f53\u5916\u7279\u6027\u548c\u5728\u53d1\u5c04\u5242\u91cf\u7684\u6027\u80fd\u548c\u7a7a\u6c14\u52a8\u529b\u5b66\u7c92\u5f84\u5206\u5e03; \u2462\u5168\u8eabPK \u66b4\u9732\u76f8\u5f53; \u2463\u4e34\u5e8a\u7597\u6548\u76f8\u5f53\u3002HC \u7684\u8981\u6c42\u4e0eFDA \u7684\u8981\u6c42\u76f8\u4f3c\u3002<\/section>\n
\u800cEMA \u5219\u91c7\u7528\u9010\u6b65\u7684\u65b9\u6cd5: \u9996\u5148\uff0c\u8fdb\u884c\u4f53\u5916\u8bd5\u9a8c\u3002<\/section>\n
\u82e5\u4f53\u5916\u7814\u7a76\u4e0d\u7b49\u6548\uff0c\u5219\u8fdb\u884cPK \u7814\u7a76\u3002<\/section>\n
PK \u7814\u7a76\u5305\u542b\u6709\u6548\u6027( \u4f7f\u7528\u6d3b\u6027\u70ad\u963b\u65ad\u80c3\u80a0\u9053\u5438\u6536\uff0c\u6bd4\u8f83\u7ecf\u80ba\u90e8\u5438\u6536\u7684\u6d3b\u6027\u4ee3\u8c22\u4ea7\u7269\u7684PK \u60c5\u51b5) \u548c\u5b89\u5168\u6027( \u5728\u4e0d\u4f7f\u7528\u6d3b\u6027\u70ad\u7684\u60c5\u51b5\u4e0b\u6bd4\u8f83\u5168\u8eabPK \u66b4\u9732\u60c5\u51b5) \u3002<\/section>\n
\u82e5PK \u7814\u7a76\u5931\u8d25\uff0c\u9700\u8fdb\u884c\u4e34\u5e8a\u6216PD \u7814\u7a76\u3002<\/section>\n
\u867d\u7136\u6240\u6709\u673a\u6784\u90fd\u65e8\u5728\u63d0\u4f9b\u5b89\u5168\u3001\u6709\u6548\u548c\u8d39\u7528\u8f83\u4f4e\u7684\u836f\u7269\uff0c\u4f46\u5b83\u4eec\u5bf9\u540c\u4e00\u4ea7\u54c1\u7684BE\u8bc4\u4ef7\u8981\u6c42\u4ecd\u5b58\u5728\u5f88\u5927\u5dee\u5f02\u3002<\/section>\n
\u5185\u5bb9\u7531\u5c0f\u7f16\u67e5\u9605\u6587\u732e\u9009\u53d6\uff0c\u6392\u7248\u4e0e\u7f16\u8f91\u4e3a\u539f\u521b\u3002\u5982\u8f6c\u8f7d\uff0c\u8bf7\u5c0a\u91cd\u52b3\u52a8\u6210\u679c\uff0c\u6ce8\u660e\u6765\u6e90\u4e8e\u516c\u4f17\u53f7\u3002<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n
\n
\n

4<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

\u5173\u4e8eOIDPs \u4e00\u81f4\u6027\u8bc4\u4ef7\u4e2dPK \u7814\u7a76\u7684\u4e00\u4e9b\u5173\u952e\u95ee\u9898\u7684\u8ba8\u8bba<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n
\n
4. 1 \u6d3b\u6027\u70ad\u7684\u4f7f\u7528<\/strong><\/section>\n<\/section>\n
\n
