抗肿瘤药物临床药师培训及其参与合理用药的应用进展

临床药学是药学的重要分支,临床药师为病人提供药学监护,优化了使用药物治疗,促进康复,加强了保健和疾病的预防。开展临床药师教育,有利于临床用药审查,并将为培养临床药师的工作提供参考。回顾近年来国内外的临床药师及抗肿瘤药物专业临床药师的培训经验和合理用药的进展情况,分别对临床药师培养模式、理论课程设置、药学查房带教、临床记录书写和业务学习等方面作了总结。本文通过系统性的回顾了和对比了国内外的临床药师的培养方案,从理论和实践两方面的应用进展分析了临床药师在临床中的重要作用。     

我国心血管专科临床科研数据中心的建设与思考

中国是心血管疾病的数据大国,但是从数据质量和临床科研上讲,并非强国。为了提高心血管数据在临床质量评估和科研中的应用,我院心内科开始了心血管专科临床科研数据中心的尝试和建设。通过借鉴美国相关经验,以及对我国心血管临床质量评估以及科研需求的深入调研,我们建设了以心血管专科临床数据仓库以及心血管注册数据中心为核心的心血管专科临床科研数据中心。在此基础上,进一步探索并建设了自定义科研表单,多维度组合筛选,基于随访策略的心血管随访管理,基于个性化诊疗计划的心血管病人院后管理,相关性分析及不良心血管事件模式发现等应用和工具,有助于提升心血管专科的临床流程效率,临床质量评估和科研水平,同时为建立全国性的心血管疾病注册数据库打下了基础。     

The Cooperative Landscape of Multinational Clinical Trials

The scale and nature of cooperative efforts spanning geopolitical borders in clinical research have not been elucidated to date. In a cross-sectional study of 110,428 interventional trials registered in Clinicaltrials.gov, we characterized the evolution, trial demographics, and network properties of multinational clinical research. We reveal that the relative growth of international collaboratives has remained stagnant in the last two decades, although clinical trials have evolved to become much larger in scale. Multinational clinical trials are also characterized by higher patient enrollments, industry funding, and specific clinical disciplines including oncology and infectious disease. Network analyses demonstrate temporal shifts in collaboration patterns between countries and world regions, with developing nations now collaborating more within themselves, although Europe remains the dominant contributor to multinational clinical trials worldwide. Performances in network centrality measures also highlight the differential contribution of nations in the global research network. A city-level clinical trial network analysis further demonstrates how collaborative ties decline with physical distance. This study clarifies evolving themes and highlights potential growth mechanisms and barriers in multinational clinical trials, which may be useful in evaluating the role of national and local policies in organizing transborder efforts in clinical endeavors.     

大数据时代信息化管理平台在医院专科建设中的价值

大数据时代利用信息化管理平台可以优化并规范临床诊疗流程、提升诊疗服务质量与效率、提高科研质量与水平,符合医改对医院精细化管理和循证医学时代精准医疗的要求。此信息化管理平台可以自动获取临床诊疗全程结构化数据,通过顶层设计达到规范医疗文件内容,减轻临床文书工作的目的;通过一次记录同时满足临床科研、运营管理及常规临床文件的需求,对规范化诊疗、临床科研、科室运营管理意义重大,在医院专科建设中有较好的临床应用及推广价值。     

Les essais cliniques en médecine nucléaire

The EU clinical trials directive (2001/20/EC) was published on the 4th April 2001 and was transposed into French law in 2004. This new clinical trial regulation has modified considerably the research area including clinical trials conducted with radiopharmaceutical medicinal products. This new regulation aims at ensuring the protection of the health and safety of clinical trial participants, the ethical soundness and the reliability and robustness of data generated in clinical trials. In practice, the sponsor has to submit a clinical trial application to the Afssaps for authorization and to the concerned Ethics Committee for a positive opinion. The content of the clinical trial application regarding the investigational medicinal product is very detailed and a heavy technical dossier could be required in order to justify the quality of the medicinal product used in the clinical trial. Furthermore, pharmacy and radiopharmacy required specific authorizations for preparing these medicinal products. This new regulation could refrain nuclear medicine from conducting clinical trials.     

