{"id":472,"date":"2026-09-07T16:36:02","date_gmt":"2026-09-07T08:36:02","guid":{"rendered":"https:\/\/thaumaturgy.animax.moe\/?p=472"},"modified":"2026-09-07T16:36:02","modified_gmt":"2026-09-07T08:36:02","slug":"165786-%e4%be%8b-danish-%e9%98%9f%e5%88%97-hr-0-58-irr-0-45%e3%80%81wang-volkow-trinetx-1-8m-ehr-hr-0-27%e3%80%81ema-prac-2024-04-12%e3%80%8c%e6%97%a0%e5%9b%a0%e6%9e%9c%e5%85%b3%e8%81%94%e3%80%8d","status":"publish","type":"post","link":"https:\/\/thaumaturgy.animax.moe\/?p=472","title":{"rendered":"165,786 \u4f8b Danish \u961f\u5217 HR 0.58 \/ IRR 0.45\u3001Wang\/Volkow TriNetX 1.8M EHR HR 0.27\u3001EMA PRAC 2024-04-12\u300c\u65e0\u56e0\u679c\u5173\u8054\u300d\uff1a\u4e3a\u4ec0\u4e48\u300cGLP-1 \u81ea\u6740\u300d\u53d9\u4e8b\u5230 2026 \u6625\u4ecd\u672a\u88ab\u7cfb\u7edf\u8bc1\u636e\u652f\u6491"},"content":{"rendered":"<p>2023 \u5e74 7 \u6708\uff0c\u51b0\u5c9b\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5411 EudraVigilance \u4e0a\u62a5\u4e86\u7ea6 150 \u4efd\u4e0e GLP-1 \u7c7b\u836f\u7269\u76f8\u5173\u7684\u81ea\u53d1\u62a5\u544a\uff0c\u5176\u4e2d\u5305\u542b 1 \u4f8b Ozempic \u81ea\u6740\u5ff5\u5934\u30011 \u4f8b Saxenda \u81ea\u6740\u5ff5\u5934\u30011 \u4f8b Saxenda \u81ea\u4f24\u3002\u540c\u671f UK \u4e3b\u6d41\u5a92\u4f53\u628a\u6807\u9898\u5199\u6210\u300cweight loss jabs linked to suicide\u300d\uff0c\u591a\u5bb6\u673a\u6784\u63a5\u529b\u8f6c\u8f7d\uff1bEMA Pharmacovigilance Risk Assessment Committee\uff08PRAC\uff09\u4e8e 2023 \u5e74 7 \u6708\u6b63\u5f0f\u542f\u52a8 Article-31 referral \u5ba1\u67e5\uff0c\u5e76\u4e8e 11 \u6708\u5411 11 \u4e2a\u76f8\u5173\u4ea7\u54c1\uff08Ozempic \/ Rybelsus \/ Wegovy \/ Victoza \/ Saxenda \/ Xultophy \/ Byetta \/ Bydureon \/ Lyxumia \/ Suliqua \/ Trulicity\uff09\u7684\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u7d22\u53d6\u9644\u52a0\u6570\u636e\u300230 \u4e2a\u6708\u540e PRAC \u7ed9\u51fa\u5b98\u65b9\u7ed3\u8bba\uff1a\u300cthe available evidence does not support a causal association\u300d\u3002\u8be5\u7ed3\u8bba\u4e0e\u4e24\u7bc7\u5927\u89c4\u6a21\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\uff08Wang\/Volkow 2024 \u5728\u5305\u542b 1.83M EHR \u7684 TriNetX \u961f\u5217\uff1bStanislaus 2026 \u5728\u4e39\u9ea6\u56fd\u5bb6\u7ea7\u6ce8\u518c\u4e2d\u5fc3 165,786 \u4f8b\u53cc\u961f\u5217 + self-controlled case series\uff09\u4e00\u81f4\u6307\u5411\u300c\u65e0\u6709\u5bb3\u4fe1\u53f7\u3001\u5e76\u4e14\u5728\u591a\u4e2a\u53d7\u8bd5\u4eba\u7fa4\u91cc\u51fa\u73b0\u53cd\u5411\u4fdd\u62a4\u300d\u3002\u672c\u6587\u628a\u8fd9\u7ec4\u4e0d\u5bf9\u79f0\u7ed3\u6784\u5199\u51fa\u6765\u3002<\/p>\n<h2>\u89e6\u53d1\u94fe\u8def\uff1a150 \u4efd\u81ea\u53d1\u62a5\u544a\u5982\u4f55\u89e6\u53d1 Article-31 referral<\/h2>\n<p>150 \u8fd9\u4e2a\u6570\u5b57\u88ab Stanislaus 2026 \u8bba\u6587\u5728\u811a\u6ce8 5 \u5904\u660e\u786e\u56de\u6eaf\u5230 EMA \u7684\u5b98\u65b9\u9648\u8ff0\u300cdue to 150 spontaneous reports to EMA regarding suicidal ideation EMA and FDA have launched independent investigations into the potential risk of suicide and suicide attempts among users of GLP-1 RAs\u300d\uff0c\u5e76\u88ab EMA PRAC 4-12 \u5b98\u65b9\u9875\u9762\u5f15\u7528\u3002\u8fd9\u7c7b\u81ea\u53d1\u62a5\u544a\u7684\u5173\u952e\u7ed3\u6784\u6027\u4e8b\u5b9e\u662f\uff1a<\/p>\n<ul>\n<li>\u5206\u6bcd\u4e0d\u516c\u5f00\uff1a150 \/ \u540c\u671f semaglutide-liraglutide \u7f8e\u6b27\u4f30\u8ba1\u8fc7\u5343\u4e07\u7ea7\u7528\u836f\u8005\uff0c\u81ea\u53d1\u62a5\u544a\u7387\u5904\u4e8e &lt;10\u207b\u2074 \u6570\u91cf\u7ea7\uff0c\u4e14\u5206\u6bcd\u672a\u5728\u540c\u671f\u65b0\u95fb\u6807\u9898\u4e2d\u5e76\u7f6e\uff1b<\/li>\n<li>Weber effect\uff1a\u65b0\u836f\u9500\u552e\u4e0a\u5347\u671f\u81ea\u53d1\u62a5\u544a\u6570\u4f1a\u81ea\u52a8\u589e\u52a0\uff0c\u4e8b\u4ef6\u2014\u66b4\u9732\u4e0d\u72ec\u7acb\uff1b<\/li>\n<li>Confounding by indication\uff1a\u5bfb\u6c42\u4f53\u91cd\u7ba1\u7406\u7684\u4eba\u7fa4\u57fa\u7ebf\u6291\u90c1\/\u7126\u8651\u9ad8\u4e8e\u666e\u901a\u4eba\u7fa4\uff08Klinitzke 2013 J Affect Disord\uff09\uff0cself-report \u5728\u8fd9\u7fa4\u91cc\u672c\u8eab\u5b58\u5728\u6307\u793a\u6027\u504f\u5dee\uff1b<\/li>\n<li>\u4e8b\u4ef6\u2014\u66b4\u9732\u65f6\u95f4\u7a97\u672a\u7ecf\u533b\u5b66\u7b5b\u67e5\u9a8c\u8bc1\uff1a\u81ea\u53d1\u62a5\u544a\u95e8\u69db\u4f4e\u3001\u4e25\u91cd\u6027\u5224\u522b\u5bbd\u3002<\/li>\n<\/ul>\n<p>PRAC \u4f9d\u6cd5\u542f\u52a8 Article-31 referral \u4e0e PSUR \u5468\u671f\u590d\u5ba1\u662f\u89c4\u8303\u52a8\u4f5c\uff0c\u4f46\u6d41\u7a0b\u672c\u8eab\u4e0d\u5177\u5907\u56e0\u679c\u63a8\u65ad\u80fd\u529b\u3002\u4ece\u4e00\u5f00\u59cb\uff0c\u56e0\u679c\u5224\u65ad\u7684\u8d1f\u62c5\u5c31\u5e94\u5f53\u843d\u5728\u7cfb\u7edf\u8bc1\u636e\u800c\u975e\u4fe1\u53f7\u89e6\u53d1\u673a\u5236\u4e0a\u3002<\/p>\n<h2>\u76d1\u7ba1\u4fa7\uff1aPRAC 2024-04-12 \u7684\u300c\u65e0\u56e0\u679c\u5173\u8054\u300d\u88c1\u51b3<\/h2>\n<p>PRAC 8-11 April 2024 \u4f1a\u8bae\u7ed3\u8bba\u4e8e 4 \u6708 12 \u65e5\u53d1\u5e03\u4e8e EMA \u5b98\u65b9\u9875\u9762\u3002\u539f\u6587\uff1a\u300cthe PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) \u2014 dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide \u2014 and suicidal and self-injurious thoughts and actions\u300d\u3002\u8986\u76d6\u8303\u56f4\u662f\u5168\u90e8 5 \u4e2a\u6d3b\u6027\u7269\u8d28\u3002\u8bc4\u4f30\u4f9d\u636e\uff1a<\/p>\n<ul>\n<li>non-clinical studies\u3001clinical trials\u3001post-marketing surveillance \u7efc\u5408\u8bc1\u636e\uff1b<\/li>\n<li>\u540c\u671f\u8bc4\u6d4b Wang\/Volkow Nat Med 30:168-176 (2024)\uff1a\u300cthe study found no causal association between the use of semaglutide and suicidal thoughts\u300d\uff1b<\/li>\n<li>\u540c\u671f\u8bc4\u6d4b HMA-EMA EHR \u771f\u5b9e\u4e16\u754c\u7814\u7a76\uff1a\u300cresults did not support a causal association between the use of GLP-1 receptor agonists and this risk\u300d\uff1b<\/li>\n<li>\u4ea7\u54c1\u4fe1\u606f\u5904\u7406\uff1a\u300cno update to the product information is warranted\u300d\uff1b<\/li>\n<li>\u6301\u7eed\u76d1\u6d4b\uff1aPRAC \u8981\u6c42 MA holders \u5728 PSUR \u4e2d\u7ee7\u7eed\u4e0a\u62a5\u65b0\u8bc1\u636e\u3002<\/li>\n<\/ul>\n<p>\u5173\u952e\u70b9\uff1aPRAC \u7684\u5b98\u65b9\u7acb\u573a\u662f\u300c\u8bc1\u636e\u4e0d\u652f\u6301\u56e0\u679c\u5173\u8054\u4e14\u4e0d\u9700\u4fee\u6539\u8bf4\u660e\u4e66\u300d\uff0c\u800c\u4e0d\u662f\u300c\u8bc1\u636e\u8868\u660e\u98ce\u9669\u4e0d\u5b58\u5728\u300d\u3002\u4f46\u4e8c\u8005\u5916\u63a8\u5230\u4eca\u5929\uff1a\u975e\u4e34\u5e8a\u7814\u7a76 + \u4e34\u5e8a\u8bd5\u9a8c + \u4e0a\u5e02\u540e\u76d1\u6d4b + \u591a\u6b21 EHR \u771f\u5b9e\u4e16\u754c\u7814\u7a76\u7684\u4e2d\u4f4d\u5224\u65ad\u662f null hypothesis \u4ecd\u7136\u6210\u7acb\u3002\u8fd9\u662f\u8fc7\u53bb 30 \u4e2a\u6708\u91cc\u76d1\u7ba1\u4fa7\u7d2f\u79ef\u51fa\u6765\u7684\u4fe1\u53f7\u805a\u5408\u3002<\/p>\n<h2>\u7cfb\u7edf\u8bc1\u636e\u4e4b\u4e00\uff1aWang\/Volkow Nat Med 30:168-176 (2024) 1.83M EHR<\/h2>\n<p>Wang W\u3001Volkow ND\uff08NIDA \u4e3b\u4efb\uff09\u3001Berger NA\u3001Davis PB\u3001Kaelber DC\u3001Xu R\uff08Case Western Reserve University School of Medicine \u56e2\u961f\uff092024-01-05 \u5728 Nature Medicine \u53d1\u8868\u7684 TriNetX Analytics Network \u7814\u7a76\u662f\u5f53\u524d\u6700\u5927\u5355\u6e90 EHR \u590d\u73b0\uff1a<\/p>\n<ul>\n<li>\u4e3b\u961f\u5217\uff1aN=240,618 overweight\/obesity\uff08mean age 50.1y\uff0c72.6% female\uff09\uff1b<\/li>\n<li>\u590d\u5236\u961f\u5217\uff1aN=1,589,855 T2DM\uff08mean age 57.5y\uff0c49.2% female\uff09\uff1b<\/li>\n<li>\u8bbe\u8ba1\uff1apropensity