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PubMed2003

Xemilofiban: SC 54684A, xemlofiban.

Xemilofiban [SC 54684, SC 54684A (HCl), xemlofiban], a glycoprotein IIb/IIIa antagonist, is an orally available prodrug of a non-peptide mimetic of the tetrapeptide RGDF. It is converted to the active metabolite, SC 54701 (the free base form of SC 54701A). Development was initiated by Searle (Monsanto). Searle became part of Pharmacia Corporation, which was acquired by, and merged into, Pfizer in April 2003. Searle had co-development and co-marketing agreements with Sankyo in Japan; these have been discontinued. In January 2003, Pharmacia donated the intellectual property for xemilofiban to Western Michigan University. In February 2003, Western Michigan University granted an exclusive worldwide licence of xemilofiban to VDDI Pharmaceuticals (formerly Virtual Drug Development Inc.). Xemilofiban was in a phase III clinical trial, the Evaluation of Xemilofiban in Controlling Thrombotic Events (EXCITE) trial, with Searle (Monsanto) in the US and Europe for the treatment of thrombosis in patients with unstable angina pectoris and acute myocardial infarction undergoing angioplasty. However, as xemilofiban demonstrated no significant clinical benefit, Searle discontinued its development. In Japan, Sankyo discontinued the development of xemilofiban for thrombosis at phase II following Searle's decision to drop the project. VDDI Pharmaceuticals plans to develop xemilofiban in cardiovascular disorders following on from the phase III studies completed by Pharmacia; a restructured dosing schedule and narrowed patient selection will be used. VDDI has research facilities worldwide and will utilise facilities in Ireland for the European clinical development programme; research facilities in the Southwest Michigan Innovation Center are planned while the head office of VDDI is based in Tennessee. Xemilofiban is in phase III development for the treatment of cardiovascular disease in conjunction with percutaneous coronary intervention.

Angina Pectoris↗

PubMed2001

Ethical challenges in pharmacoepidemiological research in Colombia.

PURPOSE: To illustrate and to discuss some ethical challenges encountered during pharmacoepidemiological research in a developing country (Colombia), as well as the decisions made to solve them. METHODS: The authors in Bogotá describe three recent studies. The first one collected data from clinical records to evaluate the prescriptions patterns in recently graduated physicians. The second used an interrupted time series design, with a set of observations prior and after a combined intervention, to assess whether it improved the quality of intravenous antibiotic prescribing practices in a university-based hospital. The third evaluated pharmacists' advice in childhood acute respiratory infection and acute diarrhea through a community survey, followed by focus groups and in-depth interviews of key informers. RESULTS: The ethical issues raised by these studies include the need for obtaining informed consent from participants (physicians in Study 1 and drug sellers in Study 3), deciding when to intervene in case of gross prescription mistakes detected during the collection of data as part of the time series assessment (Study 2), the use of simulated clients to collect data in the community survey, and the use of study resources to buy, in some cases, useless medications (Study 3). CONCLUSION: Although ethical challenges in pharmacoepidemiology in non-industrialized countries like Colombia may be different from those in developed nations, ethical principles that guide research remain the same. The processes to safeguard these principles in Colombia for virtually all research are also universal in nature, and include the ethical review committee, subject privacy, informed consent, and disclosure of funding sources.

Anti-Bacterial Agents↗

PubMed1999

Positioning of dental implants using computer-aided navigation and an optical tracking system: case report and presentation of a new method.

A navigation system for computer-aided surgery (Virtual Patient System, VPS) has been described in previous studies for different indications in oral and maxillofacial surgery. The aim of the system is the intraoperative transfer of preoperative planning on radiographs or CT scans on the patient, in real-time, and independent of the position of the patient's head. Until now an electromagnetic tracking system has been used for intra-operative position measurement. For placement of dental implants, the electromagnetic tracking system is not suitable since the motor of the implant drill leads to a considerable distortion of the magnetic field, thus direct visualization of drilling the implant socket was not possible. To overcome this problem, an optical tracking system which is not disturbed by conductive materials was integrated in the VPS system. The first patient operated on with this system had a posttraumatic loss of the upper incisors; three implants have been placed according to the prosthetic axis previously planned on radiographs and CT scans. The experience gained in this intervention led to the conclusion that computer-aided surgery provides a valuable tool in implant dentistry.