Information retrieval for patient care.

Doctors need clinical information during most consultations with patients, and much of this need could be satisfied by material from online sources. Advances in data communication technologies mean that multimedia information can be transported rapidly to various clinical care locations. However, selecting the few items of information likely to be useful in a particular clinical situation from the mass of information available is a major problem. Current information retrieval systems are designed primarily for use in research rather than clinical care. The design, implementation, and critical evaluation of new information retrieval systems for clinical care should be guided by knowledgeable clinical users.     

Cancer immunotherapy: recent breakthroughs and perspectives

Immunotherapy of cancer has long been considered as an attractive therapeutic approach but with no impact on clinical practice. Two clinical protocols of immunotherapy, one based on a cancer vaccine in patients with prostate cancer or melanoma and the other using an immunomodulator targeting T cells (anti-CTLA4 mAb) in melanoma patients, have demonstrated clinical efficacy in two phase?III clinical trials. To improve these encouraging clinical results, biomarkers to better select patients which may benefit from this therapy are actively searched. In addition, immunosuppression associated with cancer has to be overcome to allow a better immunostimulation. In contrast to chemotherapy, clinical variables to monitor the efficacy of immunotherapy has to be revisited and overall survival appears to be a better endpoint than clinical response defined by the RECIST criteria. Combination of immunotherapy with conventional treatments (chemotherapy, anti-angiogenic, etc.) should further improve this approach both in its effectiveness and in its clinical indications.     

临床试验进展: 适应性设计及透明性

临床试验中的适应性设计是根据累积信息来修正试验的一种设计方法,旨在使临床试验和临床开发计划效率更高,并为患者提供更加有效的治疗。此外,因信息隐匿造成试验失败和患者死亡,从而导致公众对医药行业的信任度下降,故关于公开临床数据的观点已开始朝着提升透明度方向调整。介绍3 类适应性设计方法的特点和应用,以及国外药政部门和制药企业对提高临床试验透明性的举措。     

临床蛋白质组学———蛋白质组学在临床研究中的应用

临床蛋白质组学是将蛋白质组学技术应用于临床医学研究,它主要围绕疾病的预防、早期诊断和治疗等方面开展研究,其中,恶性肿瘤是临床蛋白质组学研究的一个重点研究对象.由于肿瘤生物标志物对早期诊断具有重要价值,所以临床蛋白质组学的主要目标之一是寻找合适的肿瘤生物标志物,多分子生物标志物已成为寻找肿瘤生物标志物的一个研究趋势.简要介绍了临床蛋白质组学的基本概念,实验设计,临床样本收集与预处理以及蛋白质组学技术在临床研究中的应用与进展.     

高职高专临床医学教育早期接触临床的途径和方法

随着经济、社会的发展,社会保障制度的完善,基层医院的医疗资源和医疗水平逐渐完善和提高,在基层医院就诊看病的人数也越来越多。因此,大力培养基层医院的临床医学人才是高等医学院校应该担当的责任。本文针对高职高专的短学制临床医学教育,改变传统的教学模式,提出早期接触临床的途径和方法,着力从以下几个方面入手,一是整合基础医学和临床医学的综合课程;二是综合实验项目内容专题化、研究化;三是实行阶段式教学;四是实行临床预见习和观摩手术。因而有效解决了大专层次的临床医学教育学制短、临床技能不足的缺陷。     

临床试验进展：临床数据与实验室质量管理规范

将临床研究数据用于临床日常规范及健康相关决策的制定对于改善全球医疗保健至关重要。汤森路透Cortellis 临床试验情报对临床试验数据的应用价值及各国临床实验室质量管理规范的实施情况进行了介绍,提供描绘临床图景关键元素和当前趋势的专家分析,从而指导临床开发决策。     

