Gastroprotective Effect of the Three Glucuronopyranoside Flavonoids in Rats

In this study, we investigated the protective action of glucuronopyranoside flavonoids (QGC, AGC, LGC) on gastritis in rats. QGC, AGC and omeprazole decreased the gastric volume significantly, and each ID₅₀ was 0.75, 0.54 and 8.5 mg/kg, respectively, thus the order of potency was AGC, QGC and omeprazole. They also decreased acid output, and each ID₅₀ was 7.81, 0.58 and 6.71 mg/kg, respectively, thus the order of potency was AGC, omeprazole and QGC. They inhibited gastritis induced by indomethacin, and it recovered significantly by increasing the GSH levels in gastritis. The gastric MPO activity in the gastritis group increased more than in the normal group. QGC, LGC, or AGC administration reduced moderately the MPO activity in a dose-dependent manner. This study demonstrated that AGC, QGC, or LGC showed potent efficacy on the gastritis, by preventing oxidative stress. These results suggest that QGC, AGC, or LGC have gastroprotective effect in rats.     

胰岛素刺激对HIT-T15细胞胰岛素原基因表达的影响

【摘要】目的 探讨短期外源性胰岛素刺激对HIT-T15胰岛β细胞胰岛素原（PI）基因表达的影响及机制。方法 HIT-T15仓鼠胰岛瘤细胞随机分为4组：含1.4mmol/L葡萄糖完全培养基组作为空白对照(LG组),为抑制内源性胰岛素释放干扰以低糖联合硝苯地平作为条件对照（LGC组）,在LGC基础上分别加0.5U/L或5U/L的外源性胰岛素作为实验组(分别为LINS组和HINS组),分别在刺激后0、30、60、90、120min以荧光定量PCR检测各组PI mRNA,免疫组化检测各组细胞胰岛素受体底物1（IRS1）酪氨酸磷酸化水平。结果（1）LINS组、HINS组细胞PI mRNA表达均上调,在刺激后60min PI mRNA表达量达高峰。（2）实验组在刺激后30min IRS1酪氨酸磷酸化水平较对照组明显增高,高、低浓度胰岛素组细胞酪氨酸磷酸化达高峰时间不同。（3）LG组和LGC组间PI mRNA表达及IRS1酪氨酸磷酸化水平无明显差异。结论短期外源性胰岛素能上调胰岛β细胞PI基因的表达,且高浓度的胰岛素较低浓度胰岛素作用强。PI表达调控与IRS1信号传导有关。     

Linear structural equation model in analyzing quality-of-life-data from clinical trials

Assessment of quality of life (QOL) in clinical trials becomes a challenging task from the viewpoint of clinical biostatistics. The responses of the items for measuring QOL indices usually vary widely from patient to patient and from time to time. Measurement errors might be present in the responses of the items, and they might be correlated. Hence, in analyzing QOL data, the usual assumption that there are no measurement errors in responses is too liberal. Because the QOL indices are likely to be correlated, separate analysis of each index might not be efficient from the point of view of statistical methodology. We apply linear structural equation modeling (LISREL) in assessing the QOL data obtained from a clinical trial. A basic premise of the LISREL approach is that the abstract concepts (latent constructs) that are not directly measurable can be studied. LISREL is a statistical procedure for conceiving and testing structural hypotheses that cannot be tested adequately with other statistical procedures. It allows us to specify relations between unobserved and observed variables while controlling for measurement errors and correlations among both the measurement errors and the latent constructs.     

临床路径在医院管理中的应用

临床路径是一种属于质量效益型的医疗管理模式,在医院管理中得到了广泛的应用。通过采用临床路径,能够使诊疗行为更加规范、医疗质量得到提高、医疗安全得以保证、使医疗费用更加合理化、就医者的满意程度得到提高、推动着医院的专业化管理的全面发展进程。     

药物临床试验各环节的风险管理

随着我国创新药物研发能力的不断提高,新药临床试验的数量也在不断增加。新药临床试验是验证药品有效性和安全性的关键环节,其结果的可靠性直接关系到百姓的用药安全。临床试验的完成质量受多方因素的影响,其中临床试验机构的管理起重要的作用。通过分析药物临床试验各环节的质量风险因素,并探讨了降低风险的应对措施,以期为药物临床试验的质量管理以及项目质量的提升提供借鉴。     

