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NDMA\uff08N-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\uff09\u5206\u5b50\u5f0fC2H6N2O\uff0c\u5206\u5b50\u91cf74.08\uff0c\u9ec4\u8272\u6db2\u4f53\uff0c\u53ef\u6eb6\u4e8e\u6c34\u3001\u4e59\u9187\u3001\u4e59\u919a\u3001\u4e8c\u6c2f\u7532\u70f7\uff0c\u7531\u4e8c\u7532\u80fa\u4e0e\u4e9a\u785d\u9178\u76d0\u5728\u9178\u6027\u6761\u4ef6\u4e0b\u53cd\u5e94\u800c\u751f\u6210\u3002\u8be5\u7269\u8d28\u5728\u73af\u5883\u4e2d\u5e7f\u6cdb\u5b58\u5728\u3002<\/span><\/p>\n

\u4e03\u3001\u7f2c\u6c99\u5766\u539f\u6599\u836f\u4e3a\u4ec0\u4e48\u8981\u6539\u53d8\u5de5\u827a\uff1f\u53d8\u66f4\u8fc7\u7a0b\u662f\u5426\u5408\u89c4\uff1f<\/span><\/strong><\/span><\/p>\n

\u516c\u53f8\u539f\u6709\u5de5\u827a\u5b58\u5728\u5de5\u827a\u8f6c\u5316\u7387\u4f4e\u3001\u201c\u4e09\u5e9f\u201d\u4ea7\u751f\u91cf\u5927\u3001\u5f02\u6784\u4f53\u6742\u8d28\u6c34\u5e73\u6ce2\u52a8\u7b49\u95ee\u9898\u3002\u6539\u53d8\u7f2c\u6c99\u5766\u539f\u6599\u836f\u751f\u4ea7\u5de5\u827a\u540e\uff0c\u5de5\u827a\u8f6c\u5316\u7387\u63d0\u9ad8\u7ea630%\u3001\u201c\u4e09\u5e9f\u201d\u4ea7\u751f\u91cf\u964d\u4f4e\u7ea630%\u3001\u5f02\u6784\u4f53\u6742\u8d28\u4e5f\u5f97\u5230\u4e86\u6709\u6548\u63a7\u5236\u3002\u57fa\u4e8e\u4e0a\u8ff0\u539f\u56e0\uff0c\u516c\u53f8\u4e8e2012\u5e74\u5f00\u59cb\uff0c\u6309\u7167\u76f8\u5173\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u5de5\u827a\u53d8\u66f4\u7684\u6cd5\u89c4\u8981\u6c42\uff0c\u5c06\u5de5\u827a\u53d8\u66f4\u4e3a\u73b0\u884c\u5de5\u827a\u3002<\/span><\/p>\n

\u516b\u3001\u4f01\u4e1a\u662f\u5982\u4f55\u53d1\u73b0\u7f2c\u6c99\u5766\u539f\u6599\u836f\u4e2d\u5b58\u5728\u6742\u8d28NDMA\u7684\uff1f<\/span><\/strong><\/span><\/p>\n

2018\u5e746\u670815\u65e5\uff0c\u516c\u53f8\u5728\u5bf9\u7f2c\u6c99\u5766\u539f\u6599\u836f\u751f\u4ea7\u5de5\u827a\u8fdb\u884c\u4f18\u5316\u8bc4\u4f30\u8fc7\u7a0b\u4e2d\uff0c\u53d1\u73b0\u5e76\u68c0\u5b9a\u5176\u4e2d\u4e00\u672a\u77e5\u6742\u8d28\u4e3aN-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\uff08NDMA\uff09\u3002NDMA\u662f\u6309\u7167\u73b0\u884c\u6ce8\u518c\u5de5\u827a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u610f\u6599\u4e4b\u5916\u7684\u5fae\u91cf\u6742\u8d28\u3002\u4e8b\u4ef6\u53d1\u751f\u4e4b\u524d\uff0c\u5404\u56fd\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u5747\u672a\u5bf9\u8be5\u6742\u8d28\u63d0\u51fa\u68c0\u6d4b\u8981\u6c42\u3002<\/span><\/p>\n

