国家医疗器械质量监督抽验分析及思考

该文对国家医疗器械抽验13年来的抽验品种、抽验数量及质量状况进行了统计分析,对抽验过程中取得的成果进行了的总结,同时针对国家抽验过程中发现的问题提出了建议与对策,为下一步更好的开展国家抽验工作提供参考。     

上海市基本药物质量抽验数据分析及对抽验模式调整的思考

药品抽验体现的是国家对药品质量实行的技术监督,是药品质量事后监督的重要内容之一。优化药品抽验模式,提高抽验效能,对于强化药品质量保障体系具有重要意义。本文通过对上海市近年来基本药物质量抽验数据的横向、纵向分析,及与非基本药物质量抽验数据的交叉分析,客观评价上海市基本药物的质量状况和抽验情况,并寻找基本药物抽验监管的薄弱环节和薄弱点。为更好地调整抽验模式,最大限度地发挥抽验的技术监督作用提出建议。     

一季度抽验不合格药品及被撤销批准文号药品名单

一季度药品抽验结果公布 132个品种277个批号不合格 卫生部近日公布了今年第一季度药品质量抽样检验结果,并对抽验查出的假劣药品予以曝光。 中国药品生物制品检定所组织各省药品检验所按计划在生产、经营、使用等部门抽检了部分药品,并对1996年抽验不合格的药品进行了跟踪抽验,有197个生产单位的132个品种、277个批号不合格。此次抽验中查出的劣药、假药及被撤销批准文号的药品名单如下:     

医疗器械注册产品标准在质量监督抽殓中的应用

目的：加强医疗器械质量监督抽验中注册产品标准的管理。方法：依据国家局《国家医疗器械质量监督抽验管理规定（试行）》、《医疗器械标准管理办法》等法规,分析监督抽验中注册产品标准在实施中的困难。结果与结论：在医疗器械质量监督抽验方案中应明确对注册产品标准的获取和保密工作。     

国家医疗器械质量监督抽验回顾及思考

通过对7年来开展国家医疗器械质量监督抽验工作的回顾,对抽样、产品质量、异议处理等情况进行分析,为进一步做好国家抽验工作提供参考。     

2007年滨州市不合格药品情况分析

目的了解与分析滨州市2007年度药品抽验中发现的不合格药品概况,以利于有目的有重点地对药品的质量进行有效监督。方法根据滨州市食品药品监督管理局2007年抽验药品的统计数据,对抽验的不合格药品进行统计分析。结果全年共抽验药品2592批次,其中不合格的481批次,不合格率为18.6%。不合格率最高的是中药材,其次是化学药品。结论我市应加强中药材及化学药品的监督与指导,保护人民健康。     

四川医疗器械产品质量监督抽验现状及对策探讨

目的：探索四川医疗器械产品质量监督抽验优势与不足,促进产品质量监管的规范化、制度化。方法：通过文献查阅,到质量监管部门调研与访谈,分析影响因素,提出思考与对策。结果：四川产品质量监督取得显著成绩的同时,在抽验品种数、范围和抽样任务等方面不适应产品发展需要。结论：要保证产品质量,必须扩大抽验范围、增加样品来源、提高抽验人员素质、强化政府监管职能,才能促进四川医疗器械健康发展。     

国家食品药品监督管理局发布2011年第2期国家医疗器械质量公告

2011年8月2日,国家食品药品监督管理局发布2011年第2期(总第49期)国家医疗器械质量公告,公布了对一次性使用无菌注射器进行质量监督抽验的结果。本次共抽验一次性使用无菌注射器(带针)产品1050批次,涉及全国31个省(区、市)730家使用单位128家生产企业。经检验,1034批次产品被抽验项目     

倡导公众健康服务 保障首都用药安全

《健康北京"十二五"发展建设规划》要求:"十二五"期间,药品抽验合格率不低于98%。为进一步保障首都居民身体健康,促进首都社会和谐发展,倡导公众健康服务,结合北京市政府《健康北京"十二五"发展建设规划》内容要求,北京市药品监督管理局落实有关工作要求。完成药品抽验工作,抽验合格率不低于98%开展基本药物和社区卫生服务零差率药品专项抽验,抽验合格率达100%,保证居民用药安全。     

生化类检测试剂盒监督抽验问题探讨

体外诊断试剂作为医疗器械的重要组成部分,是预防和诊断、保障人民健康的重要手段.监督抽验是确保体外诊断试剂产品合格的关键监管手段.总结近年生化类检测试剂盒监督抽验遇到的问题,分析这些问题产生的原因,并提出相应的建议,希望为监督抽验提供建设性建议.     

