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FDA 批准degarelix 治疗晚期前列腺癌
作者:网络来源 时间:2009/02/22 点击:981 来源:中国医药数字图书馆网站
<P class=MsoNormal style="BACKGROUND: white; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0; mso-pagination: widow-orphan"><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">美国</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">FDA </FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">批准</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">degarelix</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">注射剂用于晚期前列腺癌的治疗。本品为几年来</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">FDA </FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">首次批准的前列腺癌治疗新药。本品为促性腺激素释放激素(</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">GnRH</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">)受体抑制剂,其通过抑制体内睾丸激素水平来减缓前列腺癌细胞的生长进程。睾丸激素(睾酮)在维持前列腺癌的生长中扮演重要的角色。</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman"> <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></FONT></SPAN></FONT></P><BR> <P class=MsoNormal style="BACKGROUND: white; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0; mso-pagination: widow-orphan"><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">此前的激素治疗药物在治疗初期会引起睾丸激素水平暂时性升高,然后才会使睾丸激素水平降低,所以这就可能造成肿瘤细胞初始会被刺激生长而不是被抑制。而</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">Degarelix</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">从一开始就能抑制体内睾丸激素水平,而不会出现暂时升高的情况。前列腺癌是美国癌症死亡的第二大杀手,而且前列腺癌的诊断率很高,在</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">2004</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">年大约有</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">19</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">万男性被诊断为前列腺癌患者,而当年因前列腺癌的死亡人数就高达</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">2.9</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">万人。</SPAN></FONT><SPAN lang=EN style="mso-ansi-language: EN"><BR><SPAN style="mso-spacerun: yes"><FONT face="Times New Roman" size=3></FONT></SPAN></SPAN><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">目前针对不同阶段前列腺癌的治疗方案包括观察、手术摘除病变前列腺、放射治疗、化学治疗、以及针对</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">GnRH</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">的激素治疗等。</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman"> <o:p></o:p></FONT></SPAN></FONT></P><BR> <P class=MsoNormal style="BACKGROUND: white; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0; mso-pagination: widow-orphan"><FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">在临床研究中,本品与醋酸亮丙瑞林(</SPAN><SPAN lang=EN style="mso-ansi-language: EN"><FONT face="Times New Roman">leuprolide</FONT></SPAN><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’; mso-ansi-language: EN">)的效果相似。由于本品在治疗初期不会引起睾酮的暂时性增加。所以这是本品与其他治疗药物不同之处。在临床研究中本品最常见的不良反应为:注射部位出现疼痛、红肿,面部出现潮红、体重增加,易疲乏、肝酶类增加等。</SPAN><FONT face="Times New Roman"><SPAN style="mso-ansi-language: EN"> </SPAN></FONT></FONT></P> <P class=MsoNormal style="BACKGROUND: white; MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0; mso-pagination: widow-orphan"><FONT size=3><FONT face="Times New Roman"><SPAN style="mso-ansi-language: EN"></SPAN><SPAN lang=EN-US style="FONT-SIZE: 9pt; LINE-HEIGHT: 150%"><o:p></o:p></SPAN></FONT></FONT></P>
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