| 摘要: |
| 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。 |
| 关键词: 超说明书用药 伦理 循证 知情同意 风险防范 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2017.10.015 |
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| 基金项目: |
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| Off-Lable Drug Use Based on the Perspective of Ethics |
| Lu Xiaotong, Liu Yan |
| (Xinhua Hospital Affiliate to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China) |
| Abstract: |
| Off-lable drug use is prevalent in clinical practice, and this phenomenon mainly due to limited clinical drug trials of special population or disease. At the same times, medical staffs爷duty and legal consciousness are absent, and the risk of the existence of off-lable drug use is underestimated. So we explored this phenomenon from the prespective of ethics, and thought the using of off-lable drug use should be fully weighed on the benefits and risks of patients, and doctors should pay attention to informed consent and respect for patient rights. We also recommend that study of clinical drug trial should be professional, and the evidence-based basis should be
reliable. Management of off-lable drug use should be strengthened to ensure routine treatment. Standardized the using of off-lable drug use will increase the safety and effective, decrease the risk of off-lable drug use in clinic。 |
| Key words: off-lable drug use ethics evidence-based informed consent risk prevention |
