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药物非说明书处方用途数据库的建立
The Establishment of a Drug Off-Label Use Database
【作者】 杨立;
【导师】 贺林;
【作者基本信息】 上海交通大学 , 生物学, 2013, 硕士
【摘要】 药物重定位(Dru g repos ition ing)指的是将疗效已知的药物用于治疗新的疾病,这种方法近年来已经成为药物研发过程中的一种新的有效手段。比起新药的研发,开发已知药物的新用途具有更安全,更经济,周期更短的特点,可能更适于我国这样的发展中国家。临床医师在诊疗患者病情时,会根据实际情况,以及自身行医经验开具在他们看来最合理、最有效的用药处方。这其中有相当一部分用药并非通过权威机构,如美国食品与药品管理局(FDA)的批准,这样的情况即药物非说明书处方用法(Off-label u se)。临床处方中记录了针对某一病症的用药具体信息,通过挖掘处方信息中的这些药物非说明书处方用法案例,可以用于药物重定位研究过程中的假设与检验环节,并且提供可靠的记录。基于上述原因,我们收集诊疗信息反馈系统中的临床处方用药信息,在一体化医学语言系统(UMLS)下与根据药物说明书建立的规范用药信息知识库进行比照,筛选出临床应用中的药物的新用途信息,建立了DOLU(Dru g Off-Label Use)这样一个包含8 59种药品,6 76 2个药物非说明书处方案例的药物非说明书处方用途数据库。对于每一个药物的非说明书处方用途的质量,我们建立了一个评估系统可以为药物重定位等进一步的研究提供参考依据。
【Abstract】 Drug repositioning is the application of known drugs to new indications, and has become a new effective means for the process of drug research and development in recent years. Compared with the development of new drugs, the use of known drugs can be safer, economical and with shorter development cycle, especially suitable for developing countries like China.In diagnosis and treatment, physicians always prescribe the drug which they think is safe and effective according to the actual situation and their medical practice. In many cases, the pharmaceuticals are prescribed for the indications other than the ones designated by the label, and those prescriptions have not been approved by the authorities like the European Medicines Agency (EMEA) and the Food and Drug Administration (FDA), which are so-called off-label uses. The clinical prescriptions record the use of drugs for a specific disease. By mining those off-label uses from clinical prescriptions, we can establish a reliable resource to detect and track off-label uses, and to help the drug repositioning hypotheses testing.For the above reasons, we collect the prescriptions from the diagnosis and treatment report system, and filter the off-label uses by eliminating the on-label use from our knowledge base under the Unified Medical Language System (UMLS). As such, a drug off-label use database is created, which indexes off-label indications for 859 distinct drugs from a total of 6,762 off-label-use events. We also set up an evaluating system for each off-label use for the reference of the downstream research like drug repositioning.
- 【网络出版投稿人】 上海交通大学 【网络出版年期】2017年 07期
- 【分类号】TP311.13;R95
- 【下载频次】74