\u5728\u7ed9\u836f\u524d\u53ca\u7ed9\u836f\u540e\u4e0d\u540c\u65f6\u95f4\u95f4\u9694\u670d\u7528\u6d3b\u6027\u70ad\uff0c\u53ef\u963b\u65ad\u80c3\u80a0\u9053\u7684\u5438\u6536\uff0c\u8fd9\u6837\u8840\u836f\u6d53\u5ea6\u4ec5\u4ee3\u8868\u4ece\u547c\u5438\u9053\u5438\u6536\u7684\u90e8\u5206\u3002<\/section>\n
EMA \u5173\u4e8eOIDPs \u7684PK \u7814\u7a76\u5305\u62ec\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u8981\u6c42\uff0c\u6240\u4ee5\u8981\u6c42\u540c\u65f6\u5177\u5907\u6709\u6d3b\u6027\u70ad\u548c\u65e0\u6d3b\u6027\u70ad\u963b\u65ad\u4e24\u90e8\u5206\u7814\u7a76\uff3b5\uff3d\u3002<\/section>\n
\u4f46\u5f53\u80c3\u80a0\u9053\u5438\u6536\u5bf9\u5168\u8eab\u66b4\u9732\u53ef\u4ee5\u5ffd\u7565\u4e0d\u8ba1( \uff1c 5%) \u65f6\uff0c\u4ec5\u9700\u8981\u65e0\u6d3b\u6027\u70ad\u963b\u65ad\u7684PK \u7814\u7a76\u5373\u53ef\u540c\u65f6\u6ee1\u8db3\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u8981\u6c42\u3002<\/section>\n
\u82e5\u4f7f\u7528\u70ad\uff0c\u90a3\u4e48\u4f7f\u7528\u70ad\u7684\u65b9\u6cd5\u5e94\u8be5\u5f97\u5230\u5145\u5206\u9a8c\u8bc1\uff3b5\uff3d\u3002\u6fb3\u5927\u5229\u4e9a\u6709\u5173\u6d3b\u6027\u70ad\u7684\u8981\u6c42\u4e0eEMA \u5927\u4f53\u76f8\u4f3c\uff3b6\uff3d\u3002<\/section>\n
FDA \u548c\u52a0\u62ff\u5927\u5efa\u8baePK \u7814\u7a76\u4ec5\u9700\u901a\u8fc7\u5168\u8eab\u66b4\u9732\u60c5\u51b5\u6765\u6bd4\u8f832 \u79cd\u5236\u5242\u7684\u5b89\u5168\u6027\uff0c\u6d3b\u6027\u70ad\u7684\u4f7f\u7528\u4e0d\u662f\u5f3a\u5236\u6027\u7684\u3002<\/section>\n<\/section>\n
\n
4. 2 \u53d7\u8bd5\u8005\u5438\u5165\u6280\u672f\u7684\u57f9\u8bad<\/strong><\/section>\n<\/section>\n
\n
\u5b9e\u8df5\u4e2d\uff0c\u6211\u4eec\u53d1\u73b0\u5728\u957f\u671f\u4f7f\u7528OIDPs \u6cbb\u7597\u7684\u54ee\u5598\u548c\u6162\u6027\u963b\u585e\u6027\u80ba\u75be\u75c5\u60a3\u8005\u4e2d\uff0c\u5438\u5165\u88c5\u7f6e\u4f7f\u7528\u7684\u9519\u8bef\u7387\u6781\u9ad8\uff0c\u751a\u81f3\u5f88\u591a\u533b\u52a1\u4eba\u5458\u4e0d\u61c2\u5982\u4f55\u6b63\u786e\u5730\u4f7f\u7528\u5438\u5165\u88c5\u7f6e\u3002<\/section>\n
\u56e0\u6b64\u5728OIDPs \u7684PK \u7814\u7a76\u4e2d\uff0c\u53cd\u590d\u8fdb\u884c\u5438\u5165\u88c5\u7f6e\u7684\u57f9\u8bad\u4ee5\u4fdd\u8bc1\u53d7\u8bd5\u8005\u6b63\u786e\u5e76\u4e00\u81f4\u5730\u4f7f\u7528\u88c5\u7f6e\u662f\u975e\u5e38\u91cd\u8981\u7684\u3002<\/section>\n
