超说明书用药在一定程度上满足了临床用药,实现了患者最需要的治疗,推动了医学的发展,但同时也存在一定风险.通过对超说明书用药现象进行分析,从医学伦理学的视角提出应坚持行善原则和尊重原则,具体来说,端正超说明书用药的动机、严格审查支持证据、保障患者的知情同意、加强伦理审查、引入保险分担机制,以实现既保障患者用药安全又规避医务人员的执业风险.%Off-label drug use to some extent meets the clinical medication,achieves the most needed treat-ment of patients and promotes the development of medicine,but there exists certain risks at the same time.Through the analysis of the phenomenon of off-label drug use,from the perspective of medical ethics,this paper proposed that it should adhere to the principles of beneficence and respect,specifically,correcting the motives of off-label drug use,strict review of supporting evidence,ensuring patient's informed consent,strengthening ethical review andintroducing the insurance sharing mechanism,so as to achieve both the guarantee of patient's medication safety and the aversion of medical personnel's practice risks.
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