| <P style="TEXT-INDENT: 24pt; MARGIN: 0cm 0cm 0pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0"><FONT size=3><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">9</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">12</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，美国</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">FDA</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">批准</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">Aubagio</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">（</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">teriflunomide</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，特立氟胺），每天一次片剂治疗成人复发型多发性硬化症（</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">MS</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）。</SPAN></FONT><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT size=3 face=Arial> <WBR> <WBR> <WBR></FONT></SPAN></SPAN> <FONT size=3><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">“在一项临床试验中服用</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">Aubagio</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的患者复发率约比安慰剂组低</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">30</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">％。多发性硬化症可损害运动、感觉、思维能力，所以患者需要有多种治疗选择。”</SPAN> <SPAN style="FONT-FAMILY: Arial; COLOR: black"><SPAN lang=EN-US XML:LANG="EN-US"><FONT face=Arial>FDA</FONT></SPAN></SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">药物评价和研究中心神经学药品部门主任</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">Russell Katz</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">说。</SPAN></FONT><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US"><BR><FONT size=3><FONT face=Arial><SPAN style="mso-spacerun: yes"> <WBR> <WBR> <WBR></SPAN> MS</FONT></FONT></SPAN><FONT size=3><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">是一种中枢神经系统慢性，炎症性的自身免疫性疾病，它扰乱大脑和身体的其它部分之间的通信。它是年轻成年人的神经功能障碍最常见的原因，女性发病至少为男性的两倍。大多数</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">MS</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">患者病情刚刚得到缓解随即功能又开始恶化（复发）。随着时间的推移，恢复越来越不完全，导致疾病进行性恶化。</SPAN></FONT><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT size=3 face=Arial> <WBR> <WBR> <WBR></FONT></SPAN></SPAN> <FONT size=3><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">在临床试验中服用</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">Aubagio</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的患者所经历的最常见副作用包括腹泻、肝功能异常、恶心、脱发。</SPAN></FONT><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT size=3 face=Arial> <WBR> <WBR> <WBR></FONT></SPAN></SPAN> <FONT size=3><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">该药物标签中有一个黑框警告，提醒医师和患者肝脏问题，包括死亡风险，和出生缺陷风险。患者开始服用</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">Aubagio</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">前应先做血液检查，治疗期间需定期检查肝功能。</SPAN></FONT></P>
<P style="TEXT-INDENT: 24pt; MARGIN: 0cm 0cm 0pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0"><FONT size=3><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">黑框警告中还指出：根据动物研究，该药可能对胎儿造成伤害。出于这个原因，</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">Aubagio</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">标记为妊娠</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">X</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">类，这就是说启动治疗前育龄妇女怀孕测试必须呈现阴性，在治疗过程需采取有效的避孕手段。</SPAN></FONT><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US"><BR><FONT size=3><FONT face=Arial><SPAN style="mso-spacerun: yes"> <WBR> <WBR> <WBR></SPAN> Aubagio</FONT></FONT></SPAN><FONT size=3><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">说明书附有患者用药指南，提供重要的药品安全使用信息。</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">Aubagio</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">是有赛诺菲</SPAN><SPAN style="FONT-FAMILY: Arial; COLOR: black" lang=EN-US XML:LANG="EN-US">-</SPAN><SPAN style="COLOR: black; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">安万特生产。</SPAN></FONT></P> |