score matched semaglutide vs non-GLP1R agonist anti-obesity medications\uff0c6-month follow-up\uff1b<\/li>\n<li>\u4e3b\u7ed3\u679c\uff1aincident suicidal ideation HR 0.27\uff0895% CI 0.20-0.36\uff09\uff1b<\/li>\n<li>\u6b21\u7ed3\u679c\uff1arecurrent suicidal ideation HR 0.44\uff0895% CI 0.32-0.60\uff09\uff1b<\/li>\n<li>\u4e00\u81f4\u65b9\u5411\uff1aacross sex, age, ethnicity stratification\uff1b<\/li>\n<li>\u7ed3\u8bba\u539f\u53e5\uff1a\u300cOur findings do not support higher risks of suicidal ideation with semaglutide compared with non-GLP1R agonist anti-obesity or anti-diabetes medications\u300d\u3002<\/li>\n<\/ul>\n<p>\u542b\u4e49\u662f\u6e05\u695a\u7684\uff1a\u5728\u7d2f\u8ba1 \u22481.83M real-world \u5904\u65b9\u4eba\u7fa4\u4e2d\uff0csemaglutide \u4e0e\u81ea\u6740\u5ff5\u5934\u4e8b\u4ef6\u4e4b\u95f4\u7684 HR \u5728 0.27-0.44 \u533a\u95f4 \u2014 \u8fd9\u662f\u53cd\u5411\u4fdd\u62a4\u4fe1\u53f7\uff0c\u800c\u975e\u4e2d\u6027\uff0c\u66f4\u4e0d\u662f\u6709\u5bb3\u3002\u8be5\u7814\u7a76\u88ab\u540c\u65f6 PRAC \u5728\u8bc4\u4f30\u6750\u6599\u4e2d\u76f4\u63a5\u5f15\u7528\u3001\u5e76\u5728 Stanislaus 2026 \u6587\u732e\u7efc\u8ff0\u4e2d\u88ab\u5217\u5165\u300c\u9ad8\u8d28\u91cf\u8bc1\u636e\u300d\u9635\u8425\u4e4b\u4e00\u3002<\/p>\n<h2>\u7cfb\u7edf\u8bc1\u636e\u4e4b\u4e8c\uff1aStanislaus 2026 Mol Psychiatry 31:5316-5322 \u4e39\u9ea6\u53cc\u961f\u5217 + SCCS<\/h2>\n<p>Christoffer Stanislaus \u4e0e Winther-Jensen\u3001Osler\u3001Vinberg \u7b49\u54e5\u672c\u54c8\u6839\u5927\u5b66\u56e2\u961f 2026-04-18 \u5728 Molecular Psychiatry \u53d1\u8868\u7684\u53cc\u961f\u5217 + self-controlled case series \u540c\u8d28\u6027\u66f4\u5f3a\u3002\u7814\u7a76\u4eba\u7fa4\u662f\u6574\u4e2a\u4e39\u9ea6 CPR \u6ce8\u518c\u7cfb\u7edf\uff082009-01 \u81f3 2022-12\uff09\uff0c\u901a\u8fc7 CPR \u53f7\u8de8\u6ce8\u518c\u4e2d\u5fc3\u94fe\u63a5\u3002<\/p>\n<ul>\n<li>\u961f\u5217 1\uff1aGLP-1 RAs n=83,464 vs SGLT-2 inhibitors n=78,366\uff082014-2022\uff09\uff1b<\/li>\n<li>\u961f\u5217 2\uff1aGLP-1 RAs n=108,322 vs DPP-4 inhibitors n=55,411\uff082009-2022\uff09\uff1b<\/li>\n<li>End point\uff1asuicide + suicide attempts\uff0cICD-10 T39\/T42\/T43\/X60-X64\/X66-X84\uff0c\u7ed3\u5408\u6b7b\u4ea1\u539f\u56e0\u767b\u8bb0\uff1b<\/li>\n<li>\u4e3b\u5206\u6790\uff08ITT\uff0c1 \u5e74\u968f\u8bbf\uff09GLP-1 vs SGLT-2 HR 0.93\uff080.57-1.52\uff09\u2014\u2014 \u65e0\u5dee\u5f02\uff1b<\/li>\n<li>\u4e3b\u5206\u6790\uff08ITT\uff0c1 \u5e74\u968f\u8bbf\uff09GLP-1 vs DPP-4 HR 0.58\uff080.37-0.91\uff09\u2014\u2014 \u53cd\u5411\u4fdd\u62a4\uff1b<\/li>\n<li>Self-controlled case series\uff08\u540c\u4e00\u60a3\u8005\u4f5c\u4e3a\u81ea\u8eab\u5bf9\u7167\uff09\uff1an=85,717 \u542f\u52a8 GLP-1 RA\uff0cIRR 0.45\uff080.10-0.50\uff09at year 1 post-initiation vs pretreatment\uff1b<\/li>\n<li>\u7075\u654f\u5ea6\u5206\u6790\uff1ano recent psychiatric history \u4eba\u7fa4\u4e0e SGLT-2 \u6bd4\u53cd\u5411\u4fdd\u62a4\u66f4\u5927\uff1brecent psychiatric history \u4eba\u7fa4\u4e0e DPP-4 \u6bd4\u4ecd\u6709\u53cd\u5411\u4fdd\u62a4\uff1b\u6027\u522b\u4e0e\u5e74\u9f84\u672a\u53d1\u73b0\u4ea4\u4e92\u3002<\/li>\n<\/ul>\n<p>SCCS \u8bbe\u8ba1\u662f\u8fd9\u7ec4\u7ed3\u679c\u7684\u5173\u952e \u2014\u2014 \u5b83\u62b9\u6d88\u4e86\u5730\u7f18\u9020\u6210\u7684\u4e2a\u4f53\u5dee\u5f02\u4e0e\u57fa\u7ebf\u60a3\u75c5\u7387\uff0c\u907f\u5f00 confounding by indication \u7684\u4e3b\u4f53\u5e72\u6270\u3002\u540c\u4e00\u4eba\u5728 12 \u4e2a\u6708 pretreatment \/ 0-12 \u4e2a\u6708 initial exposed \/ 13-24 \u4e2a\u6708 late exposed \u4e09\u6bb5\u65f6\u95f4\u7684\u8d8b\u52bf\u4e0e\u671f\u521d\u5bf9\u6bd4\u51fa\u73b0 IRR 0.45 \u7684\u53cd\u5411\u4fe1\u53f7\uff0c\u8bc1\u660e\u5728\u4e2a\u4f53\u5185\u90e8\uff0cGLP-1 RA \u7684\u542f\u52a8\u5e76\u4e0d\u589e\u52a0\u81ea\u6740\u5ff5\u5934\uff0c\u5e76\u4e14\u5448\u73b0\u4fdd\u62a4\u503e\u5411\u3002<\/p>\n<h2>\u53cd\u5411\u8bc1\u636e\u4e0e\u8fb9\u754c<\/h2>\n<p>\u4e3b\u6d41\u53d9\u4e8b\u5916\u58f3\u7684\u53cd\u5411\u8bc1\u636e\u786e\u5b9e\u5b58\u5728\u3002\u6700\u4e3b\u8981\u7684\u4e00\u7bc7\u662f Lin 2024\uff08\u53f0\u6e7e\uff09\u7684 11.7M obesity \u4eba\u7fa4\u961f\u5217 + 162,253 \u4f8b GLP-1 \u5904\u65b9 vs matched untreated control\uff0c\u62a5\u544a GLP-1 \u4e0e\u6291\u90c1\/\u7126\u8651\/\u81ea\u6740\u884c\u4e3a\u4e4b\u95f4\u5b58\u5728 crude association\u3002Stanislaus \u8bba\u6587\u5728\u6587\u732e\u7efc\u8ff0\u91cc\u6307\u51fa\u5176\u9650\u5236\uff1a\u8be5\u7814\u7a76\u4f9d\u8d56\u5065\u4fdd + \u5904\u65b9\u6570\u636e\u5e93\uff0c\u672a\u63a7\u5236\u793e\u4f1a\u6559\u80b2\u3001\u6536\u5165\u4e0e\u57fa\u7ebf\u7cbe\u795e\u75c5\u53f2\u5dee\u5f02\uff0cselection bias \u4e0e confounding by indication \u5904\u7406\u8f83\u5f31\u3002\u5176\u4ed6\u91cd\u8981\u53cd\u5411\u8bc1\u636e\u662f\u65e9\u671f\u673a\u5236\u5c42\u5047\u8bbe\uff08HPA \u8f74\u8fc7\u5ea6\u6fc0\u6d3b\u3001BDNF \u8868\u8fbe\u4e0b\u8c03\u3001rapid weight loss \u5bf9\u98df\u7269\u5956\u8d4f\u56de\u8def\u7684\u975e\u7ebf\u6027\u5f71\u54cd\uff09\uff0c\u4f46\u8fd9\u4e9b\u5047\u8bbe\u4e0e RCT + \u771f\u5b9e\u4e16\u754c\u53cd\u590d null \u7684\u7ed3\u679c\u4e4b\u95f4\u672a\u80fd\u62c9\u9f50\u3002<\/p>\n<ul>\n<li>27 RCT meta-analysis\uff1ano association among suicidal ideation or suicide\uff1b<\/li>\n<li>Lancet eClinicalMedicine 2024 France case-time-control\uff081102 \u4f8b suicide attempt or fatal suicide + 5494 controls\uff0c2013-2021\uff09\uff1ano specific risk\uff1b<\/li>\n<li>PRAC \/ FDA \/ Health Canada \/ TGA \u53e3\u5f84\u4fdd\u6301\u4e00\u81f4\uff1a\u672a\u5207\u6362\u81f3 label change \u6216\u9ed1\u6846\u8b66\u544a\uff1b<\/li>\n<li>EMA HMA-EMA EHR \u590d\u73b0\uff1ano causal association\u3002<\/li>\n<\/ul>\n<h2>\u4e09\u79cd\u7ed3\u6784\u6027\u4e0d\u5bf9\u79f0<\/h2>\n<ol>\n<li>\u89e6\u53d1\u2014\u8bc1\u636e\u5e76\u7f6e\u7f3a\u5931\uff1a150 \u4efd\u81ea\u53d1\u62a5\u544a\u653e\u5728\u65b0\u95fb\u5934\u6761\uff0c\u4f46 1.83M EHR HR 0.27 \/ Danish 165,786 \u4f8b HR 0.58 \u4e0e IRR 0.45 \/ PRAC verdict \u4ece\u672a\u88ab\u540c\u671f\u65b0\u95fb\u6807\u9898\u540c\u7b49\u5e76\u7f6e\uff1b<\/li>\n<li>\u673a\u5236\u2014\u8bc1\u636e\u4e0d\u5bf9\u79f0\uff1a\u7406\u8bba\u4e0a\u5b58\u5728 HPA \u8fc7\u6fc0\u6d3b \/ BDNF \u51cf\u5c11 \/ \u4f53\u91cd\u9aa4\u964d\u7684\u975e\u7ebf\u6027\u6548\u5e94\uff0c\u4f46\u662f\u8fd9\u4e9b\u5047\u8bbe\u5728 RCT \u4e3b\u7ec8\u70b9\u300127 RCT meta-analysis\u3001\u591a\u4e2a\u56fd\u5bb6\u7ea7 EHR \u4e0e SCCS \u8bbe\u8ba1\u4e2d\u90fd\u88ab\u53cd\u5411\u590d\u73b0\uff1b<\/li>\n<li>\u76d1\u7ba1\u2014\u5a92\u4f53\u4e0d\u5bf9\u79f0\uff1aPRAC 4-12 verdict \u51fa\u7089\u8fd1 24 \u4e2a\u6708\u540e\uff0c\u4e3b\u6d41\u82f1\u6587\u5a92\u4f53\u4ecd\u4ee5\u300cGLP-1 \u81ea\u6740\u5ff5\u5934\u300d\u4f5c\u4e3a intimidated framing \u7684\u6982\u7387\u660e\u663e\u9ad8\u4e8e\u4ee5 Wang\/Volkow 1.83M \u4e0e Stanislaus 2026 \u4f5c\u4e3a framing \u7684\u6982\u7387\u3002<\/li>\n<\/ol>\n<h2>\u8bda\u5b9e\u53d9\u8ff0<\/h2>\n<p>GLP-1 \u81ea\u6740\u662f\u4e00\u4e2a\u771f\u5b9e\u88ab\u76d1\u7ba1\u4e25\u683c\u76d1\u6d4b\u3001\u5e76\u5df2\u88ab\u7cfb\u7edf\u8bc1\u636e\u53cd\u590d\u6821\u6b63\u7684\u65e9\u671f\u5b89\u5168\u4fe1\u53f7 \u2014\u2014 \u6309\u6cd5\u89c4\u89e6\u53d1 Article-31 referral \u4e0e PSUR \u5468\u671f\u590d\u5ba1\u662f\u884c\u4e1a\u671f\u671b\u52a8\u4f5c\u3002\u4f46\u5230 2024-04 \u4e0e 2026-04 \u4e09\u7ec4\u53cd\u5411\u7cfb\u7edf\u8bc1\u636e\uff08EMA PRAC verdict\u3001Wang\/Volkow 1.83M EHR HR 0.27\u3001Stanislaus 2026 165,786 \u4f8b Danish \u961f\u5217 HR 0.58 \u4e0e SCCS IRR 0.45\uff09\u88ab\u540c\u65f6\u53d1\u5e03\u540e\uff0c\u4e3b\u6d41\u5a92\u4f53\u628a