{"id":135463,"date":"2020-03-17T11:58:06","date_gmt":"2020-04-21T03:41:48","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/135463\/"},"modified":"2020-04-21T11:41:49","modified_gmt":"2020-04-21T03:41:49","slug":"e68d59c279","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/135463\/","title":{"rendered":"\u4ece PK\/PD \u89d2\u5ea6\u6d45\u8c08\u65b0\u51a0\u80ba\u708e\u60a3\u8005\u6cbb\u7597\u4e2d\u5948\u8bfa\u6c99\u661f\u7528\u836f\u65b9\u6848\u5408\u7406\u6027"},"content":{"rendered":"
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\u674e\u946b<\/span> 1,2,3<\/sup>, \u5f90\u6653\u52c7<\/span> 4<\/sup>,\u9648\u6e0a\u6210 <\/span>3,5*<\/sup><\/p>\n<\/section>\n<\/section>\n

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(1 \u590d\u65e6\u5927\u5b66\u9644\u5c5e\u534e\u5c71\u533b\u9662\u6297\u751f\u7d20\u7814\u7a76\u6240, \u4e0a\u6d77, 200040; 2 \u536b\u5065\u59d4\u6297\u751f\u7d20\u4e34\u5e8a\u836f\u7406\u91cd\u70b9\u5b9e\u9a8c\u5ba4, \u4e0a\u6d77, 200040; 3 \u56fd\u5bb6\u8001\u5e74\u75be\u75c5\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3, \u4e0a\u6d77, 200040; 4 \u6d59\u6c5f\u533b\u836f\u80a1\u4efd\u6709\u9650\u516c\u53f8, \u7ecd\u5174, 312366; 5 \u590d\u65e6\u5927\u5b66\u9644\u5c5e\u534e\u5c71\u533b\u9662\u4e00\u671f\u4e34\u5e8a\u7814\u7a76\u5ba4, \u4e0a\u6d77, 200040)<\/p>\n<\/section>\n<\/section>\n

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(* \u901a\u8baf\u4f5c\u8005: \u8054\u7cfb\u7535\u8bdd: 021-54602085, Email: cyc_1983@163.com)<\/p>\n

(\u7b2c\u4e00\u4f5c\u8005: \u8054\u7cfb\u7535\u8bdd: 021-52888193, Email: lxxj6311@163.com)<\/p>\n<\/section>\n<\/section>\n

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\u5948\u8bfa\u6c99\u661f\u4e3a\u65e0\u6c1f\u55b9\u8bfa\u916e\u7c7b\u836f\u7269\uff0c\u4e3b\u8981\u7528\u4e8e\u6cbb\u7597\u8f7b\u4e2d\u5ea6\u793e\u533a\u83b7\u5f97\u6027\u80ba\u708e (Community-acquired pneumonia\uff0cCAP)\uff0c\u8bf4\u660e\u4e66\u4e2d\u8f7d\u660e\u7684\u7ed9\u836f\u65b9\u6848\u4e3a 500 mg\uff0c\u6bcf\u65e5\u4e00\u6b21\uff0c\u8fde\u7eed 7\uff5e14 \u5929\u3002\u5948\u8bfa\u6c99\u661f\u5bf9\u80ba\u708e\u94fe\u7403\u83cc\u548c\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc (\u7b80\u79f0\u91d1\u8461\u83cc) \u5177\u6709\u8f83\u597d\u7684\u6297\u83cc\u6d3b\u6027\uff0c\u7279\u522b\u662f\u9752\u9709\u7d20\u8010\u836f\u80ba\u708e\u94fe\u7403\u83cc (Penicillin-resistant streptococcus pneumoniae<\/em>, PRSP) \u548c\u7532\u6c27\u897f\u6797\u8010\u836f\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc (Methicillin resistant Staphylococcus aureus<\/em>\uff0cMRSA)\u3002<\/span><\/section>\n

