Numbers of minority health professionals: where do we stand?

This overview has pointed to a continuing racial and ethnic imbalance in the health professions that applies to North Carolina as well as the nation. Great strides have been made early in the development of programs to enhance racial and ethnic representation, but they have generally reached a plateau in terms of growth and progress. Resistance to affirmative action programs and subsequent uncertainty over their legal standing can be cited as one factor thwarting progress, but that issue has been resolved and schools, professions, and the North Carolina General Assembly can move forward with a clear understanding of how to proceed. A full generation has matured with the benefit of positive emphasis on increasing the proportion of minorities in the health professions. The coming generations must build and expand on the programs and initiatives that brought the nation and the state to where we are now. But these goals must be re-stated, and intensified efforts are required if any reasonable parity in representation of minorities among the health professions is to be achieved.     

Racial differences in serum total bilirubin levels in health and in disease (pernicious anemia)

Common usage prescribes a single normal range for serum bilirubin levels. However, we have not only confirmed that men have higher levels than women but have discovered significant racial differences as well. Among 1,538 healthy Americans, blacks had lower mean bilirubin levels than whites of European origin, Latin Americans, and Asians. These racial differences, which were more pronounced among women than men, were maintained in pernicious anemia. Even though bilirubin levels rose in our 174 patients with this disease, they continued to be lower among blacks than among whites and Latin Americans. Moreover, the actual bilirubin level changes caused by pernicious anemia were themselves smaller among blacks. The racial differences, thus, persisted in pernicious anemia despite similar degrees of anemia, whereas the sex differences disappeared. We suggest that the lower serum bilirubin levels in blacks in health and disease do not stem primarily from lower bilirubin production than in whites.     

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.     

Recruitment and progress of minority medical school entrants 1970-1972.

This is a report on a national study of minority group applicants and entrants to the 1970, 1971, and 1972 entering classes of U.S. medical colleges. The aim of the investigation was to further understanding of the factors involved in attempting to increase minority representation in education for the practice of medicine. Data from the Association of American Medical Colleges are used to examine characteristics of successful and unsuccessful minority applicants to medical school. Socieconomic, personal, institutiona, and geographical factors that relate to the recruitment and progress of minority students in medicine are analyzed and evaluated. Differences between Caucasian and minority group students affecting admissions, retention, and promotion are documented. The investigators also compare the projections of a 1970 AAMC task force report with actual occurrences in the national effort to expand educational opportunities in medicine for blacks and other underrepresented minority students (that is, American Indians, Mexican Americans, and mainland Puerto Ricans). This comparison shows substantial progress toward the projected figures but a need for renewed commitment if they are to be reached. Suggestions are offered for improving the recruitment and progress of minority medical school entrants by such means as the AAMC Simulated Minority Admissions Exercises and by ongoing programs at individual medical schools. The study also yielded such pertinent findings as the following: 1. Confirmation that the racial characterizations self-reported by medical school applicants have a high degree of accuracy and an increasing degree of completeness. 2. An encouraging increase in the number of black premedical students who will potentially apply for the medical school classes entering in 1976 and 1977. 3. Growth in the enrollment of low-income medical students, most of it explained by the increase in the numbers of minority group members who have been admitted in recent years. 4. More mobility among blacks than Caucasians with regard to attending medical schools in other than their region of legal residence. 5. A higher proportion of women, of older, and of married students among minority medical school matriculants than among Caucasian matriculants. 6. A slightly higher medical school retention rate for Caucasians than for students from underrepresented minority groups, possibly explained in part by the greater diversity in the socioeconomic and educational backgrounds of the latter. 7. A positive relationship for blacks between the size of undergraduate college attended and successful completion of the first year of medical school.     

