肿瘤是全球人类第二大死因.一些肿瘤通常难以用像手术、放疗和化疗等常规治疗方法治疗,但可用肿瘤疫苗帮助刺激人体的免疫应答使其得到控制.将疫苗用于由诸如乙型肝炎病毒和人乳头瘤病毒(HPV)等致瘤病毒引起的感染现已非常成功地降低了这些感染导致的肿瘤发病率.治疗性肿瘤疫苗从免疫疗法兴起之初就给人们带来了很大的希望.尽管治疗性肿瘤疫苗在临床试验取得一些成功并有一种治疗前列腺肿瘤的疫苗获得批准,但大多数治疗性疫苗仍在临床试验之中.为了了解国际治疗性肿瘤疫苗的开发与研究现状,依据美国药物研究与生产商协会(PhRMA)最近发布的报告及临床试验数据库(Clinicaltrials.gov)与相关新药数据库中的数据,重点对进入Ⅲ期临床试验的3种抗原疫苗、3种肿瘤细胞疫苗、6种树突状细胞疫苗、5种核酸疫苗和2种其他治疗性肿瘤疫苗进行了分析和综述.分析结果表明,这19种肿瘤疫苗中许多在中期分析报告中,无论是在延长无复发生存率(RFS)和总生存率(OS)方面,还是在耐受性、安全性等方面,都显示出良好的开发前景.
依据美国药物研究与生产商协会(PhRMA)发布的报告和临床试验数据库(clinicaltrials.gov)与相关新药数据库的数据,对2014年进入Ⅱ~Ⅲ期临床试验或获批的用于治疗类风湿关节炎的34个候选新药的临床研发情况进行统计分析,着重将其中进入Ⅲ期临床试验或获批的9个药物分为化学合成的、生物学原创的和仿制生物学的缓解病情类抗风湿药物以及治疗性疫苗等类别进行综述.
目的:了解目前国际上血液系统恶性肿瘤新药的开发研究状况.方法:根据美国药物研究与生产商协会(PhRMA)的相关报告和新药数据库等对国际上241种用于治疗血液系统恶性肿瘤候选新药的临床研发情况进行归纳和概括,并重点对2013年进入Ⅲ期临床试验或递交新药申请(NDA,BLA或获得批准)的抗白血病、淋巴瘤、骨髓瘤等血液肿瘤候选新药开发进行分析.结果:241种治疗血液肿瘤的药物分为6大类,其中用于治疗血液系统恶性肿瘤的药物24种,治疗白血病的97种,治疗淋巴瘤的98种,治疗骨髓瘤的52种,治疗骨髓增殖性肿瘤(MPN)和骨髓增生异常综合征(MDS)的各15种,共进行Ⅰ~Ⅲ期临床试验或递交NDA(BLA或获得批准)356项.进入Ⅲ期临床试验或递交NDA的治疗血液肿瘤的候选新药有56种,但有6种因各种原因终止临床试验或其NDA/BLA被驳回.结论:原创新药是国际大型制药公司或生物制药公司开发血液肿瘤新药的重点,用于新适应症或新型制剂的药物所占比例较大,生物技术类药较多,包括单抗、单抗-药物缀合制剂、β-葡聚糖和治疗性疫苗等.
Vandetanib is an orally active antagonist of vascular endothelial growth factor(VEGF) receptor-2(VEGFR-2),epidermal growth factor receptor(EGFR) and RET kinase.It was approved for the treatment of metastatic medullary thyroid cancer(MTC) by U.S.Food and Drug Administration(FDA) on June 4,2011.The pharmacokinetics and pharmacodynamics of vandetanib were reviewed in this paper.Also,it is mainly introduced that the antitumor activity of vandetanib in some phase II to phase III clinical trials,such as its antitumor activity in the phase II ZACTHYF trial and the phase III ZETA trial for MTC,as well as the negative results or no overall survival advantages of the four randomized phase III clinical trials for non-small cell lung cancer(NSCLC).Meanwhile,the therapeutic or clinical benefits of vandetanib and the adverse events in the patients with MTC and NSCLC were evaluated and discussed.Additionally,some phase II clinical trials evaluating the efficacy of vandetanib in prostate cancer,advanced breast cancer,malignant glioma,and so on,have been completed.Some phase II clinical trials in recurrent high-grade gliomas,biliary tract cancer,locally advanced or metastatic urinary tract cancer,and so on,are currently recruiting participants.These clinical trials will better define the appropriate schedule,the optimal setting of evaluation,and the safety of long-term use of vandetanib.