A six country study of young children’s media exposure,logo recognition,and dietary preferences

Childhood obesity is a global public health concern. Previous research, mainly conducted in developed countries, suggests that marketing and media exposure is associated with unhealthy eating behaviors. This cross-sectional study was done with 2422 children, mean age 5.5 years, SD = .5, from six low- and middle-income counties (LMICs) (Brazil, China, India, Nigeria, Pakistan, and Russia). The analyses investigated media exposure, logo recognition, and preferences for international foods and beverages, such as globally distributed items like McDonald’s hamburgers and Coca-Cola soft drinks. Overall and in each country, path analysis models showed that media exposure and logo recognition directly and indirectly predicted the selection of international foods and beverages, controlling for child’s sex, age, home location, and parental education. Public health and communication experts must continue to investigate and understand these relationships, so as to inform regulations around food and beverage marketing.     

Workshop report: Nucleic acid delivery devices for HIV vaccines: Workshop proceedings,National Institute of Allergy and Infectious Diseases,Bethesda, Maryland,USA, May 21, 2015

On May 21st, 2015, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) convened a workshop on delivery devices for nucleic acid (NA) as vaccines in order to review the landscape of past and future technologies for administering NA (e.g., DNA, RNA, etc.) as antigen into target tissues of animal models and humans. Its focus was on current and future applications for preventing and treating human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS) disease, among other infectious-disease priorities. Meeting participants presented the results and experience of representative clinical trials of NA vaccines using a variety of alternative delivery devices, as well as a broader group of methods studied in animal models and at bench top, to improve upon the performance and/or avoid the drawbacks of conventional needle-syringe (N–S) delivery. The subjects described and discussed included (1) delivery targeted into oral, cutaneous/intradermal, nasal, upper and lower respiratory, and intramuscular tissues; (2) devices and techniques for jet injection, solid, hollow, and dissolving microneedles, patches for topical passive diffusion or iontophoresis, electroporation, thermal microporation, nasal sprayers, aerosol upper-respiratory and pulmonary inhalation, stratum-corneum ablation by ultrasound, chemicals, and mechanical abrasion, and kinetic/ballistic delivery; (3) antigens, adjuvants, and carriers such as DNA, messenger RNA, synthesized plasmids, chemokines, wet and dry aerosols, and pollen-grain and microparticle vectors; and (4) the clinical experience and humoral, cellular, and cytokine immune responses observed for many of these target tissues, technologies, constructs, and carriers. This report summarizes the presentations and discussions from the workshop (https://web.archive.org/web/20160228112310/https://www.blsmeetings.net/NucleicAcidDeliveryDevices/), which was webcast live in its entirety and archived online (http://videocast.nih.gov/summary.asp?live=16059).     

Heavy Metals in Aquatic Macrophytes from Two Small Rivers Polluted by Urban,Agricultural and Textile Industry Sewages SW Poland

This article presents the results from a study of the comparison of 2 lowland rivers: the Olobok and the Pilawa in southwest Poland polluted by urban, agricultural, and textile industry sewages. pH and concentrations of Ca, Cd, Co, Cr, Cu, Fe, K, Mg, Mn, Ni, Pb, Zn, nitrate, nitrite, ammonia, phosphate, and sulfate were measured in water samples and concentrations of Ca, Cd, Co, Cr, Cu, Fe, K, Mg, Mn, N, Na, Ni, P, Pb, S, and Zn were measured in stream bottom sediments and in the aquatic macrophytes Elodea canadensis, Callitriche verna, Potamogeton crispus, Potamogeton natans, and Ceratophyllum demersum from the river Olobok and Elodea canadensis, Polygonum amphibium, Potamogeton crispus, and Veronica beccabunga from the river Pilawa. The matrix of concentrations of 16 elements in 27 plant samples of 7 species from 15 sampling sites of 2 rivers and concentrations of 15 elements and pH in water samples and 16 elements and pH in bottom sediment samples of these sites was submitted to numerical classification, which revealed that sampling sites from the rivers were differentiated by the value of factor 1 of principal component analysis (PCA), which was related to the pH of water, Ca, Cu, Mg, Mn, and Ni in water and Cd, Cr, Cu, Fe, K, Mg, Na, Ni, P, and S in bottom sediments. More polluted parts of both rivers were differentiated from less polluted parts by the value of factor 2 of PCA, which was related to Pb, Zn, and sulfates in water and Ca and Zn in bottom sediments. Macrophytes from the Olobok and Pilawa rivers were differentiated by the value of factor 1, which was related to Ca, Co, Cr, Cu, Fe, Mg, Ni, N, Na, Pb, and S. Groups of macrophytes of more and less polluted parts of both rivers differed by the value of factor 2, which was related to P, K, and Mn. Downstream of the sewage outputs in both rivers, a significantly increased level of pollution occurs with elements correlated with factor 1: Among others were Cu and Cr, typical for the textile industry along the river Pilawa, and among others were Mn and Ni, typical for the urban and agricultural activities in the river Olobok.     