抗癫药物分类及作用机制的研究进展

 药物是治疗癫的一线手段,抗癫药物已经经历了一个多世纪的发展。从1978年以前上市的传统抗癫药物,到1993年以后上市的新型抗癫药物,抗癫药物在作用机制、疗效与不良反应方面的研究都取得了一些新进展。近年一批新药正在进行临床试验,未来有望用于临床;某些可能具有抗癫作用的靶点、机制及通路也是目前的研究热点。本文将从药理机制上对历代抗癫药物及其可能的新的作用机制的研究进展作一回顾与综述。     

靶向糖基化磷脂酰肌醇生物合成的抗真菌药物研究进展

抗真菌药物研究的两大策略,一是改造氮唑类或棘白菌素类抗真菌药物分子产生“Me Better”的新药分子,二是发现作用于新靶点的全新结构的“First in Class”的原创新药。后者已进入临床研究阶段的重要原创候选药物有靶向Sec14 的Turbinmicin、靶向糖基化磷脂酰肌醇（glycosylphosphatidylinositol,GPI）锚定蛋白合成转运的氨基吡啶类化合物,靶向二氢乳清酸脱氢酶（dihydroorotate dehydrogenase,DHODH）的F901318等。其中GPI锚定蛋白合成转运途径药物的发现已有10多年历史,研究比较充分,且具有广谱高效抗真菌和增强宿主抗真菌免疫反应的双重作用,本文主要综述靶向GPI生物合成的抗真菌药物的研究进展。     

Should research samples reflect the diversity of the population?

Recent research governance documents say that the body of research evidence must reflect population diversity. The response to this needs to be more sophisticated than simply ensuring minorities are present in samples. For quantitative research looking primarily at treatment effects of drugs and devices four suggestions are made. First, identify where the representation of minorities in samples matters-for example, where ethnicity may cause different treatment effects. Second, where the representation of a particular group matters then subgroup analysis of the results will usually be necessary. Third, ensuring representation and subgroup analysis will have costs; deciding on whether such representation is worthwhile will involve cost benefit analysis. Fourth, the representation of minorities should not be seen as mainly a locality issue. For qualitative research it is argued that the representation of diversity is often important. Given the small samples of many qualitative projects, however, the best way to ensure representation occurs is to allow a proliferation of such research, not to stipulate such representation in samples.     

Ethical dilemmas in malaria drug and vaccine trials: a bioethical perspective.

Malaria is a disease of developing countries whose local health services do not have the time, resources or personnel to mount studies of drugs or vaccines without the collaboration and technology of western investigators. This investigative collaboration requires a unique bridging of cultural differences with respect to human investigation. The following debate, sponsored by The Institute of Medicine and The American Society of Tropical Medicine and Hygiene, raises questions concerning the conduct of trans-cultural clinical malaria research. Specific questions are raised about the difficulties of informed consent in different cultural settings and whether there is any role for community involvement. Discussants debate whether drug and vaccine trials not approved in an industrialised country are ever defensible if performed in a third-world setting. Potential conflicting priorities between investigators are discussed and ideas regarding conflict resolution are offered.     

抗结核药物的研究进展

随着结核病耐药频率不断升高,结核病治疗面临严峻的挑战,因此,研发新型抗结核药物显得尤为重要。在过去十年中,抗结核药物的研发取得了重要进展。本文将对近年来被批准用于临床和正在进行临床试验的新化学实体按靶点进行分类,并综述其作用机制、体内外药理活性、药代动力学性质以及临床研究结果。对抗结核药物的研发进行了展望,以期对结核病药物研发提供参考。     

