为加强疫苗临床试验质量管理,落实《疫苗临床试验质量管理指导原则(试行)》(食药监药化管〔2013〕228号)等相关规范性文件要求,国家食品药品监督管理总局将进一步加强疫苗临床试验现场检查,现将有关事项通知如下:(1)加强疫苗临床试验的质量管理。申办者和临床试验机构应按食药监药化管〔2013〕228号文件等要求,加大监查和稽查力度,对存在的问题进行整改,严格执行质量管理的各项措施,不断完善疫苗临床试验质量管理体系。

关键词：药品监督;现场检查;临床试验;食药监;质量管理;指导原则;现场核查;药品审评中心;信息公示;大监;

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目的优化大孔树脂纯化芒萁总皂苷的工艺参数。方法分别用AB-8、D-101、Hz-803、HZ-816大孔树脂对芒萁皂苷进行静态吸附与解吸试验,筛选出分离效果最好的一种树脂,并研究该树脂分离芒萁总皂苷的动力学曲线和动态吸附性能。以BHT为对照,考察纯化后的芒萁总皂苷清除DPPH自由基的效果。结果优化的D-101大孔树脂对芒萁皂苷的吸附条件为:流速2BV·h-1时,料液的pH值和浓度分别为5和20.5 mg·ml-1;优化的洗脱条件:流速为2BV·h-1,洗脱溶剂为3BV 70%的乙醇水溶液。纯化后总皂苷含量为64.9%,纯化倍数为2.2倍;纯化后的芒萁总皂苷对DPPH自由基的清除效果比BHT好,...

关键词：芒萁;总皂苷;大孔吸附树脂;纯化;抗氧化

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Osteoporosis is a disease that reduces the mass and density of a bone, resulting in an increased risk of fracture. In this disease, the risk of fracture increases due to the permeability and fragility of the bones. Often there are no symptoms observed until the first fracture occurs. Some of the risk factors responsible for osteoporosis include aging, low body weight, low sex hormones or menopause, and smoking. Osteoporosis affects men and women of all races. It is estimated that, globally, 1 in 5 men and 1 in 3 women are at risk of an osteoporotic fracture.

关键词：骨质疏松症；药物；市场

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The Global Enteric Disease Testing market is one of the fastest growing IVD markets. Over the years, the market has experienced remarkable growth, and is expected to witness an improvement in its growth rate and post a CAGR of 2.83 percent during the period 2013-2018. The majority of the growth stems from the Americas, followed by the EMEA and APAC regions. Although a majority of the growth is derived from the Bacterial Disease Testing segment, other segments such as Parasitic and Viral Disease Testing are expected to make significant contributions to the overall market revenue in the future.

关键词：肠道疾病；病毒；细菌；寄生虫

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Although the combination of radiation therapy and androgen deprivation therapy (ADT) is initially effective in many patients, biochemical failure rates of 20at 5-years to 50at 10-years have been reported, highlighting the need for improved treatments, particularly for men with high- risk prostate cancer. ADT in the neo-adjuvant setting is used to reduce tumor volume and improve the response to radiation. Additionally, ADT causes infiltration of lymphocytes into the prostate. B cell infiltrates may promote prostate cancer progression and development of castration resistant prostate cancer by the production of inflammatory cytokines and skewing CD4+ T cell responses towards Th2. We hypothesized that depletion of B cells at the time of castration would improve tumor control. Our results demonstrate that the depletion of B cells at the time of castration improves tumor latency.

关键词：治疗技术；前列腺；放疗和雄激素剥夺疗法(ADT)

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Therapeutic options for patients suffering from end-stage renal disease have improved tremendously over the last decades and can be divided into three categories: hemodialysis, peritoneal dialysis and kidney transplantation. Transplantation remains the treatment of choice, however, lack of donor organs results in the necessity of performing -temporary-dialysis therapies of which hemodialysis is carried out in the majority of patients. To facilitate adequate hemodialysis therapy a reliable vascular access is mandatory and can be provided by either surgically connecting an artery with a vein (arteriovenous fistula), surgically connecting an artery with a vein using an interposition of prosthetic graft material (arterioven-ous graft) or a central venous catheter. This chapter shortly reviews the condition of end-stage renal disease after which history of vascular access, different options to create a vascular access, pre-operative work-up, surgical procedure, monitoring and usage, post-operative complications and the role of hemodynamics will be discussed. Finally, some future directions for vascular access creation and management will be identified.

