山东省青岛市城阳区糖尿病患者慢性并发症现状调查

目的对山东省青岛市城阳区糖尿病(DM)患者的慢性并发症现状进行横断面调查。方法对2019年3—12月青岛市城阳区参与“三高共管”项目的8个辖区街道的DM患者进行随机抽样调查,按有无慢性并发症将患者分为2组,对患者的人口学资料、人体测量学等指标进行问卷调查,比较2组DM患者的特点,并对DM慢性并发症的影响因素进行Logistic回归分析。结果本研究共随机抽取DM患者26090例进行调查,其中男12560例,女13530例,有慢性并发症者18950例,无慢性并发症者7140例;肥胖、文化程度低、血糖控制欠佳、遵医嘱行为差、合并基础疾病的DM患者更容易出现并发症。亚组分析表明,女性DM患者的心血管疾病、神经病变和眼科疾病的发生率高于男性,差异有统计学意义(P<0.05或P<0.01);糖化血红蛋白(HbA1c)水平越高,DM病程越长,DM患者的慢性并发症发生率均越高,差异有统计学意义(P<0.05或P<0.01)。患者慢性并发症越多,则人均治疗费用越高,年住院次数越多,住院时间越长,差异有统计学意义(P<0.05或P<0.01)。多因素Logistic回归分析显示,性别、年龄、体质量指数(BMI)、DM病程、HbA1c、空腹血糖(FBG)、低密度脂蛋白(LDL)、尿白蛋白肌酐比值(UACR)、24 h尿蛋白定量、文化程度、规律服药程度、规律测量血糖程度均是DM慢性并发症的影响因素(P<0.05或P<0.01)。结论青岛市城阳区DM患者慢性并发症发生率较高,且影响因素较多,尽早明确危险因素有助于防治DM慢性并发症。     

Intérêt du test HPV dans le dépistage primaire du cancer du col en milieu rural à Madagascar

Background

Testing for high-risk human papilloma virus (HR-HPV) is an effective approach to the prevention of cervical cancer. This study in the Atsinanana area of Madagascar aimed to compare the management of women screened by visual inspection after coloration with acetic acid (VIA) and the management of women screened by HPV with VIA as a triage test.

The need for new control strategies for particulate matter in parenterals

An undesirable characteristic in lyophilized parenteral products is the potential presence of particulate matter in the final product, which may affect patient safety. In this study, quality risk management tools described in the International Conference on Harmonization Guideline Q9 were used to estimate the risks for a pharmaceutical manufacturing line, based on three critical quality attributes: (1) visible particulate matter; (2) lyo-cake collapse traces; and (3) lyo-cake melt-back traces. Together with a Process Failure Mode Effect Analysis (PFMEA), an input-output analysis of the individual unit operations identified seven major material classes of extrinsic particulate matter. In addition to the process assessment, an experimental investigation of the location of impurities in lyophilized products was performed. To that end, intentionally contaminated vials were examined to locate the particulate matter and its possible migration. The results emphasize the importance of a full transmission mode release testing since the particles may enter the interior of the lyo-cake. A theoretical explanation of the observed impurity locations is provided.     

药品审评检查机构质量管理体系建设实践探索

目的:贯彻国务院强化质量管理、落实全国药监部门完善自身质量管理体系工作部署,梳理山东省药品审评检查机构质量管理体系建设情况,总结经验、查找不足,加强审评检查质量管理。方法:调研药品审评检查机构导入质量管理体系的现实意义,剖析山东省药品审评检查机构质量管理体系建设的实践经验,思考存在的问题。结果:行之有效的质量管理体系对药品审评检查机构规范化建设和药品审评检查发展起到了积极的推动作用。结论:药品审评检查机构推进质量管理体系建设,对规范自身建设、提高工作质量、降低业务风险、服务医药产业发展具有重要作用,也是必然要求,药品审评检查机构质量管理体系需要持续改进,逐渐与国际接轨。     

Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children–1 study

BackgroundVisual inspection (VIS) with radiographic examination (RAD) is the recommended diagnostic strategy for detecting caries in children; however, this recommendation is based on accuracy studies. The authors conducted a clinical trial to compare the detection and subsequent treatment of carious lesions in primary molars performed with VIS alone and with RAD.MethodsChildren (3-6 years old) were randomly assigned to 2 groups according to the diagnostic strategy used for caries detection on primary molars: VIS or RAD. Participants were diagnosed and treated according to the management plan related to the allocated group. The primary outcome was the number of new operative interventions during the 2-year follow-up period. Other secondary outcomes were also compared. Comparisons were performed with Mann-Whitney test using an intention-to-treat approach.ResultsOf the 252 children included and randomized, 216 were followed-up after 2 years (14.3% attrition rate). There was no difference between the groups for the primary outcome (P = .476). For the secondary outcomes, the RAD group had more restoration replacements (P = .038) and more restorations performed since the beginning of the study (P = .038) compared with the VIS group. In addition, the RAD group had a higher number of false-positive results than the VIS group (P < .001).ConclusionsSimultaneous use of VIS and RAD for caries diagnosis in primary molars of children who seek dental treatment does not provide additional benefits compared with VIS alone.Practical ImplicationsDentists should perform VIS only, not RAD, for detecting carious lesions in preschool-aged children.ClinicalTrials.gov: NCT02078453.     

Neoadjuvant therapy and breast specimen processing and reporting

Neoadjuvant therapy (NAT) is becoming a common approach to treat breast cancers. The most important advantage of NAT is the opportunity to evaluate the tumor response to treatment within few months after starting the medication. Pathology is the gold standard to determine the post therapy changes and response. An accurate and reproducible pathology report requires a multidisciplinary approach, a standard and appropriate handling of the gross specimen and recognizing the microscopic changes associated with a post NAT specimen. This review focuses on the standard approach for a post NAT breast specimen, based on the available guidelines and other related articles.     

刍议医院纪检监察在医院建设中的作用和实施

随着社会经济的快速发展,国内医疗事业的竞争日益激烈,医疗机构需要积极提高自身的业务水平和管理水平,才能强化医疗技术水平,获得更多的社会经济效益。在国内医疗体制深化变革的趋势下,纪检监察在医院建设中发挥着越来越重要的作用,主要职责是管理和监督医院各项制度的落实、健康环境的建设等,旨在规范机构医疗服务,提高机构服务质量,促使医院树立良好的社会形象,保障医院的社会经济效益。该文针对医院纪检监察在医院建设中的作用和实施展开分析。     

药品化妆品抽样及检验的有关问题探讨

目的:对药品、药包材、化妆品抽样及检验工作中发现的问题进行分析研究,旨在为监管部门和检验机构提供参考,规范抽样和检验,提高监管效能和服务水平。方法:通过抽样、样品寄送、收样、检验等环节,对药品、药包材、化妆品抽样及检验工作中发现的有关问题进行分析研究,提出相应的解决措施和意见建议。结果与结论:部分药品/药包材/化妆品的抽查检验存在抽样不规范、抽样信息不完整、抽样与检查未能兼顾、样品寄送不规范、检验登记单和检验报告信息不完整或填写不规范、检验不规范、部分产品的批号效期标识不规范,以及部分品种因抽样量大导致抽样难以覆盖基层等问题,影响了监管效能。应根据药品、药包材、化妆品的产品特性和监管要求,分类设置并完善抽样及检验检测信息,并从强化人员培训、监督和检验有机结合、针对基层用药特点完善抽检工作机制、加强学习交流提高检验报告质量等方面加以解决。