The development and implement of the international policies of open access(OA)were discussed,and the OA policies enacted mainly by the countries such as USA,UK Sweden,India,China and international institutions such as the European Research Council(ERC),and so on were described.The enlightenments were achieved from the OA policies to China.That were selecting and conforming the agencies and institutions which enact OA policy,formulating required OA polices, and choosing one or some appropriate literature databases as China's national scietific literature repository.
This paper summaries the significance of establishing a platform of the integrated OA medical information service and discusses the aim and basic principles,framework,the main workflow of the platform.The workflow includes information collection,organization and service.When the service platform is established,it will provide "all-in-one" medical information service for the medical researchers,health care personnel,teachers and health policy makers in the medial institutions,which would improve and strengthen the supportive capacities and information service of the medical library to provide medical literature and information and to play important role in medical science and technology innovation,health policy decision and disease control/prevention.
Described in this paper is the development of open access(OA) models in foreign countries with stress laid on the OA policies established by National Institute of Health(NIH),European Research Council(ERC),European Organization for Nuclear Research(CERN),and Harvard University Faculty of ARTS and Sciences.Outlined are the measures taken by international academic institutions and libraries,such as Max Planck Society(MPS)and Yale University Library,to resist the escalating price of journal databases developed and printed journals published by commercial and OA publishers,as well as problems found in OA models.The conclusion made by the authors is that OA model has become the inevitable trend in academic publications and further study is needed on problems such as finances.
This paper is based on the report of 2009: New Medicines in Development for Heart Disease and Stroke and the Medicines in Development Database published by the Pharmaceutical Research and Manufacturers of America(PhRMA).Thirty-two new medicines for hypertension currently in the clinical development are statistically analyzed.According to the classification in the Chinese Guidelines for Prevention,Detection,Evaluation,and Treatment of High Blood Pressure,there are only each one agents in 2 classes of the traditional 5 classes,and 16 agents in 10 newer classes;6 agents in 4 classes are ones approved or not added with new technologies;and each one agent in 2 classes are approved for other diseases.The results show that newer agents are much more than older ones,and both therapeutic vaccines and dual acting receptor antagonists will be the newer anti-hypertensive agents,but the new medicines in the development for hypertension are mingled with hope and fear.
目的了解我国17种图书情报类核心期刊的质量和影响力。方法通过《中国知网》(CNKI)《中国学术期刊文献评价统计分析系统》的数据,对17种图书情报类核心期刊2004-2006年的影响因子、即年指标、被引半衰期、Web即年下载率和h指数进行了统计、分析和研究。结果影响因子排名中《中国图书馆学报》连续3年排第1名,《大学图书馆学报》连续3年排第2名,《图书馆论坛》、《图书馆》和《情报学报》积分列第3~5名。即年指标排名中,仍以《中国图书馆学报》和《大学图书馆学报》排第1名和第2名,《图书馆》排第3名,《图书馆工作与研究》排第4名,《图书情报知识》排第5名。被引半衰期排名中,《情报学报》排第1名,《中国图书馆学报》排第2名,《情报理论与实践》排第3名,《图书与情报》排第4名,《图书情报工作》排第5名。Web下载率排名中,《大学图书馆学报》、《情报学报》、《情报科学》并列第1名,《情报理论与实践》排第4名,《情报杂志》排第5名。h指数排名中,《图书馆论坛》排第1名,《中国图书馆学报》排第2名,《图书馆》排第3名,《图书馆工作与研究》排第4名,《大学图书馆学报》排第5名。综合各项得分,《大学图书馆学报》排第1名,《中国图书馆学报》排第2名,《情报学报》排第3名,《图书馆》排第4名,《图书馆论坛》排第5名。结论《中国图书馆学报》、《大学图书馆学报》和《情报学报》是国内图书情报界公认的质量最好的图书情报专业期刊,《图书馆》和《图书馆论坛》近年来质量有明显提高。
A statistical analysis was made for the impact factor,immediate index,citation half-life,immediate Web download and h index of 5 medical information journals covered in CNKI,including Medical Information Journal,Chinese Journal of Medical Library and Information Science,China Journal of Traditional Chinese Medical Information,Journal of Preventive Medical Information and Medical Information.The problems in medical information journals and suggestions for their solution were pointed out.
