沙利度胺临床新用途研究文献计量分析

Bibliometric analysis of thalidomide in new clinical application

目的:检索和分析1964–2010年国内外有关沙利度胺文献资料,为了解沙利度胺治疗病种文献,确定沙利度胺研究课题提供参考。方法:在Embase、Pubmed、Cochrane、ISI和CBMdisc数据库中检索全部关于沙利度胺的文献,采用文献计量学方法,对纳入研究文献的发表年限、作者排序、文章类型、治疗病种等进行分析。结果:国内外沙利度胺相关文献总数为17366篇,其中,中文789篇,外文16577篇。自1957年上市后,1961年因致畸致死等严重药害事件,沙利度胺文献迅速减少;而20世纪90年代初期,大量基础研究文献报道了沙利度胺具有免疫调节和抗肿瘤活性,FDA分别于1998年和2003年批准了麻风性结节性红斑和多发性骨髓瘤作为其新适应证,沙利度胺文献数目随之激增,尤其是对新治疗病种的研究文献逐年递增。结论:经过50多年对沙利度胺药理作用机制的不断深入研究,其在免疫性疾病和肿瘤疾病的临床应用越来越广泛,且发现其对多种罕见难治性疾病的临床新用途。

Objective： To investigate both domestic and international thalidomide researches during 1964 to 2010 in order to provide information for clinical application of thalidomide and evidence-based research. Methods： All publications about thalidomide were collected from Embase, Pubmed, the Cochrane library, ISI and CBMdisc. Bibliometric analysis was performed according to the publication years, authors, publication types and clinical applications. Results： A total of 17 366 articles were found, including 789 Chinese articles and 16 577 articles in other languages. Thalidomide was marketed in 1957, and the research articles of thalidomide had rapidly decreased since 1961 for its severe teratogenic and lethal events. In early 1990s, thalidomide was found a wide range of pharmacological effects,which were mainly concentrated in immunomodulatory and antitumor activity. It was approved by the Food and Drug Administration （FDA） in 1998 for the treatment of erythe manodosum leprosumand and multiple myeloma in 2003. Articles about thalidomide increased fast, especially for new indications. Conclusion： With the advanced studies on the pharmacological mechanism of thalidomide for 50 years, more and more researches focus on the management of numerous neoplasic and autoimmune diseases, and the curative effect on a variety of rare refractory diseases have been found.