Durational and generational differences in Mexican immigrant obesity: Is acculturation the explanation?

Using the Los Angeles Family and Neighborhood Survey (L.A.FANS-2; n = 1610), we explore the link between Mexican immigrant acculturation, diet, exercise and obesity. We distinguish Mexican immigrants and 2nd generation Mexicans from 3rd+ generation whites, blacks and Mexicans. First, we examine variation in social and linguistic measures by race/ethnicity, duration of residence and immigrant generation. Second, we consider the association between acculturation, diet and exercise. Third, we evaluate the degree to which acculturation, diet, exercise, and socioeconomic status explain the association between race/ethnicity, immigrant exposure to the US (duration since immigration/generation), and adult obesity. Among immigrants, we find a clear relationship between acculturation measures, exposure to the US, and obesity-related behaviors (diet and exercise). However, the acculturation measures do not clearly account for the link between adult obesity, immigrant duration and generation, and race/ethnicity.     

Special Considerations for Prophylaxis for and Treatment of Anthrax in Pregnant and Postpartum Women

In August 2012, the Centers for Disease Control and Prevention, in partnership with the Association of Maternal and Child Health Programs, convened a meeting of national subject matter experts to review key clinical elements of anthrax prevention and treatment for pregnant, postpartum, and lactating (P/PP/L) women. National experts in infectious disease, obstetrics, maternal fetal medicine, neonatology, pediatrics, and pharmacy attended the meeting, as did representatives from professional organizations and national, federal, state, and local agencies. The meeting addressed general principles of prevention and treatment for P/PP/L women, vaccines, antimicrobial prophylaxis and treatment, clinical considerations and critical care issues, antitoxin, delivery concerns, infection control measures, and communication. The purpose of this meeting summary is to provide updated clinical information to health care providers and public health professionals caring for P/PP/L women in the setting of a bioterrorist event involving anthrax.     

肥胖对中小学生生理机能与常见疾病的影响

目的 使用2009年、2012年、2015年3个年份的样本量来分析重庆地区在2009—2015年间的肥胖检出情况、肥胖对学生的身体机能和常见疾病的影响情况,为改善学生生理机能、降低相关疾病寻找依据和方法。方法 通过分析2009年、2012年、2015年重庆市学生体质健康监测的累加数据,观察肥胖对学生血压、肺活量、肺活量指数、视力等身体机能的影响以及对近视、龋齿等常见疾病的影响。结果 2009年、2012年、2015年学生累计样本数为202 235人,体质量指数为肥胖的学生9 529人,肥胖率为4.71%,其中男生肥胖率为5.79%,女生肥胖率为3.73%,男生肥胖率高于女生,差异有统计学意义(χ2=473.66,P<0.01);城市学生肥胖率为5.88%,乡村学生肥胖率为3.66%,城市学生肥胖率高于乡村学生,差异有统计学意义(χ2=551.30,P<0.01)。在生理功能方面,非肥胖组学生右眼视力、左眼视力、收缩压、舒张压、肺活量、肺活量指数均优于肥胖组学生,差异有统计学意义(P<0.01)。肥胖组学生龋失补总牙数均值与非肥胖组学生比较,差值为-0.22颗/人,差异有统计学意义(t=-16.31,P<0.01);肥胖组与非肥胖组的龋齿检出率分别为13.43%和20.54%,差异有统计学意义(χ2=113.34,P<0.01);肥胖组近视检出率右眼左眼分别为57.45%、 57.00%,非肥胖组近视检出率右眼左眼分别为51.86%、51.47%,肥胖组近视检出率与非肥胖组近视检出率差异有统计学意义(χ2右眼=113.34,P<0.01;χ2左眼=109.11,P<0.01)。结论 2009年、2012年、2015年重庆市中小学生肥胖检出率均处于一个较低水平,肥胖表现出了显著的性别间、城乡间差异;肥胖易使学生视力降低、血压升高、肺功能储备降低。     

Neuropsychological sequelae of exposure to welding fumes in a group of occupationally exposed men

