孙奇　郝继英　马骏涛　杨志滨

中圖分类号 R951 文献标志码 A 文章编号 1001-0408（2018）01-0131-04

DOI 10.6039/j.issn.1001-0408.2018.01.32

摘 要 目的：为药学工作人员根据不同需求选择不同的药品说明书数据库提供参考。方法：搜集Drugs@FDA、FDA Online Label Repository和DailyMed三大开放获取药品说明书数据库的信息组织方式，从检索功能设置、检索结果显示内容、数据来源与服务目标三个方面进行比较分析。结果与结论：在检索功能上，以DailyMed最丰富；在检索结果显示内容上，DailyMed的数据格式化程度最高，FDA Online Label Repository次之，而Drugs@FDA只进行了部分格式化；3个数据库都提供页面复制和打印的功能，其中DailyMed的界面更为友好、内容更开放、提供了全部下载功能；在数据来源与服务目标上，Drugs@FDA和FDA Online Label Repository的系统开发者都为FDA，DailyMed为美国国立医学图书馆，Drugs@FDA采用的数据来源为经过FDA严格审批之后的药品说明书，对某一药品信息的描述最全面；FDA Online Label Repository则为厂商提交给FDA的原始说明书，其内容最新，甚至有未上市的药品；DailyMed采用的数据来源取自于已上市的药品包装盒上的信息，还包括很多上市但未经过严格审批的说明书信息，其覆盖药品最全。

关键词 药品说明书；数据库；Drugs@FDA；FDA Online Label Repository；DailyMed

ABSTRACT OBJECTIVE： To provide reference for pharmacy staff to choose different drug label databases according to different needs. METHODS： The information organization mode of the three open access drug label databases that included Drugs@FDA， FDA Online Label Repository and DailyMed had been collected and analyzed comparatively from three aspects： retrieval function settings， search results display， data resources and service targets. RESULTS & CONCLUSIONS： In respect of retrieval function， DailyMed provided the most abundant retrieval functions than others. In respects of search results display， DailyMed provided the highest degree of formatted data， followed by FDA Online Label Repository， while Drugs@FDA provided semi-formatted data. Three databases provided the functions of page replication and printing， among which the interface of DailyMed was friendlier and the content of DailyMed was more open； it provided all the download functions. In respects of data resources and service targets， developers of Drugs@FDA and FDA Online Label Repository were FDA， and that of DailyMed was National Library of Medicine （NLM）. The data sources used by Drugs@FDA were the drug labels after strict approval by FDA， and the description of drug information by Drugs@FDA was the most comprehensive. FDA Online Label Repository was the original drug labels submitted by the manufacturer to FDA， which was the latest content， and even included unlisted drugs. The data sources of DailyMed were from the information listed on the drug package， and included the information of drug label which was listed but not approved strictly； it covered most comprehensive drugs.

KEYWORDS Drug label； Database； Drugs@FDA； FDA Online Label Repository； DailyMed

药品说明书不仅可作为指导医师和患者安全用药的依据[1]，也可作为科研工作者寻找医学临床证据、挖掘药品疾病关系的来源数据。随着新药的不断推出，仅靠药品手册及教科书的查阅已不能满足用户对用药信息的及时获取需求，而网络在线药品数据库的使用可极大限度地解决这一问题。药品说明书较好地揭示了药品、适应证、活性成分、禁忌证、剂量、剂型、药理机制、生产厂商等经过精炼的重要信息，并将药品与疾病之间的治疗关系蕴含其中。……