{"id":3899,"date":"2025-09-04T13:57:55","date_gmt":"2025-09-04T05:57:55","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=3899"},"modified":"2025-09-04T13:57:55","modified_gmt":"2025-09-04T05:57:55","slug":"mdr%e5%8c%bb%e5%ad%a6%e4%b8%8a%e6%98%af%e4%bb%80%e4%b9%88%e6%84%8f%e6%80%9d","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=3899","title":{"rendered":"mdr\u533b\u5b66\u4e0a\u662f\u4ec0\u4e48\u610f\u601d"},"content":{"rendered":"

1. MDR\u5728\u533b\u5b66\u4e0a\u662f\u4ec0\u4e48\u610f\u601d\uff1f\u5168\u9762\u89e3\u6790\u5176\u5b9a\u4e49\u3001\u5f71\u54cd\u4e0e\u5e94\u5bf9<\/strong><\/p>\n

\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\uff0c\u5c24\u5176\u662f\u4e34\u5e8a\u5b9e\u8df5\u548c\u836f\u54c1\u5b89\u5168\u76d1\u7ba1\u4e2d\uff0cMDR\u662f\u4e00\u4e2a\u81f3\u5173\u91cd\u8981\u7684\u7f29\u5199\u8bcd\uff0c\u5b83\u53ef\u80fd\u6307\u5411\u4e24\u4e2a\u6838\u5fc3\u4f46\u622a\u7136\u4e0d\u540c\u7684\u6982\u5ff5\uff1a\u591a\u91cd\u8010\u836f\u6027\uff08Multidrug Resistance\uff09\u548c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation\uff09\u3002\u7406\u89e3MDR\u5728\u533b\u5b66\u4e0a\u7684\u53cc\u91cd\u542b\u4e49\uff0c\u5bf9\u4e8e\u533b\u7597\u4e13\u4e1a\u4eba\u5458\u3001\u60a3\u8005\u4e43\u81f3\u6574\u4e2a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u90fd\u81f3\u5173\u91cd\u8981\u3002\u672c\u6587\u5c06\u6df1\u5165\u63a2\u8ba8MDR\u7684\u8fd9\u4e24\u79cd\u542b\u4e49\uff0c\u89e3\u6790\u5176\u5b9a\u4e49\u3001\u4ea7\u751f\u673a\u5236\u3001\u5f71\u54cd\u53ca\u5e94\u5bf9\u7b56\u7565\uff0c\u65e8\u5728\u4e3a\u8bfb\u8005\u63d0\u4f9b\u4e00\u4e2a\u5168\u9762\u800c\u6e05\u6670\u7684\u89c6\u89d2\u3002<\/p>\n<\/p>\n

2. MDR\u4f5c\u4e3a\u591a\u91cd\u8010\u836f\u6027\uff08Multidrug Resistance\uff09\u7684\u6df1\u5ea6\u89e3\u6790<\/strong><\/p>\n

MDR\u6700\u5e38\u89c1\u4e14\u5173\u4e4e\u516c\u5171\u5065\u5eb7\u7684\u542b\u4e49\u662f\u591a\u91cd\u8010\u836f\u6027\uff08Multidrug Resistance\uff09\u3002<\/p>\n