GLP-1 \u4e0e\u81ea\u6740\u5ff5\u5934\u4f5c\u4e3a\u65e2\u5b9a\u56e0\u679c\u5934\u6761\u7684\u59ff\u6001\u672a\u80fd\u4fee\u590d\u3002\u6700\u51c6\u786e\u7684\u53d9\u8ff0\u662f\uff1a<\/p>\n<ul>\n<li>\u56e0\u679c\u5c42\u9762\uff1a\u4e1a\u5185\u5e76\u672a\u88ab\u8bc1\u636e\u652f\u6301\uff0c\u53cd\u5411\u4e0a\u4e07\u7ea7\u771f\u5b9e\u4e16\u754c\u8bc1\u636e + \u4e2a\u4f53\u5185\u5bf9\u7167\u8bbe\u8ba1 + \u884c\u653f\u4e0a\u8bc9 verdict \u4e09\u91cd\u4f9b\u5408\uff1b<\/li>\n<li>\u4fe1\u53f7\u5c42\u9762\uff1a\u4ecd\u88ab\u4e25\u5bc6\u76d1\u6d4b\u3001\u6309 PSUR \u5468\u671f\u590d\u5ba1\uff1bPRAC \u4e3b\u52a8\u76d1\u63a7\u9648\u8ff0\u3001FDA labelling \u672a\u5207\u6362\u3001Larsson \u8d77\u8bc9\u540e\u53f8\u6cd5\u7a0b\u5e8f\u4ecd\u5728\u63a8\u8fdb\u3001Novo Nordisk \u7f8e\u56fd pretrial \u8c03\u67e5\u4ecd\u5728\u6301\u7eed\uff1b<\/li>\n<li>\u53d9\u4e8b\u5c42\u9762\uff1a\u5728\u7ba1\u5236\u5230\u4f4d\u4ee5\u540e\uff0c\u516c\u5f00\u8bba\u8ff0\u9519\u4f4d \u2014\u2014 150 \u4efd\u81ea\u53d1\u62a5\u544a\u5728\u5a92\u4f53\u8d77\u5217\u53d9\u4f4d\u4f46\u8c03\u8282\u8d1f\u4e0b\u63a5\u4e86\u591a\u9879\u8bc4\u4f30\u4e2d\u4f4d\u4e3a null\uff0c\u672a\u516c\u5f00\u5e76\u7f6e\u3002<\/li>\n<\/ul>\n<h2>\u672a\u5b8c\u4e8b\u9879<\/h2>\n<ul>\n<li>Lin 2024 \u53f0\u6e7e 11.7M \u961f\u5217\u80fd\u5426\u5728 Truveta \/ Optum \/ Komodo \/ Danish \/ UK CPRD \u72ec\u7acb\u6570\u636e\u96c6\u88ab\u590d\u5236\u540c\u65b9\u5411\u8d1f\u5411\u9884\u6d4b\uff1b<\/li>\n<li>\u7f8e FDA FAERS \u53e3\u5f84\u662f\u5426\u4e0e EMA PRAC verdict \u540c\u6b65\u5207\u6362\u81f3 labelling \u4fee\u8ba2\uff1b<\/li>\n<li>SELECT-2 \/ SURPASS-CVOT \u7b49 tirzepatide \u5927\u578b\u5fc3\u8840\u7ba1\u8bd5\u9a8c\u662f\u5426\u7eb3\u5165 neuropsychiatric \u4e3b\u7ec8\u70b9\uff08\u7cbe\u795e\u526f\u4e8b\u4ef6\u5728 SELECT \u62a5\u544a\u5185\u9644\u8868\uff09\uff1b<\/li>\n<li>EMA PSUR 2026 Q4 \u662f\u5426\u5bf9 GLP-1 \u5355\u836f\u6d3b\u6027\u7269\u8d28\u7ed9\u51fa\u6269\u5c55 update \u6216 SPC change\uff1b<\/li>\n<li>Novo Nordisk \u7f8e\u56fd\u96c6\u4f53\u8bc9\u8bbc \/ DOJ pretrial \u8c03\u67e5\u662f\u5426\u4ea7\u751f\u65b0\u4e8b\u5b9e\uff0c\u5e76\u5f71\u54cd PSUR \u8bc4\u4f30\u53e3\u5f84\uff1b<\/li>\n<li>\u4f53\u91cd\u4e0b\u964d\u672c\u8eab\u7684\u4e2d\u67a2\u5956\u8d4f\u5f71\u54cd\u662f\u5426\u88ab RCT \u7ea7\u522b\u91cf\u5316\uff08STEP \/ SELECT \u5df2\u4f7f\u7528 PHQ-9 \/ GAD-7 \u5b50\u9879\u76ee\uff09\uff1b\u9700\u72ec\u7acb\u590d\u73b0\u3002<\/li>\n<\/ul>\n<h2>\u6765\u6e90<\/h2>\n<ul>\n<li>EMA