Assuring the quality of a clinical pharmacokinetics service

A quality assurance program for a clinical pharmacokinetics service that meets current Joint Commission on Accreditation of Hospitals (JCAH) requirements for quality assurance is described. The clinical pharmacokinetics service is provided by pharmacists who have been certified through a staff development program. The clinical pharmacokinetics quality assurance program is part of the department's overall quality assurance program. Information from records maintained by pharmacists who are involved in the pharmacokinetics service is reviewed monthly and compared with 14 criteria that were approved by the pharmacy and therapeutics committee. Results of the monthly audits are summarized in a trend report; these results are communicated to the pharmacists involved, and any necessary corrective actions are taken. The program has led to more appropriate selection of target peak and trough serum drug concentrations, improved documentation of patient data, and better monitoring of each patient's renal function. Physician use of the service has increased as the quality of the service has improved. The quality assurance program has provided mechanisms for monitoring the quality of patient-care services and satisfying current JCAH requirements.     

临床研究中数据管理及其质量评价

探讨数据管理的概念及范畴,认识数据管理是贯穿临床研究各个环节的以质量控制为中心的综合过程;在临床研究的不同阶段,数据管理的内容和评价重点各不同,一是临床资料收集过程中的数据管理,二是纸张文字资料录入计算机过程的数据管理,三是数据信息的安全及文档管理。     

加强过程监查，提高药物临床试验质量

新药临床试验质量是药品上市后安全有效的保障。加强药物临床试验监督管理,对提高新药临床试验质量具有重大的意义。我国CCP规范强调了药物临床试验中质量管理的重要性,其中监查是保证药物临床试验质量的一个重要环节。但目前新药临床试验中的监查还存在一定的问题,需要通过分析问题产生的根源,探讨解决的办法,提出加强药物临床试验过程的监查,使药物临床试验质量得到进一步提高。     

Feasibility of modified DLQI-based questionnaires for evaluation of clinical efficacy of herbal medicine in chronic skin diseases

BACKGROUND: The efficacy of herbal medicines is thought to be ambiguous. The quality of life (QOL) of patients has been well-recognized as an useful measurement and we thought it to be a measurement of the efficacy of herbal medicine. OBJECTIVE: The aim of this study was to examine the feasibility of modified DLQI-based questionnaires in evaluating the efficacy of herbal drugs in chronic skin diseases. METHODS: 19 in-patients with chronic skin diseases were selected and treated by the herbal medicines just added on the previous drugs. By using the QOL-sheet, the patients' QOL before and after herbal treatments were converted to scores and we examined the scores to be a useful measurement. The QOL-sheet was made referring to the dermatology life quality index (DLQI) with our original questions and visual analogue scale (VAS) in Japanese. RESULTS: The herbal drugs were effective as the treatment with significant difference (P < 0.05) at clinical impression, DLQI and VAS. No significant differences of correlation between clinical impression, DLQI/DLQI with AQ and VAS/VAS with AQ was proved (P > 0.05). CONCLUSIONS: The QOL-sheet scored both by DLQI and by VAS may be useful to evaluate the efficacy of herbal medicines. However it may be necessary to reconsider the contents of our original questions.     

浅谈临床实验室质量控制在药物临床试验工作中的重要性

临床实验室质量管理是医院全面质量管理的重要组成部分,同时也是医院药物临床试验管理规范(GCP)建设的重要内容。检验科实行全面的质量管理是为了向临床提供精准的、可信赖的、高品质的检验结果,并得到药物临床试验受试者、临床医师或研究者和药物临床试验机构办公室的信赖与认可。但是在实际工作中,仅通过检验科实行全面的质量管理还不够,同时还需要与各个临床科室进行多种形式的有效沟通,以此来实现检验科质量管理的提升。所以把检验科质量控制增加到GCP质量管理体系是非常有必要的,与此同时还要和医院质量管理体系有机结合才能使医院的医疗质量得到了显著的提升,GCP的研究水平也就得到了相应的提升。     

Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG warehouse

The FDA mandates that digital electrocardiograms (ECGs) from ‘thorough’ QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.     

从临床药师制建设探讨临床药师的基本素质和专业技能

目的探讨临床药师制建设过程中如何提升临床药师的基本素质和专业技能。方法从制度建设与人才培养入手,通过临床药师培训试点基地工作和临床药师制试点工作,初步探索临床药师应具备的一些基本素质与专业技能。结果通过本院的临床药师双试点工作经验,得出了临床药师应具有积极主动、勇于创新的基本素质。以及对疾病、药品、循证医学、药物经济学等多学科充分掌握的专业技能,才能更好的服务于临床。结论临床药师制试点过程中,制度建设是临床药师工作的最关键一步,临床药师基本素质是临床药师制顺利实施的基础;临床药师的临床专业技能和临床科研能力是临床药师不断进行自我提升的前提。     

Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse

The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.     

