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FDA提醒谨慎应用GnRH激动剂
作者:本站 时间:2010-11-07 点击:611 来源:中国医学论坛报
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">2010</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">10</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">20</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日,美国食品与药物管理局</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">(FDA)</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">发布声明,要求在促性腺激素释放激素(</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GnRH</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">)激动剂药品标签添加新的安全信息,提醒接受该药治疗的前列腺癌患者,其发生糖尿病和部分心血管疾病(心脏病发作、心脏性猝死、卒中)的风险升高。</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></SPAN></P><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">  </SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA; mso-fareast-font-family: 宋体">FDA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">此次声明基于对几项已发表研究的回顾分析,其中多数研究报告,接受</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA; mso-fareast-font-family: 宋体">GnRH</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">激动剂的患者糖尿病和(或)心血管事件风险轻微升高,其升高有统计学意义。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA; mso-fareast-font-family: 宋体">FDA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">建议,医疗保健专业人士应评估患者发生上述疾病的危险因素,在明确前列腺癌治疗方案前须慎重权衡</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA; mso-fareast-font-family: 宋体">GnRH</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">激动剂的益处与风险。对接受</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA; mso-fareast-font-family: 宋体">GnRH</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA">激动剂治疗者,应定期监测血糖和(或)糖化血红蛋白及提示出现心血管疾病的症状和体征。</SPAN>
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