{"id":1314,"date":"2024-04-04T22:24:47","date_gmt":"2024-04-04T14:24:47","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=1314"},"modified":"2024-04-04T22:24:48","modified_gmt":"2024-04-04T14:24:48","slug":"%e8%ae%b0%e4%bd%8f%e6%89%80%e6%9c%89fda%e7%94%9f%e7%89%a9%e8%8d%af-%e6%bf%80%e6%b4%bb%e7%b4%a0%e4%bf%a1%e5%8f%b7%e6%8a%91%e5%88%b6%e5%89%82-winrevair-sotatercept%e7%b4%a2%e7%89%b9%e8%a5%bf","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=1314","title":{"rendered":"\u8bb0\u4f4f\u6240\u6709FDA\u751f\u7269\u836f | \u6fc0\u6d3b\u7d20\u4fe1\u53f7\u6291\u5236\u5242 | WINREVAIR\u00ae Sotatercept\u7d22\u7279\u897f\u666e | \u52a8\u8109\u6027\u80ba\u52a8\u8109\u9ad8\u538bPAH"},"content":{"rendered":"\n

\u7528\u56fe\u50cf\u8bb0\u5fc6\u7684\u65b9\u6cd5\uff0c\u4e00\u4e2a\u836f\u4e00\u5f20\u56fe\uff0c\u8bb0\u4f4f\u6240\u6709FDA\u6279\u51c6\u4e0a\u5e02\u751f\u7269\u5236\u5242\u7684\u540d\u79f0\uff0c\u9776\u70b9\uff0c\u9002\u5e94\u75c7\u7b49\u4fe1\u606f\u3002<\/p>\n\n\n\n

Winrevair\u00ae Sotatercept\u662fAcceleron Pharma\u516c\u53f8\u7814\u53d1\u7684\u4e00\u6b3e\u7f55\u89c1\u75c5\u836f\u7269\u3002<\/p>\n\n\n\n

\u7f8e\u56fd\u9ed8\u6c99\u4e1c\u516c\u53f8\uff08MSD\uff09\u57282021\u5e74\u8017\u8d44115\u4ebf\u7f8e\u5143\u6536\u8d2dAcceleron Pharma\uff0c\u4ece\u800c\u83b7\u5f97\u4e86\u8be5\u836f\u7269\u7684\u6743\u76ca\u3002<\/p>\n\n\n\n

Sotatercept\u662f\u4e00\u79cd\u6fc0\u6d3b\u7d20\u4fe1\u53f7\u6291\u5236\u5242\uff0c\u9009\u62e9\u6027\u6291\u5236\u8f6c\u5316\u751f\u957f\u56e0\u5b50\u03b2\uff08TGF-\u03b2\uff09\u5bb6\u65cf\u914d\u4f53\uff0c\u4ece\u800c\u6062\u590d\u80ba\u52a8\u8109\u58c1\u548c\u53f3\u5fc3\u5ba4\u91cd\u6784\u76f8\u5173\u7684\u4fe1\u53f7\u901a\u8def\u7684\u5e73\u8861\u3002<\/p>\n\n\n\n

\u836f\u7269\u4e8e2024\u5e743\u6708\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u52a8\u8109\u6027\u80ba\u52a8\u8109\u9ad8\u538b\uff08PAH\uff09\u3002<\/p>\n\n\n\n

\u7531\u4e8e\u8be5\u836f\u7269\u7684\u6539\u5584\u8840\u6d41\u4f5c\u7528\uff0c\u5bf9\u8fd0\u52a8\u5458\u6709\u76ca\u3002\u56e0\u6b64Sotatercept\u88ab\u5217\u4e3a\u4e16\u754c\u53cd\u5174\u594b\u5242\u6761\u4f8b\u4e2d\u7684\u8fdd\u7981\u836f\u7269\u3002<\/p>\n\n\n\n

