查看“艾普罗”的源代码

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            <strong>[[艾普罗]]</strong>（<strong>[[Epkinly]]</strong>，通用名：<strong>[[埃比妥单抗]]</strong>）是一种基于<strong>[[DuoBody]]</strong>技术平台开发的<strong>[[IgG1]]</strong>型全人源<strong>[[双特异性抗体]]</strong>。作为全球首个且目前唯一获批采用<strong>[[皮下注射]]</strong>（SC）给药方式的<strong>[[CD20]]</strong>/<strong>[[CD3]]</strong>衔接器，它通过同时结合<strong>[[B细胞]]</strong>表面的<strong>[[CD20]]</strong>抗原和<strong>[[T细胞]]</strong>表面的<strong>[[CD3]]</strong>受体，重定向并激活<strong>[[T细胞]]</strong>对恶性<strong>[[B细胞]]</strong>进行精准杀伤。<strong>[[艾普罗]]</strong>目前已被<strong>[[FDA]]</strong>与<strong>[[NMPA]]</strong>批准用于治疗既往接受过至少两线系统治疗的复发或难治性<strong>[[弥漫性大B细胞淋巴瘤]]</strong>（DLBCL）及<strong>[[滤泡性淋巴瘤]]</strong>（FL），为血液肿瘤的<strong>[[精准医疗]]</strong>提供了极具便捷性的高效方案。
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            <div style="font-size: 1.2em; font-weight: bold; letter-spacing: 1.2px;">艾普罗(Epkinly)</div>
            <div style="font-size: 0.7em; opacity: 0.85; margin-top: 4px; white-space: nowrap;">埃比妥单抗·CD20×CD3双抗·点击展开</div>
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                <div style="font-size: 0.8em; color: #64748b; margin-top: 12px; font-weight: 600;">核心靶标：<strong>[[CD20]]</strong>/<strong>[[CD3]]</strong></div>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0; width: 40%;"><strong>[[Entrez]]</strong>ID</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">931(<strong>[[MS4A1]]</strong>)/916</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;"><strong>[[UniProt]]</strong></th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">P11836/P07766</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">药物类型</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">双特异性单克隆抗体</td>
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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>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;">约148kDa</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">研发厂家</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #0f172a;"><strong>[[Genmab]]</strong>/<strong>[[艾伯维]]</strong></td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569; border-bottom: 1px solid #e2e8f0;">给药途径</th>
                    <td style="padding: 6px 12px; border-bottom: 1px solid #e2e8f0; color: #1e40af;">皮下注射(SC)</td>
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                    <th style="text-align: left; padding: 6px 12px; background-color: #f1f5f9; color: #475569;">审批状态</th>
                    <td style="padding: 12px; color: #16a34a;"><strong>[[NMPA]]</strong>/<strong>[[FDA]]</strong>已上市</td>
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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;">药理机制：T细胞定向杀伤与动力学优化</h2>
    
