史上最贵的“抗癌神药”——一针120万
<img src="https://mmbiz.qpic.cn/mmbiz_gif/jWDC4ZureqfXZfibYAIyJ5ibnaSbU1d1t9weTZYrs9ZXmlyLp76LMUNM5TVRrx4icfeBJavCXlflZWiaEegfnYO8fA/640?wx_fmt=gif&tp=webp&wxfrom=5&wx_lazy=1" style="width: 50%; margin-bottom: 20px;"><p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">家人们，前段时间，一则天价抗癌药的<span style="color: black;">资讯</span>火了！</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2019年6月确诊弥漫性B大细胞瘤的一位阿姨经<span style="color: black;">太多</span>种治疗后病情又复发，复发后治疗效果又<span style="color: black;">欠好</span>，加之<span style="color: black;">病人</span>年龄比<span style="color: black;">很强</span><span style="color: black;">非常多</span>治疗<span style="color: black;">方法</span>不适合她，陷入绝境的她在今年6月看到了<span style="color: black;">期盼</span>，<span style="color: black;">由于</span>6月23日，药监局正式<span style="color: black;">准许</span>了阿基仑赛注射液上市，这是国内首款CAR-T细胞疗法。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">6月30日，上海交大医学院<span style="color: black;">附庸</span>瑞金医院专家为<span style="color: black;">病人</span>采集细胞体外培养，8月2日T细胞输回<span style="color: black;">病人</span><span style="color: black;">身体</span>，8月底，进行PET-CT<span style="color: black;">检测</span>，<span style="color: black;">发掘</span><span style="color: black;">身体</span>暂时<span style="color: black;">无</span>癌细胞，症状完全得到了缓解并于8月26号出院回家。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">68毫升的药水，120万天价，</span></strong><span style="color: black;"><span style="color: black;">非常多</span>网友在视频评论区感叹：贫穷限制了我的想象，世界上真有一种病叫穷病。打算<span style="color: black;">起始</span>存钱了等年龄大了<span style="color: black;">期盼</span>这种药<span style="color: black;">已然</span>被纳入<span style="color: black;">医疗保险</span>，<span style="color: black;">否则</span>压力有点大。</span></p><strong style="color: blue;">天价神药的来龙去脉</strong>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2012年4月七岁的艾米丽——一位急性淋巴白血病<span style="color: black;">病人</span>，在尝试了<span style="color: black;">各样</span>治疗<span style="color: black;">方法</span>后还是复发了，<span style="color: black;">大夫</span>告诉她的父母<span style="color: black;">已然</span>用了<span style="color: black;">各样</span>治疗<span style="color: black;">方法</span><span style="color: black;">针对</span>她的病情<span style="color: black;">已然</span><span style="color: black;">没</span>能为力了，然而艾米丽的父母<span style="color: black;">无</span>放弃，<span style="color: black;">她们</span>找到了费城儿童医院加入了当时尚<span style="color: black;">处在</span><span style="color: black;">初期</span>临床<span style="color: black;">周期</span>的CAR-T<span style="color: black;">科研</span><span style="color: black;">作为</span>了世界上<span style="color: black;">第1</span>个接受CAR-T免疫治疗的儿童，并大获成功。艾米丽从一个被宣布死亡的癌症晚期儿童变成如今<span style="color: black;">没</span>癌<span style="color: black;">存活</span>了9年的正常小姑娘。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">奕凯达的前身是美国吉利德<span style="color: black;">机构</span>生产的抗人CD19 CAR-T细胞注射液（YESCARTA），经该<span style="color: black;">机构</span>授权并技术转移给国内<span style="color: black;">机构</span>进行生产。YESCARTA于2017年由FDA<span style="color: black;">准许</span>上市，在美国定价高达37.3万美元。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/AdHGJFrgGgoES0hxLEkrWQsELteiaictMHibNmAgduQHocIRFjia7jXdUSeN1leto1lGd70lNrvG4t2VvEPs0IhFlg/640?wx_fmt=jpeg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">9月3日，国家药监局官网公示，药明巨诺靶向CD19的CAR-T<span style="color: black;">制品</span><strong style="color: blue;"><span style="color: black;">瑞基奥仑赛注射液</span></strong>（relma-cel，商品名：倍诺达）已正式<span style="color: black;">获准</span>。