\u76ee\u524d\u56fd\u5185\u6682\u672a\u4e0a\u5e02\uff0c\u5728\u56fd\u5bb6\u4f53\u80b2\u603b\u5c40\u516c\u5e03\u7684\u300a\u53cd\u5174\u594b\u5242\u6761\u4f8b\u300b\u4e2d\uff0cSotatercept\u547d\u540d\u4e3a\u7d22\u7279\u897f\u666e\u3002<\/p>\n\n\n\n

1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n

Sotatercept\u7684\u7ed3\u6784<\/strong><\/p>\n\n\n

\n
\"\"
Bone . 2010 Apr;46(4):1082-8.<\/em>Sotatercept<\/figcaption><\/figure>\n<\/div>\n\n\n

\u4ece\u5176\u836f\u7269\u540d\u79f0\u5c31\u53ef\u4ee5\u770b\u51fa\u662f\u4e00\u6b3e\u53d7\u4f53\u878d\u5408\u86cb\u767d\u836f\u7269\u3002\u5176\u7ed3\u6784\u53ef\u4ee5\u5206\u4e3a\u4ee5\u4e0b\u4e24\u4e2a\u90e8\u5206\uff1a<\/p>\n\n\n\n

    \n
  • ActRIIA\u53d7\u4f53\u80de\u5916\u7ed3\u5408\u57df\uff1a\u8d1f\u8d23\u4e0e\u6fc0\u6d3b\u7d20\u914d\u4f53\u7ed3\u5408\u3002\u6bcf\u4e2aActRIIA\u53d7\u4f53\u7ed3\u5408\u57df\u7531\u4e24\u4e2aIgG\u6837\u7ed3\u6784\u57df\u7ec4\u6210\u3002\u8fd9\u4e24\u79cd\u7ed3\u6784\u57df\u5f62\u6210\u4e00\u4e2a\u53e3\u888b\uff0c\u53ef\u4ee5\u4e0e\u6fc0\u6d3b\u7d20\u914d\u4f53\u7684C\u7aef\u7ed3\u6784\u57df\u7ed3\u5408\u3002<\/li>\n\n\n\n
  • Fc\u7247\u6bb5\uff1a\u8d1f\u8d23Sotatercept\u7684\u514d\u75ab\u7403\u86cb\u767d\u6027\u8d28\uff0c\u5305\u62ec\u5176\u957f\u534a\u8870\u671f\u548c\u4e0eFc\u53d7\u4f53\u7684\u7ed3\u5408\u80fd\u529b\u3002<\/li>\n<\/ul>\n\n\n\n

    Sotatercept\u901a\u8fc7\u4e0e\u6fc0\u6d3b\u7d20\u914d\u4f53TGF-\u03b2\u4e9a\u5bb6\u65cf\u6210\u5458\uff08\u5982Activin A\u3001GDF8\u548cGDF11\uff09\u7ed3\u5408\uff0c\u963b\u65ad\u5176\u4e0eActRIIA\u53d7\u4f53\u7684\u7ed3\u5408\uff0c\u4ece\u800c\u6291\u5236ActRIIA-Smad2\/3\u4fe1\u53f7\u901a\u8def\u3002\u8be5\u901a\u8def\u7684\u6291\u5236\u5bfc\u81f4\u80ba\u52a8\u8109\u9ad8\u538b\u60a3\u8005\u80ba\u8840\u7ba1\u91cd\u5851\u7684\u9006\u8f6c\u3002<\/p>\n\n\n\n

    Sotatercept\u7684\u4f5c\u7528\u673a\u5236<\/p>\n\n\n

    \n
    \"\"
    N Engl J Med. 2021 Apr 1;384(13):1204-1215.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n

    Sotatercept\u7684\u4f5c\u7528\u673a\u5236\u4e3b\u8981\u4e3a\u4ee5\u4e0b\u51e0\u4e2a\u6b65\u9aa4\uff1a<\/p>\n\n\n\n

