| <P style="TEXT-INDENT: 21pt; LINE-HEIGHT: 150%; mso-char-indent-count: 2.0"><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%">REFLEXION</SPAN><SPAN style="FONT-SIZE: 10.5pt; LINE-HEIGHT: 150%">试验<SPAN lang=EN-US><FONT size=3>3</FONT></SPAN>年结果显示，与多发性硬化症（<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>）临床确诊后接受治疗的患者相比，首次脱髓鞘事件患者早期皮下注射干扰素<SPAN lang=EN-US><FONT size=3>β<?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /><st1:chmetcnv w:st="on" TCSC="0" NumberType="1" Negative="True" HasSpace="False" SourceValue="1" UnitName="a">-1a</st1:chmetcnv></FONT></SPAN>可显著延缓<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>进展时间，且最佳剂量为<SPAN lang=EN-US><FONT size=3>44 μg</FONT></SPAN>，<SPAN lang=EN-US><FONT size=3>3</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>。<SPAN lang=EN-US><BR><SPAN style="mso-spacerun: yes"><FONT size=3> </FONT></SPAN></SPAN>该项试验是Ⅲ期双盲<SPAN lang=EN-US><FONT size=3>REFLEX</FONT></SPAN>试验的延长试验，将持续<SPAN lang=EN-US><FONT size=3>5</FONT></SPAN>年。主要研究者、渥太华医院<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>研究中心主任、渥太华大学神经学教授<SPAN lang=EN-US><FONT size=3>Mark Freedman</FONT></SPAN>博士将在<st1:chsdate w:st="on" IsROCDate="False" IsLunarDate="False" Day="25" Month="4" Year="2012"><SPAN lang=EN-US><FONT size=3>4</FONT></SPAN>月<SPAN lang=EN-US><FONT size=3>25</FONT></SPAN>日</st1:chsdate>召开的美国神经学会年会上报告最新的<SPAN lang=EN-US><FONT size=3>3</FONT></SPAN>年研究结果。<SPAN lang=EN-US><BR><SPAN style="mso-spacerun: yes"><FONT size=3> </FONT></SPAN></SPAN>在<SPAN lang=EN-US><FONT size=3>REFLEX</FONT></SPAN>试验中，<SPAN lang=EN-US><FONT size=3>517</FONT></SPAN>例首次脱髓鞘事件患者随机接受<SPAN lang=EN-US><FONT size=3>24</FONT></SPAN>个月的<SPAN lang=EN-US><FONT size=3>3</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>或<SPAN lang=EN-US><FONT size=3>1</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>的<SPAN lang=EN-US><FONT size=3> 44 μg</FONT></SPAN>干扰素<SPAN lang=EN-US><FONT size=3>β<st1:chmetcnv w:st="on" TCSC="0" NumberType="1" Negative="True" HasSpace="False" SourceValue="1" UnitName="a">-1a</st1:chmetcnv></FONT></SPAN>治疗或安慰剂处置。受试者在临床确诊多发性硬化症（<SPAN lang=EN-US><FONT size=3>CDMS</FONT></SPAN>）后转换为<SPAN lang=EN-US><FONT size=3>3</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>的干扰素治疗。结果显示，与安慰剂相比，两种剂量的干扰素早期治疗均可显著延缓<SPAN lang=EN-US><FONT size=3>CDMS</FONT></SPAN>和<SPAN lang=EN-US><FONT size=3>McDonald</FONT></SPAN>标准（更多依据核磁共振成像）<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>的进展，并且<SPAN lang=EN-US><FONT size=3> 3</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>干扰素治疗延缓<SPAN lang=EN-US><FONT size=3>McDonald</FONT></SPAN>标准<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>疾病进展的效果比<SPAN lang=EN-US><FONT size=3>1</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>治疗更为显著。<SPAN lang=EN-US><BR><SPAN style="mso-spacerun: yes"><FONT size=3> </FONT></SPAN></SPAN>在接下来的<SPAN lang=EN-US><FONT size=3>REFLEXION</FONT></SPAN>试验中，所有<SPAN lang=EN-US><FONT size=3>REFLEX</FONT></SPAN>试验受试者均符合纳入标准，其中<SPAN lang=EN-US><FONT size=3>402</FONT></SPAN>例（<SPAN lang=EN-US><FONT size=3>78%</FONT></SPAN>）参加了试验。