| <P style="TEXT-INDENT: 31.5pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">2010</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">年</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">10</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">月</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">20</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">日，美国食品药品管理局（</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">FDA</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">）告知促性腺激素释放激素（</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">）激动剂生产厂商，要求在说明书的警示部分增加新的安全性信息。这些新的安全警示包括增加的糖尿病和某些心血管疾病的风险（心脏病发作、心源性猝死、中风）。</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="TEXT-INDENT: 31.5pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂（商品名包括</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">Lupron</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">、</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">Zoladex</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">、</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">Viadur</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">、</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">Trelstar</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">和</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">Eligard</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">）可降低雄激素，从而使得前列腺肿瘤萎缩或抑制前列腺癌的发展。虽然在接受</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂治疗前列腺癌的患者中出现糖尿病和心血管疾病的风险较低，但专业医疗人员应充分评估这些疾病的风险因素。在决定使用</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂治疗前列腺癌时应仔细权衡使用的利弊。接受</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂治疗的患者应定期监测血糖和</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">或糖化血红蛋白</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">(HbA1c)</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">。血糖水平的升高预示患者可能出现糖尿病或糖尿病患者血糖控制失败。</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="TEXT-INDENT: 28.1pt; LINE-HEIGHT: 150%"><B><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">患者须知的信息</SPAN></B><B><SPAN style="FONT-SIZE: 14pt; LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312">:</SPAN></B><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂的商品名有</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">Lupron, Zoladex, Trelstar, Viadur</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">和</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??"> Eligard.</SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">如患有糖尿病、心脏疾病、曾有过心脏病发作、中风或其他任何心血管风险因素（如高血压、高胆固醇、或吸烟），请在接受</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂治疗前将这些情况告诉专业医护人员。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">对使用</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂有任何疑问请咨询专业医护人员。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">请将使用</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂的任何副作用告知</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">FDA</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="TEXT-INDENT: 28.1pt; LINE-HEIGHT: 18pt; TEXT-ALIGN: left" align=left><SPAN style="FONT-FAMILY: ??"></SPAN></P>
<P style="TEXT-INDENT: 28.1pt; LINE-HEIGHT: 18pt; TEXT-ALIGN: left" align=left><B><SPAN style="FONT-SIZE: 11.5pt; FONT-FAMILY: 宋体">医护人员须知的信息：</SPAN></B><B><SPAN style="FONT-SIZE: 11.5pt; FONT-FAMILY: ??"></SPAN></B></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"> </SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">FDA</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">评估的大多数研究结果表明接受</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂的患者糖尿病和</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">或某些心血管疾病的风险增幅较小，但具有统计学意义。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">在决定使用</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂为患者治疗前列腺癌之前应充分衡量利弊。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">在使用</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">GnRH</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">激动剂治疗的过程中应定期监测患者的血糖和</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">或糖化血红蛋白。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">注意监测可能出现的心血管疾病的体征和症状。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">请确定患者的心血管风险如吸烟、高血压、高血糖、高胆固醇以及超重等得到较好地控制。</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28pt; LINE-HEIGHT: 150%; TEXT-ALIGN: right" align=right><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">（美国</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">FDA</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">网站）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"> </SPAN></P>
<P style="LAYOUT-GRID-MODE: char; TEXT-INDENT: 28.1pt; LINE-HEIGHT: 150%; TEXT-ALIGN: left" align=left><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P> |