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\u8fd1\u65e5\uff0c\u300a\u67f3\u53f6\u5200-\u547c\u5438\u75c5\u5b66\u300b\u6742\u5fd7\u5728\u7ebf\u53d1\u8868\u7684\u901a\u8baf\u6587\u7ae0\u300a2019 \u51a0\u72b6\u75c5\u6bd2\u53d1\u70ed\u95e8\u8bca\u7684\u6cbb\u7597\u548c\u5206\u6d41\u7b56\u7565\u300b\u63d0\u5230\uff0c\u5bf9\u8bca\u65ad\u4e3a\u75c5\u6bd2\u6027\u80ba\u708e\u4e14\u4f34\u547c\u5438\u56f0\u96be\u3001\u7f3a\u6c27\u7684\u60a3\u8005\uff0c\u4f7f\u7528\u547c\u5438\u55b9\u8bfa\u916e (\u83ab\u897f\u6c99\u661f\u548c\u5de6\u6c27\u6c1f\u6c99\u661f)+\u963f\u6bd4\u6735\u5c14\u6cbb\u7597\u672a\u597d\u8f6c\u65f6\uff0c\u8003\u8651\u91c7\u7528\u6297\u75c5\u6bd2+\u6297\u83cc (\u80ba\u708e\u94fe\u7403\u83cc\u548c\u91d1\u8461\u83cc) \u7684\u6838\u5fc3\u6cbb\u7597\u65b9\u6cd5\uff0c\u5176\u4e2d\u63a8\u8350\u5948\u8bfa\u6c99\u661f\u4f5c\u4e3a\u6297\u611f\u67d3\u6cbb\u7597\u9009\u7528\u836f\u7269\u4e4b\u4e00\uff0c\u7ed9\u836f\u65b9\u6848 750 mg\uff0c\u6bcf\u65e5\u4e00\u6b21<\/span> [1]<\/sup>\u3002\u672c\u6587\u5c06\u4ece\u836f\u52a8\u5b66 (Pharmacokinetics, PK)\u3001\u836f\u6548\u5b66 (Pharmacodynamics, PD) \u548c PK\/PD \u89d2\u5ea6\u4ecb\u7ecd\u5948\u8bfa\u6c99\u661f\uff0c\u636e\u6b64\u9610\u8ff0\u5bf9\u5948\u8bfa\u6c99\u661f\u6cbb\u7597\u65b9\u6848\u7684\u770b\u6cd5\u3002<\/span><\/section>\n<\/section>\n<\/section>\n
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1. \u836f\u52a8\u5b66<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n
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\u5948\u8bfa\u6c99\u661f\u5728\u5065\u5eb7\u53d7\u8bd5\u8005\u4e2d\u836f\u52a8\u5b66\u7ebf\u6027\u7279\u5f81\u660e\u663e\uff0c\u6d88\u9664\u901f\u5ea6\u9002\u4e2d\uff0c\u5728\u4f53\u5185\u5e7f\u6cdb\u5206\u5e03\u3002\u591a\u5242\u53e3\u670d\u82f9\u679c\u9178\u5948\u8bfa\u6c99\u661f\u80f6\u56ca 500 mg \u6216 750 mg\uff0c\u6bcf\u65e5\u4e00\u6b21\uff0c\u8fde\u7eed 10 \u5929\uff0c\u5728\u4f53\u5185\u57fa\u672c\u65e0\u84c4\u79ef (\u8868 1)\uff1b\u8fbe\u7a33\u6001\u65f6\u836f\u52a8\u5b66\u53c2\u6570\u4e0e\u9996\u5242\u7ed9\u836f\u63a5\u8fd1\uff0c\u5cf0\u6d53\u5ea6\u5206\u522b\u4e3a 7.0 \u548c 9.1 mg\/L\uff0c\u534a\u8870\u671f\u7ea6 12 h\u3002<\/section>\n<\/section>\n<\/section>\n
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\u8868 1\uff1a\u591a\u5242\u53e3\u670d\u4e0d\u540c\u5242\u91cf\u5948\u8bfa\u6c99\u661f\u836f\u52a8\u5b66\u53c2\u6570<\/span><\/p>\n<\/section>\n<\/section>\n