免疫治疗背景下提高临床肿瘤教学水平的探讨

肿瘤发病率的日益攀升以及临床肿瘤学的迅速发展,对培养专业的临床肿瘤学人才提出了更高的要求。随着第一个细胞免疫治疗药物Sipuleucel-T被美国FDA批准用于晚期前列腺癌的治疗,肿瘤治疗进入免疫治疗的新时代,现有传统临床肿瘤学教学方法及观念已经不能适应目前的要求,因此必须提高临床教学水平。本文在肿瘤免疫治疗迅速发展背景下,对如何提高临床肿瘤教学水平进行思考与探讨,通过加强肿瘤分子生物学及细胞分子免疫学理论教学,以及在教学过程中贯穿循证医学与个体化治疗相结合的理念、引入多学科参与的肿瘤综合治疗模式,并强调心理干预和人文关怀的重要性,兼顾教学理论和临床实践最新进展及趋势,有效地帮助学生树立全面、科学的临床肿瘤治疗理念,掌握改善临床肿瘤治疗的有效方法,切实提升临床肿瘤学的教学质量和水平,培养出能胜任现代临床肿瘤学实践需求的专业人才。     

临床诊断书写规范化方法研究

目的 规范临床诊断书写,为DRGs付费制度的实施做准备。方法 建立临床诊断字典,临床医师通过电子病历系统从临床诊断字典中选择诊断名称。结果 95%以上的临床诊断名称均来自临床诊断名称字典,保证了临床诊断名称的规范性,同时能够直接与ICD10编码对应。结论 建立临床诊断字典能够规范临床诊断的书写,同时为提高临床诊断编码的准确性奠定了基础。     

全国三级医院临床工程部门人员发展现状分析

目的 掌握我国临床工程部门人员发展现状,为临床工程部门发展提供建议。方法 采用问卷调查法,向全国282家三级医院临床工程部门发放调查问卷282份,对其基本发展情况进行调查,问卷回收率100%。结果 三级医院临床工程人员存在职称结构不合理、整体素质偏低、科研能力不足和继续教育项目内容过于单一等问题。结论 三级医院应当加强临床工程部门人员学历教育、鼓励开展科研、畅通职称晋升渠道、加强与国外临床工程学术交流,推动临床工程更好发展。     

Development and regulation of stem cell‐based therapies in China

BackgroundClinical researches of stem cell‐based therapies are highly active in China, while it was arduous to determine the most effective way of clinical translation of those advanced therapies.MethodsThis article briefly introduced the regulatory framework development, the progress in stem cell clinical researches and clinical trials of commercially developed stem cell‐based products, as well as the clinical review concerns of stem cell‐based products in China.Main findingsThe current regulatory framework of stem cell clinical researches in China was launched in 2015, when regulatory authorities issued “Administrative Measures on Stem Cell Clinical Research” (AMSCCR) detailing the rules of stem cell clinical research. Thereafter, the rapidly growing stem cell clinical researches were rigorously managed and clinical use of stem cell therapy was halted. Meanwhile, commercially developed stem cell‐based products are supervised by Drug Administration Law (DAL).ConclusionThe regulatory framework of stem cell‐based therapy in China has progressed in the last few decades, which is currently regulated according to AMSCCR and DAL. Well‐designed and patient‐focused clinical trial is required for commercially developed stem cell‐based products, and definite clinical benefit evidence is crucial to obtain marketing authorization.

This article briefly introduced the regulatory framework development of stem cell‐based therapy, progress in stem cell‐based clinical studies and clinical review concerns in China.     

Clinical penetrance of C282Y homozygous HFE haemochromatosis

The prevalence of the C282Y homozygous HFE genotype is high, approximately 1 in 200 in populations of Anglo-Celtic descent, and most authorities assumed this mutation would have a high clinical penetrance. Recent studies report the clinical penetrance of C282Y homozygous hereditary haemochromatosis is much lower than its prevalence, with possibly less than 5% developing clinical disease, although there is lack of consensus on a precise estimate. This review discusses reasons for this paradigm shift, including controversy on various definitions of clinical penetrance.It is inescapable that there are pronounced variations in clinical penetrance, and that certain C282Y homozygous individuals will not develop the clinical phenotype. This has prompted a search for modifier gene mutations amongst iron-metabolism genes, especially the known non- HFE haemochromatosis genes, and for possible environmental factors which might explain the observed variation in clinical penetrance.     