This study compares the neuropsychological function, emotional status, visual function, and illness prevalence of 76 former and current chemical industry welders primarily involved in steel welding, and exposed to welding fumes for an average of 24.9 years with that of 42 unexposed, non-welder controls. Health and occupational history questionnaires were administered, as were the neuropsychological tests included in the World Health Organization Neurobehavioral Core Test Battery, Luria Motor Test, and selected tests from the WAIS-III, and WMS-III. Emotional status tests included the BSI, POMS, BAI, and BDI, and vision tests included the Snellen near visual acuity, Lanthony d-15 color vision, Vistech Contrast Sensitivity, and Schirmer strips. While welders and controls performed similarly on tests of verbal skills, verbal retention, and auditory span, welders performed worse than controls on tests of verbal learning, working memory, cognitive flexibility, visuomotor processing speed, and motor efficiency. Welders had poorer color vision and emotional status, and increased prevalence of illnesses and psychiatric symptoms. The increased symptoms in welders were related to decreased scores on tasks measuring verbal learning, visuomotor abilities, visuospatial abilities, and information processing, and motor efficiency. Within the group of welders, the number of hours welding was negatively related to scores on verbal learning, auditory span, working memory, cognitive flexibility, and motor efficiency.     

Cholera in Haiti and other Caribbean regions, 19th century

Medical journals and other sources do not show evidence that cholera occurred in Haiti before 2010, despite the devastating effect of this disease in the Caribbean region in the 19th century. Cholera occurred in Cuba in 1833-1834; in Jamaica, Cuba, Puerto Rico, St. Thomas, St. Lucia, St. Kitts, Nevis, Trinidad, the Bahamas, St. Vincent, Granada, Anguilla, St. John, Tortola, the Turks and Caicos, the Grenadines (Carriacou and Petite Martinique), and possibly Antigua in 1850-1856; and in Guadeloupe, Cuba, St. Thomas, the Dominican Republic, Dominica, Martinique, and Marie Galante in 1865-1872. Conditions associated with slavery and colonial military control were absent in independent Haiti. Clustered populations, regular influx of new persons, and close quarters of barracks living contributed to spread of cholera in other Caribbean locations. We provide historical accounts of the presence and spread of cholera epidemics in Caribbean islands.     

How Healthy Are Health-Related Behaviors in University Students: The HOLISTic Study

The aim of this cross-sectional study was to assess the health-related behaviors among university students, with emphasis on health sciences students from Croatia, Italy, Lebanon, Poland, Romania, Spain and Turkey. We included 6222 students in Medicine, Dentistry, Nursing, Pharmacy, Nutrition and Dietetics, Sports Sciences, Veterinary, and Economics enrolled between April 2018 and March 2020. We assessed dietary patterns, sleeping habits, physical activity and perceived stress among students by means of validated questionnaires. The median age ranged between 19 and 24 years, smoking prevalence between 12.0% and 35.4%, and body mass index (BMI) ranged between 21.1 and 23.2 kg/m². Breakfast was less often and more often consumed daily in Turkey (36.7%), and Italy (75.7%), respectively. The highest Mediterranean diet score was recorded in Spain and Italy, and the lowest in Turkey, followed by students from Croatia, Lebanon, Poland and Romania. Sleep duration, physical activity and stress perception also differed between countries. Multivariable regression analysis revealed a small, but positive association between BMI and several characteristics, including age, female gender, smoking, physical activity, mobile phone use, and perceived stress. A negative association was found between BMI and sleep duration on non-working days. Self-rated health perception was positively associated with female gender, breakfast, physical activity, and time spent studying, and negatively with BMI, smoking and stress. Our results demonstrated diverse habits in students from different countries, some of which were less healthy than anticipated, given their educational background. Greater emphasis needs to be placed on improving the lifestyle of these adolescents and young adults, who will be tomorrow’s healthcare workers.     

Age-Associated Glia Remodeling and Mitochondrial Dysfunction in Neurodegeneration: Antioxidant Supplementation as a Possible Intervention

Aging induces substantial remodeling of glia, including density, morphology, cytokine expression, and phagocytic capacity. Alterations of glial cells, such as hypertrophy of lysosomes, endosomes and peroxisomes, and the progressive accumulation of lipofuscin, lipid droplets, and other debris have also been reported. These abnormalities have been associated with significant declines of microglial processes and reduced ability to survey the surrounding tissue, maintain synapses, and recover from injury. Similarly, aged astrocytes show reduced capacity to support metabolite transportation to neurons. In the setting of reduced glial activity, stressors and/or injury signals can trigger a coordinated action of microglia and astrocytes that may amplify neuroinflammation and contribute to the release of neurotoxic factors. Oxidative stress and proteotoxic aggregates may burst astrocyte-mediated secretion of pro-inflammatory cytokines, thus activating microglia, favoring microgliosis, and ultimately making the brain more susceptible to injury and/or neurodegeneration. Here, we discuss the contribution of microglia and astrocyte oxidative stress to neuroinflammation and neurodegeneration, highlight the pathways that may help gain insights into their molecular mechanisms, and describe the benefits of antioxidant supplementation-based strategies.