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        <strong>[[艾普罗]]</strong>的核心机制是通过构建物理衔接，将免疫系统的“杀手”直接引向“敌人”：
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        <li style="margin-bottom: 12px;">双靶点桥接：抗体一端高亲和力结合肿瘤细胞上的<strong>[[CD20]]</strong>，另一端结合<strong>[[T细胞]]</strong>表面的<strong>[[CD3]]</strong>。这种衔接迫使<strong>[[T细胞]]</strong>与<strong>[[B细胞]]</strong>近距离接触，形成人工免疫突触。</li>
        <li style="margin-bottom: 12px;">非依赖性活化：该过程不依赖于<strong>[[MHC-I]]</strong>抗原提呈，能够直接诱导<strong>[[T细胞]]</strong>活化、增殖并释放<strong>[[穿孔素]]</strong>和<strong>[[颗粒酶]]</strong>，导致恶性<strong>[[B细胞]]</strong>发生渗透性溶解。</li>
        <li style="margin-bottom: 12px;">皮下给药优势：通过<strong>[[皮下注射]]</strong>，艾普罗在体内的吸收较为缓慢，血药浓度峰值（Cmax）较低。这种平缓的动力学特征显著降低了<strong>[[细胞因子释放综合征]]</strong>（CRS）的剧烈程度。</li>
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                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #0f172a; width: 25%;">患者群体</th>
                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #475569;">客观缓解率(ORR)</th>
                <th style="padding: 10px; border: 1px solid #cbd5e1; color: #1e40af;">临床意义分析</th>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">复发/难治性[[DLBCL]]</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">61.0%-63.0%</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">在三线及以后治疗中表现强劲，约38%达到完全缓解(CR)。</td>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">复发/难治性[[FL]]</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">82.0%</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;">针对惰性淋巴瘤展现出极高的缓解深度，CR率达60%以上。</td>
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                <td style="padding: 8px; border: 1px solid #cbd5e1; font-weight: 600;">安全性指标</td>
                <td style="padding: 8px; border: 1px solid #cbd5e1;" colspan="2;">CRS发生率约51%，绝大多数为1-2级，中位发生时间为给药后24小时左右。</td>
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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;">诊疗策略：阶梯给药与安全性精细化管理</h2>
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        <strong>[[艾普罗]]</strong>的临床应用强调“以时间换安全”，通过严格的剂量策略规避急性风险：
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        <li style="margin-bottom: 12px;">阶梯剂量方案（Step-up Dosing）：为预防严重<strong>[[CRS]]</strong>，必须执行24天的三步给药计划。首剂0.16mg，第8天0.8mg，第15天进入48mg的维持剂量。</li>
        <li style="margin-bottom: 12px;">预防性感染监测：由于<strong>[[CD20]]</strong>靶向导致广泛的<strong>[[B细胞耗竭]]</strong>，患者易发生<strong>[[低丙种球蛋白血症]]</strong>。需定期补充<strong>[[静脉注射免疫球蛋白]]</strong>（IVIG）。</li>
        <li style="margin-bottom: 12px;">神经毒性管理：监测<strong>[[ICANS]]</strong>（免疫效应细胞相关神经毒性）。虽然发生率较低，但仍需在给药前24-48小时内密切观察患者的言语及意识。</li>
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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>
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            <li style="margin-bottom: 8px;"><strong>[[CD20]]</strong>：B细胞表面的金标准靶点，也是艾普罗锁定肿瘤的“定位器”。</li>
            <li style="margin-bottom: 8px;"><strong>[[格罗菲妥单抗]]</strong>（Glofitamab）：同靶点静脉给药双抗，是艾普罗的主要竞争产品。</li>
            <li style="margin-bottom: 8px;"><strong>[[CAR-T疗法]]</strong>：艾普罗常作为<strong>[[CAR-T]]</strong>治疗失败后的关键挽救手段或替代方案。</li>
            <li style="margin-bottom: 8px;"><strong>[[细胞因子释放综合征]]</strong>（CRS）：双抗治疗中核心且可管理的全身性炎症反应。</li>
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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>
        
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            [1] <strong>Thieblemont C, et al. (2023).</strong> <em>Epcoritamab in relapsed or refractory large B-cell lymphoma: mechanisms of action and phase 1/2 clinical results.</em> <strong>[[Journal of Clinical Oncology]]</strong>.<br>
            <span style="color: #475569;">[权威点评]：NHL-1研究确立了艾普罗在三线及以上DLBCL中的地位，皮下给药安全性极佳。</span>
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            [2] <strong>Jurczak W, et al. (2024).</strong> <em>Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma.</em> <strong>[[The Lancet Haematology]]</strong>.[Academic Review]<br>
            <span style="color: #475569;">[学术点评]：总结了该药物在FL中极高的缓解率，验证了双抗作为“现货型”疗法的长期价值。</span>
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            艾普罗(Epkinly)诊疗生态·知识图谱
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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>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[CD20]]</strong>•<strong>[[CD3]]</strong>•<strong>[[CD19]]</strong>•<strong>[[CD22]]</strong>•<strong>[[PD-L1]]</strong></td>
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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;">同类管线</td>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[格罗菲妥单抗]]</strong>•<strong>[[莫妥珠单抗]]</strong>•<strong>[[奥比妥珠单抗]]</strong>•<strong>[[博纳吐单抗]]</strong></td>
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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;">战略实体</td>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[Genmab]]</strong>•<strong>[[艾伯维]]</strong>•<strong>[[FDA]]</strong>•<strong>[[NMPA]]</strong>•<strong>[[CSCO]]</strong></td>
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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;">前沿方向</td>
                <td style="padding: 10px 15px; color: #334155;"><strong>[[一线R-CHOP联合研究]]</strong>•<strong>[[中枢神经系统淋巴瘤探索]]</strong>•<strong>[[克服靶点丢失方案]]</strong>•<strong>[[门诊模式优化]]</strong></td>
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