氟尿嘧啶缓释剂制备及植入后的生物安全性

Preparation of fluorouracil controlled release formulation and its biological safety after implantation

背景:由于氟尿嘧啶具有半衰期短、代谢快、能直接与肿瘤细胞作用的特点,被应用于抗肿瘤的治疗,氟尿嘧啶缓释剂药效作用时间长,能在靶点病灶区药物浓度达到最大,减轻不良反应,不通过胃肠道吸收,减少药物损失,有效利用药效。目的:利用万方数据库文献检索和深度分析功能,对氟尿嘧啶缓释剂制备研究的文献资料趋势进行多层次探讨分析,并探讨植入后的安全性问题。设计:文献计量学分析。资料提取:以电子检索方式对万方数据库2002-01/2011-12有关氟尿嘧啶缓释剂制备研究的文献进行分析,采用检索词为"缓释剂(controlled release formulation);氟尿嘧啶(fluorouracil);抗肿瘤药(antineoplastic);生物材料(biomaterial)",对检索的相关文献运用数据库中自带的分析功能和Excel软件绘制图表的功能进行分析,通过文字和图表的形式将统计和计量数据分析,描述其分布特征。入选标准:纳入标准:①与氟尿嘧啶缓释剂制备研究相关的基础研究论文。②与氟尿嘧啶缓释剂抗肿瘤治疗相关的论文。③与氟尿嘧啶缓释剂植入后安全性相关的论文。排除标准:①与文章目的无关的文献。②重复研究的文献。③刊社信息。④未发表的文章。⑤需电话追踪和手工检索逐一分析的文章。⑥护理内容的文献。主要数据判定指标:文献研究趋势、出版时间、文献数量、学科类别、研究机构、来源期刊、基金资助情况、主题词检索词、文献被引频次、文献下载频次和关联文献的相关分析。并对万方数据库中相关领域博士学位论文、硕士学位论文和重要会议论文进行分析,以及氟尿嘧啶缓释剂的临床应用和注意事项,植入后安全性分析。结果:在万方数据库学术期刊收录2002/2011的文献中,共检索到49篇与氟尿嘧啶缓释剂制备研究相关的文献。10年来文献发表数量基本处于平稳状态,发表最多的时间在2008年共8篇;以药剂学科分类研究为主;《中国医药工业杂志》发表文献量较多;基金资助项目共32项,以国家自然科学基金项目为主;研究相关的主题词和检索词主要有氟尿嘧啶、壳聚糖和纳米粒,以壳聚糖为载体材料的研究较多,重点为氟尿嘧啶壳聚糖纳米粒的药物释放;氟尿嘧啶缓释剂在食管癌、贲门癌、胃癌、肠癌、乳腺癌等肿瘤的治疗中有一定疗效,是一种安全有效的治疗方法。结论:通过文献计量学方法对万方数据库关于氟尿嘧啶缓释剂制备研究的文献进行分析,以及对植入后安全性的总结,可为中国从事抗肿瘤药物缓释剂基础研究和临床医务工作者进一步确定科研思路提供有价值的参考。

BACKGROUND： Due to the characteristics of short half-life, fast metabolism and direct effect to the tumor cells, controlled release formulation is applied to anti-tumor treatment. Fluorouracil controlled release formulation is characterized by long-term drug action, maximum drug concentration in the area of the target lesion, low systemic adverse reaction, as well as low damage to the liver. OBJECTIVE： Using literature search and the depth of analysis capabilities of Wanfang database, to analyze the data trends in the study of fluorouracil controlled release formulation, and to explore the safety after its implantation. DESIGN： Bibliometric data analysis. DATA RETRIEVAL： A search of related literature of fluorouracil controlled release formulation was performed in Wanfang database, with key words of＂controlled release formulation＂, ＂fluorouracil＂, ＂antineoplastic＂ and ＂biomaterial＂, from 2002 01 to 2011 12. The retrieval results were analyzed, and the trends were described in words and graphics. SELECTION CRITERIA： Inclusive criteria： （1）Basic research papers related to fiuorouracil controlled release formulation. （2）Papers related to the controlled release formulation for anti-tumor treatment. （3）Papers related to the security issues after implantation of fluorouracil controlled release formulation. Exclusive criteria： （1）Literature has nothing to do with the purpose of this review. （2）Duplication of research literature. （3）Journal＇s own information. （4）Unpublished papers. （5）The article needs to be retrieved by phone or manual searches. （6） The literature focuses on nursing. MAIN OUTCOME MEASUREMENTS： The literatures were analyzed by data trends published year, literature number, subject category, research institutions, source journals, literature citations, literature download frequency, associated literature, distribution of the author, distribution of the funding and major keywords. The Ph.D. thesis, outstanding master＇s degree papers, conference papers, and the clinical applications of fluorouracil controlled release formulation were analyzed as well as the safety after implantation. RESULTS： A total of 49 research literatures related to fluorouracil controlled release formulation were retrieved in Wanfang database during 2002 2011. The number of papers was in the steady state. Most of literatures were published in 2008 （n=8）. And the literatures were focused on pharmaceutical discipline. Zhongguo Yiyao Gongye Zazhi published more literatures than others. A total of 32 projects were supported by funding, and most of them supported by the National Natural Science Foundation of China. The frequently used subject words and key words are ＂fluorouracil＂, ＂chitosan＂ and ＂nanoparticles＂, respectively. In many literatures, chitosan is selected as a carrier, and fluorouracil-loaded chitosan nanoparticle for drug delivery is the focus of the study. Fluorouracil controlled release formulation has a certain effect in the treatment of esophagus, cardia, gastric cancer, colon cancer, breast cancer, which is a safe and effective treatment. CONCLUSION： The bibliometric data analysis on fluorouracil controlled release formulation in Wanfang database and summary on safety after implantation can provide valuable reference for Chinese medical workers in both basic research and clinical study of anti-tumor controlled release formulation.