| <P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">美国食品药品监督管理局（<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>）<SPAN style="FONT-SIZE: 10.5pt">2</SPAN>月<SPAN style="FONT-SIZE: 10.5pt">18</SPAN>日宣布，长效</FONT></SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%">?</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">受体激动剂<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">(LABAs)</SPAN>类药品不能再单独用于儿童和成人的哮喘治疗。相关生产企业将被要求修改产品说明书，增加此项警告，并采取其他措施以减少此类药品的使用风险。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">这些新的要求是基于<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>对<SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>的临床试验分析结果而提出的。这些结果表明此类药品与哮喘症状的恶化有关，甚至导致患者（儿童和成人）住院或死于哮喘。涉及的药品包括单独成份的<SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>（<SPAN style="FONT-SIZE: 10.5pt">Serevent</SPAN>和<SPAN style="FONT-SIZE: 10.5pt">Foradil</SPAN>）和与吸入性</FONT></SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">皮质类固醇的复方</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">制剂（<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">Advair</SPAN>和<SPAN style="FONT-SIZE: 10.5pt"> Symbicort</SPAN>）。这些药品用于哮喘和慢性阻塞性肺病（<SPAN style="FONT-SIZE: 10.5pt">COPD</SPAN>）的治疗，但此次<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>的建议仅适用于哮喘的治疗。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; 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">要求修订的产品说明书中包括以下信息：<SPAN style="FONT-SIZE: 10.5pt"></SPAN></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; FONT-FAMILY: Wingdings">l </SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">未使用吸入性皮质类固醇等哮喘控制药物的情况下，禁用<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>。<SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>单药制剂必须与一种哮喘控制药物联合使用，不能单用<SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>。<SPAN style="FONT-SIZE: 10.5pt"> </SPAN></FONT></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; FONT-FAMILY: Wingdings">l </SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">哮喘控制药物效果不佳，哮喘不能得到很好控制的患者，才可以长期使用<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; FONT-FAMILY: Wingdings">l </SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">LABAs</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">使用持续时间应为控制哮喘症状所需的最短时间，如果可能，一旦达到哮喘控制的效果就应停用<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>，随后患者继续使用其他控制哮喘的药物维持治疗。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt; FONT-FAMILY: Wingdings">l </SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">需要在吸入性</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">皮质类固醇</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">基础上添加<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>的儿童及青少年患者，应使用含有吸入性</FONT></SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">皮质类固醇</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">以及<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">LABAs</SPAN>的联合制剂，以确保对两种药物的治疗依从性。<SPAN style="FONT-SIZE: 10.5pt"></SPAN></FONT></SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; 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还要求为</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">LABAs</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">制定风险评估和最小化计划(REMS)，包括修订患者用药指南，对医务人员进行正确使用LABAs的教育。此外，FDA还要求制药公司开展新的临床试验，以深入评价LABAs与吸入性皮质类固醇联合应用的安全性。FDA将于2010年3月10-11日召开咨询委员会会议，听取对这些研究的建议。</SPAN></FONT></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>FDA认为，对于需要使用LABAs的患者，如果将LABAs与一种哮喘控制药联合应用，对于改善哮喘症状效益大于风险。FDA相信，推荐的安全性使用方法将提高此类产品的安全性。</FONT></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><FONT face=宋体><SPAN></SPAN></FONT><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 宋体"><SPAN style="FONT-SIZE: 10.5pt"><FONT style="FONT-SIZE: 10.5pt" face=宋体>FDA</FONT></SPAN></A><FONT style="FONT-SIZE: 10.5pt" face=宋体><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt">批准的含<SPAN style="FONT-SIZE: 10.5pt">LABA</SPAN></SPAN></SPAN><SPAN style="FONT-SIZE: 10.5pt">的药品如下表所示。</SPAN></FONT></SPAN></P>
<DIV align=center>
<TABLE style="BORDER-RIGHT: medium none; BORDER-TOP: medium none; BORDER-LEFT: medium none; BORDER-BOTTOM: medium none; BORDER-COLLAPSE: collapse" cellSpacing=0 cellPadding=0 width=552 border=1>
<TBODY>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><B><SPAN style="FONT-SIZE: 12pt">商品名</SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></B></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="TEXT-ALIGN: center" align=center><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">LABA </SPAN></B><B><SPAN style="FONT-SIZE: 12pt">成份</SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></B></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="TEXT-ALIGN: center" align=center><B><SPAN style="FONT-SIZE: 12pt">皮质类固醇成份</SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></B></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="TEXT-ALIGN: center" align=center><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">FDA</SPAN></B><B><SPAN style="FONT-SIZE: 12pt">批准的适应症</SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></B></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Serevent Diskus</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="MARGIN: 0cm 0cm 0pt 0.05pt; TEXT-INDENT: -1.45pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">沙美特罗<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 1.55pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">无<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">哮喘<FONT