简要分析了国际OA期刊及其数据库的发展,并对其数量增长情况进行统计分析。在对国外几种主要引文索引数据库统计分析和参考国内相关数据库的基础上,分析了国际科技期刊价格增长的情况,并据此对2009年科技期刊的价格进行了预测。
简述了h指数的定义和全球科学家对h指数的评价,着重介绍了h指数的在个人绩效和科技期刊影响力方面的应用,提出了h指数应用中应注意的几个问题。
目的 了解目前世界上已获得批准的抗HIV/AIDs药品与预防和治疗HIV/AIDs并发症的药品及其研发特点.方法 参考美国FDA公布的数据和对一些有代表性的相关丈献,对1987年以来获得批准的抗HIV/AIDs药与预防和治疗HIV/AIDs并发症的药品归纳、分析、总结和概括性介绍.结果 抗HIV/AIDs药在近年来取得了较大进展,除了传统的核苷类逆转录酶抑制剂(NRTIs),蛋白酶抑制剂(PIs),非核苷类逆转录酶抑制剂(NNRTIs)和进入抑制剂(Enny inhibitors)类药物都有新的产品获得批准外,还有诸如整合酶抑制剂和复方抑制剂.但在数量上并不多,每年获得批准的产品仅有2-3种.获得批准的预防和治疗HIV/AIDs并发症的药分为抗生素、抗真菌制剂、抗病毒制剂、抗肿瘤制剂和其他5大类,但这些药多为已获得批准药品又申请用于新的适应证.结论 在单种和新种类抗HIV/AIDs新药不断获得批准的基础上,单类型和多类型复方制剂逐渐增多;获得批准的抗HIV/AIDs并发症的药品以已获得批准药品用于新适应证的为多;抗HIV/AIDs及其并发症新药的数量长期处于低水平增长状态.
In this paper,we described the international incidence and treatment of cardiovascular diseases in the last few years.More than 270 new medicines are internationally developed to treat and prevent cardiovascular diseases and the related diseases.We reviewed and outlined these medicines based on the Medicines in Development Database created by the Pharmaceutical Research and and Manufacturers of America(PhRMA) and related literature.The new medicines for the treatment of the diseases with higher incidence,such as acute coronary syndrome(ACS),atherosclerosis,hypertension and thrombosis,are also analyzed and discussed.In conclusion,the number of the new medicines for cardiovascular diseases in Phase I and Phase II is less;many of the new medicines in clinical development are approved as medicines for other diseases;the percentage of biotechnology medicines is very high.
Based on the current status of global HIV prevalence and various countermeasures adopted in prevention and treatment of AIDS by international organizations and governments,especially by Chinese government,the status quo of development of new medicines and vaccines for HIV/AIDs and related diseases were described in this article.In 2007,92 new medicines and vaccines have been reviewed to treat or prevent these diseases internationally,especially the new antivirals,immunomodulators and vaccines to treat or prevent HIV/AIDS.Compared with 77 new medicines and vaccines in 2006,the number of the medicines and vaccines developed has increased by 19.48% in 2007.Although the common types of antivirals are still developed,the international research-based pharmaceutical and biotechnology companies are strenthening their efforts to develop new classes of antiretrovirals,such as integrase inhibitors,maturation inhibitors,interleukins and interferons as well as preventive and therapeutic vaccines,immunomodulators and gene therapy.
分析了军队院校图书馆在管理观念、管理体制、信息资源建设、军事信息资源管理元数据标准和军事信息资源安全管理中存在的问题,并在此基础上提出了对策,包括以科学发展观为指导,明确图书馆发展思路;加强馆内外协作,实现管理体制的创新等.
简要分析了国际期刊市场出版商为垄断价格继续兼并和采取复合型开放存取政策等动态及影响科技期刊价格的诸因素;根据国外几种主要引文索引数据库的统计,分析了国际科技期刊价格增长的情况,并据此对2008年科技期刊的价格进行了预测。
This paper discussed the existing problems of the traditional publishing model,the definition of open access(OA),the advances in the development of OA and the related policies enacted by some countries such as the US,UK,China,Indian and so on.The viewpoints of commercial publishers,society and other non-profit publishers,library associations and librarians were summed up and the future development of OA was perspected as well.
In this review,we described the status quo of international development of new medicines,and the 771 new medicines and vaccines to treat the major diseases affecting women in 2007,in comparison with the development in 2005.We focused on the new medicines to treat breast cancer,osteoporosis,menopausal syndrome,and the kidney/urologic disorders.Compared with 446 new medicines and vaccines developed in 2005,the number of the medicines and vaccines has increased greatly(by 72.87%) in 2007.
随着网络全文电子版期刊数据库的出版发行,纸本期刊订购数量急剧下降,是期刊质量质问题降低了期刊的利用率?还是读者从其他途径获取了所 需信息?针对这一问题,笔者利用清华同方数据库,对<中华医学图书情报杂志>文献的网络传播情况进行了统计、分析和研究.