\u591a\u91cd\u8010\u836f\u6027\uff08MDR\uff09\u662f\u6307\u5fae\u751f\u7269\uff08\u5982\u7ec6\u83cc\u3001\u75c5\u6bd2\u3001\u771f\u83cc\u6216\u5bc4\u751f\u866b\uff09\u5bf9\u591a\u79cd\u4e0d\u540c\u7c7b\u522b\u6216\u7ed3\u6784\u7684\u6297\u83cc\u836f\u7269\u540c\u65f6\u4ea7\u751f\u8010\u836f\u6027\u7684\u73b0\u8c61\u3002\u8fd9\u610f\u5473\u7740\uff0c\u539f\u672c\u7528\u4e8e\u6cbb\u7597\u611f\u67d3\u7684\u591a\u79cd\u6807\u51c6\u836f\u7269\u90fd\u53d8\u5f97\u65e0\u6548\uff0c\u5bfc\u81f4\u611f\u67d3\u96be\u4ee5\u63a7\u5236\uff0c\u751a\u81f3\u65e0\u836f\u53ef\u533b\u3002\u4f8b\u5982\uff0c\u8010\u591a\u836f\u7ed3\u6838\u75c5\uff08MDR-TB\uff09\u5c31\u662f\u5bf9\u81f3\u5c11\u4e24\u79cd\u6700\u6709\u6548\u7684\u4e00\u7ebf\u6297\u7ed3\u6838\u836f\u7269\uff08\u5f02\u70df\u80bc\u548c\u5229\u798f\u5e73\uff09\u4ea7\u751f\u8010\u836f\u7684\u7ed3\u6838\u75c5\uff0c\u5176\u6cbb\u7597\u8fc7\u7a0b\u66f4\u6f2b\u957f\u3001\u66f4\u590d\u6742\uff0c\u4e14\u6b7b\u4ea1\u7387\u66f4\u9ad8\u3002<\/p>\n<\/p>\n

2.1 MDR\u7684\u4ea7\u751f\u673a\u5236\u4e0e\u539f\u56e0<\/strong><\/p>\n

MDR\u7684\u4ea7\u751f\u662f\u4e00\u4e2a\u590d\u6742\u7684\u8fdb\u5316\u8fc7\u7a0b\uff0c\u4e3b\u8981\u7531\u5fae\u751f\u7269\u7684\u57fa\u56e0\u7a81\u53d8\u548c\u5916\u754c\u9009\u62e9\u538b\u529b\u5171\u540c\u9a71\u52a8\u3002<\/p>\n

\u5176\u6838\u5fc3\u673a\u5236\u5305\u62ec\uff1a1. \u4e3b\u52a8\u5916\u6392\u6cf5\uff1a\u5fae\u751f\u7269\u7ec6\u80de\u819c\u4e0a\u5b58\u5728\u4e00\u79cd\u86cb\u767d\u8d28\u6cf5\uff0c\u80fd\u4e3b\u52a8\u5c06\u8fdb\u5165\u7ec6\u80de\u5185\u7684\u6297\u83cc\u836f\u7269\u6392\u51fa\uff0c\u964d\u4f4e\u836f\u7269\u6d53\u5ea6\u81f3\u65e0\u6548\u6c34\u5e73\u30022. \u836f\u7269\u9776\u4f4d\u6539\u53d8\uff1a\u5fae\u751f\u7269\u901a\u8fc7\u7a81\u53d8\uff0c\u6539\u53d8\u6297\u83cc\u836f\u7269\u4f5c\u7528\u7684\u9776\u70b9\u7ed3\u6784\uff0c\u4f7f\u836f\u7269\u65e0\u6cd5\u8bc6\u522b\u5e76\u7ed3\u5408\uff0c\u4ece\u800c\u5931\u6548\u30023. \u9176\u89e3\u6216\u4fee\u9970\u836f\u7269\uff1a\u5fae\u751f\u7269\u4ea7\u751f\u7279\u5b9a\u7684\u9176\uff08\u5982\u03b2-\u5185\u9170\u80fa\u9176\uff09\uff0c\u53ef\u4ee5\u6c34\u89e3\u6216\u4fee\u9970\u6297\u83cc\u836f\u7269\uff0c\u4f7f\u5176\u5931\u53bb\u6d3b\u6027\u30024. \u7ec6\u80de\u819c\u901a\u900f\u6027\u964d\u4f4e\uff1a\u5fae\u751f\u7269\u6539\u53d8\u7ec6\u80de\u58c1\u6216\u7ec6\u80de\u819c\u7684\u7ed3\u6784\uff0c\u51cf\u5c11\u6297\u83cc\u836f\u7269\u7684\u6444\u5165\u3002<\/p>\n