face=仿宋_GB2312><SPAN>, COPD,</SPAN>运动引起的支气管痉挛<SPAN></SPAN></FONT></SPAN></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Foradil Aerolizer</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="MARGIN: 0cm 0cm 0pt 0.05pt; TEXT-INDENT: -1.45pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">福莫特罗<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 1.55pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">无<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">哮喘<FONT face=仿宋_GB2312><SPAN>, COPD,</SPAN>运动引起的支气管痉<SPAN></SPAN></FONT></SPAN></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Foradil Certihaler*</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="MARGIN: 0cm 0cm 0pt 0.05pt; TEXT-INDENT: -1.45pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">福莫特罗<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 1.55pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">无<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">哮喘<SPAN></SPAN></SPAN></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Advair Diskus</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="MARGIN: 0cm 0cm 0pt 0.05pt; TEXT-INDENT: -1.45pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">沙美特罗<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">氟替卡松<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">哮喘<SPAN><FONT face=仿宋_GB2312>, COPD</FONT></SPAN></SPAN></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Advair HFA</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="MARGIN: 0cm 0cm 0pt 0.05pt; TEXT-INDENT: -1.45pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">沙美特罗<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 0.6pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">氟替卡松<SPAN></SPAN></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN style="FONT-FAMILY: 仿宋_GB2312">哮喘<SPAN></SPAN></SPAN></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Symbicort</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt">福莫特罗</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt">布地奈德</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt">哮喘</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">, COPD</SPAN></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Brovana</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Arformoterol</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt">无</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">COPD</SPAN></P></TD></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 103.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=138>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">Perforomist</SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 81.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=108>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt">福莫特罗</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 92.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=123>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt">无</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></P></TD>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 136.85pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=182>
<P style="TEXT-ALIGN: center" align=center><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">COPD</SPAN></P></TD></TR></TBODY></TABLE></DIV>
<P style="LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="FONT-SIZE: 12pt; LINE-HEIGHT: 150%"></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 宋体"><SPAN style="FONT-SIZE: 9pt"><SPAN style="FONT-SIZE: 9pt; LINE-HEIGHT: 150%">注：标</SPAN><SPAN style="FONT-SIZE: 9pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">*</SPAN><SPAN style="FONT-SIZE: 9pt; LINE-HEIGHT: 150%">的药品目前未在美国上市</SPAN></SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 14pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><SPAN><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">Advair</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">和<FONT face=仿宋_GB2312><SPAN style="FONT-SIZE: 10.5pt">Serevent</SPAN>由葛兰素史克公司上市，<SPAN style="FONT-SIZE: 10.5pt">Foradil</SPAN>由诺华公司上市，<SPAN style="FONT-SIZE: 10.5pt">Symbicort</SPAN>由阿斯利康公司上市。</FONT></SPAN></SPAN></SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28.1pt; LINE-HEIGHT: 150%"><B><SPAN style="FONT-SIZE: 14pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体><SPAN style="FONT-SIZE: 10.5pt"><A name=_Ref252304498><B><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT style="FONT-SIZE: 10.5pt" face=宋体>背景数据</FONT></SPAN></B></A><A name=_Ref252304498></SPAN></FONT></SPAN></B></A></P><SPAN style="FONT-SIZE: 10.5pt">
<P style="TEXT-JUSTIFY: inter-ideograph; FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: justify"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">FDA要求修改说明书和制定REMS的决定是基于对沙美特罗多中心哮喘研究试验（SMART）的分析、沙美特罗全国性监测研究(SNS)以及一项2008年由FDA开展的荟萃分析，该荟萃分析在2008年11月的专家委员会上进行了讨论。</SPAN></SPAN></P>
<P style="TEXT-JUSTIFY: inter-ideograph; FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: justify"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">SMART是一项为期28周的大型、随机、安慰剂对照临床试验，用于评估12岁以上接受标准哮喘治疗合并沙美特罗或安慰剂治疗的患者，总计26,355名患者参加试验。结果显示，接受沙美特罗组的患者与哮喘相关死亡的风险较安慰剂组高；亚群分析发现，高加索和非洲人种哮喘相关死亡的发生率更高（参加试验的人种包括高加索人、非洲人、西班牙人和亚洲人）。如表1所示。</SPAN></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt">表<SPAN style="FONT-SIZE: 10.5pt">1<SPAN style="FONT-SIZE: 10.5pt"> </SPAN>SMART</SPAN>研究结果</SPAN></SPAN></P></SPAN>