\u836f\u7269\u4e2d\u672a\u77e5\u6742\u8d28\u80fd\u5426\u68c0\u51fa\u4e3b\u8981\u4f9d\u8d56\u4e8e\u4eba\u7c7b\u7684\u8ba4\u8bc6\u8ba4\u77e5\u6c34\u5e73\uff0c\u4ee5\u53ca\u68c0\u6d4b\u624b\u6bb5\u7684\u53d1\u5c55\u6c34\u5e73\u3002\u5173\u4e8e\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7684\u63a7\u5236\u6307\u5357\u201cICH M7\u201d2010\u5e74\u88abICH\u7ba1\u7406\u59d4\u5458\u4f1a\u6b63\u5f0f\u63d0\u51fa\uff0c\u4e8e2013\u5e74\u5b9a\u7a3f\uff0c\u8fd9\u624d\u9010\u6b65\u5f15\u8d77\u533b\u836f\u4e1a\u7684\u91cd\u89c6\u3002\u516c\u53f8\u4ece2004\u5e74\u5f00\u59cb\u7814\u53d1\u7f2c\u6c99\u5766\uff0c\u5bf9\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7684\u7814\u7a76\u65b9\u9762\u662f\u4e00\u4e2a\u9010\u6e10\u6df1\u5165\u7684\u8fc7\u7a0b\uff1b\u4ece\u6700\u521d\u7684\u53e0\u6c2e\u6b8b\u7559\u7814\u7a76\uff0c\u5230\u540e\u671f\u7684\u6eb4\u5316\u7269\u7cfb\u5217\u6742\u8d28\u7684\u6b8b\u7559\u7814\u7a76\uff0c\u518d\u5230\u672c\u6b21NDMA\u7684\u53d1\u73b0\u548c\u68c0\u5b9a\u3002\u9274\u4e8e\u5f53\u65f6\u7684\u7814\u7a76\u548c\u8ba4\u77e5\u6c34\u5e73\uff0c\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7814\u7a76\u662f\u6839\u636e\u6f5c\u5728\u57fa\u56e0\u6bd2\u6027\u8b66\u793a\u7ed3\u6784\u6307\u5357\u5f00\u5c55\u7684\uff0c\u5728\u8d77\u59cb\u7269\u6599\u3001\u4e2d\u95f4\u4f53\u3001\u4e3b\u6210\u5206\u3001\u4e3b\u53cd\u5e94\u526f\u4ea7\u7269\u53ca\u76f4\u63a5\u4f7f\u7528\u7684\u8bd5\u5242\u8fd9\u6761\u4e3b\u7ebf\u4e0a\u4f7f\u7528\u4e1a\u754c\u901a\u884c\u7684\u6392\u67e5\u3001\u68c0\u6d4b\u624b\u6bb5\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\u548c\u63a7\u5236\u3002\u7531\u4e8e\u672c\u6b21NDMA\u662f\u6eb6\u5242\u964d\u89e3\u7269\u8d28\u4e0e\u540e\u4e00\u6b65\u7684\u53cd\u5e94\u8bd5\u5242\u53cd\u5e94\u4ea7\u751f\u7684\uff0c\u4e14\u5728\u4ea7\u54c1\u4e2d\u6b8b\u7559\u91cf\u6781\u5fae\uff0c\u6309\u7167\u5f53\u65f6\u6ce8\u518c\u6279\u51c6\u7684\u5206\u6790\u65b9\u6cd5\u65e0\u6cd5\u68c0\u51fa\uff0c\u4e5f\u5c31\u65e0\u6cd5\u5bf9\u8be5\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u8fdb\u884c\u9488\u5bf9\u6027\u7684\u63a7\u5236\u3002\u56e0\u6b64\uff0cNDMA\u8fd9\u4e2a\u6742\u8d28\u662f\u968f\u7740\u4ea7\u54c1\u79d1\u5b66\u8ba4\u77e5\u7684\u6df1\u5165\u3001\u79d1\u5b66\u6280\u672f\u7684\u53d1\u5c55\u4ee5\u53ca\u68c0\u6d4b\u624b\u6bb5\u7684\u63d0\u5347\u800c\u65b0\u53d1\u73b0\u7684\u3002<\/span><\/p>\n

\u672c\u6b21\u4e8b\u4ef6\u662f\u4e00\u4e2a\u72ec\u7acb\u7684\u3001\u5076\u7136\u7684\u6280\u672f\u6027\u4e8b\u4ef6\u3002\u7ecf\u8fc7\u5bf9\u516c\u53f8\u5176\u4ed6\u4ea7\u54c1\u7684\u6392\u67e5\uff0c\u5747\u672a\u53d1\u73b0\u6709NDMA\u6742\u8d28\u5b58\u5728\u3002\u516c\u53f8\u5c06\u8fdb\u4e00\u6b65\u5b8c\u5584\u57fa\u56e0\u6bd2\u6027\u5728\u7814\u53d1\u3001\u5de5\u827a\u53d8\u66f4\u9636\u6bb5\u7684\u8bc4\u4f30\u4f53\u7cfb\uff0c\u5065\u5168\u201c\u6f5c\u5728\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7814\u7a76\u4e0e\u98ce\u9669\u8bc4\u4f30\u201d\u6307\u5bfc\u6587\u4ef6\uff0c\u6709\u6548\u6307\u5bfc\u542b\u6709\u8b66\u793a\u7ed3\u6784\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7684\u7814\u7a76\u548c\u63a7\u5236\uff0c\u4e0d\u65ad\u63d0\u9ad8\u4ea7\u54c1\u54c1\u8d28\u3001\u907f\u514d\u7c7b\u4f3c\u4e8b\u4ef6\u518d\u6b21\u53d1\u751f\u3002<\/span><\/p>\n

 <\/span> <\/span><\/span><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n

 <\/span><\/p>\n

\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/span><\/p>\n

2018\u5e747\u670830\u65e5<\/span><\/p>\n


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

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\u5173\u4e8eN-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\uff08NDMA\uff09\u7684<\/strong><\/span><\/p>\n