Clinical versus laboratory detection of alcohol abuse: the alcohol clinical index.

To determine reliable indicators of alcohol abuse a comprehensive set of clinical and laboratory information was acquired from three groups of subjects with a wide range of drinking histories: 131 outpatients with alcohol problems, 131 social drinkers, and 52 patients from family practice. Findings from clinical examination provided greater diagnostic accuracy than laboratory tests for detecting alcohol abuse. Logistic regression analysis produced an overall accuracy of 85-91% for clinical signs, 84-88% for items from the medical history, and 71-83% for laboratory tests in differentiating the three groups. Further analyses showed 17 clinical signs and 13 medical history items that formed a highly diagnostic instrument (alcohol clinical index) that could be used in clinical practice. A probability of alcohol abuse exceeding 0.90 was found if four or more clinical signs or four or more medical history items from the index were present. Despite recent emphasis on the laboratory diagnosis of alcohol abuse simple clinical measures seem to provide better diagnostic accuracy.     

The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3): a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer) to usual care, compared to usual care alone in patients with lung cancer

The conduct of clinical trials in the UK has been affected by the recent introduction of managed clinical networks, clinical research networks and rigorous governance regulations. This commentary considers the challenges that these changes have posed for clinical triallists in the UK, based on experiences derived in the conduct of a multicentre neonatal clinical trial under the conditions that now prevail. We conclude that the considerable skills and knowledge that are now required to be an effective Principal Investigator should be recognised and that application processes, including issuing honorary contracts, should be simplified and centralised.     

圣乔治教堂诺卡菌引起的肺部感染1例

诺卡菌肺部感染可引起肺诺卡菌病,因其无特异性的临床表现,容易误诊、漏诊。因此,临床实验室的培养鉴定能力非常重要,若不能及时诊治,则会导致病死率较高。诺卡菌病临床较为少见,为引起临床实验室对诺卡菌的鉴定和药敏试验的重视,本文报道了上海市嘉定区中心医院2019年2月收治的1例由圣乔治教堂诺卡菌(Nocardia cyriacigeorgica)感染引起的肺诺卡菌病病例,针对其临床特征、实验室检测及治疗等进行分析,期望对临床诊治诺卡菌病有所帮助。     

Evidence-Based Medicine,Clinical Practice Guidelines,and Common Sense in the Management of Osteoporosis

ObjectiveTo evaluate the benefits and limitations of randomized controlled trials (RCTs), clinical practice guidelines (CPGs), and clinical judgment in the management of osteoporosis.MethodsA review was conducted of the English-language literature on the origins and applications of RCTs, CPGs, evidence-based medicine, and clinical judgment in the management of osteoporosis.ResultsEvidence-based medicine is use of the currently available best evidence in making clinical decisions for individual patients. CPGs are recommendations for making clinical decisions based on research evidence, sometimes with consideration of expert opinion, health care policy, and costs of care. The highest levels of medical evidence are usually thought to be RCTs and meta-analyses of high-quality RCTs. Although it is desirable and appropriate for clinicians to consider research evidence from RCTs and recommendations presented in CPGs in making clinical decisions, other factors—such as patient preference, comorbidities, affordability, and availability of care—are important for the actual implementation of evidence-based medicine.ConclusionDecisions about who to treat, which drug to use, how best to monitor, and how long to treat require clinical skills in addition to knowledge of medical research. The necessity of integrating common sense and clinical judgment is highlighted by the fact that many patients treated for osteoporosis in clinical practice would not qualify for participation in the pivotal clinical trials that demonstrated efficacy and safety of the drugs used to treat them. (Endocr Pract. 2009;15:573-579)