FDA \u5173\u4e8eOIDPs \u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u6307\u5357\u5efa\u8bae: \u4e3a\u786e\u4fdd\u5438\u6c14\u6d41\u901f\u548c\u5438\u6c14\u6301\u7eed\u65f6\u95f4\u76f8\u5bf9\u4e00\u81f4\uff0c\u53d7\u8bd5\u8005\u5728\u6bcf\u6b21\u7ed9\u836f\u524d\uff0c\u5e94\u63a5\u53d7\u4ee5\u6807\u51c6\u65b9\u5f0f\u5438\u5165\u836f\u7269\u7684\u57f9\u8bad\u3002<\/section>\n
\u9488\u5bf9\u5438\u5165\u6280\u672f\u57f9\u8bad\u4f7f\u7528\u6700\u591a\u7684\u662f\u5438\u5165\u5242\u7684\u5b89\u6170\u5242\u88c5\u7f6e\u3002<\/section>\n
\u53e6\u5916\u8fd8\u6709\u4e00\u4e9b\u8f85\u52a9\u8bbe\u5907\u53ef\u7528\u4e8e\u8bc4\u4f30\u53d7\u8bd5\u8005\u7684\u5438\u6c14\u6d41\u901f\uff0c\u5982\u6c14\u96fe\u5242\u5438\u5165\u76d1\u6d4b\u4eea( AIM) \u3001\u88c5\u7f6e\u8bad\u7ec3\u9644\u4ef6\u3001Flo \uff0d Tone \u8bad\u7ec3\u5668\u3001In \uff0d Check DIAL \u5438\u6c14\u6d41\u901f\u4eea\u7b49\u3002<\/section>\n
\u53ef\u4ee5\u91c7\u7528\u7684\u57f9\u8bad\u65b9\u5f0f\u6709\u73b0\u573a\u4f7f\u7528\u65b9\u6cd5\u7684\u8bb2\u89e3\uff0c\u5438\u5165\u88c5\u7f6e\u4f7f\u7528\u793a\u8303\uff0c\u89c6\u9891\uff0c\u8bed\u97f3\u6307\u4ee4\u7684\u64ad\u653e\u7b49\u3002<\/section>\n
\u5bf9\u4e8e\u538b\u529b\u5b9a\u91cf\u5438\u5165\u5668( pMDIs) \u7531\u4e8e\u9700\u8981\u7ed9\u836f\u548c\u5438\u5165\u7684\u914d\u5408\uff0c\u5728\u8fdb\u884c\u53d7\u8bd5\u8005\u57f9\u8bad\u65f6\u9700\u8fdb\u884c\u7ed9\u836f\u8005( \u533b\u62a4\u4eba\u5458) \u7ed9\u836f\u53ca\u53d7\u8bd5\u8005\u5438\u5165\u7684\u914d\u5408\u8bad\u7ec3\u3002<\/section>\n<\/section>\n
\n
4. 3 \u6f31\u53e3\u5728OIDPs \u7ed9\u836f\u4e2d\u7684\u4f5c\u7528<\/strong><\/section>\n<\/section>\n
\n
\u56fd\u5185\u4e00\u9879\u5173\u4e8e\u6c99\u4e01\u80fa\u9187\u6c14\u96fe\u5242\u7684PK \u7814\u7a76\u4e2d\uff0c1\u540d\u53d7\u8bd5\u8005\u8bef\u5c06\u7b2c1\uff0c2 \u6b21\u5438\u5165\u540e\u7684\u6f31\u53e3\u6c34\u54bd\u4e0b\u3002<\/section>\n