\u9020\u6210MDR\u6cdb\u6ee5\u7684\u4e3b\u8981\u539f\u56e0\u5219\u662f\u6297\u83cc\u836f\u7269\u7684\u6ee5\u7528\u548c\u8bef\u7528\uff0c\u65e0\u8bba\u662f\u5728\u4eba\u7c7b\u533b\u7597\uff08\u5982\u4e0d\u5fc5\u8981\u7684\u6297\u751f\u7d20\u5904\u65b9\uff09\u3001\u755c\u7267\u4e1a\uff08\u4f5c\u4e3a\u751f\u957f\u4fc3\u8fdb\u5242\uff09\u8fd8\u662f\u60a3\u8005\u7684\u4e0d\u89c4\u8303\u7528\u836f\uff08\u672a\u5b8c\u6210\u7597\u7a0b\uff09\uff0c\u90fd\u6781\u5927\u5730\u52a0\u901f\u4e86\u8010\u836f\u83cc\u7684\u7b5b\u9009\u548c\u4f20\u64ad\u3002<\/p>\n<\/p>\n

2.2 MDR\u7684\u4e25\u5cfb\u5f71\u54cd\u4e0e\u5168\u7403\u6311\u6218<\/strong><\/p>\n

MDR\u7684\u8513\u5ef6\u5bf9\u5168\u7403\u516c\u5171\u536b\u751f\u6784\u6210\u4e86\u524d\u6240\u672a\u6709\u7684\u5a01\u80c1\u3002<\/p>\n

\u5176\u5f71\u54cd\u662f\u6df1\u8fdc\u4e14\u591a\u65b9\u9762\u7684\uff1a\u9996\u5148\uff0c\u5b83\u5bfc\u81f4\u611f\u67d3\u6027\u75be\u75c5\u6cbb\u7597\u5931\u8d25\u7387\u4e0a\u5347\uff0c\u60a3\u8005\u4f4f\u9662\u65f6\u95f4\u5ef6\u957f\uff0c\u533b\u7597\u8d39\u7528\u6025\u5267\u589e\u52a0\u3002\u5176\u6b21\uff0c\u5b83\u4f7f\u5f97\u4e00\u4e9b\u5e38\u89c4\u624b\u672f\uff08\u5982\u5256\u8179\u4ea7\u3001\u9acb\u5173\u8282\u7f6e\u6362\u672f\uff09\u548c\u5316\u7597\u53d8\u5f97\u9ad8\u98ce\u9669\uff0c\u56e0\u4e3a\u60a3\u8005\u4e00\u65e6\u53d1\u751fMDR\u83cc\u611f\u67d3\uff0c\u5c06\u7f3a\u4e4f\u6709\u6548\u7684\u9884\u9632\u6216\u6cbb\u7597\u624b\u6bb5\u3002\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u5df2\u5c06\u6297\u83cc\u7d20\u8010\u836f\u6027\u5217\u4e3a\u5168\u7403\u5341\u5927\u516c\u5171\u536b\u751f\u5a01\u80c1\u4e4b\u4e00\uff0c\u547c\u5401\u5404\u56fd\u91c7\u53d6\u7d27\u6025\u534f\u8c03\u7684\u884c\u52a8\u6765\u5e94\u5bf9\u8fd9\u4e00\u5371\u673a\u3002<\/p>\n<\/p>\n

2.3 \u5982\u4f55\u5e94\u5bf9\u4e0e\u9884\u9632MDR\uff1f<\/strong><\/p>\n

\u5e94\u5bf9MDR\u9700\u8981\u5168\u793e\u4f1a\u591a\u5c42\u9762\u7684\u5171\u540c\u52aa\u529b\u3002<\/p>\n

