{"id":3772,"date":"2010-02-26T09:00:56","date_gmt":"2010-02-26T01:00:56","guid":{"rendered":"http:\/\/localhost:9966\/?p=3772"},"modified":"2026-06-23T15:47:04","modified_gmt":"2026-06-23T07:47:04","slug":"%e8%8d%af%e5%93%81%e4%b8%8d%e8%89%af%e5%8f%8d%e5%ba%94%e4%bf%a1%e6%81%af%e9%80%9a%e6%8a%a5%ef%bc%88%e7%ac%ac25%e6%9c%9f%ef%bc%89","status":"publish","type":"post","link":"https:\/\/www.blpa.com.cn\/?p=3772","title":{"rendered":"\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\uff08\u7b2c25\u671f\uff09"},"content":{"rendered":"

\n\t\u5173\u4e8e\u897f\u5e03\u66f2\u660e\u7684\u6700\u65b0\u56fd\u9645\u5b89\u5168\u6027\u4fe1\u606f<\/span><\/span><\/span>\n<\/p>\n

\n\t\u53d1\u5e03\u65e5\u671f\uff1a<\/span>2010-02-26<\/span><\/span>\n<\/p>\n

\n\t<\/span><\/b>\n<\/p>\n

\n\t\u7f16\u8005\u6309\uff1a<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u4f5c\u4e3a\u6211\u56fd\u836f\u54c1\u5b89\u5168\u76d1\u7ba1\u3001\u4fdd\u969c\u516c\u4f17\u7528\u836f\u5b89\u5168\u800c\u5efa\u7acb\u7684\u4e00\u9879\u5236\u5ea6\uff0c\u5bf9\u63a8\u52a8\u6211\u56fd\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u5de5\u4f5c\uff0c\u4fdd\u969c\u5e7f\u5927\u4eba\u6c11\u7fa4\u4f17\u7528\u836f\u5b89\u5168\u8d77\u5230\u4e86\u79ef\u6781\u6709\u6548\u7684\u4f5c\u7528\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u968f\u7740\u836f\u54c1\u5e02\u573a\u7684\u5168\u7403\u5316\uff0c\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e5f\u8d8b\u4e8e\u56fd\u9645\u5316\uff0c\u5176\u4ed6\u56fd\u5bb6\u7684\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4fe1\u606f\u5bf9\u4fdd\u969c\u6211\u56fd\u516c\u4f17\u7528\u836f\u5b89\u5168\u540c\u6837\u5177\u6709\u975e\u5e38\u91cd\u8981\u7684\u4f5c\u7528\u3002\u7531\u6b64\uff0c\u81ea\u300a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u300b\u7b2c<\/span>13\u671f\u5efa\u7acb\u4e86\u56fd\u5916\u4fe1\u606f\u7248\uff0c\u4ecb\u7ecd\u7531\u56fd\u5916\u5176\u4ed6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u53d1\u5e03\u7684\u6700\u65b0\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u5206\u6790\u5b89\u5168\u6027\u4fe1\u606f\u53d1\u5e03\u7684\u80cc\u666f\u53ca\u76f8\u5173\u6280\u672f\u8d44\u6599\uff0c\u540c\u65f6\u53c2\u8003\u901a\u62a5\u54c1\u79cd\u5728\u6211\u56fd\u4e34\u5e8a\u4f7f\u7528\u60c5\u51b5\uff0c\u8bc4\u4f30\u5176\u5728\u6211\u56fd\u7684\u6548\u76ca\/\u98ce\u9669\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u5bf9\u4e8e\u51cf\u80a5\u836f\u7684\u5b89\u5168\u6027\u95ee\u9898\u4e00\u76f4\u4e88\u4ee5\u5173\u6ce8\u3002<\/span>2004\u5e74\u66fe\u5728\u7b2c6\u671f\u300a\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u300b\u4e2d\u901a\u62a5\u4e86\u76d0\u9178\u82ac\u6c1f\u62c9\u660e\u7684\u5fc3\u8840\u7ba