【作者】 李小宁；

【导师】 梁立明；

【作者基本信息】 大连理工大学 ， 科学学与科学技术管理， 2010， 博士

【摘要】 什么样的根本性因素有助于建立并维持一个成功的药品监管体制,以保证广泛的社会成员都能够获得安全、有效、及时的药品供给,对于药品监管体制还颇为软弱的中国来说,这是一个需要重视的深层次问题。迄今,对于药品及相关事务监管问题的研究虽有大量成果,但大都局限于公共事务管理的定性分析,鲜见科学计量学视角的探讨。这正是本文致力于探索和解答的重大问题。药品及相关事务的监管活动,必须有多个学术领域的研究者和技术人员的专业支持；监管活动不仅是政府部门的行政职责,而且必须有涉及自己切身利益的社会公众参与,包括非政府的商务组织,范围广泛的社会中介组织和其它民间团体,以及反映药品监管活动舆论参与的社会媒体。由此形成和呈现出药品监管的多元参与格局。值得注意的是,药品监管领域的这种多元参与状况,不仅可以从政府和非政府组织有关药品监管的大量政策、法规、意见和建议等监管事务文件中获取,而且可以从学术界以不同学科开展药品监管领域研究活动的学术成果中获得。后者本身就是药品监管多元参与活动中不可或缺的重要组成部分。这些事务文件和研究文献,为从科学计量学的视角全面考察和定量分析药品监管的多元参与局面,提供了前提条件。用科学计量学方法研究药品监管领域的多元参与,尝试通过深入探索这一公共事务领域所处的社会环境和学术知识环境,来发现建立和维持成功的药品监管体制所需的根本性因素,从而为建设和完善科学、公正、高效的药品监管体制提供可资参考的依据。药品监管领域的事务文件数据和研究文献数据,来源于3个重要的国际或国内、专业性或综合性的文献数据库——MEDLINE、SinoMed、Web of Science。从这些文献数据库中检索出的与药品监管有关的文献样本分别应用于本文的各部分研究。探讨药品监管多元参与所采用的具体科学计量学方法,有MeSH主题词频次计量、共被引分析、关键词共现分析、聚类分析、引文分析、可视化以及对于发表或发布文献的机构进行分类和计量等。同时,还使用了常见于人文社会科学研究的文献研究方法,以及人文社会科学领域的“第三部门”概念,并与上述科学计量学方法结合在一起。使用上述分析方法探索药品监管的多元参与活动,发现了建立和维持成功的药品监管体制所需的一些根本性因素,这些根本性因素可以在以下两个方面进行总结：首先,在学术知识环境方面。多个学科参与了这个监管领域的知识构成,这些学科在现有知识体系的学科门类频谱中占有一个宽广的谱带。作为药品监管学术基础的学术研究成果十分丰富,紧紧围绕着监管实践中的各种具体问题。这些学术成果既包括一些历史悠久的经典著作,也包括晚近发表的成果,其中若干文献在学术基础的演化过程中起到了关键作用。即使是监管实践中产生的若干最为具体的概念,多个学科的研究者也都先后参与了相关的研究。这些概念的内涵随着监管实践的发展不断丰富,与之有关的学术思想也随之在争鸣辩论中不断深化,力图保证监管决策的科学和公正。其次,在社会环境方面。对于一个能够较为充分地贯彻科学公正原则、较为迅速地对于公众需要作出反应的药品监管体制来说,发达的市场经济为其提供了物质、技术基础,第三部门在药品监管领域的积极参与是其存在的社会条件。参考这些研究结果,分析我国药品监管中存在的现实问题,提出了如下建议：一、各学术领域的研究者和专业技术人员应加强对这一监管领域中问题的研究,为药品监管提供扎实的学术基础和有效的理论支撑；二、调整和修订相关法规,以动员各类专业人士、不同社会阶层和各种社会团体广泛参与这一公共事务领域。更多还原

【Abstract】 The fundamental factors in construction and preservation of a regulation system successful to ensure that all of the people obtain timely availability of medicines with safety and efficacy require much attention of Chinese people living with a weak regulation system of medicines. Therefore the aim of this dissertation is to find these fundamental factors. A lot of achievements have been made in study of regulation of medicines. However, most of them are limited in qualitative analysis of management of public affairs and few are scientometric investigation so far. This dissertation is an effort to apply scientometric methods in study of regulation of medicines.Regulation of medicines needs support of professional work of researchers in a variety of academic domains. Regulation of medicines is a domain where not only governmental agencies have an administrative duty but also the public must participate because of their vital interests involved. The participants from the public include non-government-owned businesses, a wide range of intermediary organizations, various civil societies and the media conveying public opinion, and therefore a pattern of multiagent participation emerges in this regulation domain. It is worth noting that this participation pattern can be reflected in the data about work files including policies and regulations issued by governmental agencies and proposals put forward by non-governmental organizations as well as in the data about academic achievements gotten in researches on regulation of medicines in a variety of disciplines. And to perform these researches is an indispensable and important way to participate in this regulation domain.The data about these work files and academic literature is the basis for comprehensive investigation and quantitative analysis of multiagent participation in regulation of medicines from scientometric perspective. This dissertation makes thorough exploration of environment of academic knowledge and social environment for existence of this public affairs domain in order to search fundamental factors in construction and preservation of a successful regulation system of medicines. The findings of studies in this dissertation can be guidance for establishment and improvement of a scientific, impartial and efficient regulation system of medicines.The data about these work files and academic literature come from three international or domestic, comprehensive or biomedical bibliographical databases. They are MEDLINE, SinoMed and Web of Science. Literature with main topic as regulation of medicines is derived from each database and makes up one or more samples analyzed respectively in the parts of this dissertation. Specific scientometric methods used in this dissertation are measurement of frequency of MeSH terms, co-citation analysis, keywords co-occurrence analysis, cluster analysis, citation analysis, visualization and analysis of institutions authoring the sample literature. Moreover, approach of literature study applied frequently in humanities and social sciences is combined with scientometric approach in this dissertation. So do the conception of Third Sector which has emerged in some domains in humanities and social sciences.With these analytical methods, this dissertation has found some fundamental factors in construction and preservation of a successful regulation system of medicines. These fundamental factors lie in 2 aspects and are summed up as below:1) In academic knowledge environment. A variety of disciplines is involved in the knowledge element of this regulation domain and forms a wide band in spectrum of disciplines in existing knowledge system. Abundant research achievements are tightly around all kinds of specific problems in regulation of medicines and make up the academic base of this regulation domain. These achievements include classics of long history as well as those published recently. Several of them play a key role in evolution of this academic base. Even each of the most specific conceptions having stemmed from the practice of regulation attracts researchers majoring in different disciplines. With the development of regulation practice, the meaning of these conceptions become more and more complex and academic thoughts concerned with them are being intensified all the time in the debate in order to ensure rationality and impartiality of decisions in regulation of medicines.2) In social environment. As far as a scientific, righteous and efficient regulation system of medicines is concerned, a developed market economy is substantial and technological basis of it and third sector’s active participation in this regulation domain is a social prerequisite to its existence.In the light of results gained in studies in this dissertation, having analyzed-the existing problems in medicines regulation in China, suggestions are given including:1) to encourage researchers in a wide range of academic domains to do more researches concerned with this regulation domain, thus providing solid academic basis and effective theoretical support for regulation; 2) to revise related regualtions to encourage people living in different social strata and belonging to various civil societies to participate in this public affairs domain.更多还原