我国强制隔离戒毒治疗人群的大麻使用现状

目的 了解我国强制隔离戒毒治疗人群大麻使用特征,为我国大麻禁毒政策提供参考。方法 利用2016年公安部重点城市毒品滥用规模评估项目数据,对全国30个省、自治区和直辖市的55个省会城市和重点城市的强制隔离戒毒治疗人群中大麻使用者社会人口学、毒品使用特征进行描述性分析,采用χ²检验、Fisher精确检验和Kruskal-Wallis秩和检验比较不同人群中大麻、海洛因、合成类毒品和混合毒品使用率的差异,以及大麻使用者中多药使用情况及地区间的差异。 结果 共纳入强制隔离戒毒治疗人员25 366人,大麻使用率为2.2%(546/25 366)。在大麻使用人群中,男性占83.5%,少数民族占41.0%,初中及以上学历占30.8%,无业人员占44.1%,平均年龄为(33.3±8.2)岁,平均首次吸毒年龄为(24.8±7.7)岁,首次吸毒到首次强制隔离戒毒的平均间隔时间为(5.4±4.6)年。35岁及以下、少数民族、在职、新疆的强制隔离戒毒人群大麻使用率较高。使用大麻的546人中,91.4%人存在多药使用情况,13.6%只合用海洛因,42.1%只合用合成类毒品,35.7%混合使用海洛因和合成类毒品。49.6%的大麻使用者集中在新疆维吾尔族自治区、江苏和上海三个地区。新疆大麻使用者中少数民族和初中及以下人群所占比例较高,有79.6%大麻使用者合用海洛因;江浙沪地区大麻使用者中汉族和高中及以上人群所占比例较高,有92.7%大麻使用者合用甲基苯丙胺。结论 我国强制隔离戒毒治疗人群中大麻使用率较监测吸毒人群中的大麻使用率高,并且存在地域聚集性和较高的多药使用现象,提示宜针对不同地区和人群,加强对大麻使用情况的监测,加大对大麻的管控力度,制定符合我国国情的禁毒政策。     

我国强制隔离戒毒治疗人群的大麻使用现状

目的 了解我国强制隔离戒毒治疗人群大麻使用特征,为我国大麻禁毒政策提供参考。方法 利用2016年公安部重点城市毒品滥用规模评估项目数据,对全国30个省、自治区和直辖市的55个省会城市和重点城市的强制隔离戒毒治疗人群中大麻使用者社会人口学、毒品使用特征进行描述性分析,采用χ²检验、Fisher精确检验和Kruskal-Wallis秩和检验比较不同人群中大麻、海洛因、合成类毒品和混合毒品使用率的差异,以及大麻使用者中多药使用情况及地区间的差异。 结果 共纳入强制隔离戒毒治疗人员25 366人,大麻使用率为2.2%(546/25 366)。在大麻使用人群中,男性占83.5%,少数民族占41.0%,初中及以上学历占30.8%,无业人员占44.1%,平均年龄为(33.3±8.2)岁,平均首次吸毒年龄为(24.8±7.7)岁,首次吸毒到首次强制隔离戒毒的平均间隔时间为(5.4±4.6)年。35岁及以下、少数民族、在职、新疆的强制隔离戒毒人群大麻使用率较高。使用大麻的546人中,91.4%人存在多药使用情况,13.6%只合用海洛因,42.1%只合用合成类毒品,35.7%混合使用海洛因和合成类毒品。49.6%的大麻使用者集中在新疆维吾尔族自治区、江苏和上海三个地区。新疆大麻使用者中少数民族和初中及以下人群所占比例较高,有79.6%大麻使用者合用海洛因;江浙沪地区大麻使用者中汉族和高中及以上人群所占比例较高,有92.7%大麻使用者合用甲基苯丙胺。结论 我国强制隔离戒毒治疗人群中大麻使用率较监测吸毒人群中的大麻使用率高,并且存在地域聚集性和较高的多药使用现象,提示宜针对不同地区和人群,加强对大麻使用情况的监测,加大对大麻的管控力度,制定符合我国国情的禁毒政策。     

药物临床试验统计分析规范性操作的探讨

统计分析是药物临床试验整个过程中的一个重要环节,规范化的统计分析能真实地揭示药物的性能.本文针对药物临床试验统计分析存在的一些问题,依据国内外药物临床试验统计分析的有关法规,就统计分析的各个环节提出了一些具体的操作方法,用于保证临床试验的结果真实可靠.     