Adult↗

PubMed2005

Preventing complicated transseptal puncture with intracardiac echocardiography: case report.

BACKGROUND: Recently, intracardiac echocardiography emerged as a useful tool in the electrophysiology laboratories for guiding transseptal left heart catheterizations, for avoiding thromboembolic and mechanical complications and assessing the ablation lesions characteristics. Although the value of ICE is well known, it is not a universal tool for achieving uncomplicated access to the left atrium. We present a case in which ICE led to interruption of a transseptal procedure because several risk factors for mechanical complications were revealed. CASE PRESENTATION: A case of a patient with paroxysmal atrial fibrillation and atrial flutter, and distorted intracardiac anatomy is presented. Intracardiac echocardiography showed a small oval fossa abouting to an enlarged aorta anteriorly. A very small distance from the interatrial septum to the left atrial free wall was seen. The latter two conditions were predisposing to a complicated transseptal puncture. According to fluoroscopy the transseptal needle had a correct position, but the intracardiac echo image showed that it was actually pointing towards the aortic root and most importantly, that it was virtually impossible to stabilize it in the fossa itself. Based on intracardiac echo findings a decision was made to limit the procedure only to ablation of the cavotricuspid isthmus and not to proceed further so as to avoid complications. CONCLUSION: This case report illustrates the usefulness of the intracardiac echocardiography in preventing serious or even fatal complications in transseptal procedures when the cardiac anatomy is unusual or distorted. It also helps to understand the possible mechanisms of mechanical complications in cases where fluoroscopic images are apparently normal.

Aged↗

PubMed2006

Long-term follow up of diabetic patients treated with sirolimus-eluting stents. An angiographic and three-dimensional intravascular ultrasound study.

BACKGROUND: Sirolimus-eluting stents (SES) have already demonstrated their long-term effectiveness in suppressing neointimal hyperplasia in non-high risk patients. The long-term follow up of diabetic patients treated with SES has not been yet evaluated. METHODS AND RESULTS: Quantitative coronary angiography and intravascular ultrasound analysis were performed in 35 diabetic patients treated with a SES at short- (6.0 +/- 1.0 months) and long-term (18.5 +/- 4.9 months) follow up. There were no significant changes in the in-stent minimum lumen diameter (MLD) between short- and long-term follow up (2.69 +/- 0.46 vs. 2.61 +/- 0.44 mm; p = 0.5), as well as in the in-lesion MLD (2.38 +/- 0.54 vs. 2.30 +/- 0.62 mm; p = 0.6). None of the patients reached binary restenosis (diameter stenosis > 50%) at either follow-up periods. Stent obstruction volume by 3-D IVUS was very small at short-term follow up and has remained virtually the same at long-term follow up (3.4% vs. 3.5%; p = 0.8). There were no aneurysm formations, late stent strut malappositions or late stent thromboses. CONCLUSION: The present study demonstrates the 18-month efficacy and safety of SES for the treatment of diabetic patients without the so-called late catch-up phenomenon.

Aged↗

PubMedDate not supplied

The cycle of violence and victimization: a study of the school-based intervention of a multidisciplinary youth violence-prevention program.

