Developments and applications of HPLC technique in clinical research

Chromatographic method was invented about 80 years ago.Since thengreat development has been made and it is now widely used as an analyti-cal tool in chemistry,biology,medicine and environmental sciences.Since 1970,highly precise HPLC(high performance liquid chromatography)pumps,various kinds of columns and high sensitive detectors have beenmanufactured.The computerizing equipment can implement the automaticanalysis under optimal conditions and provide more precise and convenientdata acquisition and processing.The HPLC technique has become moreand more important for the biologists and medical scientists in broadening     

Financial disclosure and clinical research: what is important to participants?

OBJECTIVE: To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional questionnaire administered to 324 participants in six clinical trials conducted at the Royal Melbourne Hospital in 1999-2000 and 2006 for non-acute conditions (asthma, chronic obstructive pulmonary disease, osteoporosis, rheumatoid arthritis, diabetes and influenza vaccine efficacy). MAIN OUTCOME MEASURES: Participants' desire for information on study funding, investigators' conflicts of interest, and use of accrued funds. RESULTS: 259 participants (80%) completed the survey. Participants wanted to be informed about the identity of the project sponsor (148 participants; 57%), whether the investigators owned shares in the company (105; 41%) or received travel grants (83; 32%), how much funding was accrued at study completion (88; 34%), how accrued funds were used (98; 38%), and who approved their use (91; 35%). After adjusting for year of survey and level of education, younger subjects (aged 相似文献   

From clinical trials to clinical practice: How long are drugs tested and then used by patients?

ObjectiveEvidence is scarce regarding the safety of long-term drug use, especially for drugs treating chronic diseases. To bridge this knowledge gap, this research investigated the differences in drug exposure between clinical trials and clinical practice.Materials and MethodsWe extracted drug follow-up times from clinical trials in ClinicalTrials.gov and compared the difference between clinical trials and real-world usage data for 914 drugs taken by 96 645 927 patients.ResultsA total of 17.5% of drugs had longer median exposure in practice than in trials, 6% of patients had extended exposure to at least 1 drug, and drugs treating nervous system disorders and cardiovascular diseases were the most common among drugs with high rates of extended exposure.ConclusionsFor most of patients, the drug use length is shorter than the tested length in clinical trials. Still, a remarkable number of patients experienced extended drug exposure, particularly for drugs treating nervous system disorders or cardiovascular disorders.     

Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated?

CONTEXT: Practice guidelines need to be up-to-date to be useful to clinicians. No published methods are available for assessing whether existing practice guidelines are still valid, nor does any empirical information exist regarding how often such assessments need to be made. OBJECTIVES: To assess the current validity of 17 clinical practice guidelines published by the US Agency for Healthcare Research and Quality (AHRQ) that are still in circulation, and to use this information to estimate how quickly guidelines become obsolete. DESIGN, SETTING, AND PARTICIPANTS: We developed criteria for defining when a guideline needs updating, mailed surveys to members of the original AHRQ guideline panels (n = 170; response rate, 71%), and searched the literature for evidence through March 2000 (n = 6994 titles yielding 173 articles plus 159 new guidelines on the same topics). MAIN OUTCOME MEASURES: Identification of new evidence calling for a major, minor, or no update of the 17 guidelines; survival analysis of the rate at which guidelines became outdated. RESULTS: For 7 guidelines, new evidence and expert judgment indicated that a major update is required; 6 were found to be in need of a minor update; 3 were judged as still valid; and for 1 guideline, we could reach no conclusion. Survival analysis indicated that about half the guidelines were outdated in 5.8 years (95% confidence interval [CI], 5.0-6.6 years). The point at which no more than 90% of the guidelines were still valid was 3.6 years (95% CI, 2.6-4.6 years). CONCLUSIONS: More than three quarters of the AHRQ guidelines need updating. As a general rule, guidelines should be reassessed for validity every 3 years.     

Serum SP1, HPL levels and urinary estrogen/creatinine ratio in the detection of low birth weight.

Serum pregnancy specific beta 1 glycoprotein (SP1), human placental lactogen (HPL) and urinary estrogen/creatinine (E/C) ratio levels were determined to study their clinical significance in predicting low birth weight (LBW) in women with normal pregnancy and patients with LBW. The results showed that the sensitivity of urinary E/C ratio was better than that of serum SP1 and HPL, and was increased gradually with the reduction of fetal weight. The specificity in predicting LBW decreased gradually with the increase of serum SP1 and HPL levels and urinary E/C ratio. When serum SP1 level was less than 50 mg/L, HPL less than 2.0 mg/L, and E/C ratio less than 10, their specificity could increase over 90%. It is suggested that multi-indexes measurement would improve the accuracy for predicting LBW. We conclude that SP1, HPL and E/C ratio measurement could be an useful index for predicting LBW.

     

Translational research case studies： Development of antibodies for cancer diagnosis and therapy

Antibodies are primary tools in several areas of biomedical sciences, including basic research, diagnostics, and molecular therapeutics. Antibodies are widely used in diagnostic applications for clinical medicine. Analysis of cells and tissues in pathology laboratories includes the use of antibodies on tissue sections. Further, antibodies are making rapid inroads into medical therapeutics, driven by technological evolution from chimeric and humanized to fully human antibodies. The therapeutic antibody market has the potential to reach $30 billion by 2010. Our lab has developed a monoclonal antibody, named Met4 that was raised against the extracellular domain of Met specifically with the goal of measuring Met in FFPE tissues. The Met receptor kinase is expressed on the cell surface of a significant number and variety of human primary solid tumors and in their metastases. The characterization of the Met4 antibody suggests it should possess adequate performance for quantification of Met expression in clinical specimens. We have also generated a fully human Fab fragment against EGFR; conjugated it to taxol as an immuno-chemotherapy agent; and investigated its in vitro antitumor efficacy on EGFR positive A431 epidermoid carcinoma cells.[第一段]     

