超说明书用药在临床普遍存在,主要原因是特殊人群或特殊疾病药物临床试验开展有限,医务人员对超说明书用药的责任与法律意识不强,对超说明书用药存在的风险估计不足。从伦理的角度对超说明书用药进行探讨,提出超说明书用药应充分权衡患者的获益与风险,重视知情同意,尊重患者权利,确保药物治疗的科学性以及具有可靠的循证依据支持,加强管理,规范超说明书用药的常规性治疗,防范风险。 Super instruction manual medication is ubiquitous in clinical practice, mainly due to the limited clinical trial of special population or special disease drugs, the medical staff’s responsibility and legal consciousness of using super manual medicine is not strong, and the risk of using super instruction manual is underestimated. From the ethical point of view to discuss the use of drugs in the super instruction manual, it is suggested that the use of the super instructions should weigh the benefits and risks of the patients adequately, pay attention to the informed consent, respect the rights of the patients, ensure the scientificity of the drug treatment and have reliable evidence base support, strengthen management , Regulate super manual medication for routine treatment, to prevent risks.