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魏则西事件追踪:斯坦福大学未与中方医院合作

2016-05-04 09:41:57   新华时报

4DC-CIK主要适应症是什么?

李昂介绍,DC-CIK适应症包括肺癌、肝癌、胃癌、肠癌、肾癌、急慢性白血病、淋巴瘤、恶性黑色素瘤、鼻咽瘤、乳腺癌、宫颈癌、前列腺癌、舌癌、甲状腺癌等。但他表示,以前有人做过很多研究,用DC-CIK疗法去治疗各种肿瘤,但总体上发现,它并没有任何效果。

关于DC-CIK治疗的副作用,李昂说,患者可能会出现发热的症状,有的患者会出现兴奋或者是疲劳的情况。但一般不会出现严重事件。

5国内医院开展情况如何?

据微信公众号“知识分子”称,CIK或DC-CIK疗法此前已在美国历经多年研究,但其相关临床试验在美国基本全部宣告失败,绝大多数基于该方法的治疗技术均未得到上市批准。目前,美国已鲜有DC-CIK疗法的临床试验。前期研究没有看到有效的疗效,也就不能在临床上推广使用,但是如果有新的变化,用于临床研究还是可以。

李昂介绍,生物免疫疗法在国内医院开展的不少,但大部分都是部队医院或者相对小一点的医院。真正的市属、卫生部直属的三甲医院基本上没有做这个的。

“按照规定,DC-CIK疗法目前还处于临床研究阶段,三甲医院要对病人用这种疗法,医生一般会给病人看知情同意书,让他知道,用这种疗法会产生什么样的效果。此外,因为这种疗法目前处于研究阶段,因此按照方案要求,必须征求病人他是否愿意参加到试验中来,才可以实施这种疗法。因此,不可能给病人收费。而且这种治疗如何收费,市属、部属医院目前也还没有相关规定。”

6免疫疗法是否接受监管?

李昂表示,治疗性的技术在医学上前期会有一期、二期、三期的临床试验。通过了试验,证明有效才可以大规模地引用。

而据有关媒体报道,按照《医疗技术临床应用管理办法》相关规定,卫计委需在批准这一疗法之前组织临床试验和伦理审查。在2014年

南方周末

的报道中,有业内人士曾表示,卫计委从未组织过此类试验或审查,就将细胞免疫疗法归为允许开展临床应用的第三类医疗技术。

对此,科学家们也曾想过拿出合理的解决方案。2009年,曾益新院士联合中山大学附属肿瘤医院、天津肿瘤医院、北京三零二医院和中国科技大学四家单位,从四个环节开展了细胞免疫疗法的标准研究和制定。这一研究项目在2013年结题并提交给卫计委,但至今未有下文。

而到了2015年5月,一纸命令取消了第三类医疗技术的审批工作,这项始终没有认定安全性和有效性的疗法,就此彻底游走于灰色地带。

责任编辑:赵逸 CN039
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