临床试验注册制度与循证医学

本文介绍了当前新药临床试验,院内制剂、上市后药物临床试验及其他类型临床试验的管理情况,世界卫生组织临床试验注册平台的结构和运作机制以及全球临床试验注册制度的建立概况,中国临床试验注册中心和中国临床试验注册与发表协作网及其运作机制;提出以循证医学基本思想作为临床试验研究者的思想和行为准则是临床试验真实性的内部保障系统。     

中风病中药新药临床试验方案设计要点

目的：探讨中风病中药新药临床试验设计关键点的变化及特点,及其所呈现的差异和新特点。方法收集并整理自1997年1月起至今开展的中风病中药新药临床试验项目,以 Excel 建立数据库,统计方案设计中的剂型变化、诊断标准的选择、疗程及评价时点的设置、对照药选择等关键点。结果在诊断标准的选择上,由国内专家共识逐渐采用国内最新的指南或临床指导原则;试验疗程及评价时点的设置方面,出现中风病（恢复期）疗程8周、12周并且呈增多趋势,且评价时点逐渐延长;采用多个评价量表进行综合评价;对照设计方面也出现了安慰剂对照及安慰剂、阳性药同时对照（三臂试验）,且呈增加的趋势。结论随着新药评审制度的进一步完善,中风病临床研究的深入以及研究方法的不断更新,中风病中药新药的方案设计也呈现出新特点,促进中风病新药临床试验更加科学,实际操作性更强。     

Ethnic disparities in diabetic complications in an insured population

CONTEXT: Higher rates of microvascular complications have been reported for minorities. Disparate access to quality health care is a common explanation for ethnic disparities in diabetic complication rates in the US population. Examining an ethnically diverse population with uniform health care coverage may be useful. OBJECTIVE: To assess ethnic disparities in the incidence of diabetic complications within a nonprofit prepaid health care organization. DESIGN AND SETTING: Longitudinal observational study conducted January 1, 1995, through December 31, 1998, at Kaiser Permanente Medical Care Program in northern California. PARTICIPANTS: A total of 62 432 diabetic patients, including Asians (12%), blacks (14%), Latinos (10%), and whites (64%). MAIN OUTCOME MEASURES: Incident myocardial infarction (MI), stroke, congestive heart failure (CHF), and nontraumatic lower extremity amputation (LEA), defined by primary hospitalization discharge diagnosis, procedures, or underlying cause of death; and end-stage renal disease (ESRD), defined as renal insufficiency requiring renal replacement therapy or transplantation for survival or by underlying cause of death. RESULTS: Patterns of ethnic differences were not consistent across complications and frequently persisted despite adjustment for a wide range of demographic, socioeconomic, behavioral, and clinical factors. Adjusted hazard ratios (relative to that of whites) were 0.56, 0.68, and 0.68 for blacks, Asians, and Latinos, respectively (P<.001), for MI; 0.76 and 0.72 for Asians and Latinos, respectively (P<.01), for stroke; 0.70 and 0.61 for Asians and Latinos, respectively (P<.01), for CHF; 0.40 for Asians (P<.001) for LEA; and 2.03, 1.85, and 1.46 for blacks, Asians, and Latinos, respectively (P<.01), for ESRD. There were no statistically significant black-white differences for stroke, CHF, or LEA and no Latino-white differences for LEA. CONCLUSIONS: This study confirms previous reports of elevated incidence of ESRD among ethnic minorities, despite uniform medical care coverage, and provides new evidence that rates of other complications are similar or lower relative to those of whites. The persistence of ethnic disparities after adjustment suggests a possible genetic origin, the contribution of unmeasured environmental factors, or a combination of these factors.     

Are racial differences in the prevalence of diabetes in adults explained by differences in obesity?

To determine whether the higher prevalence of diabetes found among blacks in the United States is explained by racial differences in obesity, we examined the prevalence of diabetes adjusted for adiposity, education, and income in a cohort of US Army veterans from the Vietnam era. Among 12,558 white men and 1677 black men, aged 30 to 47 years, blacks were more likely than whites to have diagnosed diabetes (adjusted prevalence ratio, 1.9; 95% confidence interval, 1.3 to 2.7). Within every age, adiposity, and socioeconomic stratum, blacks had a higher prevalence of diagnosed diabetes than whites. In a subgroup of veterans for whom fasting serum glucose values were measured, blacks were more likely than whites to have fasting hyperglycemia (fasting serum glucose value greater than or equal to 7.8 mmol/L) (adjusted prevalence ratio, 5.7; 95% confidence interval, 2.7 to 12.0). These data provide evidence that the higher prevalence of diabetes found among blacks is not explained by differences in obesity.     