未发生<SPAN lang=EN-US><FONT size=3>CDMS</FONT></SPAN>的所有初始安慰剂组患者均转为<SPAN lang=EN-US><FONT size=3>3</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>干扰素治疗，未发生<SPAN lang=EN-US><FONT size=3>CDMS</FONT></SPAN>的初始干扰素治疗组患者仍接受原方案治疗。整合两项试验数据并按最初治疗分组进行分析后发现，安慰剂<SPAN lang=EN-US><FONT size=3>/</FONT></SPAN>延迟治疗组、<SPAN lang=EN-US><FONT size=3>1</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>治疗组和<SPAN lang=EN-US><FONT size=3>3</FONT></SPAN>次<SPAN lang=EN-US><FONT size=3>/w</FONT></SPAN>治疗组<SPAN lang=EN-US><FONT size=3>36</FONT></SPAN>个月<SPAN lang=EN-US><FONT size=3>CDMS</FONT></SPAN>累计发生率分别为<SPAN lang=EN-US><FONT size=3>41.3%</FONT></SPAN>、<SPAN lang=EN-US><FONT size=3>27.6%</FONT></SPAN>和<SPAN lang=EN-US><FONT size=3>27.1%</FONT></SPAN>，<SPAN lang=EN-US><FONT size=3>36</FONT></SPAN>个月<SPAN lang=EN-US><FONT size=3> McDonald</FONT></SPAN>标准<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>发生率分别为<SPAN lang=EN-US><FONT size=3>87%</FONT></SPAN>、<SPAN lang=EN-US><FONT size=3>79%</FONT></SPAN>和<SPAN lang=EN-US><FONT size=3>67%</FONT></SPAN>。同<SPAN lang=EN-US><FONT size=3>REFLEX</FONT></SPAN>试验结果一样，无论基于临床还是<SPAN lang=EN-US><FONT size=3>MRI</FONT></SPAN>诊断标准，两个干扰素治疗组与安慰剂组<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>疾病进展时间均呈显著差异，不同剂量干扰素治疗组<SPAN lang=EN-US><FONT size=3>McDonald</FONT></SPAN>标准<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>疾病进展时间也具有显著差异性。与小剂量组相比，大剂量组初始治疗患者的额外收益与干扰素<SPAN lang=EN-US><FONT size=3>β<st1:chmetcnv w:st="on" TCSC="0" NumberType="1" Negative="True" HasSpace="False" SourceValue="1" UnitName="a">-1a</st1:chmetcnv></FONT></SPAN>相关的持续性类流感症状减少有关。<SPAN lang=EN-US><BR><SPAN style="mso-spacerun: yes"><FONT size=3> </FONT></SPAN></SPAN>试验所用干扰素<SPAN lang=EN-US><FONT size=3>β<st1:chmetcnv w:st="on" TCSC="0" NumberType="1" Negative="True" HasSpace="False" SourceValue="1" UnitName="a">-1a</st1:chmetcnv></FONT></SPAN>为已在多个国家上市的不含人血清白蛋白制剂，但在美国尚未上市。预示患者首次脱髓鞘事件的临床症状包括刺痛、麻木、肌无力或平衡问题，他们在<SPAN lang=EN-US><FONT size=3>MRI</FONT></SPAN>检查中至少还存在<SPAN lang=EN-US><FONT size=3>2</FONT></SPAN>处无临床症状的脑损伤。出现第<SPAN lang=EN-US><FONT size=3>2</FONT></SPAN>次临床发作或扩展残疾状态量表（<SPAN lang=EN-US><FONT size=3>EDSS</FONT></SPAN>）评分持续增加<SPAN lang=EN-US><FONT size=3>>1.5</FONT></SPAN>者确诊为<SPAN lang=EN-US><FONT size=3>CDMS</FONT></SPAN>。初始使用安慰剂但没有发展为<SPAN lang=EN-US><FONT size=3>CDMS</FONT></SPAN>患者（即入组<SPAN lang=EN-US><FONT size=3>REFLEXION</FONT></SPAN>试验后转为干扰素治疗的患者）开始接受干扰素治疗时距离他们首次症状出现平均时间为<SPAN lang=EN-US><FONT size=3>58 d</FONT></SPAN>。<SPAN lang=EN-US><BR><SPAN style="mso-spacerun: yes"><FONT size=3> </FONT></SPAN></SPAN>研究者指出，该结果再次证明干扰素<SPAN lang=EN-US><FONT size=3>β<st1:chmetcnv w:st="on" TCSC="0" NumberType="1" Negative="True" HasSpace="False" SourceValue="1" UnitName="a">-1a</st1:chmetcnv></FONT></SPAN>早期治疗具有长期作用，表明早期治疗是控制<SPAN lang=EN-US><FONT size=3>MS</FONT></SPAN>进展的最佳机会。此外，该研究还解决了其他试验中遗留的最佳剂量问题。<SPAN lang=EN-US><BR><FONT size=3><SPAN style="mso-spacerun: yes"> </SPAN>REFLEXION</FONT></SPAN>试验由默克雪兰诺公司资助。<SPAN lang=EN-US><FONT size=3>Freedman</FONT></SPAN>博士无相关利益冲突披露。<SPAN lang=EN-US><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></SPAN></P> |