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\u6ce8: R \u84c4\u79ef\u7cfb\u6570<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u5948\u8bfa\u6c99\u661f\u5728 CAP \u60a3\u8005\u4e2d\u7684\u836f\u52a8\u5b66\u4e0e\u5065\u5eb7\u53d7\u8bd5\u8005\u7c7b\u4f3c\u3002\u6bcf\u65e5\u53e3\u670d\u5948\u8bfa\u6c99\u661f 500 mg \u6216 750 mg \u540e\uff0c\u8fde\u7eed 10 \u5929\uff0c\u5cf0\u6d53\u5ea6\u5206\u522b\u4e3a 4.8 mg\/L \u548c 7.2 mg\/L\uff0cAUC0-24 h<\/sub> \u5206\u522b\u4e3a 46.9 mg\u00b7h\/L \u548c 70.0 mg\u00b7h\/L\uff0cT1\/2<\/sub> \u7ea6 9 h<\/span> [2]<\/sup>\u3002<\/span><\/span><\/section>\n<\/section>\n<\/section>\n
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\u4f53\u5916\u6297\u83cc\u4f5c\u7528\u7814\u7a76\u663e\u793a\uff0c\u5948\u8bfa\u6c99\u661f\u5bf9 PRSP \u548c MRSA \u5177\u6709\u9ad8\u5ea6\u6297\u83cc\u6d3b\u6027\u3002\u5948\u8bfa\u6c99\u661f\u5bf9\u4e34\u5e8a\u5206\u79bb PRSP \u7684 MIC50<\/sub> \u548c MIC90<\/sub> \u5747\u4e3a 0.06 mg\/L\uff0c\u4f18\u4e8e\u5de6\u6c27\u6c1f\u6c99\u661f\uff0c\u4e0e\u83ab\u897f\u6c99\u661f\u76f8\u4eff\uff1b\u5bf9 MRSA \u7684 MIC<\/span>50<\/sub> \u548c MIC90<\/sub> \u5206\u522b\u4e3a 0.5 mg\/L \u548c 1 mg\/L\uff0c\u4f18\u4e8e\u5de6\u6c27\u6c1f\u6c99\u661f\u548c\u83ab\u897f\u6c99\u661f\uff0c\u4e0e\u4e07\u53e4\u9709\u7d20\u548c\u5229\u5948\u5511\u80fa\u76f8\u5f53<\/span> [3]<\/sup>\u3002\u5bf9\u4e8e CAP \u5176\u4ed6\u5e38\u89c1\u75c5\u539f\u83cc\u5982\u80ba\u708e\u514b\u96f7\u4f2f\u83cc\u548c\u80ba\u708e\u652f\u539f\u4f53\u4e5f\u663e\u793a\u826f\u597d\u4f53\u5916\u6297\u83cc\u6d3b\u6027 (\u8868 2)<\/span> [4]<\/sup>\u3002CAP \u60a3\u8005\u611f\u67d3\u7684\u9769\u5170\u9633\u6027\u83cc\u4e3b\u8981\u4e3a\u80ba\u708e\u94fe\u7403\u83cc\u548c\u91d1\u8461\u83cc\u3002III \u671f\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u4e2d\uff0c\u5948\u8bfa\u6c99\u661f\u5bf9\u8fd9\u4e24\u79cd\u83cc MIC90<\/sub> \u5747\u4e3a 0.125 mg\/L\uff0c\u63d0\u793a\u5177\u6709\u826f\u597d\u6297\u83cc\u6d3b\u6027<\/span> [5]<\/sup>\u3002<\/span><\/span><\/section>\n<\/section>\n<\/section>\n
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\u8868 2\uff1a\u5948\u8bfa\u6c99\u661f\u4f53\u5916\u836f\u654f\u7ed3\u679c (\u5355\u4f4d: mg\/L)<\/span><\/section>\n<\/section>\n
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MIC: \u6700\u4f4e\u6291\u83cc\u6d53\u5ea6<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u82f9\u679c\u9178\u5948\u8bfa\u6c99\u661f\u80f6\u56ca II \u671f\u4e34\u5e8a\u8bd5\u9a8c\u91c7\u7528\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u53cc\u6a21\u62df\u3001\u5e73\u884c\u5bf9\u7167\u8bbe\u8ba1\uff0c\u5206\u4e3a\u8bd5\u9a8c\u836f\u5948\u8bfa\u6c99\u661f 500 mg \u7ec4\u548c 750 mg \u7ec4\uff0c\u4ee5\u53ca\u5bf9\u7167\u836f\u5de6\u6c27\u6c1f\u6c99\u661f 500 mg \u7ec4\uff0c\u5747\u4e3a\u6bcf\u65e5\u4e00\u6b21\uff0c\u8fde\u7eed 7\uff5e10 \u5929\u53e3\u670d\u7ed9\u836f\uff0c\u6cbb\u7597\u793e\u533a\u83b7\u5f97\u6027\u80ba\u708e\u3002\u7d2f\u8ba1\u5165\u7ec4\u4e2d\u56fd\u6210\u4eba CAP \u60a3\u8005 192 \u4f8b\uff0c\u4e09\u7ec4\u4e34\u5e8a\u6cbb\u6108\u7387\u5206\u522b\u4e3a 