This article reports on the school-based intervention component of a multidisciplinary program intended to reduce and prevent youth violence in the East New York neighborhood of Brooklyn. This intervention is based on three theories. The first theory posits that modifying beliefs, attitudes, and norms will help youths develop behaviors that support nonviolence. The second theoretical construct asserts that enhancing relationships with peers and family will buffer youths from the effects of exposure to violence. Finally, the third theory suggests that changing aspects of the setting and climate that contribute to violent behavior will prevent violence. The school-based intervention, the Safe Harbor, is a victim-assistance and violence-prevention program. The Safe Harbor offers activities including a 20-lesson violence-prevention and victim-assistance curriculum, counseling, parent involvement, teacher training, and school-change campaigns. The evaluation design is a panel study, with cohorts surveyed longitudinally at nonequivalent intervals. One hundred and fifteen seventh- and eighth-grade students who receive the curriculum and other services are the experimental group; the other 879 students in the seventh and eighth grades serve as the comparison group. Baseline data were collected through a survey of the entire school before the program's implementation in January 1995. Subsequent data collection will include interviews and focus groups; future analysis will address how participation in other parts of the Safe Harbor program or other programs in the school affects outcomes. The participation rate for the baseline survey in the experimental group was 86%, in the comparison group 76%. Responses to the survey questions were virtually identical between the two groups. Preliminary analyses reflect a climate of pervasive violence in the school, family, and community. More than half of the sample reported witnessing a severe beating in the school or their community within the past four months. Forty-four percent witnessed someone being attacked with a weapon in their neighborhood. The psychological consequences of exposure to violence were severe-51% of the sample reported post-traumatic stress disorder (PTSD) symptoms. A number of lessons have been learned from implementing and evaluating this project, including the importance of fostering community partnership and strong relationships with the school, and addressing both reactions to victimization and norms and beliefs about aggression.

Adolescent↗

PubMed2001

Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial.

CONTEXT: Electroconvulsive therapy (ECT) is highly effective for treatment of major depression, but naturalistic studies show a high rate of relapse after discontinuation of ECT. OBJECTIVE: To determine the efficacy of continuation pharmacotherapy with nortriptyline hydrochloride or combination nortriptyline and lithium carbonate in preventing post-ECT relapse. DESIGN: Randomized, double-blind, placebo-controlled trial conducted from 1993 to 1998, stratified by medication resistance or presence of psychotic depression in the index episode. SETTING: Two university-based hospitals and 1 private psychiatric hospital. PATIENTS: Of 290 patients with unipolar major depression recruited through clinical referral who completed an open ECT treatment phase, 159 patients met remitter criteria; 84 remitting patients were eligible and agreed to participate in the continuation study. INTERVENTIONS: Patients were randomly assigned to receive continuation treatment for 24 weeks with placebo (n = 29), nortriptyline (target steady-state level, 75-125 ng/mL) (n = 27), or combination nortriptyline and lithium (target steady-state level, 0.5-0.9 mEq/L) (n = 28). MAIN OUTCOME MEASURE: Relapse of major depressive episode, compared among the 3 continuation groups. RESULTS: Nortriptyline-lithium combination therapy had a marked advantage in time to relapse, superior to both placebo and nortriptyline alone. Over the 24-week trial, the relapse rate for placebo was 84% (95% confidence interval [CI], 70%-99%); for nortriptyline, 60% (95% CI, 41%-79%); and for nortriptyline-lithium, 39% (95% CI, 19%-59%). All but 1 instance of relapse with nortriptyline-lithium occurred within 5 weeks of ECT termination, while relapse continued throughout treatment with placebo or nortriptyline alone. Medication-resistant patients, female patients, and those with more severe depressive symptoms following ECT had more rapid relapse. CONCLUSIONS: Our study indicates that without active treatment, virtually all remitted patients relapse within 6 months of stopping ECT. Monotherapy with nortriptyline has limited efficacy. The combination of nortriptyline and lithium is more effective, but the relapse rate is still high, particularly during the first month of continuation therapy.

Antidepressive Agents↗

PubMed2004

Has exercise an antifracture efficacy in women?