临床药学专业学生人文精神的内涵探究与测量

目前为止，对临床药学专业学生人文精神还没有形成统一的衡量标准。本文在借鉴众多学者研究成果的基础上，调研了来自各级医院、卫生管理部门、高校的临床药学、药事管理等方面的专家意见，对临床药学专业学生的人文精神内涵进行了系统全面地剖析，尝试对临床药学专业学生人文精神进行界定。通过问卷调研的方式量化上述研究内容并对调查问卷的数据进行因子分析，最终构建出临床药学专业学生人文精神测量指标体系。该指标体系可以用于临床药学教育的人文素质培养现状测试以及数据分析，对于临床药学专业人文素质教育有一定借鉴意义。     

基于临床试验机构办公室质量控制认知的调研

临床试验机构办公室作为管理部门,通过质量控制实现对临床试验的质量监管。为了了解目前临床试验机构办公室质量控制的意义、效果及改进空间,笔者通过网络问卷的方式对78位临床试验参与人员进行调查,调查内容包括对机构办公室质量控制的总体认知和评价,对机构办公室质量控制提出建议,以期探索出充分发挥机构办公室质量管理职责、提升机构办公室质量控制效能的有效方法,从机构管理角度促进临床试验质量提高。     

Citation analysis of selected clinical pharmacology journals

Perceptions of pharmacy and medical journal quality vary widely. One objective measure of the quality of a scientific journal is the impact factor that can be defined as "a measure of the frequency with which the 'average article' in a journal has been cited in a particular year." The purpose of this study was to evaluate the clinical pharmacology journals available through the Science Citation Index and determine those that have the greatest impact. From these data, it appears that the premier primary literature journal in clinical pharmacology is Clinical Pharmacology and Therapeutics while the premier review journal has been Clinical Pharmacokinetics. Possible explanations for impact factor fluctuations over time are also discussed.     

Implementing a performance evaluation system in a correctional managed care pharmacy.

The development and implementation of a departmental performance evaluation system for a correctional managed care pharmacy are described. Health care services for approximately 150,000 offenders within the Texas Department of Criminal Justice are provided through an arrangement with two university systems, the University of Texas Medical Branch (UTMB) and Texas Tech University Health Sciences Center. UTMB provides all distributive pharmacy services through a central pharmacy located in Huntsville, Texas. The pharmacy department distributes 9,000-15,000 medication orders daily to over 140 facilities. Each department within UTMB Correctional Managed Care is evaluated against predetermined quality indicators. This evaluation system is collectively called the operational performance evaluation system (OPES) and is used, in part, to determine pay-for-performance eligibility. Before fiscal year 2001, pharmacy distributive services were provided under a third university system. Joining the UTMB system required the pharmacy department to not only participate in OPES but to develop quality indicators and measurement systems to evaluate departmental performance. Indicators were chosen to reflect a commitment to quality while assuring appropriate productivity in the provision of pharmaceutical care. Seven pharmaceutical care quality indicators were chosen and weighted by perceived importance. A system for data collection, measurement, and reporting was also developed. Implementation of a departmental performance evaluation system provides a means to measure service quality, identify areas of weakness, track performance over time, and lower costs. By setting concrete goals, this system raises awareness and promotes interdependence among department personnel.     

影像医学与核医学留学生临床教学中的问题与对策

留学生医学教育是新时期教育国际化的一个重要组成部分,如何提高留学生医学教学质量是目前亟待探索的课题。笔者结合影像学、临床实习教学实践,分析留学生医学影像学临床实习教学中存在的问题,并从留学生医学影像学临床实习教学特点、师资准备、教材选择、教学形式方面寻找提高留学生医学影像学临床实习教学质量的方法和对策。     

临床调脂治疗的阶梯和综合策略

通过复习来自PubMed(www．ncbi．nlm．nih．gov)调脂治疗的主要文献,分类调脂治疗的措施并阐述其特点,我们总结了临床调脂治疗的一种新策略,它由缓降型方案(slow-lowering program,S方案)和速降型方案(rapid-lowering program,R方案)组成,包括生活方式干预、中医药、化学药如他汀类、血液处理如献血和其他等措施,适合不同人群调脂治疗的应用。