93.3%\uff0c87.3% \u548c 88.5%\uff0c\u5948\u8bfa\u6c99\u661f 500 mg \u4e0e 750 mg \u6cbb\u7597 CAP \u7684\u4e34\u5e8a\u7597\u6548\u4e0d\u52a3\u4e8e\u5de6\u6c27\u6c1f\u6c99\u661f 500 mg\u3002\u5176\u4e2d\uff0c\u5165\u7ec4\u7684 4 \u4f8b\u91d1\u8461\u83cc\u611f\u67d3 CAP \u60a3\u8005\u4e2d 3 \u4f8b\u4e3a MRSA \u611f\u67d3\uff0c2 \u4f8b\u5728\u5948\u8bfa\u6c99\u661f 500 mg \u7ec4\uff0c1 \u4f8b\u5728\u5948\u8bfa\u6c99\u661f 750 mg \u7ec4\uff0c\u5747\u6210\u529f\u6cbb\u6108\u3002\u4e09\u7ec4\u7684\u5fae\u751f\u7269\u6e05\u9664\u7387\u5206\u522b\u4e3a 83.3%\u300183.3% \u548c 80.0%\uff0c\u4e09\u7ec4\u4e4b\u95f4\u5fae\u751f\u7269\u6e05\u9664\u7387\u5747\u65e0\u7edf\u8ba1\u5b66\u5dee\u5f02 (P>0.05)\u3002\u7ed3\u679c\u63d0\u793a\uff0c\u5948\u8bfa\u6c99\u661f 500 mg \u4ee5\u53ca 750 mg \u53e3\u670d 7\uff5e10 \u5929\u7597\u7a0b\u5bf9 CAP \u5177\u6709\u826f\u597d\u7684\u4e34\u5e8a\u548c\u5fae\u751f\u7269\u5b66\u7597\u6548<\/span> [6]<\/sup>\u3002<\/span><\/span><\/section>\n<\/section>\n<\/section>\n
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3. PK\/PD<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n
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\u5948\u8bfa\u6c99\u661f PK\/PD \u7279\u70b9\u4e3b\u8981\u4e3a\u6d53\u5ea6\u4f9d\u8d56\u6027\u3002\u76ee\u524d\u5df2\u62a5\u9053\u7684\u5948\u8bfa\u6c99\u661f PK\/PD \u7814\u7a76\u5747\u91c7\u7528\u4f53\u5916\u6a21\u578b\u7814\u7a76\u9776\u503c\u6216\u55b9\u8bfa\u916e\u7c7b\u836f\u7269\u9776\u503c\u3002\u4f53\u5916 PK\/PD \u7814\u7a76\u8868\u660e\uff0cPK\/PD \u6307\u6570 fAUC0-24 h<\/sub>\/MIC\u3001fCmax<\/sub>\/MIC \u548c%fT>MIC \u4e0e\u5948\u8bfa\u6c99\u661f\u6297\u83cc\u4f5c\u7528\u5747\u6709\u826f\u597d\u76f8\u5173\u6027 (f \u4e3a\u6e38\u79bb\u5206\u6570)\uff0c\u4f7f\u83cc\u843d\u8ba1\u6570\u964d\u4f4e\u81f3\u57fa\u7ebf\u5343\u5206\u4e4b\u4e00\u7684\u9776\u503c\u5206\u522b\u4e3a 47.05\uff0c5.07 \u548c 54.3% <\/span>[7]<\/sup>\u3002\u5176\u4ed6\u55b9\u8bfa\u916e\u7c7b\u6297\u83cc\u836f\u7269\u52a8\u7269 PK\/PD \u7814\u7a76\u591a\u6709\u62a5\u9053\uff0c\u7597\u6548\u76f8\u5173 PK\/PD \u6307\u6570\u4e3a fAUC\/MIC \u548c fCmax<\/sub>\/MIC\uff0c\u5bf9\u80ba\u708e\u94fe\u7403\u83cc\u8fbe\u5230\u6291\u83cc\u4f5c\u7528\u7684\u9776\u503c\u4e3a fAUC0-24 h<\/sub>\/MIC = 25\uff5e50\uff0c\u5bf9\u8461\u8404\u7403\u83cc\u548c\u9769\u5170\u9634\u6027\u83cc\u4e3a fAUC0-24 h<\/sub>\/MIC \u2265 80\uff5e125 \u53ca fCmax<\/sub>\/MIC>10<\/span> [8]<\/sup>\u3002<\/span><\/span><\/section>\n<\/section>\n<\/section>\n
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\u5948\u8bfa\u6c99\u661f 500 mg \u548c 750 mg \u7ed9\u836f\u65b9\u6848\u5bf9\u80ba\u708e\u94fe\u7403\u83cc AUC0-24 h<\/sub>\/MIC90<\/sub> \u5206\u522b\u4e3a 375 \u548c 560\uff0cCmax<\/sub>\/MIC90<\/sub> \u4e3a 38.5 \u548c 57.5\uff0c\u5747\u9ad8\u4e8e\u6587\u732e\u62a5\u9053\u9776\u503c\uff1b\u5bf9\u91d1\u8461\u83cc\u7684 AUC0-24 h<\/sub>\/MIC90<\/sub> \u5206\u522b\u4e3a 93.8 \u548c 140\uff0cCmax<\/sub>\/MIC90<\/sub> \u4e3a 9.6 \u548c 14.4\uff0c500 mg \u7ed9\u836f\u540e PK\/PD \u6307\u6570\u4e0e\u9776\u503c\u76f8\u8fd1\uff0c750 mg \u53ef\u8fbe\u9776\u503c\u4ee5\u4e0a\u3002\u4ee5 fAUC0-24 h<\/sub>\/MIC = 47.05 \u4e3a\u9776\u503c\u8fdb\u884c\u8499\u7279\u5361\u6d1b\u6a21\u62df\uff0c\u5948\u8bfa\u6c99\u661f 500 mg\uff0c\u6bcf\u65e5\u4e00\u6b21\u8fde\u7eed 10 \u5929\u53e3\u670d\u7ed9\u836f\u5bf9\u80ba\u708e\u94fe\u7403\u83cc\u548c\u91d1\u8461\u83cc\u7d2f\u79ef\u54cd\u5e94\u767e\u5206\u7387 (Cumulative fraction of response\uff0cCFR) \u5206\u522b\u4e3a 98% \u548c 95%\uff0c\u63d0\u9ad8\u5242\u91cf\u81f3 750 mg \u540e\u5747\u53ef\u8fbe 99% \u4ee5\u4e0a\uff1b\u5bf9\u4e8e MIC \u2264 0.5 mg\/L \u7684\u83cc\u682a\uff0c500 mg \u8fde\u7eed\u7ed9\u836f\u8fbe\u6807\u6982\u7387 (Probability of target attainment\uff0cPTA) \u53ef\u8fbe 98% \u4ee5\u4e0a\uff0c750 mg \u63a5\u8fd1 100% (\u56fe 1)\u3002\u5bf9\u4e8e MIC \u2264 1 mg\/L \u7684\u83cc\u682a\uff0c500 mg \u8fde\u7eed\u7ed9\u836f PTA \u4ec5\u4e3a 20%\uff0c750 mg \u4e3a 80% (\u56fe 1)\u3002\u6587\u732e\u62a5\u9053\uff0c\u55b9\u8bfa\u916e\u7c7b\u6297\u83cc\u836f\u5bf9\u91d1\u8461\u83cc\u9776\u503c\u901a\u5e38\u9ad8\u4e8e 47.05\uff0c\u56e0\u6b64\uff0c\u5bf9\u4e8e MIC \u4e3a 1 mg\/L \u7684\u91d1\u8461\u83cc\u611f\u67d3\uff0c\u5b9e\u9645 PTA \u4f4e\u4e8e 80%<\/span> [9]<\/sup>\u3002<\/span><\/span><\/section>\n<\/section>\n<\/section>\n
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\"\u4ece<\/section>\n<\/section>\n<\/section>\n
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\u56fe 1\uff1a\u5948\u8bfa\u6c99\u661f\u5bf9\u80ba\u708e\u94fe\u7403\u83cc\uff08\u5de6\u56fe\uff09\u548c\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc\uff08\u53f3\u56fe\uff09\u7684 MIC \u5206\u5e03\u53ca\u5176 fAUC0-24<\/sub>\/MIC \u8fbe\u6807\u6982\u7387 (PTA) \u66f2\u7ebf [\u5b9e\u7ebf\u548c\u865a\u7ebf\u5206\u522b\u4ee3\u8868\u9776\u503c\u53d6 35(\u83cc\u843d\u8ba1\u6570\u964d\u81f3\u57fa\u7ebf 10%) \u548c 47(\u83cc\u843d\u8ba1\u6570\u964d\u81f3\u57fa\u7ebf 1\u2030), \u67f1\u72b6\u56fe\u8868\u793a MIC \u5206\u5e03\u9891\u7387\uff0c\u6c34\u5e73\u865a\u7ebf\u8868\u793a 90% \u8fbe\u6807\u6982\u7387)<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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PK\/PD \u5206\u6790\u7ed3\u679c\u663e\u793a\uff0c\u5948\u8bfa\u6c99\u661f 500 mg \u548c 750 mg \u8fde\u7eed\u7ed9\u836f\u6cbb\u7597\u80ba\u708e\u94fe\u7403\u83cc\u548c\u91d1\u8461\u83cc\u611f\u67d3 CAP \u9884\u671f\u53ef\u83b7\u5f97\u826f\u597d\u4e34\u5e8a\u548c\u5fae\u751f\u7269\u7597\u6548\u3002\u4e0e 500 mg \u76f8\u6bd4\uff0c750 mg \u7ed9\u836f\u63d0\u9ad8\u8fbe\u6807\u6982\u7387\uff0c\u5bf9\u4e8e MIC \u8f83\u9ad8\u7684\u83cc\u682a (\u5982 1 mg\/L) \u5f15\u8d77\u7684\u611f\u67d3\u4ecd\u53ef\u83b7\u5f97\u8f83\u597d\u6cbb\u7597\u6548\u679c\u3002<\/span><\/section>\n<\/section>\n<\/section>\n
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4. \u5b89\u5168\u6027<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n