      \n
    1. Sotatercept\u4e0e\u6fc0\u6d3b\u7d20\u914d\u4f53\u7ed3\u5408\uff1a<\/strong>Sotatercept\u7684ActRIIA\u53d7\u4f53\u7ed3\u5408\u57df\u53ef\u4ee5\u4e0e\u591a\u79cd\u6fc0\u6d3b\u7d20\u914d\u4f53\uff0cTGF-\u03b2\u4e9a\u5bb6\u65cf\u6210\u5458\u7ed3\u5408\uff0c\u5305\u62ecActivin A\u3001GDF8\u548cGDF11\u3002\u963b\u6b62\u4e86\u8fd9\u4e9b\u914d\u4f53\u4e0eActRIIA\u53d7\u4f53\u7684\u7ed3\u5408\u3002<\/li>\n\n\n\n
    2. ActRIIA-Smad2\/3\u4fe1\u53f7\u901a\u8def\u7684\u6291\u5236\uff1a<\/strong>\u6fc0\u6d3b\u7d20\u914d\u4f53\u4e0eActRIIA\u53d7\u4f53\u7ed3\u5408\u540e\uff0c\u4f1a\u6fc0\u6d3bSmad2\/3\u4fe1\u53f7\u901a\u8def\u3002\u5bfc\u81f4\u80ba\u8840\u7ba1\u5e73\u6ed1\u808c\u7ec6\u80de\u7684\u589e\u6b96\u548c\u8fc1\u79fb\uff0c\u4ee5\u53ca\u80f6\u539f\u86cb\u767d\u7684\u6c89\u79ef\uff0c\u6700\u7ec8\u5bfc\u81f4\u80ba\u8840\u7ba1\u91cd\u5851\u3002Sotatercept\u963b\u65ad\u6fc0\u6d3b\u7d20\u914d\u4f53\u4e0eActRIIA\u53d7\u4f53\u7684\u7ed3\u5408\uff0c\u4ece\u800c\u6291\u5236Smad2\/3\u4fe1\u53f7\u901a\u8def\u3002<\/li>\n\n\n\n
    3. \u80ba\u8840\u7ba1\u91cd\u5851\u7684\u9006\u8f6c\uff1a<\/strong>Smad2\/3\u4fe1\u53f7\u901a\u8def\u7684\u6291\u5236\u5bfc\u81f4\u80ba\u8840\u7ba1\u5e73\u6ed1\u808c\u7ec6\u80de\u589e\u6b96\u548c\u8fc1\u79fb\u51cf\u5c11\uff0c\u80f6\u539f\u86cb\u767d\u6c89\u79ef\u51cf\u5c11\uff0c\u6700\u7ec8\u5bfc\u81f4\u80ba\u8840\u7ba1\u91cd\u5851\u7684\u9006\u8f6c\u3002<\/li>\n<\/ol>\n\n\n\n

      2\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n

      \u80ba\u52a8\u8109\u9ad8\u538b\uff08pulmonary hypertension\uff0c PH\uff09\uff1a<\/strong><\/p>\n\n\n\n

      \u6307\u7531\u591a\u79cd\u5f02\u6e90\u6027\u75be\u75c5\uff08\u75c5\u56e0\uff09\u548c\u4e0d\u540c\u53d1\u75c5\u673a\u5236\u6240\u81f4\u80ba\u8840\u7ba1\u7ed3\u6784\u6216\u529f\u80fd\u6539\u53d8\uff0c\u5f15\u8d77\u80ba\u8840\u7ba1\u963b\u529b\u548c\u80ba\u52a8\u8109\u538b\u529b\u5347\u9ad8\u7684\u4e34\u5e8a\u548c\u75c5\u7406\u751f\u7406\u7efc\u5408\u5f81\uff0c\u7ee7\u800c\u53d1\u5c55\u6210\u53f3\u5fc3\u8870\u7aed\u751a\u81f3\u6b7b\u4ea1\u3002<\/p>\n\n\n\n