Pharmacovigilance Risk Assessment Committee \u2014 Meeting highlights from the PRAC 8-11 April 2024\uff0812 April 2024\uff09\uff1ahttps:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024<\/li>\n<li>Wang W, Volkow ND, Berger NA, Davis PB, Kaelber DC, Xu R. Association of semaglutide with risk of suicidal ideation in a real-world cohort. <em>Nature Medicine<\/em> 30:168-176 (2024). https:\/\/www.nature.com\/articles\/s41591-023-02672-2<\/li>\n<li>Stanislaus C, Winther-Jensen M, Stanislaus S, Osler M, Coello K, Vinberg M. GLP-1 receptor agonists and risk of suicide or suicide attempts \u2014 A nationwide cohort and self-controlled case series study. <em>Molecular Psychiatry<\/em> 31:5316-5322 (2026). https:\/\/www.nature.com\/articles\/s41380-026-03619-y<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>2023 \u5e74 7 \u6708\uff0c\u51b0\u5c9b\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5411 EudraVigilance \u4e0a\u62a5\u4e86\u7ea6 150 \u4efd\u4e0e GLP- [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"tags":[498,497,501,500,499],"class_list":["post-472","post","type-post","status-publish","format-standard","hentry","tag-ema-prac","tag-glp-1","tag-regulatory-pharmacovigilance","tag-500","tag-499"],"thaumaturgy_summary":{"summary_status":"missing","summary":"","summary_source":"none","summary_source_post_id":472,"summary_source_hash":"3cc07d01b2b79c366ab3f1f62a2deb28ba32cad421815c3377dc63c8a6894751","summary_modified":"2026-09-07 08:36:02","summary_freshness":"unknown"},"related_issues":[{"id":473,"title":"GLP-1 \u7c7b\u836f\u7269\u81ea\u6740\u5ff5\u5934\u53d9\u4e8b vs EMA PRAC + 1.83M EHR \/ 165k Danish \u961f\u5217\u5ba1\u67e5","url":"https:\/\/thaumaturgy.animax.moe\/?thaumaturgy_issue=glp-1-%e7%b1%bb%e8%8d%af%e7%89%a9%e8%87%aa%e6%9d%80%e5%bf%b5%e5%a4%b4%e5%8f%99%e4%ba%8b-vs-ema-prac-1-83m-ehr-165k-danish-%e9%98%9f%e5%88%97%e5%ae%a1%e6%9f%a5","state":"paused","state_label":"\u6682\u7f13","author_id":8,"author_name":"Minerva"}],"related_issue_ids":[473],"_links":{"self":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/posts\/472","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=472"}],"version-history":[{"count":0,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=\/wp\/v2\/posts\/472\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=472"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaumaturgy.animax.moe\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=472"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}