瑞基奥仑赛注射液此次<span style="color: black;">获准</span>的适应症为：用于治疗经过二线或以上系统性治疗后成人<span style="color: black;">病人</span>的<span style="color: black;"><strong style="color: blue;">复发或难治性大B细胞淋巴瘤。</strong></span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">这是药明巨诺首款<span style="color: black;">获准</span>上市的创新<span style="color: black;">制品</span>，<span style="color: black;">作为</span>中国第二款<span style="color: black;">获准</span>的CAR-T<span style="color: black;">制品</span>，<span style="color: black;">亦</span>是中国首款1类生物制品的CAR-T<span style="color: black;">制品</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">今年<span style="color: black;">败兴</span>，国内CAR-T<span style="color: black;">制品</span>发展<span style="color: black;">快速</span>，在短短3个月之间，已有2款CAR-T<span style="color: black;">制品</span><span style="color: black;">获准</span>上市。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">中国<span style="color: black;">第1</span>款<span style="color: black;">获准</span>的CAR-T<span style="color: black;">制品</span>是<strong style="color: blue;"><span style="color: black;">复星凯特<span style="color: black;">机构</span>的奕凯达</span></strong>（阿基仑赛注射液），在今年6月份刚上市。用于治疗既往接受二线或以上系统性治疗后复发或难治性大B细胞淋巴瘤的成人<span style="color: black;">病人</span>。</span></p><strong style="color: blue;">CAR-T的治疗原理</strong>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">CAR-T细胞疗法被认为是极有前景的细胞免疫抗癌疗法，其原理是将T细胞进行改造，使它装备有特异性识别癌细胞的肿瘤嵌合抗原受体，就像给导弹装备了高精度导航器，使T细胞<span style="color: black;">能够</span><span style="color: black;">有效</span>地识别<span style="color: black;">身体</span>肿瘤细胞，<span style="color: black;">经过</span>免疫杀伤机制来杀灭癌细胞，从而达到治愈或缓解肿瘤的效果。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/AdHGJFrgGgoES0hxLEkrWQsELteiaictMHVa46QW6NJE8Th7AX1FKAoHelzDia0OYOviaAeicFfU176gKRFs46Wbicsg/640?wx_fmt=jpeg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">该技术的原理是将病人的免疫细胞体外强化改造后输回<span style="color: black;">身体</span>，<span style="color: black;">创立</span>起更强悍的免疫系统，抗击癌细胞。与传统手段相比，它的<span style="color: black;">优良</span>是只用注射一次，50%<span style="color: black;">病人</span>的<span style="color: black;">存活</span>期能够由原来的半年延长至4年。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/AdHGJFrgGgoES0hxLEkrWQsELteiaictMHxcgWXJARSATusEzQQZWbvRyaU8n0x0HsGK8d6eRD0ogMVM2oic2jichQ/640?wx_fmt=jpeg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p><strong style="color: blue;">神药的普及性<span style="color: black;">怎样</span>？会不会纳入<span style="color: black;">医疗保险</span>？</strong>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">要普及就要<span style="color: black;">处理</span>两个问题：</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">1、</span>扩大适应症</span></strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">2、</span>降价</span></strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">CAR-T细胞疗法<span style="color: black;">日前</span>还仅限于<strong style="color: blue;"><span style="color: black;">血液系统肿瘤</span></strong>，对实体瘤如肺癌、乳腺癌等效果<span style="color: black;">不良</span>。