\u8ba4\u77e5\u8bf4\u660e<\/strong><\/span><\/p>\n

\u4e00\u3001\u6982\u8ff0<\/span><\/p>\n

N-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\uff0c\u53c8\u79f0N-\u4e8c\u7532\u57fa\u4e9a\u785d\u80fa\uff0c\u82f1\u6587\u7b80\u79f0NDMA\uff0c\u5206\u5b50\u5f0fC2H6N2O\uff0c\u5206\u5b50\u91cf74.08\uff0c\u9ec4\u8272\u6db2\u4f53\uff0c\u53ef\u6eb6\u4e8e\u6c34\u3001\u4e59\u9187\u3001\u4e59\u919a\u3001\u4e8c\u6c2f\u7532\u70f7\uff0c\u7531\u4e8c\u7532\u80fa\u4e0e\u4e9a\u785d\u9178\u76d0\u5728\u9178\u6027\u6761\u4ef6\u4e0b\u53cd\u5e94\u800c\u751f\u6210\u3002\u8be5\u7269\u8d28\u5728\u73af\u5883\u4e2d\u5e7f\u6cdb\u5b58\u5728\uff0c\u65e5\u5e38\u751f\u6d3b\u4e2d\u6bcf\u4eba\u65e5\u5747\u6444\u5165\u91cf\u4e3a0.16~134ug [IARC\u5173\u4e8e\u4eba\u7c7b\u81f4\u764c\u98ce\u9669\u8bc4\u4f30\u7684\u4e13\u845717: 125-76 (1978)]\u3002<\/span><\/p>\n

\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u6240\u5c5e\u673a\u6784\u56fd\u9645\u764c\u75c7\u7814\u7a76\u673a\u6784\uff08IARC\uff092017\u5e7410\u670827\u65e5\u516c\u5e03\u7684\u81f4\u764c\u7269\u6e05\u5355\uff0c\u5c06 NDMA \u5f52\u4e3a 2A \u7c7b\u81f4\u764c\u7269\u8d28\u30022A \u7c7b\u662f\u6307\u5728\u52a8\u7269\u5b9e\u9a8c\u4e2d\u6709\u76f8\u5e94\u6570\u636e\u652f\u6301\uff0c\u4f46\u5bf9\u4eba\u7c7b\u81f4\u764c\u6027\u8bc1\u636e\u6709\u9650\u7684\u7269\u8d28\u3002\u4e0eNDMA\u540c\u5c5e\u4e8e2A\u7c7b\u7269\u8d28\u7684\u5171\u670981\u79cd\uff0c\u5305\u62ec\u6cb9\u70b8\u98df\u54c1\u4e2d\u666e\u904d\u5b58\u5728\u7684\u4e19\u70ef\u9170\u80fa\u3001\u6e29\u5ea6\u9ad8\u4e8e65\u5ea6\u7684\u996e\u6599\u3001\u7ea2\u8089\u7b49\u7269\u8d28\u3002\u6b64\u5916\uff0c\u663c\u591c\u8282\u5f8b\u6253\u4e71\u7684\u8f6e\u73ed\u5de5\u4f5c\u4e5f\u5c5e\u4e8e2A\u7c7b\u81f4\u764c\u98ce\u9669\u884c\u4e3a\u3002\u867d\u7136\u5728\u975e\u5e38\u9ad8\u5242\u91cf\u7684\u52a8\u7269\u7814\u7a76\u4e2d\u53d1\u73b0NDMA\u53ef\u589e\u52a0\u764c\u75c7\u7684\u53d1\u751f\u7387\uff0c\u4f46\u8be5\u6742\u8d28\u5bf9\u4eba\u4f53\u7684\u5f71\u54cd\u5c1a\u65e0\u5145\u5206\u6570\u636e\u652f\u6301\u3002<\/span><\/p>\n


<\/p>\n

\u4e8c\u3001\u5404\u56fd\u76d1\u7ba1\u90e8\u95e8\u98ce\u9669\u8bc4\u4f30\u610f\u89c1<\/strong><\/span><\/p>\n


<\/p>\n

2.1\u7f8e\u56fdFDA\u5b98\u65b9\u516c\u544a<\/strong>\uff08https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm613916.htm\uff09<\/span><\/p>\n

\u201cUpdate [07\/27\/2018] On July 13th, FDA announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). Valsartan is a medication commonly used to treat high blood pressure and heart failure.\u201d<\/span><\/p>\n

\u66f4\u65b0[07\/27\/2018] 7\u670813\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5ba3\u5e03\u53ec\u56de\u67d0\u4e9b\u6279\u6b21\u7684\u7f2c\u6c99\u5766\u7247\uff0c\u8fd9\u662f\u7531\u4e8e\u4e00\u4e2a\u540d\u4e3aN-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\uff08NDMA\uff09\u7684\u5316\u5b66\u7269\u8d28\u3002\u7f2c\u6c99\u5766\u662f\u4e00\u79cd\u5e38\u7528\u4e8e\u6cbb\u7597\u9ad8\u8840\u538b\u548c\u5fc3\u529b\u8870\u7aed\u7684\u836f\u7269\u3002<\/span><\/p>\n

\u201cNDMA has been found to increase the occurrence of cancer in animal studies. These animal studies were done using amounts of NDMA much higher than the impurity levels in recalled valsartan batches. Based on these animal studies, the U.S. Environmental Protection Agency considers NDMA a probable human carcinogen\u2014a chemical that can increase the risk of cancer in humans. NDMA is found in some water supplies and in some foods . Consuming up to 96 nanograms NDMA\/day is considered reasonably safe for human ingestion . It is estimated that over the course of a person\u2019s lifetime, consuming this amount of NDMA would result in less than one additional case of cancer for every 100,000 people. To put this in context, currently one out of every three people in the US will experience cancer in their lifetime.\u201d<\/span><\/p>\n

