中药临床试验方案科学审查背后的伦理问题

Ethical promblems behind the scientific review of TCM clinical trials

随着中医药临床研究的不断深入,基于受试者安全和权益保护的伦理审查已得到广泛重视。对临床试验方案的伦理审查,主要包括伦理审查和科学审查两个方面。对于后者,人们习惯从纯粹的技术角度,而不是伦理角度讨论分析并提出建议,进而淡化了临床试验方案伦理审查的意义。鉴此,文章从临床试验方案设计中的中药不良反应报告、不良反应预警、疗效过度渲染、安慰剂、中药阳性对照药、剂量、疗程、适应证、基础用药、疗效级别、检验方法选择11个方面,揭示了科学审查中隐藏的伦理问题,旨在提高科学审查的伦理意识,自觉、理性地保护受试者的权益和安全。

Along with the development of traditonal Chinese medicine（TCM） clinical research,ethical review based on a protection of the safty and right of subjects have gained a extensive attention.The ethical review of clinical trial schemes mainly include the ethical review and the scientific review.For the latter,people are used to analyze from the perspective of a skill rather than the ethic,resulting in downplaying the significance of ethical review.Therefore,to improve the ethical awareness and reasoningly and subjectively protect the safty and right of subjects,this paper reveals some ethical problems in scientific review from some aspects,such as defective adverse drug reaction（ADR） report,ADR warning,exaggerated curative effect,placebo,the choice of TCM drug as positive control,dosage,period of treatment,indication,basic drug,curative effect degree,test method,etc.