\u7b56\u7565\u4e3b\u8981\u5305\u62ec\uff1a1. \u8c28\u614e\u4f7f\u7528\u6297\u83cc\u836f\u7269\uff1a\u533b\u7597\u5de5\u4f5c\u8005\u5e94\u4e25\u683c\u9075\u5b88\u6297\u751f\u7d20\u4f7f\u7528\u6307\u5357\uff0c\u4ec5\u5728\u6709\u660e\u786e\u6307\u5f81\u65f6\u5f00\u5177\u5904\u65b9\u3002\u516c\u4f17\u5e94\u4e0d\u81ea\u884c\u8d2d\u4e70\u6216\u8981\u6c42\u4f7f\u7528\u6297\u751f\u7d20\uff0c\u5e76\u786e\u4fdd\u5b8c\u6210\u6574\u4e2a\u7597\u7a0b\u30022. \u52a0\u5f3a\u611f\u67d3\u9884\u9632\u4e0e\u63a7\u5236\uff1a\u5728\u533b\u9662\u548c\u793e\u533a\u4e2d\uff0c\u4e25\u683c\u6267\u884c\u624b\u536b\u751f\u3001\u6d88\u6bd2\u9694\u79bb\u7b49\u63aa\u65bd\uff0c\u9632\u6b62\u8010\u836f\u83cc\u7684\u4f20\u64ad\u30023. \u5f00\u53d1\u65b0\u578b\u836f\u7269\u548c\u7597\u6cd5\uff1a\u9f13\u52b1\u5236\u836f\u884c\u4e1a\u6295\u5165\u7814\u53d1\u65b0\u578b\u6297\u83cc\u836f\u7269\u3001\u66ff\u4ee3\u7597\u6cd5\uff08\u5982\u566c\u83cc\u4f53\u7597\u6cd5\uff09\u548c\u5feb\u901f\u8bca\u65ad\u5de5\u5177\u30024. \u5168\u7403\u76d1\u6d4b\u4e0e\u5408\u4f5c\uff1a\u5efa\u7acb\u548c\u5b8c\u5584\u8010\u836f\u83cc\u53ca\u6297\u83cc\u836f\u7269\u4f7f\u7528\u7684\u5168\u7403\u76d1\u6d4b\u7f51\u7edc\uff0c\u5171\u4eab\u6570\u636e\uff0c\u534f\u8c03\u884c\u52a8\u3002<\/p>\n<\/p>\n

3. MDR\u4f5c\u4e3a\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation\uff09\u7684\u6df1\u5ea6\u89e3\u6790<\/strong><\/p>\n

\u5728\u53e6\u4e00\u4e2a\u622a\u7136\u4e0d\u540c\u7684\u8bed\u5883\u4e0b\uff0cMDR\u6307\u4ee3\u7684\u662f\u6b27\u76df\u9881\u5e03\u7684\u300a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u300b\u3002<\/p>\n

2017\u5e745\u6708\uff0c\u6b27\u76df\u6b63\u5f0f\u53d1\u5e03\u4e86\u65b0\u7248\u7684\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08EU 2017\/745\uff09\uff0c\u7b80\u79f0MDR\uff0c\u5e76\u5df2\u4e8e2021\u5e745\u670826\u65e5\u5168\u9762\u751f\u6548\u3002\u5b83\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD\uff09\uff0c\u65e8\u5728\u5efa\u7acb\u4e00\u4e2a\u66f4\u900f\u660e\u3001\u66f4\u5b89\u5168\u3001\u66f4\u4e00\u81f4\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u6846\u67b6\uff0c\u4ee5\u5e94\u5bf9\u8fc7\u53bb\u51e0\u5341\u5e74\u91cc\u533b\u7597\u5668\u68b0\u6280\u672f\u7684\u5feb\u901f\u53d1\u5c55\u548c\u4e00\u4e9b\u91cd\u5927\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\uff08\u5982PIP\u4e73\u623f\u5047\u4f53\u4e11\u95fb\uff09\u6240\u5e26\u6765\u7684\u6311\u6218\u3002<\/p>\n<\/p>\n

3.1 MDR\u6cd5\u89c4\u7684\u4e3b\u8981\u53d8\u5316\u4e0e\u6838\u5fc3\u8981\u6c42<\/strong><\/p>\n

\u4e0e\u4e4b\u524d\u7684\u6307\u4ee4\u76f8\u6bd4\uff0cMDR\u7684\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\u548c\u5168\u9762\u3002<\/p>\n