\u5728\u52a8\u7269\u7814\u7a76\u4e2d\u5df2\u53d1\u73b0NDMA\u53ef\u589e\u52a0\u764c\u75c7\u7684\u53d1\u751f\u7387\u3002\u8fd9\u4e9b\u52a8\u7269\u7814\u7a76\u4f7f\u7528\u7684NDMA\u91cf\u8fdc\u8fdc\u9ad8\u4e8e\u53ec\u56de\u7684\u7f2c\u6c99\u5766\u6279\u6b21\u4e2d\u7684\u6742\u8d28\u6c34\u5e73\u3002\u57fa\u4e8e\u8fd9\u4e9b\u52a8\u7269\u7814\u7a76\uff0c\u7f8e\u56fd\u73af\u5883\u4fdd\u62a4\u5c40\u8ba4\u4e3aNDMA\u662f\u4e00\u79cd\u53ef\u80fd\u7684\u4eba\u7c7b\u81f4\u764c\u7269\u8d28 \u2014\u4e00\u79cd\u53ef\u80fd\u589e\u52a0\u4eba\u7c7b\u764c\u75c7\u98ce\u9669\u7684\u5316\u5b66\u7269\u8d28\u3002NDMA\u5728\u4e00\u4e9b\u996e\u7528\u6c34\u548c\u98df\u54c1\u4e2d\u6709\u88ab\u53d1\u73b0\u3002\u4eba\u7c7b\u6bcf\u5929\u6444\u516596\u7eb3\u514b\u7684NDMA \u88ab\u8ba4\u4e3a\u662f\u76f8\u5bf9\u5b89\u5168\u7684\u3002\u636e\u4f30\u8ba1\uff0c\u5728\u4eba\u7684\u4e00\u751f\u4e2d\uff0c\u56e0\u6444\u5165\u8fd9\u79cd\u5242\u91cf\u7684NDMA\u4f1a\u5bfc\u81f4\u6bcf10\u4e07\u4eba\u4e2d\u589e\u52a0\u4e0d\u5230\u4e00\u4f8b\u764c\u75c7\u60a3\u8005\u3002\u4f5c\u4e3a\u53c2\u7167\u4fe1\u606f\uff0c\u76ee\u524d\u5728\u7f8e\u56fd\u6c11\u4f17\u7684\u4e00\u751f\u4e4b\u4e2d\u6bcf3\u4e2a\u4eba\u5c31\u67091\u4eba\u4f1a\u7ecf\u5386\u764c\u75c7\u3002<\/span><\/p>\n

\u201cThe amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The agency wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. This assessment led to FDA\u2019s decision to have these batches recalled.\u201d<\/span><\/p>\n

\u5728\u53ec\u56de\u7684\u7f2c\u6c99\u5766\u6279\u6b21\u4e2d\u53d1\u73b0\u7684NDMA\u542b\u91cf\u8d85\u8fc7\u4e86\u8fd9\u4e9b\u53ef\u63a5\u53d7\u7684\u6c34\u5e73\u3002\u7f8e\u56fd\u76d1\u7ba1\u673a\u6784\u5e0c\u671b\u5bf9\u4f7f\u7528\u4e86\u53ef\u80fd\u542b\u6709\u9ad8NDMA\u7684\u7f2c\u6c99\u5766\u4e0d\u540c\u5236\u5242\u7684\u60a3\u8005\u6240\u9762\u4e34\u7684\u5b9e\u9645\u6f5c\u5728\u98ce\u9669\u8fdb\u884c\u5206\u6790\u3002\u6839\u636e\u53ec\u56de\u7684\u7f2c\u6c99\u5766\u4ea7\u54c1\u5236\u9020\u5546\u7684\u8bb0\u5f55\uff0c\u5728\u542b\u6709\u7f2c\u6c99\u5766\u7684\u4ea7\u54c1\u4e2d\uff0c\u8be5\u6742\u8d28\u53ef\u80fd\u5b58\u5728\u4e86\u957f\u8fbe\u56db\u5e74\u3002FDA\u7684\u79d1\u5b66\u5bb6\u4eec\u4f30\u8ba1\uff0c\u5982\u679c\u67098000\u4eba\u8fde\u7eed\u56db\u5e74\u6bcf\u5929\u670d\u7528\u53ec\u56de\u6279\u6b21\u7684\u6700\u9ad8\u7f2c\u6c99\u5766\u4ea7\u54c1\u5242\u91cf\uff08320mg\uff09\uff0c\u90a3\u4e48\u5728\u8fd98000\u4eba\u7684\u4e00\u751f\u4e2d\u53ef\u80fd\u4f1a\u589e\u52a0\u4e00\u4f8b\u764c\u75c7\u3002\u8be5\u8bc4\u4f30\u5bfc\u81f4FDA\u51b3\u5b9a\u53ec\u56de\u8fd9\u4e9b\u6279\u6b21\u3002<\/span><\/p>\n

