随着医学研究实践不断的更新完善和药品市场的日益繁荣，药品生产厂商利益与药品价值的矛盾冲突，药品说明书和医疗执业行为的自身局限等主、客观因素决定了超说明书用药不可避免，成为临床药物治疗中必然存在的现象。而全球与药品超说明书使用相关立法的国家却仅有7个，它们是美国、德国、意大利、荷兰、新西兰、印度和日本，虽然中国还没有对超说明书用药有法律或权威的界定，但业内人员都有一个共识，即超说明书用药中有一部分是可取的，有其合理性和必要性，但当下的关键是如何更好地引导与规范，让超说明书用药既能保障患者用药安全，又能规避医疗机构和医务人员的执业风险。本文简要介绍超说明书用药的定义、国内外超说明书用药现状、产生原因及管理态度，并对我国规范超说明书用药提出意见和建议。% With the constant updating of medical research practice and growing prosperity of pharmaceutical market, conflict between the profits of pharmaceutical manufacturers and values of medicine, and some subjective and objective factors, such as package inserts and the limits of medical practices, off-label use of medicines becomes inevitable, which is a definitely existing phenomenon in clinical pharmacotherapy. Nowadays, only seven countries have laws related to off-label drug use, including America, Germany, Italy, Netherland, New Zealand, India and Japan. Although there is no legal or authoritative definition of off-label drug use in China, medical personnel have a consensus that part of off-label drug use is desirable, which has its rationality and necessity. While the key point is how to guide and regulate the off-label use of medicine better, which can not only ensure the safety of patients in treatment, but also can avoid occupational risks of medical institutions and medical staff. This review briefly introduces the definition of off-label drug use, current situation of domestic and international off-label drug use, causes and attitude of management, and finally suggestions and recommendations for regulating off-label drug use in China were put forwards.
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