关键词：治疗技术 透析

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The U.S. military is currently fitting amputees with state-of-the- art prosthetic devices. In addition to walking and changing direction on a variety of surfaces, amputees must be able to manage uneven terrain, crowded environments, stairs, ramps, and hills. The largest problem for a lower extremity amputee is falls. Among individuals with a lower extremity amputation, 52reported having fallen in the previous 12 months, 49reported being fearful of falling, and 65had low balance confidence scores. Falling history and balance confidence are associated with reduced mobility capability and social activity. As a result, lower extremity amputees with limited balance and stability are at risk for diminished quality of life. The goal of this research effort is to rehabilitate lower extremity amputees to reduce falls using a novel training method. In this first year of the research effort, we have developed a novel experimental method to induce unexpected trips to amputees under controlled laboratory conditions. We have identified objective biomechanical variables that are causally related to the success or failure in avoiding a fall after a trip, objective tests to quantify functional outcomes, and a subject-specific questionnaire to determine if the training method is effective. Enrollment has begun. Our target is to deliver a quantitatively derived, deployment-ready, advanced gait rehabilitation system that can improve functional outcomes and/or shorten the time required for injured servicemen and women to return to active duty or to a productive civilian life.

关键词：康复计划；截肢；艺术假肢设备

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In October 2011, the Institute of Medicine (IOM) released the report Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence, assessing the published evidence for the effectiveness of using cognitive rehabilitation therapy (CRT) to treat people with traumatic brain injury (TBI). TBI has gained increasing attention in the past 15 years because of its status as the signature wound of American military conflicts in Iraq and Afghanistan. Growing numbers of U.S. service members are suffering traumatic brain injuries and are surviving them, given that (a) the majority of traumatic brain injuries are mild and (b) lifesaving measures for more severe injuries have significantly improved. People with any level of injury can require ongoing health care in their recovery, helping them to regain (or compensate for) their losses of function and supporting their full integration into their social structure and an improved quality of life.

关键词：治疗技术；康复治疗(CRT)；创伤性脑损伤(TBI)

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Tamoxifen, the first targeted therapy, has shown great success in treating estrogen receptor (ER) positive breast cancer. However, both acquired and de novo resistance to this therapy prevents it from being effective in all situations. Multiple lines of evidence indicate that increased signaling through growth factor pathways, such as the IGF pathway, mediates resistance to tamoxifen. The link between ER and ICGF1R leads us to hypothesize that IGF system crosstalk with the ER contributes to tamoxifen resistance. Tamoxifen resistance has thus provided researchers with a reason to investigate other growth factor pathways involved in breast cancer. As new targeted therapies are being developed, it will be important to examine their benefit with existing therapies. In order to examine the effectiveness of anti-IGF1R inhibitors in vitro, tamoxifen resistant (TamR) cells were generated by culturing MCF-7L and T47D cells in the presence of 4-OH-tamoxifen for >6 months. TamR cells had dimished levels of IGF1R, with unchanged levels of insulin receptor (IR). Further, TamR cells failed to respond to IGF-I induced p-AKT activation, while retaining responsiveness to both insulin and IGF-II. Additionally, IGF-I failed to enhance the proliferation and anchorage-independent growth of TamR cells; however, both insulin and IGF-II were able to enhance proliferation in MCF anchorage-independent growth. An IGF1R antibody was effective in inhibiting signaling, anchorage-independent growth, and proliferation in MCF-7L cells, but had no effect in TamR cells. In contract, an IGF1R/TR tyrosine kinase inhibitor was effective in both MCF-7L and TamR cells. In a xenograft model, an IGF1R antibody was able to inhibit estrogen stimulated tumor growth, but had no additive effect when combined with tamoxifen treatment. Further, tamoxifen-treated xenografts had diminished IGF1R levels.

关键词：治疗计划；雌激素受体；乳腺癌

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The National Institute on Disability and Rehabilitation Research (NIDRR) is one of the principal federal agencies supporting applied research, training, and development to improve the lives of individuals with disabilities. NIDRR's mission is to generate new knowledge and promote its effective use in improving the ability of persons with disabilities to perform activities of their choice in the community, as well as to expand society's capacity to provide full opportunities and accommodations for its citizens with disabilities. NIDRR aims to reach all disability types and age groups, and its mission is tied to long-term outcomes such as independence, community participation, and employment. Assessing the outcomes of research is a complex undertaking that can variably take into account the stated goals of the research, the contribution to the relevant field of research, the impact on the well-being of a particular population, or other related issues. The Government Performance and Results Act has led to a particular emphasis on establishing specific performance measures assessing the outputs of research programs. NIDRR takes pride in proactively establishing program performance measures focused on the quality of its grantee outputs, developing account ability data systems to track the results of those measures, and developing internal management systems to facilitate quality research. In 2009, NIDRR requested that the National Research Council form a committee to conduct a 'process evaluation' of aspects of its grant making and a 'summative evaluation' of the quality of grantee outputs. In addition, the committee was charged with assessing the methods it developed for conducting the summative evaluation and making recommendations for the conduct of future evaluations. The requested study was the most recent effort in a series of NIDRR-funded activities aimed at assessing and improving the agency's performance.

关键词：康复计划 进化 残疾

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