\u7ed3\u679c\u539f\u672c\u9884\u8ba1\u572815 min \u5de6\u53f3\u51fa\u73b0\u5355\u5cf0\u7684\u836f\u65f6\u66f2\u7ebf\u5448\u73b0\u51fa\u5178\u578b\u7684\u53cc\u5cf0\u73b0\u8c61\uff0c\u7b2c1 \u4e2a\u5cf0\u572815 min \u51fa\u73b0\uff0c\u7b2c2 \u4e2a\u5cf0\u57282 h \u51fa\u73b0\uff0c\u63d0\u793a\u5145\u5206\u6f31\u53e3\u867d\u4e0d\u8db3\u4ee5\u6d88\u9664\u6240\u6709\u6c89\u79ef\u5728\u53e3\u54bd\u90e8\u7684\u836f\u7269\uff0c\u4f46\u53ef\u4ee5\u9664\u53bb\u7edd\u5927\u90e8\u5206\u836f\u7269\uff3b7\uff3d\u3002<\/section>\n
\u82e5\u53ef\u4ee5\u6f31\u53e3\u66ff\u4ee3\u670d\u7528\u6d3b\u6027\u70ad\uff0c\u90a3\u4e48\u4e0d\u4ec5\u53ef\u4ee5\u540c\u65f6\u963b\u65ad\u836f\u7269\u5728\u53e3\u8154\u9ecf\u819c\u5c40\u90e8\u53ca\u80c3\u80a0\u9053\u4e24\u90e8\u5206\u7684\u5438\u6536\uff0c\u8fd8\u53ef\u4ee5\u5f88\u5927\u7a0b\u5ea6\u7b80\u5316\u8bd5\u9a8c\uff0c\u5e76\u63d0\u9ad8\u53d7\u8bd5\u8005\u7684\u4f9d\u4ece\u6027\uff0c\u4f46\u8fd9\u8fd8\u6709\u5f85\u8fdb\u4e00\u6b65\u7814\u7a76\u6765\u9a8c\u8bc1\u3002<\/section>\n<\/section>\n
\n
4. 4 \u50a8\u96fe\u7f50\u7684\u4f7f\u7528<\/strong><\/section>\n<\/section>\n
\n
pMDIs \u52a0\u7528\u50a8\u96fe\u7f50\u540e\u4e0d\u518d\u9700\u8981\u5438\u5165\u548c\u7ed9\u836f\u7684\u914d\u5408\uff0c\u4e14\u53ef\u4ee5\u964d\u4f4e\u836f\u7269\u5728\u53e3\u8154\u90e8\u4f4d\u7684\u6c89\u79ef\u3002\u6b27\u6d32\u836f\u54c1\u8bc4\u4f30\u5c40( EAM) \u89c4\u5b9a\uff0c\u5982\u679c\u836f\u7269\u53ea\u5141\u8bb8\u5728\u6709\u50a8\u96fe\u7f50\u7684\u60c5\u51b5\u4e0b\u4f7f\u7528\uff0c\u5219PK \u7814\u7a76\u9700\u8981\u4f7f\u7528\u50a8\u96fe\u7f50; \u5982\u679c\u836f\u7269\u5373\u53ef\u5728\u6709\u50a8\u7269\u7f50\u65f6\u4f7f\u7528\u4e5f\u53ef\u5728\u6ca1\u6709\u50a8\u7269\u7f50\u65f6\u4f7f\u7528\uff0c\u90a3\u4e48PK \u7814\u7a76\u9700\u8981\u5305\u62ec\u4e24\u65b9\u9762: \u6709\u50a8\u96fe\u7f50\u548c\u65e0\u50a8\u96fe\u7f50\u3002<\/section>\n
\u800c2014 \u5e74FDA \u6307\u51fa\u9664\u975e\u836f\u7269\u53ea\u80fd\u5728\u6709\u50a8\u96fe\u7f50\u65f6\u4f7f\u7528\uff0c\u5426\u5219PK \u7814\u7a76\u4e2d\u50a8\u96fe\u7f50\u5e76\u4e0d\u662f\u5fc5\u987b\u7684\uff3b4\uff3d\u3002<\/section>\n<\/section>\n
\n
4. 5 \u5438\u5165\u6027\u836f\u7269PK \u7814\u7a76\u4e2d\u7684\u7ed9\u836f<\/strong><\/section>\n<\/section>\n
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