| <P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 近日，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">）发布公告，要求更改含钆造影剂（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）药品标签，以使肾功能异常者发生</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">相关肾源性系统性纤维化（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">NSF</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）的风险最低。肾功能正常者中未见</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">NSF</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">发生，应用</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">后</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">NSF</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">风险最大的为药物清除障碍者，包括急性肾损伤（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">AKI</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）或慢性严重肾脏病</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">[</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">肾小球滤过率（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GFR</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）＜</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">30 ml/</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">min·1.73m2</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">]</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">患者。大于推荐剂量或重复用药亦可能增加</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">NSF</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">风险。</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>
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 修改后的说明书将通过以下推荐意见强调</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">应用安全性。</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 钆喷酸葡胺、钆双胺和</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">Optimark</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">禁忌用于</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">AKI</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">或慢性严重肾脏病；</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 应用</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">前须对患者进行筛查，以识别患</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">AKI</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">或慢性严重肾脏病者；</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 筛查患者病史中是否存在</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">AKI</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">特征或慢性肾功能减低的危险因素；</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 对怀疑或明确有药物清除障碍者，除非诊断必需且非增强磁共振成像或其他替代成像手段不能满足需要，否则应避免应用</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">；</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 对怀疑或明确有药物清除障碍者，应用</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">后应监测</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">NSF</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">症状和体征；</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
<P style="BACKGROUND: white; LINE-HEIGHT: 16.5pt"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"> 在单次影像学检查期间不能重复应用任何</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial">GBCA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">。</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #3e3e3e; FONT-FAMILY: Arial"> <SPAN lang=EN-US><o:p></o:p></SPAN></SPAN></P>
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