Ethnic minorities, health provision and the 1976 Race Relations Act

The present anti-racial discrimination legislation in the United Kingdom is embodied in the 1976 Race Relations Act. In essence this Act attempts to avoid any form of direct or indirect discrimination on the basis of racial or ethnic origin. However, health professionals are acutely aware that there are important racial differences in disease, some of which are, in fact, not racial but merely associated with social deprivation, poor housing and, of course, the incapacity to speak English. These new findings present the medical profession, in the climate of scarce resources, with the challenge of meeting these needs without discriminating in favour of, or against, individuals on the basis of their race. This is because there are few provision in the 1976 Act to allow for such discrimination, even when it is for an ethnic group's advantage. The dilemmas this raises for health professionals who are involved in planning services for ethnic minorities are discussed.     

新药临床试验设计中普遍存在的问题及防范措施（英文）

新药临床试验设计中存在的问题涉及指导思想、科研设计、质量控制、统计分析等临床试验研究过程中的关键环节。本文揭示了新药临床试验设计中存在的8大问题,并提供具有可操作性的防范措施。新药临床试验研究是一个非常复杂的系统工程,在新药Ⅰ、Ⅱ、Ⅲ、Ⅳ期临床试验研究过程中,特别是在新药临床试验研究方案和临床病例报告表的研制和实施过程中,必须严格参照国家相关部门制定的政策、法规、标准和操作规程。忽视临床试验设计与数据分析的科学性与严谨性,必将导致临床试验研究的失败。     

SIDS: race as a factor

In Wisconsin, the rate of postneonatal deaths attributed to sudden infant death syndrome (SIDS) for the period 1978-1987 was 6.7 per 1,000 live births for Native Americans, 3.6 for blacks, and 1.4 for whites. To investigate racial differences in case ascertainment and risk for SIDS mortality, this study used matched birth-death certificate data for the 1,111 reported SIDS deaths during the 10-year period. At least 90% of all SIDS deaths occurred before 6 months of age; seasonal variation in time of death and autopsy rates were similar by race. The reported higher risk of SIDS for male infants and those with low birth weights did not occur among Native Americans. Low birth weight was a stronger risk for SIDS among whites than blacks. Our findings suggest that diagnostic practices may not account for racial differences in SIDS mortality. Patterns of risk, however, appear to vary by race.     

Determination of HIV-1 coreceptor tropism in clinical practise

Several studies showed that the upcoming drug class of CCR5 coreceptor antagonists have potent virological and immunological activity in treatment experienced patients. In patients failing a CCR5 antagonists-based regimen, the emergence of CXCR4-tropic viral variants has been demonstrated. Clonal analysis of viral isolates from a limited number of patients revealed that these CXCR4-tropic strains did not develop by mutation of a CCR5-tropic virus during therapy, but emerged from a minor population of CXCR4-tropic variants already present in the patients at baseline. Obviously, screening for CXCR4-tropic strains with a functional assay and subsequent exclusion of positive individuals from clinical studies could not completely avoid the selection of CXCR4-tropic strains during failure. But emergence of CXCR4-tropic viruses on therapy may require a critical threshold of CXCR4 viral load at baseline, which may not be the case in patients with a very low proportion of CXCR4-using variants. Therefore, this review addresses to what extent currently available methods are suitable to detect CXCR4-tropic strains in clinical settings. Available functional assays are based on recombinant viruses. These assays are generally restricted to a few laboratories and cannot be easily included in daily clinical settings. Whereas minority detection limits of sequence analyses are generally high with 15 to 30%, functional assays achieve lower detection limits for minorities of 5%. Sequence analyses require an additional interpretation step, and the accuracy of interpretation from clinical samples by current predictions systems has to be improved. In consequence, new methods are arising: genotyping may be improved by hybridisation assays, which quantify CXCR4-tropic viruses by their homology down to 1% minorities, and functional non-infectious cell fusion assays may overcome security restrictions and make phenotypic methods suitable for routine clinical laboratory practise. The highly sensitive detection of CXCR4-tropic viruses may provide the opportunity to clarify the conditions of clinical relevance for CXCR4-tropic minorities.