\u5176\u4e3b\u8981\u53d8\u5316\u5305\u62ec\uff1a1. \u6269\u5927\u76d1\u7ba1\u8303\u56f4\uff1a\u660e\u786e\u6db5\u76d6\u4e86\u67d0\u4e9b\u65e0\u533b\u7597\u76ee\u7684\u7684\u7f8e\u5bb9\u5668\u68b0\uff08\u5982\u7528\u4e8e\u7f8e\u5bb9\u7684\u5f69\u8272\u9690\u5f62\u773c\u955c\u3001\u5438\u8102\u8bbe\u5907\u7b49\uff09\u30022. \u52a0\u5f3a\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\uff1a\u5236\u9020\u5546\u5fc5\u987b\u4e3a\u6240\u6709\u5668\u68b0\uff0c\u5305\u62ec\u9057\u7559\u5668\u68b0\uff0c\u63d0\u4f9b\u66f4\u4e25\u683c\u3001\u66f4\u6301\u7eed\u7684\u4e34\u5e8a\u6570\u636e\u8bc1\u660e\u5176\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u30023. \u5f3a\u5316\u4e0a\u5e02\u540e\u76d1\u7763\uff1a\u5efa\u7acb\u4e86\u66f4\u5b8c\u5584\u7684\u5668\u68b0\u8ffd\u6eaf\u7cfb\u7edf\uff08UDI\u7cfb\u7edf\uff09\u548c\u66f4\u4e25\u683c\u7684\u4e0a\u5e02\u540e\u76d1\u7ba1\u3001 vigilance\u62a5\u544a\u8981\u6c42\u30024. \u63d0\u9ad8\u900f\u660e\u5ea6\u548c\u53ef\u8ffd\u6eaf\u6027\uff1a\u901a\u8fc7\u5efa\u7acb\u6b27\u76df\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08EUDAMED\uff09\uff0c\u5411\u516c\u4f17\u63d0\u4f9b\u66f4\u591a\u5173\u4e8e\u5668\u68b0\u548c\u5176\u6027\u80fd\u7684\u4fe1\u606f\u30025. \u5bf9\u516c\u544a\u673a\u6784\uff08Notified Bodies\uff09\u7684\u5ba1\u6838\u8981\u6c42\u66f4\u82db\u523b\uff0c\u4ee5\u786e\u4fdd\u5176\u8ba4\u8bc1\u8fc7\u7a0b\u7684\u4e00\u81f4\u6027\u3001\u548c\u4e25\u8c28\u6027\u3002<\/p>\n<\/p>\n

3.2 MDR\u5bf9\u533b\u7597\u5668\u68b0\u884c\u4e1a\u548c\u60a3\u8005\u7684\u5f71\u54cd<\/strong><\/p>\n

MDR\u7684\u5b9e\u65bd\u5bf9\u6574\u4e2a\u533b\u7597\u5668\u68b0\u751f\u6001\u7cfb\u7edf\u4ea7\u751f\u4e86\u6df1\u8fdc\u5f71\u54cd\u3002<\/p>\n

