| <P><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><FONT face=Arial><SPAN style="mso-spacerun: yes"> </SPAN>Columbia Laboratories, Inc.</FONT></SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">和</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">Watson Pharmaceuticals, Inc.</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">表示，</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">8%</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">黄体酮凝胶</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">III</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">期试验结果显示，该药降低了孕中期经阴道超声检查判断宫颈长度短的妇女的早产率风险，并且证实可改善婴儿临床转归。</SPAN><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 style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">该项双盲、安慰剂对照研究纳入了来自</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">10</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">个国家</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">40</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">多个地区年龄在</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">15</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">至</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">45</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">岁的</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">465</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">例健康孕妇。近一半的来自美国的参与者随机分配接受</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">8%</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">黄体酮阴道凝胶或安慰剂阴道凝胶，每日一次，直至孕</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">37</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">周早期或分娩。</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">该研究将孕</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">32+6</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">周前的早产率作为主要研究终点。研究结果显示，与安慰剂凝胶相比，</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">8%</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">黄体酮凝胶与早产率统计上的显著降低相关。还证实了可改善婴儿的临床转归。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">8%</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">黄体酮凝胶的不良事件发生率与安慰剂相当。</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">该孕期试验结果为将阴道超声检查列入产前常规检查以预测产妇风险提供了强有力的证据。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial">8%</SPAN><SPAN style="COLOR: black; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">黄体酮凝胶已被批准用于治疗不孕症、继发性闭经或闭经。这两个公司表示计划在</SPAN><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">年第二季度向监管机构申请增加新适应症。</SPAN><SPAN lang=EN-US style="COLOR: black; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P> |