1\u7cfb\u7edf\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u30022009\u5e741\u6708\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u505c\u6b62\u76d0\u9178\u82ac\u6c1f\u62c9\u660e\u539f\u6599\u836f\u548c\u5236\u5242\u5728\u6211\u56fd\u7684\u751f\u4ea7\u3001\u9500\u552e\u548c\u4f7f\u7528\uff0c\u64a4\u9500\u5176\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u30022009\u5e74\u521d\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u66fe\u5bf9\u897f\u5e03\u66f2\u660e\u5f00\u5c55\u7cfb\u7edf\u6027\u8bc4\u4ef7\uff0c\u5e76\u5c31\u5f53\u65f6\u641c\u96c6\u7684\u6570\u636e\u3001\u6587\u732e\u8d44\u6599\u548c\u76f8\u5173\u60c5\u51b5\u53ec\u5f00\u4e86\u4e13\u5bb6\u54a8\u8be2\u4f1a\uff0c\u4e13\u5bb6\u5efa\u8bae\u5e94\u5728\u533b\u751f\u7684\u6307\u5bfc\u4e0b\u6309\u7167\u9002\u5e94\u75c7\u5408\u7406\u4f7f\u7528\u897f\u5e03\u66f2\u660e\uff0c\u5e76\u5173\u6ce8\u5176\u957f\u671f\u4f7f\u7528\u7684\u5b89\u5168\u6027\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u8fd1\u671f\uff0c\u4f9d\u636e\u4e00\u9879\u7531\u6b27\u76df\u5ba1\u6279\u96c5\u57f9\u516c\u53f8\u5f00\u5c55\u7684\u897f\u5e03\u66f2\u660e\u4e0a\u5e02\u540e\u7814\u7a76\u5f97\u51fa\u7684\u521d\u6b65\u7ed3\u679c\uff0c\u6b27\u76df\u3001\u7f8e\u56fd\u7b49\u56fd\u9645\u4e3b\u8981\u7684\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u5206\u522b\u91c7\u53d6\u4e86\u6682\u505c\u4e0a\u5e02\u8bb8\u53ef\u3001\u4fee\u6539\u8bf4\u660e\u4e66\u3001\u589e\u52a0\u7981\u5fcc\u75c7\u7b49\u98ce\u9669\u7ba1\u7406\u63aa\u65bd\u3002\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u5728\u83b7\u77e5\u56fd\u5916\u6700\u65b0\u7814\u7a76\u548c\u62a5\u9053\u540e\uff0c\u518d\u6b21\u5bf9\u8be5\u54c1\u79cd\u4e88\u4ee5\u9ad8\u5ea6\u5173\u6ce8\uff0c\u5e76\u7ed3\u5408\u65b0\u7684\u8bc1\u636e\u8d44\u6599\uff0c\u5bf9\u5176\u8fdb\u884c\u91cd\u65b0\u8bc4\u4ef7\u3002\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7ba1\u7ba1\u7406\u5c40\u5c06\u6839\u636e\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u7684\u8bc4\u4f30\u7ed3\u679c\u91c7\u53d6\u9002\u5b9c\u6211\u56fd\u7684\u76d1\u7ba1\u63aa\u65bd\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u4e3a\u4f7f\u533b\u52a1\u5de5\u4f5c\u8005\u3001\u836f\u54c1\u751f\u4ea7\u7ecf\u8425\u4f01\u4e1a\u4ee5\u53ca\u516c\u4f17\u53ca\u65f6\u4e86\u89e3\u8fd9\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u95ee\u9898\uff0c\u964d\u4f4e\u7528\u836f\u98ce\u9669\uff0c\u7279\u4ee5\u4e13\u520a\u5f62\u5f0f\u5bf9\u897f\u5e03\u66f2\u660e\u76f8\u5173\u60c5\u51b5\u8fdb\u884c\u901a\u62a5\u3002<\/span><\/span>
\n<\/span>      <\/span> <\/span>\u5173\u4e8e\u897f\u5e03\u66f2\u660e\u7684\u6700\u65b0\u56fd\u9645\u5b89\u5168\u6027\u4fe1\u606f<\/span><\/span><\/b><\/span>\n<\/p>\n