\u201cPatients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications.\u201d<\/span><\/p>\n

\u670d\u7528\u53ec\u56de\u6279\u6b21\u7f2c\u6c99\u5766\u7684\u60a3\u8005\u5e94\u7ee7\u7eed\u670d\u7528\u76ee\u524d\u7684\u836f\u7269\uff0c\u76f4\u5230\u4ed6\u4eec\u7684\u533b\u751f\u6216\u836f\u5242\u5e08\u63d0\u4f9b\u66ff\u4ee3\u836f\u54c1\u6216\u4e0d\u540c\u7684\u6cbb\u7597\u65b9\u6848\u3002\u91cd\u8981\u7684\u662f\u8981\u77e5\u9053\u5e76\u4e0d\u662f\u6240\u6709\u7684\u7f2c\u6c99\u5766\u4ea7\u54c1\u90fd\u542b\u6709NDMA\uff0c\u56e0\u6b64\u836f\u5242\u5e08\u53ef\u80fd\u80fd\u591f\u4ece\u4e0d\u53d7\u53ec\u56de\u5f71\u54cd\u7684\u6279\u6b21\u4e2d\u8fdb\u884c\u7f2c\u6c99\u5766\u836f\u7269\u7684\u8865\u5145\uff0c\u6216\u8005\u533b\u751f\u53ef\u80fd\u4f1a\u5f00\u51fa\u6cbb\u7597\u76f8\u540c\u9002\u5e94\u75c7\u7684\u4e0d\u540c\u836f\u7269\u3002<\/span><\/p>\n

\u201cFDA continues to evaluate the safety of valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available. If you are taking a valsartan product, be sure to check to back as the lists may change.\u201d<\/span><\/p>\n

FDA\u5c06\u7ee7\u7eed\u8bc4\u4f30\u542b\u7f2c\u6c99\u5766\u7684\u4ea7\u54c1\u7684\u5b89\u5168\u6027\uff0c\u5e76\u5c06\u968f\u7740\u66f4\u591a\u7684\u53ef\u7528\u4fe1\u606f\u66f4\u65b0\u5305\u542b\u53ec\u56de\u4ea7\u54c1\u7684\u4ea7\u54c1\u6e05\u5355\uff0c\u548c\u4e0d\u5305\u542b\u5728\u53ec\u56de\u8303\u56f4\u5185\u7684\u4ea7\u54c1\u6e05\u5355\u3002\u5982\u679c\u60a8\u6b63\u5728\u670d\u7528\u7f2c\u6c99\u5766\u4ea7\u54c1\uff0c\u8bf7\u52a1\u5fc5\u68c0\u67e5\uff0c\u56e0\u4e3a\u6e05\u5355\u53ef\u80fd\u4f1a\u53d1\u751f\u53d8\u5316\u3002<\/span><\/p>\n

iFromToxnet: https:\/\/toxnet.nlm.nih.gov\/<\/span><\/p>\n

Average Daily Intake:<\/span><\/p>\n

WATER: (assume 3 to 6 ng N-nitrosodimethylamine\/l)(1) 6 to 12 ng; direct intake from drinking water is probably much less than 1 ug\/day(2). FOOD: (assume <0.1 to 84 ug\/kg)(4) <0.16 to 134 ug.
[(1) Kimoto WI et al; Water Res 15: 1099-1106 (1981) (2) USEPA; Ambient Water Quality Criteria Doc: Nitrosamines p.C-14 (1980) EPA 440\/5-80-064 (4) IARC; IARC Monographs on the Evaluation of Carcinogenic Risks to Humans 17: 125-76 (1978)]<\/span><\/p>\n

\u5728FDA\u516c\u544a\u4e2d\uff0c\u8fd8\u5f15\u7528\u4e86Toxnet\u7684\u6bd2\u6027\u6570\u636e\u4fe1\u606f\uff0c\u65e5\u5e38\u751f\u6d3b\u4e2d\u6bcf\u4eba\u7684NDMA\u65e5\u6444\u5165\u91cf\u5982\u4e0b\uff1a<\/span><\/p>\n

\u6c34\uff1a\uff08\u5047\u8bbe\u6bcf\u5347\u6c34\u4e2dN-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\u4e3a3-6ng\uff09\uff081\uff096-12ng; \u4ece\u996e\u7528\u6c34\u7684\u76f4\u63a5\u6444\u5165\u91cf\u5f88\u53ef\u80fd\u8fdc\u4f4e\u4e8e1 ug\/day\uff082\uff09\u3002<\/span><\/p>\n

\u98df\u7269\uff1a\uff08\u5047\u8bbe\u6bcf\u516c\u65a4\u4e2dN-\u4e8c\u7532\u57fa\u4e9a\u785d\u80fa<0.1 to 84 ug\uff09\uff084\uff09<0.16 to 134 ug\u3002<\/span><\/p>\n