Exercise in girls during growth seems to confer a high peak bone mineral density (BMD). Exercise in adulthood, in the peri- and postmenopausal period, and in old age prevents bone loss or increases BMD with a magnitude of minor biological significance. However, these changes must be regarded as beneficial compared to the age-related bone loss, which inevitably will occur if no interventions are implemented. Prospective intervention studies also suggest that exercise improves muscle strength, coordination and balance, even in elderly women, all of which are improvements with a potential of reducing the number of falls. A randomised, controlled, prospective, blinded study (the only study design that tests a hypothesis) of exercise with fracture as end point is extremely difficult to conduct, due to the large sample sizes needed. At present, no such studies exist. Retrospective and prospective observational and case-control studies suggest that physical activity in women is associated with reduced fracture risk. This may be correct, but we must never forget that a consistently replicated sampling bias may produce the same outcome. The Achilles heel of exercise is the reduction or the cessation of physical activity, which commonly occurs among middle-aged women when family and work demands reduce the time available for exercise. A higher BMD or improvement in muscle size and muscle strength achieved by exercise during adolescence seems to be eroded on retirement, leaving virtually no remaining benefits in old age, the period when fragility fractures begin to be a problem of increasing magnitude. However, recreational activities seem to maintain some of the musculo-skeletal benefits, but to date we do not know the level of activity needed to retain these benefits. Dose-response relationships need to be quantified, as also the effects on bone size, shape and architecture. Another essential question that we must address is how many fewer fractures will be the result of a community-based exercise campaign. Will efforts by the community to encourage a higher level of physical exercise, with the aim of reducing bone fractures, be cost-effective? The higher level of proof, suggesting that exercise does reduce fragility fractures and thus reduces the total cost for the society, must come from well-designed and well-executed, prospective, randomised, controlled trials. The responsibility of executing these studies lies in the hands of both researchers and the community.

Accidental Falls↗

PubMed1984

Preventing death and injury in childhood: a synthesis of child safety seat efforts.

Virtually all children are at risk for injury and death as passengers in moving vehicles. Between 70% to 90% of the injury and death could be reduced or prevented if children were restrained in safety seats. However, studies show that only a minority of children are properly protected. Numerous efforts have been made to increase the number of children riding in car safety seats. This article reviews and synthesizes the various attempts to motivate safety seat usage by examining the literature on (1) informational and educational programs; (2) safety seat loaner programs; (3) state laws requiring seat usage; (4) behavioral improvement emphasis programs; (5) reward-based programs; and (6) passive prevention approaches through airbags. No one approach appears to be the solution to the complex problem of motivating the preventive behavior of acquiring and consistently using safety seats. Recommendations are forwarded for: (1) developing and determining the best techniques for which settings through comparative research; (2) utilizing a developmental perspective in identifying when and what interventions are needed; and (3) implementing creative and comprehensive programs in communities.

Accidents, Traffic↗

PubMed2006

Renal fibrosis: new insights into the pathogenesis and therapeutics.

Renal fibrosis is the inevitable consequence of an excessive accumulation of extracellular matrix that occurs in virtually every type of chronic kidney disease. The pathogenesis of renal fibrosis is a progressive process that ultimately leads to end-stage renal failure, a devastating disorder that requires dialysis or kidney transplantation. In a simplistic view, renal fibrosis represents a failed wound-healing process of the kidney tissue after chronic, sustained injury. Several cellular pathways, including mesangial and fibroblast activation as well as tubular epithelial-mesenchymal transition, have been identified as the major avenues for the generation of the matrix-producing cells in diseased conditions. Among the many fibrogenic factors that regulate renal fibrotic process, transforming growth factor-beta (TGF-beta) is one that plays a central role. Although defective matrix degradation may contribute to tissue scarring, the exact action and mechanisms of the matrix-degrading enzymes in the injured kidney have become increasingly complicated. Recent discoveries on endogenous antifibrotic factors have evolved novel strategies aimed at antagonizing the fibrogenic action of TGF-beta/Smad signaling. Many therapeutic interventions appear effective in animal models; however, translation of these promising results into humans in the clinical setting remains a daunting task. This mini-review attempts to highlight the recent progress in our understanding of the cellular and molecular pathways leading to renal fibrosis, and discusses the challenges and opportunities in developing therapeutic strategies.