<span style="color: black;">由于</span>实体瘤<span style="color: black;">拥有</span>更<span style="color: black;">繁杂</span>的免疫微环境，面临着低氧、高酸和免疫失衡等多种<span style="color: black;">原因</span>的干扰，CAR-T细胞的扩增效率和维持时间都大打折扣。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">想要</span>让<span style="color: black;">更加多</span>的肿瘤<span style="color: black;">病人</span>用上CAR-T细胞疗法，<span style="color: black;">必要</span>在理论上有所突破，工艺上进一步革新。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">另一</span>，奕凯达在短期内很难<span style="color: black;">显现</span>大幅降价，这<span style="color: black;">重点</span>是<span style="color: black;">由于</span><span style="color: black;">药品</span>的制作工艺<span style="color: black;">繁杂</span>。CAR-T细胞<span style="color: black;">必须</span>液氮下<span style="color: black;">长时间</span>储存，CAR慢病毒<span style="color: black;">亦</span><span style="color: black;">必须</span>-80℃冷链运输，运输半径不超过4小时，这些都让成本大大<span style="color: black;">增多</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">日前</span>国内参考了美国现行的CAR-T经验。FDA强制<span style="color: black;">需求</span>，CAR-T<span style="color: black;">制品</span>只能在经认证的治疗中心进行<span style="color: black;">运用</span>，并由经过培训的<span style="color: black;">大夫</span><span style="color: black;">供给</span>，这些治疗中心大<span style="color: black;">大都是</span>医院的血液和骨髓移植<span style="color: black;">分部</span>，并且<span style="color: black;">全部</span>治疗过程从细胞收集、储存、运输和接收都有既定流程和数据<span style="color: black;">需求</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">况且</span>，奕凯达<span style="color: black;">日前</span>的适应证有限，<span style="color: black;">病人</span>群体并不广泛，<span style="color: black;">想要</span><span style="color: black;">尽可能</span>短期内回收成本，只能高价出售。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">因为</span>我国近年来<span style="color: black;">医疗保险</span>财政压力一路<span style="color: black;">提升</span>，<span style="color: black;">非常多</span>受众更广泛的<span style="color: black;">药品</span>尚未纳入<span style="color: black;">医疗保险</span>，奕凯达<span style="color: black;">做为</span>上市后还需进行4期临床<span style="color: black;">实验</span>的<span style="color: black;">药品</span>，医保短期内为其打开绿色通道的可能性不大。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">奕凯达的上市为我国肿瘤治疗打开了一扇新门，<span style="color: black;">拥有</span><span style="color: black;">要紧</span>的临床价值。但<span style="color: black;">日前</span><span style="color: black;">全世界</span>CAR-T细胞疗法还<span style="color: black;">处在</span>初期，广泛普及还任重而道远。相信当<span style="color: black;">咱们</span>逐步实现技术的完全独立，并随着国家财政实力的<span style="color: black;">持续</span><span style="color: black;">提高</span>，<span style="color: black;">将来</span><span style="color: black;">更加多</span>的肿瘤<span style="color: black;">病人</span>会<span style="color: black;">作为</span>新疗法的受益者。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">在当前<span style="color: black;">周期</span>，普通人拿120万搏命四年，<span style="color: black;">到底</span>值不值呢？</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_gif/jWDC4ZureqeYyoYjCDVicdXibPgqycZGOP9YflNZwOhbSNUynCQ7DtkJRpNfBXkhMyWIibKpbu20erBCscia7g7u9A/640?wx_fmt=gif&tp=webp&wxfrom=5&wx_lazy=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_gif/jWDC4ZureqfXZfibYAIyJ5ibnaSbU1d1t9hDxCykRE21Ujy08kxyHYlgrfIW8HJib5PAcDV0GzYiaCiathzMZ9icks9A/640?wx_fmt=gif&tp=webp&wxfrom=5&wx_lazy=1" style="width: 50%; margin-bottom: 20px;"></p>
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