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\u4e00\u9879 II \u671f\u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u5948\u8bfa\u6c99\u661f 500 mg \u548c 750 mg \u7ed9\u836f\u7ec4\u53d1\u751f\u7684\u4e0e\u8bd5\u9a8c\u836f\u7269\u6709\u5173\u7684\u4e0d\u826f\u4e8b\u4ef6 (adverse event, AE) \u5747\u4e3a\u8f7b\u5ea6\u6216\u4e2d\u5ea6\uff0c\u5305\u62ec\u98df\u6b32\u7f3a\u4e4f\u3001\u6076\u5fc3\u3001\u5455\u5410\u3001\u80c3\u90e8\u4e0d\u9002\u7b49\uff0c\u60a3\u8005\u53ef\u8010\u53d7\u3002\u4e09\u4e2a\u7ed9\u836f\u7ec4 (\u5948\u8bfa\u6c99\u661f 500 mg\u3001\u5948\u8bfa\u6c99\u661f 750 mg \u548c\u5de6\u6c27\u6c1f\u6c99\u661f 500 mg) \u836f\u7269\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u53d1\u751f\u7387\u5206\u522b\u4e3a 30.6%, 35.6% \u548c 25.0%\uff0c\u5dee\u5f02\u65e0\u7edf\u8ba1\u5b66\u610f\u4e49 (P>0.05) <\/span>[6]<\/sup>\u3002\u5948\u8bfa\u6c99\u661f\u5168\u9762 QT \u4e34\u5e8a\u7814\u7a76\u663e\u793a\uff0c\u5355\u5242\u53e3\u670d\u5948\u8bfa\u6c99\u661f 500 mg \u548c 750 mg\u3001\u83ab\u897f\u6c99\u661f 400 mg \u540e\u7ecf\u57fa\u7ebf\u548c\u5b89\u6170\u5242\u6821\u6b63\u7684 QTc \u95f4\u671f\uff08\u0394\u0394QTc\uff09\u6539\u53d8\u5206\u522b\u4e3a 8.1ms\u300110.4ms \u548c 13.6ms\uff0c\u63d0\u793a\u5948\u8bfa\u6c99\u661f 500 mg \u65e0 QTc \u95f4\u671f\u5ef6\u957f\u98ce\u9669\uff0c750 mg \u6709\u6f5c\u5728\u5ef6\u957f\u98ce\u9669 (\u901a\u5e38\u8ba4\u4e3a 5\uff5e10ms \u4e4b\u95f4\u65e0\u98ce\u9669\uff0c10\uff5e15 mg \u4e4b\u95f4\u6709\u6f5c\u5728\u98ce\u9669)<\/span> [10]<\/sup>\u3002\u8003\u8651\u5230 II \u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d 500 mg \u7ec4\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7387\u7565\u4f4e\u4e8e 750 mg \u7ec4\u53ca 500 mg \u65e0 QTc \u95f4\u671f\u5ef6\u957f\u98ce\u9669\uff0c\u91c7\u7528 500 mg \u4f5c\u4e3a III \u671f\u4e34\u5e8a\u8bd5\u9a8c\u5242\u91cf\u3002III \u671f\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u4e2d\uff0c500 mg \u7ec4\u836f\u7269\u76f8\u5173 AE \u53d1\u751f\u7387\u4e3a 19.4%<\/span> [11]<\/sup>\u3002\u8868 3 \u5bf9\u4e24\u9879 II \u671f\u548c\u4e00\u9879 III \u671f\u53e3\u670d\u5948\u8bfa\u6c99\u661f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u836f\u7269\u76f8\u5173 AE \u8fdb\u884c\u603b\u7ed3\uff0c\u5176\u4e2d\u6700\u5e38\u62a5\u544a\u7684\u5305\u62ec\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3001\u6076\u5fc3\u3001\u4e19\u6c28\u9178\u8f6c\u6c28\u9176\u5347\u9ad8\u548c\u767d\u7ec6\u80de\u51cf\u5c11\u7b49<\/span> [12]<\/sup>\u3002<\/span><\/span><\/section>\n<\/section>\n<\/section>\n
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<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u8868 3\uff1a\u53e3\u670d\u5948\u8bfa\u6c99\u661f\u836f\u7269\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08\u2265 1%\uff09<\/span><\/section>\n
\uff08\u70b9\u51fb\u67e5\u770b\u5927\u56fe\uff09<\/span><\/section>\n<\/section>\n
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\"\u4ece<\/section>\n<\/section>\n<\/section>\n
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a \u5305\u62ec\u4e2d\u6027\u7c92\u7ec6\u80de\u767e\u5206\u6bd4\u6216\u8ba1\u6570\u964d\u4f4e\u548c\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u75c7<\/p>\n