      \u4e34\u5e8a\u4e0a\u5c06PH\u5206\u4e3a5\u5927\u7c7b\uff1a<\/strong><\/p>\n\n\n\n

      \uff081\uff09\u52a8\u8109\u6027PH\uff08pulmonary arterial hypertension\uff0cPAH\uff09\uff1b
      \uff082\uff09\u5de6\u5fc3\u75be\u75c5\u6240\u81f4PH\uff1b
      \uff083\uff09\u80ba\u90e8\u75be\u75c5\u548c\uff08\u6216\uff09\u4f4e\u6c27\u6240\u81f4PH\uff1b
      \uff084\uff09\u6162\u6027\u8840\u6813\u6813\u585e\u6027PH\uff08chronic thromboembolic pulmonary hypertension\uff0cCTEPH\uff09\u548c\uff08\u6216\uff09\u5176\u4ed6\u80ba\u52a8\u8109\u963b\u585e\u6027\u75c5\u53d8\u6240\u81f4PH\uff1b
      \uff085\uff09\u672a\u660e\u548c\uff08\u6216\uff09\u591a\u56e0\u7d20\u6240\u81f4PH\u3002<\/p>\n\n\n\n

      \u5173\u4e8ePAH\uff1a<\/strong><\/p>\n\n\n\n

      \u6210\u4ebaPAH \u4eba\u7fa4\u53d1\u75c5\u7387\u7ea62.4\/\u767e\u4e07\u4eba\u5e74\uff0c\u60a3\u75c5\u7387\u7ea615\/\u767e\u4e07\u3002PAH\u53c8\u53ef\u4ee5\u518d\u5206\u4e3a\u7279\u53d1\u6027\u80ba\u52a8\u8109\u9ad8\u538b\uff08IPAH\uff09\u3001\u9057\u4f20\u6027\u80ba\u52a8\u8109\u9ad8\u538b\uff08HPAH\uff09\u3001\u836f\u7269\u548c\u6bd2\u7269\u76f8\u5173PAH\uff08drug-induced pulmonary hypertension\uff0cDPAH\uff09\u7b49\u3002<\/p>\n\n\n\n

      PAH \u7684\u75c7\u72b6\u53ef\u80fd\u5305\u62ec\uff1a\u547c\u5438\u56f0\u96be\u3001\u75b2\u52b3\u3001\u80f8\u75db\uff1a\u5934\u6655\u6216\u6655\u53a5\u7b49<\/p>\n\n\n\n

      PAH\u7684\u75c5\u7406\u8868\u73b0<\/strong><\/p>\n\n\n

      \n
      \"\"
      Am J Physiol Lung Cell Mol Physiol. 2021 Jun 1;320(6):L1025-L1037.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n

      \u6b63\u5e38\u4f11\u606f\u72b6\u6001\u4e0b\u7684\u5e73\u5747\u80ba\u52a8\u8109\u538b\uff08mPAP\uff09\u572812\u81f316mmHg\u4e4b\u95f4\u3002\u5728PAH\u60a3\u8005\u4e2d\uff0cmPAP\u5728\u4f11\u606f\u65f6\u5347\u9ad8\u5230\u226520mmHg\u3002<\/p>\n\n\n\n

      \u4ec5\u6709\u5fc3\u8f93\u51fa\u91cf\u5347\u9ad8\u6216\u4ec5\u6709\u80ba\u9759\u8109\u538b\u529b\u5347\u9ad8\u5e76\u4e0d\u4f1a\u5bfc\u81f4PAH\uff0c\u56e0\u4e3a\u968f\u7740\u8840\u6d41\u589e\u52a0\uff0c\u8840\u7ba1\u5e8a\u4f1a\u653e\u677e\u3002<\/p>\n\n\n\n

      \u5728\u5927\u591a\u6570\u60c5\u51b5\u4e0b\uff0c\u589e\u52a0\u80ba\u8840\u7ba1\u963b\u529b\uff08PVR\uff09\u662fPAH\u7684\u4e3b\u8981\u539f\u56e0\u3002\u75c5\u7406\u72b6\u6001\u5982\u80ba\u52a8\u8109\u6536\u7f29\u3001\u80a5\u5927\u3001\u7ea4\u7ef4\u5316\u6216\u80ba\u6813\u585e\u53ef\u4ee5\u589e\u52a0PVR\u3002<\/p>\n\n\n\n