[(1) Kimoto WI et al; Water Res 15: 1099-1106 (1981) (2) \u7f8e\u56fd\u73af\u5883\u4fdd\u62a4\u5c40\uff08EPA\uff09; \u73af\u5883\u6c34\u8d28\u6807\u51c6\u6587\u4ef6: \u4e9a\u785d\u80fa\u7c7b p.C-14 (1980) EPA 440\/5-80-064 (4) \u56fd\u9645\u764c\u75c7\u7814\u7a76\u673a\u6784\uff08IARC\uff09; IARC\u5173\u4e8e\u4eba\u7c7b\u81f4\u764c\u98ce\u9669\u8bc4\u4f30\u7684\u4e13\u845717: 125-76 (1978)]<\/span><\/p>\n


<\/p>\n

2.2 \u6b27\u76dfEMA\u5b98\u65b9\u516c\u544a<\/strong>\uff08http:\/\/www.ema.europa.eu\/ema\/\uff09<\/span><\/p>\n

\u201cWhile further assessment is needed, there is no immediate risk and patients taking valsartan are advised not to stop their treatments unless they have been advised to do so by their pharmacist or doctor. Healthcare professionals should follow specific advice from national authorities concerning medicines in their country.\u201d<\/span><\/p>\n

\u867d\u7136\u9700\u8981\u8fdb\u4e00\u6b65\u7684\u8bc4\u4f30\uff0c\u4f46\u662f\u5e76\u6ca1\u6709\u5373\u53d1\u6027\u7684\u98ce\u9669\uff0c\u9664\u975e\u836f\u5242\u5e08\u6216\u533b\u751f\u5efa\u8bae\u505c\u836f\uff0c\u5efa\u8bae\u670d\u7528\u7f2c\u6c99\u5766\u7684\u60a3\u8005\u4e0d\u8981\u505c\u6b62\u6cbb\u7597\u3002\u533b\u7597\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u4e5f\u5e94\u9075\u5faa\u6240\u5728\u56fd\u7684\u5b98\u65b9\u673a\u6784\u5bf9\u4e8e\u836f\u54c1\u7684\u4e13\u95e8\u610f\u89c1\u3002<\/span><\/p>\n


<\/p>\n

2.3 \u8377\u5170\u5b98\u65b9\u516c\u544a<\/strong><\/span><\/p>\n

https:\/\/www.cbg-meb.nl\/actueel\/nieuws\/2018\/07\/05\/terugroepactie-aantal-bloeddrukmedicijnen-met-valsartan<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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\"\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/section>\n<\/section>\n<\/section>\n
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\u6839\u636e\u6b27\u6d32\u521d\u6b65\u5206\u6790\u663e\u793a\uff0c\u60a3\u8005\u56e0\u670d\u7528\u53d7\u6c61\u67d3\u7684\u836f\u7269\u800c\u5b9e\u9645\u4e0a\u7f79\u60a3\u764c\u75c7\u7684\u53ef\u80fd\u6027\u5f88\u5c0f\u3002\u6839\u636eRIVM\uff0c\u8fd9\u79cd\u6982\u7387\u4e0e\u7ecf\u5e38\u98df\u7528\u70e4\u8089\u800c\u5e26\u6765\u7684\u7f79\u60a3\u764c\u75c7\u7684\u989d\u5916\u98ce\u9669\u76f8\u5f53\u3002<\/span><\/p>\n


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

2.4 \u745e\u5178\u5b98\u65b9\u516c\u544a<\/strong><\/span><\/p>\n

https:\/\/lakemedelsverket.se\/Alla-nyheter\/NYHETER—2018\/Vissa-lakemedel-innehallande-valsartan-dras-in-\/<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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\"\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/section>\n<\/section>\n<\/section>\n
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\u5bf9\u60a3\u8005\u6ca1\u6709\u6025\u6027\u98ce\u9669\u3002\u957f\u671f\u7528\u836f\u7684\u60a3\u8005\uff0c\u5176\u764c\u75c7\u7684\u98ce\u9669\u53ef\u80fd\u7565\u6709\u589e\u52a0\u3002\u5bf9\u4e8e\u60a3\u8005\uff0c\u7acb\u5373\u505c\u6b62\u670d\u7528\u836f\u7269\u7684\u98ce\u9669\u6bd4\u5728\u4e0b\u4e00\u6b21\u53bb\u836f\u623f\u4e70\u836f\u524d\u7ee7\u7eed\u670d\u7528\u836f\u7269\u7684\u5065\u5eb7\u98ce\u9669\u66f4\u5927\u3002\u5efa\u8bae\u670d\u7528\u6709\u5173\u836f\u7269\u7684\u60a3\u8005\u7ee7\u7eed\u670d\u7528\u836f\u7269\uff0c\u76f4\u81f3\u53e6\u884c\u901a\u77e5\u3002<\/span><\/p>\n


<\/p>\n

2.5\u5fb7\u56fd\u5b98\u65b9\u516c\u544a<\/strong><\/span><\/p>\n

\uff08https:\/\/www.bfarm.de\/SiteGlobals\/Forms\/Suche\/Servicefunktionsuche_Formular.html?<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\"\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/section>\n<\/section>\n<\/section>\n
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\u5728\u6ca1\u6709\u54a8\u8be2\u533b\u751f\u4e4b\u524d\uff0c\u5728\u670d\u7528\u542b\u6709\u7f2c\u6c99\u5766\u7684\u836f\u7269\u7684\u60a3\u8005\u4e0d\u5e94\u8be5\u505c\u6b62\u7528\u836f\uff0c\u56e0\u4e3a\uff08\u505c\u6b62\u7528\u836f\uff09\u5e26\u6765\u7684\u98ce\u9669\u8fdc\u8fdc\u9ad8\u4e8e\u7531\u4e8e\u6742\u8d28\u800c\u5f15\u8d77\u7684\u6f5c\u5728\u98ce\u9669\u3002\u5bf9\u60a3\u8005\u6ca1\u6709\u6025\u6027\u98ce\u9669\u3002<\/span><\/p>\n


