| <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: 宋体">美国食品药品监督管理局（</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">）在</SPAN><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: ??">1</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: ??">13</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">日发布信息，称所有的二膦酸盐药物说明书的警示部分均会添加用于治疗骨质疏松症时可能出现大腿骨的非典型骨折风险（已知的有股骨转子下和大楗骨骨干骨折）的信息。</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: 宋体">二膦酸盐药物可有效预防或减少绝经后妇女骨量的丢失（如骨质疏松），从而减少因骨质疏松发生的骨折。该类药物商品名有</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??"><A href="http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm"><FONT size=3><SPAN style="COLOR: windowtext; TEXT-DECORATION: none; text-underline: none">Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia</SPAN><SPAN style="COLOR: windowtext; FONT-FAMILY: 宋体; TEXT-DECORATION: none; text-underline: none"><SPAN>和</SPAN></SPAN><SPAN style="COLOR: windowtext; TEXT-DECORATION: none; text-underline: none"> Reclast</SPAN></FONT></A></SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">等。</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: 宋体">非典型转子下大楗骨骨折发生在髋关节下。大楗骨骨干骨折发生在大腿骨较长的部分。这两种骨折在所有髋部和大楗骨骨折中的比率不超过</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">1%</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">。虽然不清楚二膦酸盐与这些非典型骨折之间的因果关系，但这些非典型骨折主要都是在服用二膦酸盐的患者中发生的。</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: 宋体">二膦酸盐新增加的警示并不影响用它来治疗佩吉特病或癌症所致的高血钙，这类药品商品名有</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">Didronel, Zometa</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: ??">Skelid</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">等。</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: 宋体">虽然尚不清楚二膦酸盐用于预防和治疗骨质疏松症的最佳用药持续时间，但这些非典型骨折的发生可能与二膦酸盐的长时间使用有关。</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">将要求在说明书的适应症与用法部分增加新的使用期限。在这部分将注明目前尚不清楚二膦酸盐用于预防和治疗骨质疏松的最佳治疗时间。</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; 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-FAMILY: 宋体">：</SPAN></B><SPAN style="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">请注意关注服用二膦酸盐患者可能出现的非典型转子下部骨折和大楗骨骨干骨折风险。</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: 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">请继续按照药品说明书处方二膦酸盐。</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">请与患者讨论使用二膦酸盐的利弊。</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: 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">请确定患者出现的大腿或腹股沟部疼痛不是由于骨折引起的。</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: 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">如出现股骨干骨折，应停止使用骨吸收抑制剂（包括二膦酸盐）。</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: 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">请定期评估是否需要继续使用二膦酸盐进行治疗，尤其是对于那些使用二膦酸盐超过</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??">5</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">年的患者。</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: 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">应及时报告使用二膦酸盐引起的所有不良事件。</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><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: 11.5pt; LINE-HEIGHT: 150%; 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: 宋体">请勿停止用药，除非按医生要求停药。</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="LINE-HEIGHT: 150%; FONT-FAMILY: ??"> </SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">如果出现大腿疼痛，想更换治疗药物，或对所服用的药品有任何疑虑，请向医生咨询。</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P>
<P style="TEXT-INDENT: 28pt; LINE-HEIGHT: 18pt; TEXT-ALIGN: left" align=left><SPAN style="FONT-FAMILY: Wingdings">l</SPAN><SPAN style="FONT-SIZE: 11.5pt; FONT-FAMILY: ??"> </SPAN><SPAN style="FONT-SIZE: 11.5pt; FONT-FAMILY: 宋体">向</SPAN><SPAN style="FONT-SIZE: 11.5pt; FONT-FAMILY: ??">FDA</SPAN><SPAN style="FONT-SIZE: 11.5pt; FONT-FAMILY: 宋体">报告二膦酸盐药物的任何副作用。</SPAN><SPAN style="FONT-SIZE: 11.5pt; FONT-FAMILY: ??"></SPAN></P>
<P style="TEXT-INDENT: 28pt; LINE-HEIGHT: 18pt; TEXT-ALIGN: left" align=left><SPAN style="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: ??">FDA</SPAN><SPAN style="FONT-SIZE: 11.5pt; LINE-HEIGHT: 150%; FONT-FAMILY: 宋体">将继续对二膦酸盐的使用安全性及非典型大楗骨骨折的发生率进行评估。</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: 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; LINE-HEIGHT: 150%; TEXT-ALIGN: center" align=center><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: ??"></SPAN></P> |