Animals↗

PubMed2005

The activated clotting time (ACT) can be used to monitor enoxaparin and dalteparin after intravenous administration.

BACKGROUND: The use of low-molecular weight heparin (LMWH) during percutaneous coronary intervention (PCI) has been limited by the presumed inability to monitor its anticoagulant effect using bedside assays. OBJECTIVES: This study was designed to compare the dose-response of enoxaparin, dalteparin and unfractionated heparin (UFH) on the activated clotting time (ACT), and to determine whether the ACT or aPTT can be used to monitor intravenous (IV) low molecular weight heparin (LMWH). METHODS: A total of 130 patients undergoing cardiac catheterization were assigned to intravenous enoxaparin 0.5 mg/kg, dalteparin 50 international units/kg or UFH 50 units/kg. Of the 130 patients, 46 (35%) underwent PCI, all of whom received a glycoprotein (GP) IIb/IIIa inhibitor. We measured ACT, activated partial thromboplastin time (aPTT) and plasma anti-Xa levels after serial sampling. RESULTS: Both enoxaparin and dalteparin induced a significant rise in the ACT and aPTT, with an ACT dose-response approximately one-half the magnitude of that obtained using UFH. The time course of changes in the ACT and aPTT after administration of enoxaparin and dalteparin was virtually identical, with a return to baseline at approximately 2 hours. The enoxaparin and dalteparin-treated patients successfully underwent PCI with no major hemorrhagic complications. CONCLUSIONS: The ACT is equally sensitive to IV enoxaparin and dalteparin. These data support an ACT-guided strategy for intravenously administered LMWH during PCI. Additional studies with larger patient populations may be indicated to determine the ideal target ACT for LMWH in PCI.

Angina Pectoris↗

PubMed1993

Effect of new investigational drug taxol on oncolytic activity and stimulation of human lymphocytes.

Taxol is a new antineoplastic agent active in the treatment of drug-refractory ovarian and metastatic breast neoplasms. Extensive investigations have been concerned with the effect of taxol on a variety of tumor cells, but there is virtually no information about its effect on human lymphocytes. Since lymphocytes, especially natural killer (NK) cells, have been recognized to play an important role in the body's defense against tumors, we studied the effect of taxol on the cytotoxicity of naive (unstimulated) peripheral blood mononuclear cells (MNCs) and NK cells as well as on these cells' activation and growth in interleukin-2 (IL-2) cultures. We found that taxol impaired the cytotoxicity of naive MNC and NK cells against the NK-sensitive cell line K-562 and against an ovarian cancer cell line, OV-2774, in a concentration-dependent fashion. The highest impairment was observed after incubation of the effector cells with 10 micrograms/ml taxol. In addition, taxol also interfered with the induction of lymphokine-activated cytotoxicity and with lymphocyte growth in IL-2 cultures. However, IL-2 preactivated NK cells displayed substantial levels of cytotoxicity even after taxol treatment. These findings, which indicate that treatment with taxol should follow rather than precede immunotherapeutic intervention, may be important in planning combined chemo- and immunotherapy strategies for cancer patients.

Analysis of Variance↗

PubMed2001

A structured debate: immediate versus deferred androgen suppression in prostate cancer-evidence for deferred treatment.