<\/p>\n

2.6\u52a0\u62ff\u5927\u5b98\u65b9\u516c\u544a<\/strong><\/span><\/p>\n

\uff08http:\/\/www.healthycanadians.gc.ca\/recall-alert-rappel-avis\/hc-sc\/2018\/67202a-eng.php\uff09<\/span><\/p>\n

\u201cNDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure\u201d<\/span><\/p>\n

NDMA\u662f\u4e00\u79cd\u957f\u671f\u66b4\u9732\u4e0b\u53ef\u80fd\u5bfc\u81f4\u4eba\u7c7b\u81f4\u764c\u7684\u7269\u8d28\u3002<\/span><\/p>\n

\u201cKeep taking your medicine if it contains valsartan, unless you have been told to stop by your doctor or pharmacist. If you have been using an affected product, contact your health care practitioner as soon as possible to discuss your treatment options\u201d<\/span><\/p>\n

\u9664\u975e\u533b\u751f\u6216\u8005\u836f\u5e08\u786e\u8ba4\uff0c\u5426\u5219\u7ee7\u7eed\u670d\u7528\u73b0\u6709\u836f\u7269\uff1b\u5982\u679c\u4f60\u670d\u7528\u7684\u836f\u7269\u662f\u53d7\u5f71\u54cd\u7684\uff0c\u8bf7\u5c3d\u5feb\u8054\u7cfb\u533b\u751f\u8ba8\u8bba\uff08\u5176\u4ed6\uff09\u6cbb\u7597\u65b9\u6848\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e09\u3001\u4e13\u5bb6\u610f\u89c1<\/strong><\/span><\/p>\n


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

\u524d\u7f8e\u56fdFDA\u8d44\u6df1\u836f\u7406\u6bd2\u7406\u5b66\u5ba1\u8bc4\u5458\uff0cGLP\/GCP\u6cd5\u89c4\u7763\u67e5\u5b98\uff0c\u73b0\u4efb\u4e2d\u56fd\u662d\u884d\u65b0\u836f\u7814\u7a76\u4e2d\u5fc3\u80a1\u4efd\u6709\u9650\u516c\u53f8\u9ad8\u7ea7\u526f\u603b\u88c1\u517c\u9996\u5e2d\u79d1\u5b66\u5bb6\u59da\u5927\u6797\u535a\u58eb\u5728\u63a5\u53d7\u5a92\u4f53\u91c7\u8bbf\u65f6\u8868\u793a\uff0c\u88ab\u51a0\u4ee5\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7684NDMA\u5b9e\u9645\u4e0a\u5e7f\u6cdb\u5b58\u5728\u4e8e\u65e5\u5e38\u98df\u7269\u3001\u996e\u54c1\u3001\u70df\u8349\u3001\u6a61\u80f6\u5236\u54c1\u7b49\u7269\u8d28\u5f53\u4e2d\uff0c\u751a\u81f3\u7a7a\u6c14\u3001\u6c34\u3001\u571f\u58e4\u5747\u662f\u5176\u91cd\u8981\u6765\u6e90\uff0c\u800c\u5564\u9152\u3001\u718f\u5236\u98df\u54c1\u3001\u9c7c\u8089\u3001\u98df\u54c1\u52a0\u5de5\u5382\u3001\u5316\u5986\u54c1\u5382\u4e5f\u662f\u5176\u91cd\u70b9\u6f5c\u5728\u91ca\u653e\u6e90\u3002\u8be5\u6742\u8d28\u5728\u7f2c\u6c99\u5766\u539f\u6599\u4e2d\u7684\u51fa\u73b0\u5c5e\u4e8e\u751f\u4ea7\u6d41\u7a0b\u5f53\u4e2d\u6240\u4ea7\u751f\u4e14\u5c5e\u4e8e\u533b\u836f\u76d1\u7ba1\u610f\u6599\u4e4b\u5916\u7684\u65b0\u60c5\u51b5\uff0c\u5e76\u975e\u751f\u4ea7\u5355\u4f4d\u8fdd\u89c4\u6dfb\u52a0\u6240\u81f4\u3002<\/span><\/p>\n

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\u5c0f\u8d34\u58eb:<\/strong><\/span><\/p>\n

1.\u7f2c\u6c99\u5766\u4e3b\u8981\u7528\u4e8e\u6cbb\u7597\u9ad8\u8840\u538b\u3002<\/span><\/p>\n

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\u6765\u6e90\u534e\u6d77\u836f\u4e1a<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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<\/p>\n

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\u6210\u90fd\u5e028 \u670824- 26\u65e5<\/span><\/span>-2018 QA\u4e13\u5458\u6280\u80fd\u5b8c\u5584\u3001\u63d0\u5347\u4e0e\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed<\/span>\u201d\u7684\u901a\u77e5<\/span><\/span><\/strong><\/a>