<DIV align=center>
<TABLE style="BORDER-RIGHT: medium none; BORDER-TOP: medium none; BORDER-LEFT: medium none; BORDER-BOTTOM: medium none; BORDER-COLLAPSE: collapse" cellSpacing=0 cellPadding=0 width=552 border=1>
<TBODY>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 110.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=147>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">患者人群<SPAN></SPAN></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">沙美特罗组哮喘相关死亡<SPAN></SPAN></SPAN></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">n (%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">安慰剂组哮喘相关死亡<SPAN></SPAN></SPAN></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">n (%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">哮喘相关死亡的相对危险度<SPAN></SPAN></SPAN></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">(95% Cl)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 80.15pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=107>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">每<FONT size=3><SPAN>1000</SPAN>名患者额外死亡<SPAN></SPAN></FONT></SPAN></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">(95% CI)</SPAN></SPAN></P></TD><SPAN></SPAN></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 110.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=147>
<P style="TEXT-ALIGN: center" align=center><SPAN><STRONG><SPAN style="FONT-WEIGHT: normal; FONT-SIZE: 12pt; FONT-FAMILY: 宋体">所有患者<SPAN></SPAN></SPAN></STRONG></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">沙美特罗<FONT size=3><SPAN>:n=13176<BR></SPAN>安慰剂<SPAN>:n=13179</SPAN></FONT></SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN><FONT size=3></FONT></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>13 (0.10%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>3 (0.02%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>4.37 (1.25, 15.34)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 80.15pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=107>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>8 (3, 13)</SPAN></SPAN></P></TD><SPAN></SPAN></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 110.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=147>
<P style="TEXT-ALIGN: center" align=center><SPAN><STRONG><SPAN style="FONT-WEIGHT: normal; FONT-SIZE: 12pt; FONT-FAMILY: 宋体">高加索患者<SPAN></SPAN></SPAN></STRONG></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">沙美特罗<SPAN><FONT size=3>:n=9281</FONT></SPAN></SPAN></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">安慰剂<SPAN><FONT size=3>:n=9361</FONT></SPAN></SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN><FONT size=3></FONT></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>6 (0.07%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>1 (0.01%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>5.82 (0.70, 48.37)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 80.15pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=107>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>6 (1, 10)</SPAN></SPAN></P></TD><SPAN></SPAN></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 110.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=147>
<P style="TEXT-ALIGN: center" align=center><SPAN><STRONG><SPAN style="FONT-WEIGHT: normal; FONT-SIZE: 12pt; FONT-FAMILY: 宋体">非洲患者者<SPAN></SPAN></SPAN></STRONG></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">沙美特罗<SPAN><FONT size=3>: n=2366</FONT></SPAN></SPAN></SPAN></P>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">安慰剂<SPAN><FONT size=3>: n=2319</FONT></SPAN></SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN><FONT size=3></FONT></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.25pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>7 (0.31%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>1 (0.04%)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 85.3pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=114>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>7.26 (0.89, 58.94)</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 80.15pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=107>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>27 (8, 46)</SPAN></SPAN></P></TD><SPAN></SPAN></TR></TBODY></TABLE></DIV><SPAN><SPAN><SPAN style="FONT-SIZE: 10.5pt">
<P style="TEXT-JUSTIFY: inter-ideograph; FONT-SIZE: 10.5pt; MARGIN: 6pt 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: justify"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>SNS是一项在标准哮喘治疗方案合并沙美特罗或沙丁胺醇治疗的患者中开展的为期6周的双盲研究，共纳入25,180名12岁以上哮喘患者。研究发现，沙美特罗组中与呼吸和哮喘相关的死亡 (0.07%，每16,787患者中有13名)高于沙丁胺醇组(0.02%，每8,393 名患者中有2名，RR=3.0, p=0.105).</FONT></SPAN></SPAN></P>
<P style="TEXT-JUSTIFY: inter-ideograph; FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: justify"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>FDA为筹备2008年12月的咨询委员会会议，进行了一项包含110项研究的荟萃分析，以评估LABAs在60,954名哮喘患者中的使用风险。该荟萃分析使用复合终点（哮喘相关死亡、插管、住院）作为哮喘症状严重恶化的指标。分析结果提示，使用LABAs的患者哮喘症状严重恶化的风险高于那些未使用LABAs的患者。</FONT></SPAN></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 6pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>每1000名治疗患者中风险差异最大的是4-11岁年龄组儿童，见表2。其他评估LABAs安全性的荟萃分析未显示哮喘症状恶化风险升高有显著性差异。</FONT></SPAN></SPAN></P>