      PAH\u7684\u5e38\u7528\u6cbb\u7597\u836f\u7269<\/strong><\/p>\n\n\n

      \n
      \"\"
      \u8be5\u836f\u7269\u76ee\u524d\u56fd\u5185\u6682\u672a\u6279\u51c6\u4e0a\u5e02<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n

      PAH\u7684\u6cbb\u7597\u836f\u7269\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n\n\n\n

        \n
      • \u9499\u79bb\u5b50\u901a\u9053\u62ee\u6297\u5242(CCBs)\uff1a\u785d\u82ef\u5730\u5e73\u3001\u6c28\u6c2f\u5730\u5e73\uff0c\u5730\u5c14\u786b\u44ec<\/li>\n\n\n\n
      • \u5185\u76ae\u7d20\u53d7\u4f53\u62ee\u6297\u5242(ERA)\uff1a\u6ce2\u751f\u5766\u3001\u5b89\u7acb\u751f\u5766\u3001\u9a6c\u6614\u817e\u5766<\/li>\n\n\n\n
      • \u78f7\u9178\u4e8c\u916f\u91765\u578b\u6291\u5236\u5242(PDE5)\uff1a\u897f\u5730\u90a3\u975e\u3001\u4ed6\u8fbe\u90a3\u975e\u3001\u4f10\u5730\u90a3\u975e<\/li>\n\n\n\n
      • \u9e1f\u82f7\u9178\u73af\u5316\u9176\u6fc0\u52a8\u5242(sGC)\uff1a\u5229\u5965\u897f\u5471<\/li>\n\n\n\n
      • \u524d\u5217\u73af\u7d20\u7c7b\u4f3c\u7269\uff1a\u4f9d\u524d\u5217\u9187\u3001\u4f0a\u6d1b\u524d\u5217\u7d20\u3001\u66f2\u524d\u5217\u5c3c\u5c14\u3001\u8d1d\u524d\u5217\u7d20<\/li>\n\n\n\n
      • \u524d\u5217\u73af\u7d20\u53d7\u4f53\u6fc0\u52a8\u5242\uff1a\u53f8\u6765\u5e15\u683c<\/li>\n\n\n\n
      • \u751f\u7269\u5236\u5242-\u6fc0\u6d3b\u7d20\u4fe1\u53f7\u6291\u5236\u5242\uff1aWinrevair\u00ae Sotatercept \u7d22\u7279\u897f\u666e<\/li>\n<\/ul>\n\n\n\n

        3\u3001\u56fe\u50cf\u8bb0\u5fc6<\/h2>\n\n\n
        \n
        \"\"
        \u9501\u94fe\u9501\u4f4f\u7684\u5965\u7279\u66fc\uff0c\u5e26\u7740\u897f\u90e8\u725b\u4ed4\u7684\u5e3d\u5b50\uff0c\u88ab\u591a\u628a\u67aa\u96c6\u706b\u653b\u51fb\uff0c\u80ba\u52a8\u8109\u90fd\u6253\u51fa\u6765\u4e86\u3002<\/figcaption><\/figure>\n<\/div>\n\n\n

        \u4f17\u591a\u67aa\u96c6\u706b<\/strong>\u5965\u7279\u66fc\uff0c\u4ee3\u8868\u836f\u7269\u673a\u5236\u6fc0\u6d3b\u7d20\u4fe1\u53f7\u6291\u5236\u5242<\/strong>\u3002<\/p>\n\n\n\n

        \u9501\u94fe\u9501<\/strong>\u4f4f\u7684\u5965\u7279<\/strong>\u66fc\u662f\u897f\u90e8<\/strong>\u725b\u4ed4\uff0c\u4ee3\u8868\u836f\u7269\u540d\u79f0\uff0c\u7d22\u7279\u897f\u666e\u3002<\/p>\n\n\n\n

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