\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u5408\u89c4\u6210\u672c\u663e\u8457\u589e\u52a0\uff0c\u9700\u8981\u6295\u5165\u66f4\u591a\u8d44\u6e90\u8fdb\u884c\u4e34\u5e8a\u8bc4\u4f30\u3001\u6280\u672f\u6587\u6863\u66f4\u65b0\u548c\u8d28\u91cf\u4f53\u7cfb\u7ba1\u7406\u3002\u4e00\u4e9b\u4e2d\u5c0f\u578b\u4f01\u4e1a\u53ef\u80fd\u56e0\u6b64\u9762\u4e34\u5de8\u5927\u6311\u6218\uff0c\u751a\u81f3\u53ef\u80fd\u5bfc\u81f4\u90e8\u5206\u8001\u65e7\u4ea7\u54c1\u9000\u51fa\u5e02\u573a\u3002\u5bf9\u4e8e\u533b\u7597\u4fdd\u5065\u63d0\u4f9b\u8005\u548c\u60a3\u8005\u800c\u8a00\uff0cMDR\u65e8\u5728\u5e26\u6765\u66f4\u9ad8\u6c34\u5e73\u7684\u5b89\u5168\u4fdd\u969c\u3002\u60a3\u8005\u53ef\u4ee5\u671f\u671b\u5e02\u573a\u4e0a\u9500\u552e\u7684\u533b\u7597\u5668\u68b0\u90fd\u7ecf\u8fc7\u4e86\u66f4\u4e25\u683c\u7684\u5ba1\u67e5\uff0c\u5e76\u4e14\u5176\u5b89\u5168\u4fe1\u606f\u66f4\u52a0\u900f\u660e\u3002\u7136\u800c\uff0c\u77ed\u671f\u5185\u4e5f\u53ef\u80fd\u51fa\u73b0\u67d0\u4e9b\u5668\u68b0\u4f9b\u5e94\u77ed\u7f3a\u6216\u4e0a\u5e02\u5ef6\u8fdf\u7684\u60c5\u51b5\u3002<\/p>\n<\/p>\n

4. \u603b\u7ed3\uff1a\u533a\u5206\u4e24\u79cdMDR\u7684\u91cd\u8981\u6027<\/strong><\/p>\n

\u7efc\u4e0a\u6240\u8ff0\uff0cMDR\u5728\u533b\u5b66\u4e0a\u662f\u4e00\u4e2a\u5177\u6709\u53cc\u91cd\u91cd\u8981\u542b\u4e49\u7684\u7f29\u5199\u3002<\/p>\n

\u5728\u4e34\u5e8a\u533b\u5b66\u548c\u5fae\u751f\u7269\u5b66\u9886\u57df\uff0cMDR\uff08\u591a\u91cd\u8010\u836f\u6027\uff09\u4ee3\u8868\u7740\u4e00\u4e2a\u65e5\u76ca\u4e25\u5cfb\u7684\u5168\u7403\u5065\u5eb7\u5371\u673a\uff0c\u5173\u4e4e\u611f\u67d3\u6027\u75be\u75c5\u7684\u6cbb\u7597\u6210\u8d25\u3002\u800c\u5728\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u9886\u57df\uff0cMDR\uff08\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff09\u4ee3\u8868\u7740\u4e00\u5957\u65e8\u5728\u63d0\u5347\u60a3\u8005\u5b89\u5168\u6027\u548c\u4ea7\u54c1\u900f\u660e\u5ea6\u7684\u6b27\u76df\u6cd5\u5f8b\u6846\u67b6\u3002\u5c3d\u7ba1\u9886\u57df\u4e0d\u540c\uff0c\u4f46\u4e24\u8005\u90fd\u6700\u7ec8\u6307\u5411\u540c\u4e00\u4e2a\u76ee\u6807\uff1a\u4fdd\u969c\u4eba\u7c7b\u5065\u5eb7\u548c\u751f\u547d\u5b89\u5168\u3002\u65e0\u8bba\u662f\u5e94\u5bf9\u4e0d\u65ad\u6f14\u53d8\u7684\u8010\u836f\u83cc\uff0c\u8fd8\u662f\u786e\u4fdd\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6709\u6548\uff0c\u90fd\u9700\u8981\u6301\u7eed\u7684\u79d1\u5b66\u7814\u7a76\u3001\u4e25\u683c\u7684\u76d1\u7ba1\u548c\u5168\u7403\u6027\u7684\u5408\u4f5c\u3002\u7406\u89e3\u8fd9\u4e24\u4e2a\u201cMDR\u201d\u7684\u5dee\u5f02\u4e0e\u91cd\u8981\u6027\uff0c\u662f\u8fc8\u5411\u66f4\u5b89\u5168\u3001\u66f4\u5065\u5eb7\u672a\u6765\u7684\u91cd\u8981\u4e00\u6b65\u3002<\/p>\n<\/p>\n

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