b \u5305\u62ec\u767d\u7ec6\u80de\u8ba1\u6570\u51cf\u5c11\u548c\u767d\u7ec6\u80de\u51cf\u5c11\u75c7<\/p>\n

c \u5305\u62ec QT \u95f4\u671f\u5ef6\u957f\u548c\u6821\u6b63 QT \u95f4\u671f\u5ef6\u957f<\/p>\n

d \u5305\u62ec\u8840\u5c0f\u677f\u8ba1\u6570\u589e\u52a0\u548c\u8840\u5c0f\u677f\u589e\u591a\u75c7<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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5. \u65b0\u51a0\u80ba\u708e\u60a3\u8005\u6cbb\u7597\u65b9\u6848<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n
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<\/section>\n<\/section>\n
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\u67f3\u53f6\u5200\u8bba\u6587\u63d0\u51fa\u5948\u8bfa\u6c99\u661f\u7528\u4e8e\u963f\u6bd4\u6735\u5c14+\u83ab\u897f\u6c99\u661f\/\u5de6\u6c27\u6c1f\u6c99\u661f\u6cbb\u7597\u540e\u4ecd\u8fdb\u5c55\u6076\u5316\u7684\u60a3\u8005\uff0c\u7ed9\u836f\u65b9\u6848\u4e3a 750 mg\uff0c\u6bcf\u65e5 1 \u6b21\uff0c\u4ece PK\/PD \u89d2\u5ea6\u770b\u4e34\u5e8a\u53ef\u4ee5\u91c7\u7528\u8be5\u5242\u91cf\u65b9\u6848\uff0c\u4f46\u9700\u8003\u8651\u5982\u4e0b\u51e0\u70b9: \u2460750 mg \u5c1a\u672a\u5f00\u5c55\u9a8c\u8bc1\u6027\u4e34\u5e8a\u7814\u7a76\uff0c\u4ec5\u5f00\u5c55\u4e86\u63a2\u7d22\u6027\u4e34\u5e8a\u7814\u7a76\uff0c\u7eb3\u5165 59 \u4f8b\u60a3\u8005\uff1b\u2461\u5065\u5eb7\u4eba\u7814\u7a76\u663e\u793a 750 mg \u6709\u6f5c\u5728\u7684 QTc \u95f4\u671f\u5ef6\u957f\u98ce\u9669\uff0c\u6b64\u5bf9\u75c5\u6bd2\u6027\u80ba\u708e\u60a3\u8005\u53ef\u80fd\u540c\u6837\u9002\u7528\uff1b\u2462\u75c5\u6bd2\u6027\u80ba\u708e\u60a3\u8005\u9700\u6709\u660e\u786e\u75c5\u539f\u5b66\u8bca\u65ad\u4f9d\u636e\u548c\u4f53\u5916\u836f\u654f\u7ed3\u679c\uff0c\u652f\u6301\u4f7f\u7528\u55b9\u8bfa\u916e\u6297\u83cc\u836f\u3002<\/span><\/section>\n<\/section>\n<\/section>\n
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<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u7efc\u4e0a\u6240\u8ff0\uff0c\u5948\u8bfa\u6c99\u661f\u80f6\u56ca 500 mg \u548c 750 mg \u5bf9 CAP \u60a3\u8005\u5747\u6709\u826f\u597d\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002500 mg \u6709 357 \u4f8b\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\u8bc1\u636e\uff0c\u4e14\u5b89\u5168\u6027\u6bd4 750 mg \u7565\u597d\uff0c\u53ef\u9996\u5148\u63a8\u8350\u7528\u4e8e\u5408\u5e76\u7ec6\u83cc\u611f\u67d3\u60a3\u8005\u7684\u6cbb\u7597\u3002PK\/PD \u5206\u6790\u63d0\u793a\u5bf9\u4e8e MIC \u8f83\u9ad8\uff08\u4f8b\u5982 MIC = 1 mg\/L\uff09\u7684\u83cc\u682a\u5f15\u8d77\u7684\u611f\u67d3\uff0c750 mg \u4ecd\u53ef\u83b7\u5f97\u8f83\u597d\u7684\u6cbb\u7597\u6548\u679c\u3002\u5bf9\u4e8e 500 mg \u6cbb\u7597\u65e0\u597d\u8f6c\uff0c\u6000\u7591\u6216\u75c5\u539f\u5b66\u8bca\u65ad\u4e3a PRSP \u548c MRSA \u611f\u67d3\u7684\u60a3\u8005\uff0c\u4e34\u5e8a\u533b\u751f\u53ef\u4f7f\u7528\u5948\u8bfa\u6c99\u661f 750 mg\uff0c\u6bcf\u65e5\u4e00\u6b21\u7ed9\u836f\u65b9\u6848\uff0c\u5728\u5173\u6ce8\u7597\u6548\u7684\u540c\u65f6\uff0c\u5e94\u5c06\u60a3\u8005\u5b89\u5168\u6027\u653e\u5728\u9996\u8981\u5730\u4f4d\u3002<\/span><\/section>\n<\/section>\n<\/section>\n
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\u53c2\u8003\u6587\u732e\uff1a<\/strong><\/p>\n

