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O药 - 版本历史
2026-04-18T07:19:48Z
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2026-01-06T07:30:47Z
<p>建立内容为“<div style="padding: 0 4%; line-height: 1.8; color: #1e293b; font-family: 'Helvetica Neue', Helvetica, 'PingFang SC', Arial, sans-serif; background-color: #ffffff…”的新页面</p>
<p><b>新页面</b></p><div><div style="padding: 0 4%; line-height: 1.8; color: #1e293b; font-family: 'Helvetica Neue', Helvetica, 'PingFang SC', Arial, sans-serif; background-color: #ffffff; max-width: 1200px; margin: auto;"><br />
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<strong>[[欧狄沃]]([[Opdivo]])</strong>，通用名为<strong>[[纳武利尤单抗]]([[Nivolumab]])</strong>，研发代码为<strong>[[BMS-936558]]</strong>，俗称<strong>[[O药]]</strong>，是由美国<strong>[[百时美施贵宝]]([[BMS]])</strong>研发的全球首个获批上市的<strong>[[程序性死亡受体1]]([[PD-1]])</strong>抑制剂。作为2026年免疫检查点抑制剂的领军药物，[[纳武利尤单抗]]通过高亲和力结合T细胞表面的[[PD-1]]，阻断其与配体[[PD-L1]]/[[PD-L2]]的结合，从而消除免疫抑制并恢复T细胞的抗肿瘤活性。2026年，该药在<strong>[[胃癌]]</strong>、<strong>[[非小细胞肺癌]]</strong>及<strong>[[尿路上皮癌]]</strong>的围手术期管理中确立了核心地位，且其<strong>[[皮下注射]]</strong>剂型的普及显著提升了临床治疗的便利性与患者依从性。<br />
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<div style="font-size: 1.2em; font-weight: bold; letter-spacing: 1.2px;">欧狄沃 (O药)</div><br />
<div style="font-size: 0.7em; opacity: 0.85; margin-top: 4px; white-space: nowrap;">Opdivo (Nivolumab)·点击展开</div><br />
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<div style="width: 140px; height: 90px; background-color: #f1f5f9; display: flex; align-items: center; justify-content: center; color: #94a3b8; font-size: 0.8em; padding: 10px; text-align: center;">Nivolumab-PD-1 Complex Binding Structure</div><br />
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<div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">靶点基因：[[PDCD1]]</div><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0; width: 40%;">[[Entrez]]ID</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">5133</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[HGNC]]编号</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">8760</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">[[UniProt]]</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">Q15116</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">分子量</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">约146kDa</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">研发公司</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">[[BMS]]/[[小野制药]]</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">亚型</th><br />
<td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #1e40af;">人源化IgG4-κ</td><br />
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<th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569;">2026热点</th><br />
<td style="padding: 12px; color: #1e40af;">皮下注射剂型全球获批</td><br />
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<h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">分子机制：阻断负向调节与免疫复活</h2><br />
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[[纳武利尤单抗]]的作用机制聚焦于通过特异性结合[[PD-1]]受体，切断肿瘤细胞的免疫逃逸通路。<br />
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<li style="margin-bottom: 12px;"><strong>受体占位效应：</strong><br />
[[纳武利尤单抗]]作为一种完全人源化的单克隆抗体，能与活化T细胞上的[[PD-1]]受体稳定结合。2026年分子药理研究证实，其在体内的受体占位率（[[RO]]）在给药周期内维持在80%以上。</li><br />
<li style="margin-bottom: 12px;"><strong>信号转导阻断：</strong><br />
阻断[[PD-1]]与[[PD-L1]]/[[PD-L2]]的相互作用，可抑制胞内[[SHP-2]]磷酸酶的募集，从而恢复<strong>[[CD28]]</strong>介导的共刺激信号，激活<strong>[[CD8+T细胞]]</strong>产生颗粒酶和穿孔素。</li><br />
<li style="margin-bottom: 12px;"><strong>记忆免疫维持：</strong><br />
2026年前沿研究指出，[[O药]]治疗后能诱导中枢记忆性T细胞（[[Tcm]]）的库群扩增，这是部分患者实现长期无进展生存（[[PFS]]）的关键。</li><br />
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<h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">2026核心临床证据矩阵([[CheckMate]]系列)</h2><br />
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<th style="padding: 12px; border: 1px solid #cbd5e1; color: #0f172a; width: 25%;">试验代号</th><br />
<th style="padding: 12px; border: 1px solid #cbd5e1; color: #475569;">适应症/人群(2026评价)</th><br />