\n\t  <\/span>2010\u5e741\u670821\u65e5\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5728\u5176\u7f51\u7ad9\u53d1\u5e03\u4fe1\u606f\u79f0\uff0c\u5176\u4eba\u7528\u836f\u54c1\u4e13\u5bb6\u59d4\u5458\u4f1a\uff08CHMP\uff09\u4f9d\u636e\u4e00\u9879\u6709\u5173\u897f\u5e03\u66f2\u660e\uff08Sibutramine\uff09\u7684\u5b89\u5168\u6027\u8bc4\u4f30\uff08SCOUT\u7814\u7a76\u7684\u521d\u6b65\u7ed3\u8bba\uff09\uff0c\u5f97\u51fa\uff1a\u8be5\u4ea7\u54c1\u98ce\u9669\u5927\u4e8e\u6548\u76ca\uff0c\u5efa\u8bae\u5728\u6b27\u76df\u8303\u56f4\u5185\u6682\u505c\u4e0a\u5e02\u8bb8\u53ef\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e3a\u4f7f\u5e7f\u5927\u533b\u52a1\u4eba\u5458\u548c\u60a3\u8005\u53ca\u65f6\u4e86\u89e3\u897f\u5e03\u66f2\u660e\u7684\u4f7f\u7528\u98ce\u9669\uff0c\u4fdd\u969c\u4e34\u5e8a\u7528\u836f\u5b89\u5168\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u7279\u901a\u62a5\u6b64\u5b89\u5168\u6027\u4fe1\u606f\u3002<\/span><\/span>
\n<\/span> \u4e00\u3001\u4ea7\u54c1\u57fa\u672c\u60c5\u51b5<\/span><\/span>\n<\/p>\n

\n\t  \u897f\u5e03\u66f2\u660e\u4e3a\u4e2d\u67a2\u795e\u7ecf\u4f5c\u7528\u51cf\u80a5\u836f<\/span>,\u5176\u4f53\u5185\u4ee3\u8c22\u4ea7\u7269\u53ef\u6291\u5236\u53bb\u7532\u80be\u4e0a\u817a\u7d20\u30015-\u7f9f\u8272\u80fa\u548c\u591a\u5df4\u80fa\u7684\u518d\u6444\u53d6\uff0c\u589e\u52a0\u9971\u98df\u611f\u5e76\u52a0\u901f\u80fd\u91cf\u6d88\u8017\u3002\u897f\u5e03\u66f2\u660e\u4e8e1997\u5e74\u7531\u96c5\u57f9\u516c\u53f8\u9996\u5148\u5728\u58a8\u897f\u54e5\u4e0a\u5e02\u3002\u6211\u56fd\u7684\u4e0a\u5e02\u65f6\u95f4\u662f2000\u5e74\uff0c\u4e3a\u5904\u65b9\u836f\uff0c\u5546\u54c1\u540d\u6709\u66f2\u7f8e\u3001\u6fb3\u66f2\u8f7b\u3001\u53ef\u79c0\u3001\u8d5b\u65af\u7f8e\u3001\u66f2\u5a77\u3001\u6d66\u79c0\u3001\u4ead\u7acb\u3001\u5965\u4e3d\u90a3\u3001\u66f2\u666f\u3001\u65b0\u82ac\u7f8e\u7433\u3001\u5e0c\u9752\u3001\u7533\u4e4b\u82b1\u3001\u8861\u97f5\u3001\u82d7\u4e50\u3001\u8bfa\u7f8e\u4ead\u7b49\u3002\u96c5\u57f9\u516c\u53f8\u4e8e2001\u5e74\u5728\u6211\u56fd\u83b7\u5f97\u8fdb\u53e3\u6ce8\u518c\u8bc1\u4e66\uff0c\u76ee\u524d\uff0c\u672a\u5728\u56fd\u5185\u9500\u552e\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u897f\u5e03\u66f2\u660e\u56fd\u5185\u836f\u54c1\u8bf4\u660e\u4e66\u660e\u786e\u897f\u5e03\u66f2\u660e\u9002\u7528\u4e8e\u996e\u98df\u63a7\u5236\u548c\u8fd0\u52a8\u4e0d\u80fd\u51cf\u8f7b\u548c\u63a7\u5236\u4f53\u91cd\u7684\u80a5\u80d6\u75c7\u6cbb\u7597\u3002\u5305\u62ec\u51cf\u8f7b\u4f53\u91cd\u548c\u7ef4\u6301\u4f53\u91cd\u7684\u51cf\u8f7b\uff0c\u6cbb\u7597\u5e94\u4e0e\u4f4e\u70ed\u91cf\u996e\u98df\u548c\u8fd0\u52a8\u7ed3\u5408\u8fdb\u884c\u3002\u63a8\u8350\u7528\u4e8e\u6cbb\u7597\u4f53\u91cd\u6307\u6570\uff08\u4f53\u91cd\u6307\u6570<\/span>=\u4f53\u91cd\/\u8eab\u9ad8\u7684\u5e73\u65b9\uff09\u4e0d\u5e94\u4f4e\u4e8e30kg\/m2\uff0c\u6216\u4e0d\u4f4e\u4e8e27kg\/m2\u5e76\u4f34\u6709\u5176\u4ed6\u5371\u9669\u56e0\u7d20\uff08\u5982\u9ad8\u8840\u538b\u3001\u7cd6\u5c3f\u75c5\u3001\u8840\u8102\u5f02\u5e38\u7b49\uff09\u7684\u80a5\u80d6\u75c7\u60a3\u8005\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e8c\u3001<\/span>SCOUT\u7814\u7a76\u60c5\u51b5\u548c\u76f8\u5173\u98ce\u9669\u63a7\u5236\u63aa\u65bd<\/span><\/span>\n<\/p>\n