[1] Zhang J., Zhou L., Yang Y., et al., Therapeutic and triage strategies for 2019 novel coronavirus disease in fever clinics. Lancet Respir Med, Published Online February 13, 2020 https:\/\/doi.org\/10.1016\/ S2213-2600(20)30071-0.<\/p>\n

[2] \u6b66\u6653\u6377. \u6297\u83cc\u65b0\u836f\u82f9\u679c\u9178\u5948\u8bfa\u6c99\u661f\u80f6\u56ca\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u53ca\u836f\u4ee3\u52a8\u529b\u5b66\/\u836f\u6548\u5b66\u7814\u7a76 [D]. \u590d\u65e6\u5927\u5b66, 2012.<\/p>\n

[3] \u6731\u5fb7\u59b9, \u5434\u57f9\u6f84, \u80e1\u4ed8\u54c1, \u7b49. \u5948\u8bfa\u6c99\u661f\u4f53\u5916\u6297\u83cc\u4f5c\u7528\u7814\u7a76 [J]. \u4e2d\u56fd\u611f\u67d3\u4e0e\u5316\u7597\u6742\u5fd7, 2015(02): 97-112.<\/p>\n

[4] Wang N., Liu W., Zhou Y., et al., In vitro activities of nemonoxacin and other antimicrobial agents against human Mycoplasma and Ureaplasmas isolates and their defined resistance mechanisms[J]. Front Microbiol. 2019, 10: 1890.<\/p>\n

[5] \u8bc4\u4ef7\u53e3\u670d\u82f9\u679c\u9178\u5948\u8bfa\u6c99\u661f\u5bf9\u6bd4\u5de6\u6c27\u6c1f\u6c99\u661f\u6cbb\u7597\u6210\u4eba\u793e\u533a\u83b7\u5f97\u6027\u80ba\u708e\u60a3\u8005\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u53cc\u6a21\u62df\u3001\u5e73\u884c\u5bf9\u7167 III \u671f\u4e34\u5e8a\u7814\u7a76\u62a5\u544a, 2012.<\/p>\n

[6] Liu Y., Zhang Y., Wu J., et al., A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia[J]. J Microbiol Immunol Infect, 2017, 50(6): 811-820.<\/p>\n

[7] Liang W., Chen Y., Cao Y., et al., Pharmacokinetics and pharmacodynamics of nemonoxacin against Streptococcus pneumoniae in an in vitro infection model[J]. Antimicrob Agents Chemother, 2013, 57(7):2942-2947.<\/p>\n

[8] David H. W, Gigi H.B, Marnie L. P, et al. Application of fluoroquinolone pharmacodynamics[J]. J Antimicrob Chemother, 2000, 46:669-683.<\/p>\n

[9] \u9648\u6e0a\u6210. \u6570\u5b66\u6a21\u578b\u4e0e\u8ba1\u7b97\u673a\u4eff\u771f\u6280\u672f\u5728\u55b9\u8bfa\u916e\u6297\u83cc\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u4e2d\u7684\u5e94\u7528. \u590d\u65e6\u5927\u5b66. \u535a\u58eb\u540e\u7814\u7a76\u5de5\u4f5c\u62a5\u544a. 2013.<\/p>\n

[10] Zhao C., Lv Y., Li X., et al., Effects of nemonoxacin on thorough ECG QT\/QTc interval: a randomized, placebo- and positive-controlled crossover study in healthy Chinese adults[J]. Clin Ther, 2018. 40(6): 983-992.<\/p>\n

[11] Yuan J., Mo B., Ma Z., et al., Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non- inferiority trial [J]. J Microbiol Immunol Infect, 2019. 52(1): 35-44.<\/p>\n

[12] Cheng S., Wu R., Chuang Y., et al. Integrated safety summary of phase II and III studies comparing oral nemonoxacin and levofloxacin in community- acquired pneumonia[J]. J Microbiol Immunol Infect, 2019, 52(5): 743-751.<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u8d23\u4efb\u7f16\u8f91\uff1a\u5218\u6069\u8302\u3001\u82cf\u8d8a<\/span><\/section>\n
\u9898\u56fe\u6765\u6e90\uff1a\u7ad9\u9177\u6d77\u6d1b<\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

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