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<\/p>
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<\/a>\u4e0a\u6d778\u67089\u65e5-11\u65e5<\/span>-\u836f\u54c1\u751f\u4ea7\u5de5\u827a\u53d8\u66f4\u7814\u7a76\u53ca\u5de5\u827a\u53d8\u66f4\u9a8c\u8bc1\u5b9e\u65bd\u4e13\u9898\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/strong><\/span><\/span><\/span><\/strong><\/strong><\/span><\/p>
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<\/strong><\/span><\/strong><\/strong>
<\/span><\/p>
\u5357\u4eac\u5e028\u6708 17 \u65e5\u81f319\u65e5<\/span><\/span>-2018CFDA\u300a\u836f\u54c1\u6570\u636e\u7ba1\u7406\u89c4\u8303\u300b\u89e3\u8bfb\u4e0e\u6848\u4f8b\u89e3\u6790\u9ad8\u7ea7\u57f9\u8bad\u73ed<\/span>\u201d<\/span><\/strong><\/span><\/a>
<\/p>

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<\/p>
\u5c71\u4e1c<\/strong><\/span><\/strong><\/span><\/p>
\u6d4e\u5357\u5e028<\/span>\u6708<\/span>26-28<\/span>\u65e5<\/span>-\u539f\u6599\u836f\u3001\u836f\u7528\u8f85\u6599\u548c\u836f\u5305\u6750\u5171\u540c\u5ba1\u8bc4\u5ba1\u6279\u89e3\u6790\u53ca\u5982\u4f55\u7f16\u5199\u7533\u62a5\u8d44\u6599\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/strong><\/span><\/a><\/p>
<\/span><\/strong>
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\u9752\u5c9b\u5e02<\/span>-8\u670830---9\u67081\u65e5 <\/span>\u65b0\u6cd5\u89c4\u73af\u5883\u4e0b\u836f\u54c1\u7814\u53d1\u8d28\u91cf\u4f53\u7cfb\u7684\u5efa\u7acb\u4e0e\u5b9e\u65bd\u548c\u64cd\u4f5c\u9ad8\u7ea7\u7ecf\u7406\u4eba\u201d<\/span><\/strong><\/span><\/a>
 <\/span>
<\/span><\/strong><\/span><\/p>
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<\/p>
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<\/p>


<\/span><\/strong>\u676d\u5dde<\/span>-<\/span>8\u670824-26\u65e5<\/span>\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f<\/span>GMP<\/span>\u5236\u5ea6\u8981\u70b9\u89e3\u6790\u53ca\u5e94\u7528\u5b9e\u65bd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/span><\/span><\/p>

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\u5929\u6d25\u5e02<\/span>9\u67082\u65e5-9\u67084\u65e5<\/span>-\u65b0\u6cd5\u89c4\u80cc\u666f\u4e0b\u4fdd\u5065\u98df\u54c1\u914d\u65b9\u8bbe\u8ba1\u3001\u914d\u65b9\u4f9d\u636e\u4e0e\u6280\u672f\u8981\u6c42\u5236\u5b9a\u5b9e\u6218\u66a8\u7ecf\u5178\u6848\u4f8b\u5206\u4eab\u54a8\u8be2\u4f1a\u201d\u7684\u901a\u77e5<\/span><\/strong><\/a><\/p>
<\/strong><\/span>
<\/p><\/section><\/pre>\n
\u7ec4\u56e2\u62a5\u540d<\/span><\/strong>\u627e\u5c1a\u8001\u5e08\u4eab<\/span>\u4f18\u60e0\u66f4\u5927\u3002<\/span><\/span><\/strong><\/a><\/span><\/strong><\/span><\/p><\/pre>\n<\/section>\n
\u57f9\u8bad\u4e2d\u5fc3\u8d1f\u8d23\u4eba\u5c1a\u4e3915652565785\uff08\u5fae\u4fe1\u540c\u53f7<\/strong><\/strong>\uff09<\/strong><\/span><\/p>\n
<\/span><\/h2>\n
QQ\u54a8\u8be2 2331466365<\/strong><\/span><\/p>\n
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<\/strong><\/span><\/p>\n
\u8bc6\u522b\u4e0b\u9762\u4e8c\u7ef4\u7801\u53ef\u586b\u5199\u62a5\u540d\u4fe1\u606f<\/strong><\/span><\/p>\n
<\/strong><\/span><\/p>\n
\n
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\"\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a                         \u836f\u4f01\u6280\u672f\u4ea4\u6d41\u8054\u76df                      <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
 \u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8 \u5173\u4e8e\u7f2c\u6c99\u5766\u6742\u8d28\u76f8\u5173\u60c5\u51b5\u7684\u8bf4\u660e \u4e00\u3001\u7f2c\u6c99\u5766\u539f\u6599\u836f\u548c\u4f7f\u7528\u8be5\u539f\u6599\u836f\u751f\u4ea7\u7684\u5236\u5242\u4e3a […]<\/p>\n","protected":false},"author":1,"featured_media":30654,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/30653"}],"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=30653"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/30653\/revisions"}],"predecessor-version":[{"id":30664,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/30653\/revisions\/30664"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/30654"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=30653"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=30653"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=30653"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}