\n\t  <\/span>SCOUT\uff08Sibutramine Cardiovascular Outcome Trial\uff09\u540d\u4e3a\u201c\u897f\u5e03\u66f2\u660e\u5fc3\u8840\u7ba1\u7ec8\u70b9\u8bd5\u9a8c\u201d\uff0c\u662f\u7531\u6b27\u76df\u4eba\u7528\u836f\u54c1\u4e13\u5bb6\u59d4\u5458\u4f1a\u6279\u51c6\uff0c\u96c5\u57f9\u516c\u53f8\u5f00\u5c55\u7684\u4e0a\u5e02\u540e\u7814\u7a76\u3002\u8fd9\u9879\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7814\u7a76\u59cb\u4e8e2002\u5e74\uff0c\u957f\u8fbe\u7ea66\u5e74\uff0c\u6ce8\u518c\u4e86\u7ea61\u4e07\u540d55\u5c81\u53ca\u4ee5\u4e0a\u3001\u8d85\u91cd\u6216\u80a5\u80d6\u3001\u5e76\u5df2\u6709\u5fc3\u8840\u7ba1\u75be\u75c5\u53f2\u6216\u2161\u578b\u7cd6\u5c3f\u75c5\u53f2\u3001\u6216\u8fd8\u5b58\u5728\u5176\u4ed6\u5fc3\u8840\u7ba1\u75be\u75c5\u98ce\u9669\u7684\u53d7\u8bd5\u8005\uff0c\u7528\u4e8e\u8bc4\u4f30\u4f7f\u7528\u897f\u5e03\u66f2\u660e\u540e\u4f53\u91cd\u4e0b\u964d\u5bf9\u5fc3\u8840\u7ba1\u7684\u5f71\u54cd\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u521d\u6b65\u7814\u7a76\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u5b89\u6170\u5bf9\u7167\u7ec4\u76f8\u6bd4\uff0c\u897f\u5e03\u66f2\u660e\u7ec4\u60a3\u8005\u51fa\u73b0\u4e25\u91cd\u3001\u975e\u81f4\u6b7b\u6027\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u98ce\u9669\u589e\u52a0\u3002\u897f\u5e03\u66f2\u660e\u7ec4\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u53d1\u751f\u7387\u4e3a<\/span>11.4%\uff0c\u800c\u5b89\u6170\u5242\u5bf9\u7167\u7ec4\u4e3a10%\u3002\u7814\u7a76\u4e2d\u5404\u7ec4\u522b\u5177\u4f53\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u60c5\u51b5\u8be6\u89c1\u4e0b\u8868\u3002\u76ee\u524d\u8fd9\u4ec5\u662f\u7814\u7a76\u7684\u521d\u6b65\u7ed3\u8bba\uff0c\u6240\u6709\u6570\u636e\u7684\u5168\u9762\u5206\u6790\u6b63\u5728\u8fdb\u884c\u4e2d\uff0c\u6b63\u5f0f\u7ed3\u8bba\u5c06\u57283\u6708\u5de6\u53f3\u516c\u5e03\u3002<\/span><\/span>\n<\/p>\n

