| <P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><FONT style="FONT-SIZE: 10.5pt" face=宋体>鉴于苯氟雷司的风险（尤其是心脏瓣膜疾病风险）高于其治疗效益，欧洲药品管理局（<SPAN style="FONT-SIZE: 10.5pt">EMA</SPAN>）近期建议将所有含有苯氟雷司的药品从欧盟市场上撤出。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><FONT style="FONT-SIZE: 10.5pt" face=宋体>苯氟雷司被批准用于与适当的饮食控制联合<SPAN style="FONT-SIZE: 10.5pt">,</SPAN>治疗超重伴有<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">糖尿病</SPAN></SPAN></SPAN>的患者。医生应停止处方含苯氟雷司的<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">药品</SPAN></SPAN></SPAN>并考虑替代治疗。目前正在服用此类<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">药物</SPAN></SPAN></SPAN>的患者应和医生联系。由于心脏瓣膜疾病可在用药后数年内发生，因此以前曾服用过苯氟雷司的患者应告知医生，以便接受心脏瓣膜疾病体征和症状的检查。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><FONT style="FONT-SIZE: 10.5pt" face=宋体>基于安全问题，法国和<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">葡萄</SPAN></SPAN></SPAN>牙的药品管理机构已将含苯氟雷司的药品从市场上召回。因此欧洲药品管理局人用<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">医药</SPAN></SPAN><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">产品</SPAN></SPAN></SPAN>委员会（<SPAN style="FONT-SIZE: 10.5pt">CHMP</SPAN>）对有关这些<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">药物</SPAN></SPAN></SPAN>安全性和有效性的数据进行了审查，并得出了苯氟雷司的使用与心脏瓣膜疾病风险有关的结论。该委员会还提示苯氟雷司在<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">糖尿病</SPAN></SPAN></SPAN>治疗方面的疗效是有限的。所以，委员会认为这些<SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; TEXT-DECORATION: none; text-underline: none"><SPAN style="FONT-SIZE: 10.5pt">药物</SPAN></SPAN></SPAN>的治疗效益不再大于其风险，并建议撤消其在欧盟所有国家内的上市授权。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><FONT style="FONT-SIZE: 10.5pt" face=宋体>上述建议已被递交至欧盟委员会以待决定。</FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%" align=right>（<SPAN style="FONT-SIZE: 10.5pt">EMA</SPAN>网站）</P> |