PURPOSE: We present a structured debate supporting the premise that immediate hormonal intervention has not been conclusively shown to provide a survival advantage in the management of advanced prostate cancer. MATERIALS AND METHODS: The literature emphasizing randomized trials was reviewed. Recommendations are based solely on a demonstrated advantage in survival. RESULTS: In patients with stage Tx Nx Mo or MI disease who did not receive other primary therapy there is no demonstrated survival advantage to immediate hormonal therapy. In men with positive lymph nodes who underwent radical prostatectomy a relatively small study showed a survival advantage in favor of immediate hormonal treatment compared to deferred treatment. This study did not reach the projected accrual of 240 patients and results have not been supported by other trials. In men with stages T2-4 Nx Mx disease who underwent primary treatment with radiotherapy a survival advantage for early hormonal therapy is primarily limited to high risk subgroups. In patients with biochemical relapse following primary treatment there are no trials. CONCLUSIONS: Because hormonal therapy is associated with the development of irreversible resistance in virtually all patients, it does not cure, there is usually a long interval from first prostate specific antigen elevation to the development of metastatic disease, and hormonal therapy has profound side effects and is expensive, delayed treatment is recommended in men with biochemical relapse following surgery or radiotherapy. Patients should be strongly encouraged to enter clinical trials to answer this question.

Antineoplastic Agents, Hormonal↗

PubMed2001

A Cost-Effective Model for Increasing Access to Mental Health Care at the Primary Care Level in Nigeria.

BACKGROUND: Although effective treatment modalities for mental health problems currently exist in Nigeria, they remain irrelevant to the 70% of Nigeria's 120 million people who have no access to modern mental health care services. The nation's Health Ministry has adopted mental health as the 9th component of Primary Health Care (PHC) but ten years later, very little has been done to put this policy into practice. Mental Health is part of the training curriculum of PHC workers, but this appears to be money down the drain. AIMS OF THE STUDY: To review the weaknesses and problems with existing mode of mental health training for PHC workers with a view to developing a cost-effective model for integration. METHODS: A review and analysis of current training methods and their impact on the provision of mental health services in PHC in a rural and an urban local government area in Nigeria were done. An analysis of tested approaches for integrating mental health into PHC was carried out and a cost-effective model for the Nigerian situation based on these approaches and the local circumstances was derived. RESULTS: Virtually no mental health services are being provided at the PHC levels in the two local government areas studied. Current training is not effective and virtually none of what was learnt appears to be used by PHC workers in the field. Two models for integrating mental health into PHC emerged from the literature. Enhancement, which refers to the training of PHC personnel to carry out mental health care independently is not effective on its own and needs to be accompanied by supervision of PHC staff. Linkage, which occurs when mental health professionals leave their hospital bases to provide mental health care in PHC settings, requires a large number of skilled staff who are unavailable in Nigeria. In view of past experiences in Nigeria and other countries, a mixed enhancement-linkage model for mental health in PHC appears to be the most cost-effective approach for these Nigerian communities. DISCUSSION: Nigeria is currently experiencing a 'double epidemic', and with high infant and maternal mortality rates, the burden of mental health problems is still invisible to policy makers. Meagre resources allocated to mental health need to be utilised maximally with cost-effective interventions. This mixed enhancement-linkage model draws on the strengths of both models, while taking into account their limitations. Concrete conclusions cannot be drawn until the model developed is fully tested. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: This model has the potential of making mental health services available, accessible and acceptable in these communities. This should reduce the burden of suffering for the mentally ill by providing treatment and restorative care, promoting mental health and preventing mental illness in the populace. IMPLICATIONS FOR HEALTH POLICY FORMULATION: The current mental health policy for Nigeria focuses on enhancement as the mode in which mental health can be successfully integrated into PHC and so far this has not been successful. Results emerging from this model can be presented to policy makers thereby supporting replication in other parts of the country. This could ultimately lead to a change in the mental health policy on training for mental health at the PHC level. IMPLICATIONS FOR FURTHER RESEARCH: Mental health services and mental health economics research are still at the stage of infancy in Nigeria. This study provides baseline information and should stimulate further research in these two vital areas.

Journal Article↗

PubMed2006

Pathogen-reduction systems for blood components: the current position and future trends.

