| <P><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN> </P>
<P><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">2011</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">3</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">4</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日，国家药品不良反应监测中心发布第</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">36</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">期《药品不良反应信息通报》，关注减肥药奥利司他安全性问题。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">奥利司他是长效的特异性胃肠道脂肪酶抑制剂，能阻止甘油三酯水解为可吸收的游离脂肪酸和单酰基甘油，使其不被吸收，从而减少热量摄入，控制体重。作为非处方药用于自我药疗时，奥利司他适用于肥胖或体重超重患者（体重指数</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">24</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，近似值计算法为体重</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">/</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">身高</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">2</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）的治疗。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">其上市后监测发现，使用奥利司他有罕见的转氨酶升高、碱性磷酸酶升高和重度肝炎的报告，并出现肝衰竭病例，其中部分患者需要进行肝移植或可直接导致死亡，目前还不能确认使用奥利司他与严重肝损害之间的关联性。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">奥利司他还有发生罕见过敏反应的报道，主要临床表现为瘙痒、皮疹、荨麻疹、血管神经性水肿、支气管痉挛和过敏性反应，出现大疱疹十分罕见。上市后监测还发现有胰腺炎的报道。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">美国食品药品监督管理局（</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">FDA</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）于</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">2010</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">5</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月警告其存在可能引起严重肝损害的风险。但基于目前的数据，还不能确认使用奥利司他与严重肝损害之间的关联性。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">截至</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">2010</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">12</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">31</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日，国家药品不良反应监测中心病例报告数据库中有关奥利司他的病例报告</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">120</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">余例，主要不良反应表现为便秘、腹痛、腹泻、头晕、月经紊乱、皮疹等。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">2010</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">9</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">1</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日，国家食品药品监督管理局发布《关于修订奥利司他制剂说明书的通知》（国食药监注</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">[2010]359</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">号），已要求在国内对奥利司他制剂说明书内容进行更新，加入相关的警示。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">国家食品药品监督管理局建议消费者仔细阅读说明书，按说明书合理使用该药物治疗肥胖和超重，当出现严重不良反应相关症状时应及时就医。同时加强不良反应监测工作，采取有效的风险管理措施最大限度地减少不良反应的发生。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
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