\n\t  <\/span>CHMP\u5728\u8bc4\u4f30\u4e2d\u63d0\u5230\uff0cSCOUT\u7814\u7a76\u4e2d\u5927\u591a\u6570\u60a3\u8005\u672a\u6309\u8bf4\u660e\u4e66\u8981\u6c42\u4f7f\u7528\u897f\u5e03\u66f2\u660e\uff0c\u56e0\u4e3a\u897f\u5e03\u66f2\u660e\u7981\u7528\u4e8e\u5df2\u77e5\u6709\u5fc3\u8840\u7ba1\u75be\u75c5\u7684\u60a3\u8005\uff0c\u6cbb\u7597\u65f6\u95f4\u4e5f\u957f\u4e8e\u5e38\u89c4\u63a8\u8350\u7684\u7597\u7a0b\u3002<\/span><\/span>\n<\/p>\n

\n\t  <\/span>SCOUT\u7814\u7a76\u5404\u7ec4\u522b\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u60c5\u51b5<\/span><\/span>\n<\/p>\n\n\n\n\n\n\n
\n

\n\t\t\t\t\t\u7ec4\u522b<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\u5b89\u6170\u5bf9\u7167\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\u897f\u5e03\u66f2\u660e\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\u5371\u5bb3\u6bd4\uff0895%\u7f6e\u4fe1\u5ea6\uff09<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\tP<\/span><\/i><\/b>\u503c<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\u7cd6\u5c3f\u75c5\u53f2\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u8be5\u7ec4\u603b\u4eba\u6570<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6<\/span>*<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u5360\u8be5\u7ec4\u603b\u6570\u6bd4<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t1,178<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t 77<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(6.5%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t1,207<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t79<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(6.5%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t1.010 (0.737, 1.383)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t0.951<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u98ce\u9669\u75c5\u53f2\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u8be5\u7ec4\u603b\u4eba\u6570<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6<\/span>*<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u5360\u8be5\u7ec4\u603b\u6570\u6bd4<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t793<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t66<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(8.3%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t759<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t 77<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(10.1%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t1.274 (0.915, 1.774)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t0.151<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\u7cd6\u5c3f\u75c5+\u5fc3\u8840\u7ba1\u98ce\u9669\u75c5\u53f2\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u8be5\u7ec4\u603b\u4eba\u6570<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6<\/span>*<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u5360\u8be5\u7ec4\u603b\u6570\u6bd4<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t2,901<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t346<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(11.9%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t2,906<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t403<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(13.9%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t1.182 (1.024, 1.354)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t0.023<\/span>++<\/span><\/sup><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n\n\n\n
\n

\n\t\t\t\t\t\u7ec4\u522b<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\u5b89\u6170\u5bf9\u7167\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\u897f\u5e03\u66f2\u660e\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t\u5371\u5bb3\u6bd4\uff0895%\u7f6e\u4fe1\u5ea6\uff09<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\tP<\/span><\/i><\/b>\u503c<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\u7cd6\u5c3f\u75c5\u53f2\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u8be5\u7ec4\u603b\u4eba\u6570<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6<\/span>*<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u5360\u8be5\u7ec4\u603b\u6570\u6bd4<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t1,178<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t 77<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(6.5%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t1,207<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t79<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(6.5%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t1.010 (0.737, 1.383)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t0.951<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u98ce\u9669\u75c5\u53f2\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u8be5\u7ec4\u603b\u4eba\u6570<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6<\/span>*<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u5360\u8be5\u7ec4\u603b\u6570\u6bd4<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t793<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t66<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(8.3%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t759<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t 77<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(10.1%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t1.274 (0.915, 1.774)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t0.151<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n

\n

\n\t\t\t\t\t\u7cd6\u5c3f\u75c5+\u5fc3\u8840\u7ba1\u98ce\u9669\u75c5\u53f2\u7ec4<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u8be5\u7ec4\u603b\u4eba\u6570<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6<\/span>*<\/span><\/b><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u5360\u8be5\u7ec4\u603b\u6570\u6bd4<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t2,901<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t346<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(11.9%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

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

\n\t\t\t\t\t2,906<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t403<\/span><\/span>\n\t\t\t\t<\/p>\n