The current multi-layered interventional approaches to blood safety have dramatically reduced the risk of viral contamination of blood components. Nowadays most of the residual transfusion transmitted infections (TTI) occur as the result of the interval between the time the donor is infected and the moment at which tests are capable of detecting the agent, the so called "window period" which has been considerably reduced by the increased sensitivity of nucleic acid testing (NAT). However, the residual risk of bacterial contamination and the unexpected appearance of some other emerging pathogens, almost every five years, are still of major concern to the public, politicians, regulatory agencies and place immense pressures on the organisations responsible for the provision of safe blood and its components. In view of these bleak scenarios, the use of human blood as a raw biological source is inherently unsafe, and screening/testing alone cannot exclude all the potential human pathogens; hence we need to put in place some sort of safer alternatives and/or additional preventative safety measures. Recently, several substitutes (alternatives) to virtual blood components have been developed and tried. Moreover, various mechanical methods such as cell washing and leukofiltration have been implemented as additional preventative safety measures but with limited success in abrogating the risk of transfusion transmitted cell-associated agents. The most promising approaches, so far, are methods that target pathogen nucleic acids (Methylene blue; Psolaren and Riboflavin UV light treatment). These procedures have undergone considerable in vitro studies to ensure their extremely high safety margins in terms of toxicity to the cells or to the recipients. In essence, while the technology of targeting nucleic acid to stop viral proliferation is common to the above three strategies, in practice these procedures differ in terms of operational, physicochemical and biological characteristics; including the potential impacts of their metabolites and photo-adducts; their effects on the spectrum of pathogens affected and the log reductions in culture infective studies. Accordingly, any strategy that involves addition of an extraneous agent or physicochemical manipulation of blood must balance the benefits of pathogen reduction against the loss or alteration to the cells and plasma functional integrity, short and long term toxicity to the cells and to the recipients, as well as the risk to the personnel involved and the community at large. Moreover, it must be noted that each method will have a different profile of adverse reactions and may differ in terms of the risk to particularly vulnerable groups of patients, requiring in depth clinical trials, while taking into consideration the cost benefit of the final process. Newer diagnostic procedures must be in place to establish the storage stability of products that have undergone pathogen inactivation, in particular tests reflecting the release of platelet-derived cytokines, cellular apoptosis or microvesiculation and their role in immunosupressiveness. This overview aims to provide an update on the continual improvements in blood component safety, in particular using methods that target pathogen nucleic acid. Emphasis is placed on methylene blue light treatment (MBLT) and Intercept or Mirasol PRT systems for platelets and plasma. The status of pathogen reduction of whole blood and red cells is also highlighted, though the progress in this area has been virtually stopped after the finding of antibody development in the clinical trial.

Anti-Infective Agents↗

PubMed2006

New insights into the epidemiology of chronic kidney disease in US Asians and Pacific Islanders.

PURPOSE OF REVIEW: In contrast to advances in our understanding of health disparities in other ethnic groups within the US, differential outcomes associated with chronic kidney disease among US Asians have gone largely unexamined. Until recently, risk estimates for chronic kidney disease outcomes among US Pacific Islanders were virtually unknown. This review highlights recent contributions to our understanding of chronic kidney disease outcomes in US Asians and Pacific Islanders. RECENT FINDINGS: Asians in the US appear to have a higher risk of end-stage renal disease relative to US whites after accounting for baseline kidney disease and many of the known risk factors for end-stage renal disease. The origins of the discrepancy in risk for end-stage renal disease between US Asians and whites do not appear to be explained by the socioeconomic and comorbidity disparities paradigm present in the US black vs. white model. Mounting evidence suggests that US Asians and Pacific Islanders receive substantially less predialysis care and proportionally fewer kidney transplants compared with US whites. Paradoxically, these populations have equivalent or better survival on dialysis. SUMMARY: These data highlight the need for studies to elucidate the mechanisms underlying the differential outcomes observed among US Asians and Pacific Islanders. Efforts to identify ethnicity-specific risk factors for kidney disease and interventions aimed at promoting predialysis care and kidney transplantation among US Asians and Pacific Islanders could substantially reduce morbidity, mortality, and costs.