Comparison of consumers’ views on electronic data sharing for healthcare and research

New models of healthcare delivery such as accountable care organizations and patient-centered medical homes seek to improve quality, access, and cost. They rely on a robust, secure technology infrastructure provided by health information exchanges (HIEs) and distributed research networks and the willingness of patients to share their data. There are few large, in-depth studies of US consumers’ views on privacy, security, and consent in electronic data sharing for healthcare and research together.Objective This paper addresses this gap, reporting on a survey which asks about California consumers’ views of data sharing for healthcare and research together.Materials and Methods The survey conducted was a representative, random-digit dial telephone survey of 800 Californians, performed in Spanish and English.Results There is a great deal of concern that HIEs will worsen privacy (40.3%) and security (42.5%). Consumers are in favor of electronic data sharing but elements of transparency are important: individual control, who has access, and the purpose for use of data. Respondents were more likely to agree to share deidentified information for research than to share identified information for healthcare (76.2% vs 57.3%, p < .001).Discussion While consumers show willingness to share health information electronically, they value individual control and privacy. Responsiveness to these needs, rather than mere reliance on Health Insurance Portability and Accountability Act (HIPAA), may improve support of data networks.Conclusion Responsiveness to the public’s concerns regarding their health information is a pre-requisite for patient-centeredness. This is one of the first in-depth studies of attitudes about electronic data sharing that compares attitudes of the same individual towards healthcare and research.     

Waiver of individual patient consent in research: when do potential benefits to the community outweigh private rights?

Health services research is important to ensure continued best quality of care, but often uses data obtained without explicit consent for this purpose. Obtaining consent may be difficult for many reasons, but excluding individuals may introduce biases that alter the significance of studies. Approval by ethics committees of a waiver of the need for consent allowed our study to proceed and provide evidence that has led to the implementation of a population-based screening policy for the prospective detection of hereditary non-polyposis colorectal cancer. This screening policy has resulted in more cases being detected routinely with better management for affected patients and their at-risk families. A need for consent would have prohibited this study, and the development of a more efficient screening policy could have been delayed for several more years. Ethics committees can effectively manage the need to uphold basic ethical principles without unnecessarily impeding socially useful research. Committees need to be familiar with the guidelines approved under sections 95 and 95A of the Privacy Act 1988 (Cwlth) in addition to the National Health and Medical Research Council National statement on ethical conduct in research involving humans.     

Experimental Study and clinical Trial of Shengmaisan（生脉散）to Protect and Treat Myocardial Injury

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The Research Quality Framework and its implications for health and medical research: time to take stock?

As the Australian university sector awaits final decisions about the introduction and stipulations of a research quality framework (RQF), to assess the quality and impact of research, we have studied international commentary on the value of such exercises. This suggests there is little hard evidence to recommend the proposed RQF. The UK government led the field in 1986 with its research assessment exercise (RAE), which is widely believed to have compromised clinical academic medicine by failing to satisfactorily acknowledge the contribution of clinical academics, not only to research but also to teaching and clinical practice. After the 2008 RAE, the UK government will move to a simpler, metrics-based system for assessing research quality and allocating funding. The New Zealand Performance Based Review Fund (PBRF), introduced in 2003, is based on a combination of peer review and performance indicators. Several concerns have been raised; among them is the real cost-benefit ratio of participation, with reports that many universities have spent more on the exercise than they will gain in funding increases. The scoring system has received the most criticism and, after the partial round assessment scheduled for this year, the controversial unit of assessment will be reviewed. It might be more cost-effective for Australia to modify existing research assessment processes than to undertake a potentially costly and arduous exercise.     

The clinical use of interventional chemotherapy and intravesical instillation for preventing recurrence of superficial bladder cancer

Objective To study the therapeutic efficacy of combined interventional chemotherapy and intravesical instillation of mitomycin on preventing bladder cancers from recurring after local ablation. Methods 28 patients with superficial bladder cancers were randomized into combined interventional chemotherapy and intravesical instillation of mitomycin or intravesical instillation of mitomycin alone for preventing recurrence after local ablation. The result was assessed by x2 test. Results The patients have been followed up for 12-26 months (mean 21 months). 1 case has had tumor recurrence in the combined modality therapy group and 4 in the intravesical instillation alone group, the tumor recurrence rate being 7% (1/14) and 29% (4/14) respectively (P<0.05). Conclusion Combined use of interventional chemotherapy and intravesical instillation of mitomycin is effective in preventing superficial bladder cancer from recurring after local ablation with fewer adverse effects. The ragimen is not only reliable but also     

A new design of internal fixation for scoliosis and its preliminary clinical application.

A new scoliotone composed of screw, socket, distraction rod, lateral mass and compression rod can produce free movement in three different planes and fix the vertebral column in three-dimensions. The instrument has a strong force of fixation, distraction, compression and anti-rotation and it can be locked in any degree angle. Preliminary clinical application in 10 cases showed that when the spinal curvature (Cobb's angle) was less than 50, the average correction rate of scoliosis was 78.2% and that of the hump was 90%; when Cobb's angle was within 50-100 degrees, the average curve correction was 68.2%, and the hump correction 87.7%; when Cobb's angle was 100 degrees, the average curve correction was 63.3%, and the hump correction 82%. The vertebral column needed no external fixation after the operation. Biomechanical characteristics of the vertebral pedicle, and the technical features are discussed.