创新性疗法的伦理挑战

Ethical Challenges for Innovative Therapy

基因编辑、干细胞治疗、细胞免疫疗法、粪菌移植等新型医疗干预使患者受益的同时,也伴随着巨大的风险和伦理争议。围绕创新性疗法对临床实践带来的挑战展开论述。首先对创新性疗法的概念进行辨析,归纳出创新性疗法的四大特点。其次,对比创新性疗法与研究和临床常规干预的关系,即具有研究性质的临床干预。创新性疗法的首要目的是治疗个体患者,同时具有研究的不确定性和相对高风险等特点。最后,根据创新性疗法的独特性质,提出监管创新性疗法的伦理框架。

Patients get benefit from medical innovation, such as gene editing, stem cell therapy, cellular immunotherapy and fecal microbiota transplantation, at the same time which also raise unforeseeable risks and ethical debates. This article discussed the ethical challenges of innovative therapy in clinical practice. First; it clarified the definition of the innovative therapy and summarized its four characteristics. Then, it indicated the differences between research and innovative therapy, standard medical practices and innovative therapy. And the author argued that innovative therapy was a kind of clinical intervention with some characteristics of research, which primary goal was to treat individual patient. Meanwhile, the innovative therapy had uncertainty and relatively high risks. At last, according to the nature of innovative therapy, it proposed an ethical framework for regulating innovative therapy.