| <SPAN style="FONT-SIZE: 18pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt">
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">2010</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">年<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">2</SPAN>月<SPAN style="FONT-SIZE: 10.5pt">23</SPAN>日</FONT></SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>， 美国食品药品监督管理局（<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>）发布信息称，正在对与使用沙奎那韦（商品名：<SPAN style="FONT-SIZE: 10.5pt">Invirase</SPAN>）合并利托那韦（商品名：<SPAN style="FONT-SIZE: 10.5pt">Norvir</SPAN>）相关的心脏副作用的临床试验数据进行评估</FONT>。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>沙奎那韦和利托那韦均为抗病毒药，可合并用于人免疫缺陷病毒感染的治疗。利托那韦低剂量给药可增加沙奎那韦在体内的水平，这个过程被称为“增效”。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>临床研究发现，患者的心电图显示了可能与沙奎那韦合并利托那韦相关的心脏电位改变，即所说的<SPAN style="FONT-SIZE: 10.5pt">QT</SPAN>间期或<SPAN style="FONT-SIZE: 10.5pt">PR</SPAN>间期延长。<SPAN style="FONT-SIZE: 10.5pt">QT</SPAN>间期延长可增加心律失常的风险，包括严重的扭转型室性心动过速；<SPAN style="FONT-SIZE: 10.5pt">PR</SPAN>间期延长与心脏传导阻滞有关。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>该项研究数据是由沙奎那韦的生产商罗氏公司根据<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>的要求提交的。<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>曾要求所有蛋白酶抑制剂（包括沙奎那韦）的生产企业开展相关研究以评估这些药品对心脏<SPAN style="FONT-SIZE: 10.5pt">QT</SPAN>间期和<SPAN style="FONT-SIZE: 10.5pt">RT</SPAN>间期的影响。研究的初步数据表明，当<SPAN style="FONT-SIZE: 10.5pt">18-55</SPAN>岁的受试者联合使用沙奎那韦合并利托那韦<SPAN style="FONT-SIZE: 10.5pt">(1000mg/</SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">100mg)</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">后，出现剂量依赖性<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">QT</SPAN>间期和<SPAN style="FONT-SIZE: 10.5pt">PR</SPAN>间期延长。该不良反应的严重程度和临床意义正在由<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>进行评估。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="TEXT-JUSTIFY: inter-ideograph; FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: justify"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>这些发现提示患者使用沙奎那韦合并利托那韦治疗可增加异常心律的发生风险，这种风险在那些已经服用可能导致<SPAN style="FONT-SIZE: 10.5pt">QT</SPAN>间期延长药物的患者中更高。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">FDA</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">建议患者不要立刻停止使用抗病毒药物，如果对用药风险有任何疑问应咨询医生；建议医疗专业人员注意以下问题：<SPAN style="FONT-SIZE: 10.5pt"></SPAN></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l </SPAN>不要给有<SPAN style="FONT-SIZE: 10.5pt">QT</SPAN>间期延长病史、缺血性心脏病、心肌病或结构性心脏病的患者使用沙奎那韦。<SPAN style="FONT-SIZE: 10.5pt"> </SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l </SPAN>不要给正在使用<SPAN style="FONT-SIZE: 10.5pt">IA</SPAN>类（如奎尼丁）或Ⅲ类<SPAN style="FONT-SIZE: 10.5pt">(</SPAN>如胺碘酮<SPAN style="FONT-SIZE: 10.5pt">)</SPAN>抗心律失常药或其他可能导致<SPAN style="FONT-SIZE: 10.5pt">QT</SPAN>或<SPAN style="FONT-SIZE: 10.5pt">PR</SPAN>间期延长药物的患者应用沙奎那韦。<SPAN style="FONT-SIZE: 10.5pt"> </SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l </SPAN>报告任何与使用沙奎那韦相关的不良事件至<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>的<SPAN style="FONT-SIZE: 10.5pt">MedWatch</SPAN>计划。<SPAN style="FONT-SIZE: 10.5pt"> </SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: right" align=right><SPAN style="FONT-SIZE: 10.5pt">（美国<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>网站）<SPAN style="FONT-SIZE: 10.5pt"></SPAN></SPAN></P>
<P style="FONT-SIZE: 10.5pt; LAYOUT-GRID-MODE: char; LINE-HEIGHT: 150%; TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 10.5pt; FONT-FAMILY: 楷体_GB2312"></SPAN> </P></SPAN></SPAN> |