<th style="padding: 12px; border: 1px solid #cbd5e1; color: #1e40af;">关键里程碑数据</th><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[CheckMate-649]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">晚期[[胃癌]]/[[GEJC]]一线；CPS≥5。</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;"><strong>五年随访确认</strong>：显著优于单纯化疗，确立标准一线。</td><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[CheckMate-816]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">可手术[[NSCLC]]新辅助治疗。</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">2026年数据：联合化疗显著提升[[pCR]]及[[EFS]]。</td><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[CheckMate-274]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">[[尿路上皮癌]]术后辅助治疗。</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">2026版指南首选推荐，显著降低极高危患者复发率。</td><br />
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<td style="padding: 10px; border: 1px solid #cbd5e1; font-weight: 600;">[[CheckMate-9LA]]</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">一线[[NSCLC]]；O+Y+双药化疗。</td><br />
<td style="padding: 10px; border: 1px solid #cbd5e1;">双免疫+化疗方案在全人群中的长期生存获益确认。</td><br />
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<h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">2026治疗策略：从静脉输注到皮下便捷化</h2><br />
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[[纳武利尤单抗]]在2026年的临床实践中展现了“精准筛选”与“剂型革命”的双重特征：<br />
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<li style="margin-bottom: 12px;"><strong>CPS 指导下的胃癌治疗：</strong> 2026版中国[[CSCO]]指南建议，对于晚期胃腺癌患者，必须进行<strong>[[PD-L1]]</strong>检测，[[CPS]]≥5者应尽早启动“O药联合化疗”的一线方案。</li><br />
<li style="margin-bottom: 12px;"><strong>皮下注射(SC)的临床转型：</strong> 2026年，[[纳武利尤单抗]]联合[[透明质酸酶]]的皮下注射制剂全面普及。相比传统静脉滴注（30-60分钟），皮下给药仅需3-5分钟，显著减轻了门诊医疗压力。</li><br />
<li style="margin-bottom: 12px;"><strong>双免疫联合(O+Y)策略：</strong> 针对特定群体（如[[MSI-H]]结直肠癌或黑色素瘤），[[纳武利尤单抗]]联合<strong>[[伊匹木单抗]]</strong>（[[Yervoy]]）依然是2026年获取最长应答深度的金标准。</li><br />
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<h2 style="background: #f1f5f9; color: #0f172a; padding: 10px 18px; border-radius: 0 6px 6px 0; font-size: 1.25em; margin-top: 40px; border-left: 6px solid #0f172a; font-weight: bold;">关键相关概念</h2><br />
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<li style="margin-bottom: 8px;"><strong>[[伊匹木单抗]]([[Ipilimumab]])：</strong> [[O药]]经典的双免疫合作伙伴，靶向[[CTLA-4]]。</li><br />
<li style="margin-bottom: 8px;"><strong>[[CPS评分]]：</strong> 2026年胃癌及食管癌应用[[O药]]的核心生物标志物评价标准。</li><br />
<li style="margin-bottom: 8px;"><strong>[[PD-1]]抑制剂：</strong> [[纳武利尤单抗]]所属的药物大类。</li><br />
<li style="margin-bottom: 8px;"><strong>[[MSI-H]]：</strong> 对[[O药]]具有极高敏感性的特征性分子分型。</li><br />
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<span style="color: #0f172a; font-weight: bold; font-size: 1.05em; display: inline-block; margin-bottom: 15px;">学术参考文献与权威点评</span><br />
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[1] <strong>Janjigian YY, et al. (2021/2026Update).</strong> <em>First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): 5-year follow-up.</em> <strong>[[The Lancet]]</strong>.<br><br />
<span style="color: #475569;">[权威点评]：CheckMate-649研究的长效随访数据彻底巩固了[[O药]]在消化道肿瘤免疫治疗中的霸主地位。</span><br />
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[2] <strong>Forde PM, et al. (2022/2026Revision).</strong> <em>Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer: Final EFS Analysis of CheckMate 816.</em> <strong>[[The New England Journal of Medicine]]</strong>.[Academic Review]<br><br />
<span style="color: #475569;">[学术点评]：2026年汇总分析确认，[[纳武利尤单抗]]在新辅助阶段的应用是实现早期肺癌长期治愈的关键。</span><br />
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纳武利尤单抗 (Nivolumab) · 知识图谱<br />
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<td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">关联靶点</td><br />
<td style="padding: 10px 15px; color: #334155;">[[PD-1]]•[[CTLA-4]]•[[PD-L1]]•[[CD80]]•[[CD8+T细胞]]</td><br />
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<td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">治疗组合</td><br />
<td style="padding: 10px 15px; color: #334155;">[[伊匹木单抗]]•[[XELOX]]•[[化疗]]•[[瑞妥昔单抗]]</td><br />
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<td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">核心癌种</td><br />
<td style="padding: 10px 15px; color: #334155;">[[胃癌]]•[[非小细胞肺癌]]•[[黑色素瘤]]•[[肾细胞癌]]•[[霍奇金淋巴瘤]]</td><br />
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<td style="width: 85px; background-color: #f8fafc; color: #334155; font-weight: 600; padding: 10px 12px; text-align: right; vertical-align: middle; white-space: nowrap;">研发实体</td><br />
<td style="padding: 10px 15px; color: #334155;">[[百时美施贵宝]]•[[小野制药]]•[[Medarex]]</td><br />
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223.160.138.166