\n\t\t\t\t\t(13.9%)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t1.182 (1.024, 1.354)<\/span><\/span>\n\t\t\t\t<\/p>\n<\/td>\n

\n

\n\t\t\t\t\t0.023<\/span>++<\/span><\/sup><\/span>\n\t\t\t\t<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\n\t
\n<\/span>  <\/span>* \u5305\u62ec\u5fc3\u810f\u75c5\u53d1\u4f5c, \u975e\u81f4\u6b7b\u6027\u5352\u4e2d\u3001\u5fc3\u810f\u9aa4\u505c\u590d\u82cf,\u5fc3\u8840\u7ba1\u6b7b\u4ea1<\/span><\/span>\n<\/p>\n

\n\t  <\/span><\/span>++<\/span>\u7edf\u8ba1\u5b66\u4e0a\u6709\u663e\u8457\u6027\u610f\u4e49<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u6839\u636e\u4ee5\u4e0a\u7814\u7a76\u7ed3\u679c\uff0c<\/span>2010\u5e741\u670821\u65e5\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5efa\u8bae\u5728\u6b27\u76df\u8303\u56f4\u5185\u6682\u505c\u897f\u5e03\u66f2\u660e\u4e0a\u5e02\u8bb8\u53ef;\u82f1\u56fd\u57fa\u4e8e\u6b27\u76df\u7684\u8bc4\u4f30\u7ed3\u679c\uff0c\u8981\u6c42\u4f01\u4e1a\u505c\u6b62\u897f\u5e03\u66f2\u660e\u7684\u9500\u552e\uff1b\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u8981\u6c42\u4f01\u4e1a\u5728\u897f\u5e03\u66f2\u660e\u7684\u8bf4\u660e\u4e66\u4e2d\u52a0\u5165\u65b0\u7684\u7981\u5fcc\uff0c\u5305\u62ec\u51a0\u8109\u75be\u75c5\u3001\u4e2d\u98ce\u3001\u77ed\u6682\u6027\u8111\u7f3a\u8840\u53d1\u4f5c\u3001\u5fc3\u5f8b\u5931\u5e38\u7b49;\u6fb3\u5927\u5229\u4e9a\u533b\u7597\u4ea7\u54c1\u5c40\uff08TGA\uff09\u5f3a\u8c03\u4e86\u897f\u5e03\u66f2\u660e\u4ea7\u54c1\u8bf4\u660e\u4e66\u4e2d\u5df2\u6709\u7684\u5efa\u8bae\uff0c\u65b0\u6dfb\u52a0\u4e86\u6709\u5173\u5bf9SCOUT\u7814\u7a76\u7684\u63cf\u8ff0\u4fe1\u606f\u548c\u4e00\u9879\u8b66\u544a\uff0c\u5373\u5efa\u8bae\u60a3\u8005\u5728\u4f7f\u7528\u897f\u5e03\u66f2\u660e\u9002\u5f53\u7597\u7a0b\u540e\u6ca1\u6709\u51cf\u80a5\u6548\u679c\u5e94\u505c\u6b62\u7528\u836f\uff0c\u5e76\u8981\u6c42\u4f01\u4e1a\u53d1\u5e03\u4e86\u81f4\u533b\u52a1\u4eba\u5458\u7684\u4fe1\uff0c\u8b66\u544a\u897f\u5e03\u66f2\u660e\u76f8\u5173\u98ce\u9669\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u4e09\u3001\u5173\u4e8e\u897f\u5e03\u66f2\u660e\u7684\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u60c5\u51b5<\/span><\/span><\/span>\n<\/p>\n

\n\t  <\/span>1\u3001\u56fd\u5185\u897f\u5e03\u66f2\u660e\u7684\u4e0d\u826f\u53cd\u5e94\u60c5\u51b5<\/span><\/span>\n<\/p>\n

