纳米给药系统在肿瘤靶向治疗中的应用

背景：纳米材料是抗肿瘤药物的理想载体,具有重要的科学价值和应用价值,为临床抗肿瘤提供了新的有效手段。目的：系统评价纳米给药系统在肿瘤靶向治疗的基础研究及临床应用。方法：以“nanoparticle, cancer, drug delivery system, nanotube, nanosphere”为关键词,计算机检索北美临床试验注册中心及Web of Science数据库2000-01-01/2012-12-31发表的纳米给药系统在肿瘤靶向治疗相关临床试验注册项目及文献。根据纳入与排除标准筛选文献,将检索结果以注册号、注册题目、项目状态、干预措施、试验的申办者、试验的疾病种类导出进行评价质量及文献分析。结果与结论：①北美临床试验注册中心关于纳米给药系统在肿瘤靶向治疗的相关临床试验研究开始于1999年,共检索到注册项目489项,经查阅后,共有429项纳入了分析。美国注册的纳米载体肿瘤靶向给药临床试验项目最多,共112项,其次为加拿大24项。中国注册的临床试验有22项,其中大陆注册8项,香港地区注册4项,台湾地区注册10项。研究的注册数量2003年跌至谷底,只有5项注册项目,之后数量大幅度升高,在2008年注册项目数量达到顶峰,为56项。2008年后,注册的项目数量处于波动状态。②北美临床试验注册中心纳米给药系统在肿瘤靶向治疗的相关临床试验项目样本量在1-2 000之间,以50人以下的小样本研究为主。研究的肿瘤类型以乳腺癌为主,其次为内分泌腺瘤及淋巴瘤。③2000-01-01/2012-12-31在Web of Science数据库发表的纳米载体肿瘤靶向给药相关文章4 497篇,其中,美国发文量占总数比重最大(66.42%),发表文章2 987篇。高被引文章主要发表在Proceedings of the National Academy of Sciences of the United States of America (《美国科学院院刊》)。

Nano drug delivery system in targeted therapy for tumor

BACKGROUND: Nano drug delivery system is an ideal drug container for targeted therapy of tumor.OBJECTIVE: To search the ClinicalTrial.gov and Web of Science database and to perform literature metrological analysis on the clinical trials of nano drug delivery system in targeted therapy of tumor. METHODS: The ClinicalTrial.gov was searched with the key words of “nanoparticle, cancer, drug delivery system, nanotube, nanosphere” for the clinical trials regarding nano drug delivery system in targeted therapy of tumor. At the same time, the Web of Science was searched using key words of “nanoparticle, cancer, drug delivery system, nanotube, nanosphere” for articles indexed between 2000 and 2012. According to inclusive and exclusive criteria, the search results were transferred into excel with items of National Clinical Trial number, title, recruitment, interventions, sponsor/collaborators, as well as diseases.  RESUTLS AND CONCLUSION: (1) There are 489 clinical trial registration projects related to nano drug delivery system in targeted therapy of tumor in the ClinicalTrial.gov, and 429 registration projects were included in the analysis. The United States registered 112 projects, which is greater than other countries. Canada ranked second with 24 projects. China, with 22 projects, listed the third. The registration projects begin from 1997, increased slowly, and down to a valley at 2003, with 5 projects. After that, it increased sharply, and reached a peak at 2008. (2) The sample sizes of registration projects ranked from 1 to 2 000, which mainly focuses on smaller sample size (less than 50). The most conditions of research were breast cancer, followed by endocrine gland neoplasms and lymphoma. (3) The number of literatures on nano drug delivery system in targeted therapy of tumor indexed from 2003 to 2012 in the Web of Science database was 4 497, and the amount of literatures published by the United States is accounted for the largest proportion of the total number (2 987 articles, 66.42%). The highly cited papers are mainly published on the Proceedings of the National Academy of Sciences of the United States of America.