中国组织工程研究
中國組織工程研究
중국조직공정연구
Journal of Clinical Rehabilitative Tissue Engineering Research
2013年
21期
3975-3982
,共8页
张朋%陈勇忠%周清碧%白靖平%锡林宝勒日
張朋%陳勇忠%週清碧%白靖平%錫林寶勒日
장붕%진용충%주청벽%백정평%석림보륵일
生物材料%生物材料学术探讨%纳米%载体材料%肿瘤%靶向性给药%生物医用材料%载药效率%北美临床试验注册%Web of Science数据库%文献计量学分析
生物材料%生物材料學術探討%納米%載體材料%腫瘤%靶嚮性給藥%生物醫用材料%載藥效率%北美臨床試驗註冊%Web of Science數據庫%文獻計量學分析
생물재료%생물재료학술탐토%납미%재체재료%종류%파향성급약%생물의용재료%재약효솔%북미림상시험주책%Web of Science수거고%문헌계량학분석
biomaterials%biomaterial academic discussion%nano%drug carrier%cancer%targeted therapy%biomedical materials%drug loading efficiency%ClinicalTrial.gov%Web of Science database%literature metrological analysis
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1-2000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4497篇,其中,美国发文量占总数比重最大(66.42%),发表文章2987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》).
揹景:納米材料是抗腫瘤藥物的理想載體,具有重要的科學價值和應用價值,為臨床抗腫瘤提供瞭新的有效手段.目的:繫統評價納米給藥繫統在腫瘤靶嚮治療的基礎研究及臨床應用.方法:以“nanoparticle, cancer, drug delivery system, nanotube, nanosphere”為關鍵詞,計算機檢索北美臨床試驗註冊中心及Web of Science數據庫2000-01-01/2012-12-31髮錶的納米給藥繫統在腫瘤靶嚮治療相關臨床試驗註冊項目及文獻.根據納入與排除標準篩選文獻,將檢索結果以註冊號、註冊題目、項目狀態、榦預措施、試驗的申辦者、試驗的疾病種類導齣進行評價質量及文獻分析.結果與結論:①北美臨床試驗註冊中心關于納米給藥繫統在腫瘤靶嚮治療的相關臨床試驗研究開始于1999年,共檢索到註冊項目489項,經查閱後,共有429項納入瞭分析.美國註冊的納米載體腫瘤靶嚮給藥臨床試驗項目最多,共112項,其次為加拿大24項.中國註冊的臨床試驗有22項,其中大陸註冊8項,香港地區註冊4項,檯灣地區註冊10項.研究的註冊數量2003年跌至穀底,隻有5項註冊項目,之後數量大幅度升高,在2008年註冊項目數量達到頂峰,為56項.2008年後,註冊的項目數量處于波動狀態.②北美臨床試驗註冊中心納米給藥繫統在腫瘤靶嚮治療的相關臨床試驗項目樣本量在1-2000之間,以50人以下的小樣本研究為主.研究的腫瘤類型以乳腺癌為主,其次為內分泌腺瘤及淋巴瘤.③2000-01-01/2012-12-31在Web of Science數據庫髮錶的納米載體腫瘤靶嚮給藥相關文章4497篇,其中,美國髮文量佔總數比重最大(66.42%),髮錶文章2987篇.高被引文章主要髮錶在Proceedings of the National Academy of Sciences of the United States of America (《美國科學院院刊》).
배경:납미재료시항종류약물적이상재체,구유중요적과학개치화응용개치,위림상항종류제공료신적유효수단.목적:계통평개납미급약계통재종류파향치료적기출연구급림상응용.방법:이“nanoparticle, cancer, drug delivery system, nanotube, nanosphere”위관건사,계산궤검색북미림상시험주책중심급Web of Science수거고2000-01-01/2012-12-31발표적납미급약계통재종류파향치료상관림상시험주책항목급문헌.근거납입여배제표준사선문헌,장검색결과이주책호、주책제목、항목상태、간예조시、시험적신판자、시험적질병충류도출진행평개질량급문헌분석.결과여결론:①북미림상시험주책중심관우납미급약계통재종류파향치료적상관림상시험연구개시우1999년,공검색도주책항목489항,경사열후,공유429항납입료분석.미국주책적납미재체종류파향급약림상시험항목최다,공112항,기차위가나대24항.중국주책적림상시험유22항,기중대륙주책8항,향항지구주책4항,태만지구주책10항.연구적주책수량2003년질지곡저,지유5항주책항목,지후수량대폭도승고,재2008년주책항목수량체도정봉,위56항.2008년후,주책적항목수량처우파동상태.②북미림상시험주책중심납미급약계통재종류파향치료적상관림상시험항목양본량재1-2000지간,이50인이하적소양본연구위주.연구적종류류형이유선암위주,기차위내분비선류급림파류.③2000-01-01/2012-12-31재Web of Science수거고발표적납미재체종류파향급약상관문장4497편,기중,미국발문량점총수비중최대(66.42%),발표문장2987편.고피인문장주요발표재Proceedings of the National Academy of Sciences of the United States of America (《미국과학원원간》).
@@@@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/col aborators, as wel 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 smal er sample size (less than 50). The most conditions of research were breast cancer, fol owed 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.