Asian↗

PubMed2001

Association of airway responsiveness with asthma and persistent wheeze in a Chinese population.

STUDY OBJECTIVES: Data from a cross-sectional study were analyzed to examine the association of increased airway responsiveness with physician-diagnosed asthma and persistent wheeze. DESIGN: Two methods for calculating the provocative dose that decreases the airflow rate by 20% (PD(20)) were used as indexes for increased airway responsiveness: (1) a 20% drop in FEV(1) calculated from baseline FEV(1) (PD(20)b), and (2) a 20% drop in FEV(1) from FEV(1) measurements after inhalation of saline solution (PD(20)s). Both PD(20)b and PD(20)s were measured through induction by varying doses of methacholine. SETTING: Anqing, Anhui Province, China. PARTICIPANTS: Study subjects were 8 to 74 years of age and were classified into four groups: children (< 15 years old), young adults (15 to 29 years old), adults (30 to 44 years old), and older adults (> or 5 years old). INTERVENTIONS: The differences in estimated odds ratios of airway hyperresponsiveness with asthma and wheeze, sensitivity and specificity, and coefficients of variation were compared between PD(20)b and PD(20)s. The sample for analysis consisted of 10,284 subjects from 2,663 nuclear families with complete data on wheeze, asthma, and major potential confounding factors. MEASUREMENTS AND RESULTS: The prevalence of asthma in this sample was lowest in subjects with no demonstrable PD(20) and had a reverse dose-response relationship with PD(20) across all age groups. Using the receiver operating characteristic, the sensitivity and specificity of the PD(20)s or PD(20)b were found to be almost identical. A similar trend was found for persistent wheeze, although the estimated odds ratios for persistent wheeze appeared slightly smaller than those for physician-diagnosed asthma. CONCLUSIONS: This study demonstrates a dose-response relationship between increased airway responsiveness and asthma and wheeze in this Chinese population. PD(20)s or PD(20)b yielded virtually indistinguishable results, which indicated that either of the two tests could serve as an index of airway hyperresponsiveness.

Adolescent↗

PubMed2004

Comparison of basal follicle-stimulating hormone versus the clomiphene citrate challenge test for ovarian reserve screening.

OBJECTIVE: To compare the value of basal follicle-stimulating hormone (FSH) measurement vs. the clomiphene citrate challenge test (CCCT) in predicting the ability to achieve a pregnancy in women who are undergoing infertility treatment. DESIGN: Meta-analysis. SETTING: All studies that evaluated either basal FSH or the CCCT for determining the likelihood of pregnancy. PATIENT(S): Infertility population undergoing treatment, which was defined as patients undergoing ovulation induction, IUI, or in vitro fertilization (IVF). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Diagnostic test characteristics were calculated and pooled using standard methods. Inability to achieve a pregnancy with treatment was considered as the "disease." RESULT(S): Twelve studies on basal FSH (with 6296 patients, mean age 33.8) and seven studies on the CCCT (with 1352 patients, mean age 34.5) fit our criteria and were analyzed. For basal FSH and the CCCT, the sensitivities were 6.6% (95% confidence interval [CI] 5.9, 7.3%) and 25.9% (95% CI 23.0, 29.0%), respectively, and specificities were 99.6% (95% CI 99.1, 99.9%) and 98.1% (95% CI 96.5, 99.1%), respectively. For "disease" prevalence ranging from 40%-100%, for basal FSH and the CCCT, the positive predictive values ranged from 91.7%-100% and 90.1%-100%, respectively, and negative predictive values ranged from 61.5%-0.0% and 66.5%-0.0%, respectively. CONCLUSION(S): Basal FSH and the CCCT are similar in predicting the ability to achieve a clinical pregnancy in women undergoing infertility treatment. With either test, a normal result is not useful, but an abnormal result virtually confirms that pregnancy will not occur with treatment.

Clomiphene↗