\n\t  <\/span>2004\u5e741\u67081\u65e5\u81f32010\u5e741\u670815\u65e5\uff0c\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u75c5\u4f8b\u62a5\u544a\u5171\u6536\u5230\u897f\u5e03\u66f2\u660e\u76f8\u5173\u4e0d\u826f\u53cd\u5e94\u62a5\u544a298\u4f8b\uff0c\u4e3b\u8981\u4e0d\u826f\u53cd\u5e94\u8868\u73b0\u4e3a\u5fc3\u60b8\u3001\u4fbf\u79d8\u3001\u53e3\u5e72\u3001\u5934\u6655\u3001\u5931\u7720\u7b49\u3002\u4e3b\u8981\u7d2f\u53ca\u7cfb\u7edf\u4e3a\u795e\u7ecf\u3001\u80c3\u80a0\u9053\u7cfb\u7edf\u3001\u4e2d\u67a2\u53ca\u5916\u5468\u795e\u7ecf\u7cfb\u7edf\u7b49\uff0c\u591a\u4e3a\u8bf4\u660e\u4e66\u5df2\u8f7d\u660e\u7684\u4e0d\u826f\u53cd\u5e94\uff0c\u76ee\u524d\u65e0\u6b7b\u4ea1\u75c5\u4f8b\u3002<\/span>
\n<\/span>2\u3001WHO\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6570\u636e\u5e93\u60c5\u51b5<\/span><\/span>\n<\/p>\n

\n\t  \u4ee5<\/span>\u201csibutramine\u201d\u4e3a\u68c0\u7d22\u8bcd\u68c0\u7d22WHO\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6570\u636e\u5e93\uff08Vigibase\uff09\uff0c\u622a\u81f32009\u5e741\u67084\u65e5\uff0c\u5171\u68c0\u7d22\u5230\u897f\u5e03\u66f2\u660e\u7684\u4e0d\u826f\u53cd\u5e94\u62a5\u544a8174\u4f8b\uff0c\u4e0d\u826f\u53cd\u5e94\u4f8b\u6b2117436\u4f8b\u6b21\u3002\u4e3b\u8981\u4e0d\u826f\u53cd\u5e94\u8868\u73b0\u4e3a\u5934\u75db\u3001\u53e3\u5e72\u3001\u5931\u7720\u3001\u9ad8\u8840\u538b\u3001\u5934\u6655\u7b49\u3002\u4e3b\u8981\u7d2f\u53ca\u7cfb\u7edf\u4e3a\u795e\u7ecf\u7d0a\u4e71\u3001\u5168\u8eab\u6027\u635f\u5bb3\u3001\u80c3\u80a0\u9053\u7cfb\u7edf\u635f\u5bb3\u3001\u4e2d\u67a2\u53ca\u5916\u5468\u795e\u7ecf\u7cfb\u7edf\u635f\u5bb3\u3001\u5fc3\u7387\u53ca\u5fc3\u5f8b\u7d0a\u4e71\u7b49\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u56db\u3001\u5efa\u8bae<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u5efa\u8bae\u533b\u751f\u5904\u65b9\u897f\u5e03\u66f2\u660e\u65f6\u6ce8\u610f\u8bf4\u660e\u4e66\u4e2d\u6807\u660e\u7684\u7981\u5fcc\u75c7\uff0c\u5c24\u5176\u662f\u5b58\u5728\u51a0\u5fc3\u75c5\u75c5\u53f2\u3001\u5145\u8840\u6027\u5fc3\u8870\u3001\u9ad8\u8840\u538b\u63a7\u5236\u4e0d\u7406\u60f3<\/span> \uff08\u8840\u538b<\/span>>145\/90 mmHg\uff09\u3001\u5fc3\u5f8b\u4e0d\u9f50\u3001\u8111\u8840\u7ba1\u75be\u75c5\u3001\u5468\u56f4\u52a8\u8109\u963b\u585e\u6027\u75be\u75c5\u7684\u60a3\u8005\u5e94\u907f\u514d\u4f7f\u7528\u3002\u5904\u65b9\u65f6\u5e94\u544a\u77e5\u60a3\u8005\u4e25\u683c\u6309\u7167\u836f\u54c1\u8bf4\u660e\u4e66\u7528\u836f\uff0c\u5e76\u5728\u4f7f\u7528\u9002\u5f53\u7597\u7a0b\u540e\u6ca1\u6709\u51cf\u80a5\u6548\u679c\u5219\u505c\u6b62\u4f7f\u7528\u3002<\/span><\/span>\n<\/p>\n