<P style="TEXT-JUSTIFY: inter-ideograph; MARGIN: 6pt 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: justify"></SPAN>表<SPAN>2<SPAN> </SPAN></SPAN>荟萃分析结果：经历了一种事件的患者数量<SPAN>*</SPAN></SPAN></SPAN></P>
<DIV align=center>
<TABLE style="BORDER-RIGHT: medium none; BORDER-TOP: medium none; BORDER-LEFT: medium none; BORDER-BOTTOM: medium none; BORDER-COLLAPSE: collapse" cellSpacing=0 cellPadding=0 width=552 border=1>
<TBODY>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 128.65pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=172>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">患者人群</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">经历了一种事件的<FONT size=3><SPAN>LABA </SPAN>患者</FONT></SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">经历了一种事件的非<FONT size=3><SPAN>LABA</SPAN>患者</FONT></SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 66.45pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=89>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">每千名治疗患者估计的风险差异</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: windowtext 1pt solid; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 77.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=103>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">95% CI</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 128.65pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=172>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>所有患者</SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>n=30,148 LABA </SPAN></SPAN><SPAN><SPAN>患者</SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>n=30,806 </SPAN></SPAN><SPAN><SPAN>非</SPAN><SPAN>LABA</SPAN></SPAN><SPAN><SPAN>患者</SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>381</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>304</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 66.45pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=89>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>2.80</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 77.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=103>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>1.11-4.49</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 128.65pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=172>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>12-17</SPAN>岁患者</SPAN><SPAN><SPAN></SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>n=3,103 LABA </SPAN>患者</SPAN><SPAN><SPAN></SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>n=3,289 </SPAN>非</SPAN><SPAN><SPAN>LABA</SPAN>患者</SPAN><SPAN><SPAN></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>48</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>30</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 66.45pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=89>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>5.57</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 77.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=103>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>0.21-10.92</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN></TR>
<TR style="HEIGHT: 19.85pt">
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: windowtext 1pt solid; WIDTH: 128.65pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=172>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>4-11</SPAN>岁患者</SPAN><SPAN><SPAN></SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>n=1,626 LABA </SPAN>患者</SPAN><SPAN><SPAN></SPAN></SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: center" align=center><SPAN><SPAN>n=1,789 </SPAN>非</SPAN><SPAN><SPAN>LABA</SPAN>患者</SPAN><SPAN><SPAN></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>61</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 70.7pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=94>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>39</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 66.45pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=89>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>14.83</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN>
<TD style="BORDER-RIGHT: windowtext 1pt solid; PADDING-RIGHT: 2.85pt; BORDER-TOP: medium none; PADDING-LEFT: 2.85pt; PADDING-BOTTOM: 0cm; BORDER-LEFT: medium none; WIDTH: 77.4pt; PADDING-TOP: 0cm; BORDER-BOTTOM: windowtext 1pt solid; HEIGHT: 19.85pt" width=103>
<P style="TEXT-ALIGN: center" align=center><SPAN><SPAN>3.24-26.43</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"></SPAN></SPAN></P></TD><SPAN></SPAN></TR></TBODY></TABLE></DIV>
<P style="MARGIN: 0cm 0cm 0pt; LINE-HEIGHT: 150%"><SPAN><SPAN>* </SPAN></SPAN><SPAN><SPAN>事件被定义为复合终点（哮喘相关死亡、插管、住院）<SPAN></SPAN></SPAN></SPAN></P><SPAN><SPAN style="FONT-SIZE: 14pt; FONT-FAMILY: 仿宋_GB2312"><SPAN style="FONT-SIZE: 10.5pt">
<P style="FONT-SIZE: 10.5pt; MARGIN: 6pt 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>目前，还没有足够的数据能够得出LABAs和一种吸入性皮质类固醇联合使用可减少或消除哮喘相关死亡或住院风险的结论。FDA要求企业开展相关研究以评估LABAs与吸入性皮质类固醇联合使用的安全性。</FONT></SPAN></SPAN></P>
<P style="FONT-SIZE: 10.5pt; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>根据已有的数据，FDA得出结论，在一些使用LABAs治疗哮喘的患者中，哮喘严重恶化的风险升高，导致儿童和成人住院或死亡。管理局要求制定REMS和修改说明书以提高此类产品的安全性。</FONT></SPAN></SPAN></P>
<P style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt"><SPAN style="FONT-SIZE: 10.5pt; FONT-FAMILY: 仿宋_GB2312"><FONT face=宋体>（美国<SPAN style="FONT-SIZE: 10.5pt">FDA</SPAN>网站）</FONT></SPAN></SPAN></P></SPAN></SPAN></SPAN></SPAN><BR><BR> |