\n\t  \u5efa\u8bae\u65e0\u8bba\u662f\u6cbb\u7597\u80a5\u80d6\u8fd8\u662f\u5e0c\u671b\u901a\u8fc7\u51cf\u5c11\u4f53\u91cd\u8fbe\u5230\u5851\u5f62\u7684\u4eba\u7fa4\uff0c\u5e94\u957f\u671f\u575a\u6301\u79d1\u5b66\u7684\u751f\u6d3b\u65b9\u5f0f\uff0c\u5982\u9002\u5f53\u63a7\u5236\u8fdb\u98df\u3001\u575a\u6301\u4f53\u529b\u52b3\u52a8\u3001\u8fd0\u52a8\u953b\u70bc\u7b49\uff0c\u624d\u80fd\u4fdd\u6301\u4f53\u91cd\uff0c\u51cf\u5c11\u53cd\u5f39\u3002\u5207\u5fcc\u5728\u6ca1\u6709\u54a8\u8be2\u533b\u751f\u7684\u60c5\u51b5\u4e0b\u64c5\u81ea\u4f7f\u7528\u51cf\u80a5\u7c7b\u836f\u7269\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t  \u5efa\u8bae\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u7acb\u5373\u5c06\u73b0\u5728\u5df2\u77e5\u7684\u7528\u836f\u98ce\u9669\u544a\u77e5\u533b\u751f\uff08\u53ef\u4ee5\u91c7\u53d6\u5411\u533b\u751f\u53d1\u4e00\u5c01\u4fe1\u7b49\u65b9\u5f0f\uff09\uff1b\u9488\u5bf9\u5df2\u77e5\u548c\u6f5c\u5728\u98ce\u9669\u7acb\u5373\u4fee\u6539\u5b8c\u5584\u8bf4\u660e\u4e66\uff0c\u63d0\u793a\u5b89\u5168\u5408\u7406\u7528\u836f\uff1b\u5236\u5b9a\u897f\u5e03\u66f2\u660e\u4e0a\u5e02\u540e\u836f\u54c1\u8b66\u6212\u8ba1\u5212\u4e66\uff0c\u5236\u5b9a\u76f8\u5e94\u7684\u4e0a\u5e02\u540e\u7814\u7a76\u3001\u7cfb\u7edf\u8bc4\u4ef7\u897f\u5e03\u66f2\u660e\u4e34\u5e8a\u5b89\u5168\u6027\u7684\u65b9\u6848\uff0c\u5e76\u4e3b\u52a8\u5b9e\u65bd\u3002<\/span><\/span><\/span>\n<\/p>\n

\n\t\u53c2\u8003\u6587\u732e\uff1a<\/span><\/span>
\n<\/span>1. http:\/\/www.mhra.gov.uk\/NewsCentre\/CON068470<\/span><\/span>\n<\/p>\n

\n\t2. http:\/\/www.tga.gov.au\/alerts\/medicines\/reductil.htm<\/span><\/span>\n<\/p>\n

\n\t3.http:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm198221.htm<\/span><\/span>\n<\/p>\n

\n\t4.http:\/\/www.ema.europa.eu\/pdfs\/human\/referral\/sibutramine\/3940810en.pdf<\/span><\/span>\n<\/p>\n

\n\t5.\u300a\u836f\u54c1\u4e34\u5e8a\u4fe1\u606f\u53c2\u8003\u300b2008\u5e74\u7248\uff0c\u56db\u5ddd\u7f8e\u5eb7\u533b\u836f\u8f6f\u4ef6\u7814\u7a76\u5f00\u53d1\u6709\u9650\u516c\u53f8\uff0c798-799<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

\u53d1\u5e03\u65e5\u671f\uff1a2010-02-26 \u7f16\u8005\u6309\uff1a   \u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u4fe1\u606f\u901a\u62a5\u4f5c\u4e3a\u6211\u56fd\u836f\u54c1\u5b89\u5168\u76d1\u7ba1\u3001\u4fdd […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[112],"tags":[],"class_list":["post-3772","post","type-post","status-publish","format-standard","hentry","category-adverse-reaction-information"],"_links":{"self":[{"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=\/wp\/v2\/posts\/3772","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3772"}],"version-history":[{"count":1,"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=\/wp\/v2\/posts\/3772\/revisions"}],"predecessor-version":[{"id":3773,"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=\/wp\/v2\/posts\/3772\/revisions\/3773"}],"wp:attachment":[{"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3772"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3772"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.blpa.com.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3772"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}