药物流行病学研究方法——分析性研究（三）试题

1 .比较确切地说 ,队列研究也可以称为A .前瞻性研究B .发病率研究C .随访研究D .纵向研究E .群组研究2 .队列研究的英文名称是A .prospectivestudyB .incidencestudyC .follow -upstudyD .longitudinalstudyE .cohortstudy3.队列研究是比较A .暴露和非暴露于某因素的两个人群的发病可能性B .暴露和非暴露于某因素的两个人群的发病率差异C .暴露和非暴露于某因素的两个人群的发病原因D .暴露和非暴露于某因素的两个人群的发病关系E .暴露和非暴露于某因素的两个人群的发病结局4 .队列研究的用途 (多选 )A .验证病因假设B .了解疾病的…     

药学继续教育 III、药物流行病学研究方法——分析性研究(三)

队列研究 (cohortstudy)有的译为定群研究或群组研究 ,又称前瞻性研究 (prospectivestudy)、发病率研究 (incidencestudy)、随访研究 (follow upstudy)和纵向研究 (longitudinalstudy)。后四个名称不确切 ,易造成混乱 ,意思比较贴切的中文名称是队列研究或群组研究。本研究方法就是在暴露于所研究的因素和非暴露的两个人群中比较其发病率 (或死亡率 )的差异。借以评价暴露因素成为研究疾病 (包括药物不良反应 )的病因可能性和确切性。具体做法在有可能发生研究疾病的个体组成人群 (高危人群 ,populationatrisk)中分成暴露 (E)及未暴露 ( E)…     

病例对照研究资料中多种暴露水平相对危险度分析方法的探讨

1 问题的提出 流行病学调查表明,许多疾病的发生不仅与暴露因素有关,而且与暴露因素的强度或水平有关。目前常用的1：1配对病例对照研究方法把病例与对照分为暴露与非暴露两个水平。这种研究方法只能分析疾病的发生是否与暴露因素有关,却不能分析与暴露因素的强度或水平的关系。本文为了探讨1：1配对病例对照研究资料中多种暴露水平相对危险度的分析方法,以1：1配对病例与对照四格表资料的分析方法为原理[1],得出1：1配对病例对照研究中多种暴露水平相对危险度的分析方法。     

老年胃癌患者手术风险性相关因素分析

目的 探讨影响老年胃癌患者手术并发症发生的相关因素.方法 对术前生理指标、免疫指标、伴随疾病及手术方式等11个指标进行单因素分析,对有意义的指标采取Logistic多因素回归分析.结果 单因素分析显示术前血清前白蛋白水平、血清CD4/CI)R比值、术前伴随疾病、手术方式及手术时间与胃癌患者手术并发症显著相关(P＜0.05).Logistic多因素回归分析显示:术前血清CD4/CD8比值、术前伴随疾病和手术方式为影响老年胃癌患者术后并发症的3个独立因素.结论 术前CD4/CD8值、术前伴随疾病及手术方式可能是影响老年胃癌患者手术危险性的因素.     

感染科护士职业暴露的危险因素调查及防护措施

目的探讨感染科护士职业暴露的危险因素及防护措施。方法 2009年1月至2012年3月对我院感染科护士进行职业暴露的危险因素调查及防护情况进行回顾性分析。结果本组调查的职业暴露中被刀、剪、针等锐器损伤及皮肤接触血液为主要危险因素,经防护知识培训干预后与干预前比较,职业暴露的发生率明显减少,与治疗前比较差异显著(P<0.05),具有统计学意义。结论感染科护士在护理操作过程中的危险性相应增加,给护士的身心构成了极大的威胁。应加强护理人员职业暴露防护知识的培训,有效避免和减少职业危害的发生。     

病例交叉设计一药物流行病学研究新方法系列讲座（五）

药物流行病学研究中面临的实际问题,如数据的缺失或不完整,推动了药物流行病学方法的发展。例如针对实际研究只能获得病例组混杂因素情况,对照组混杂资料难以得到,1991年Maclure提出评价药物急性不良事件危险性时,选择病例源人群时最好的对照来源是病例自身,因而提出了病例交叉设计（oasecrossoverdesign）,这种对研究对象的自身暴露情况做出比较的自身对照方法,尤其适合估计短暂药物效应相关的急性不良事件危险性,近年来还引发了药物处方数据库研究技术的发展,这些方法在药物疗效研究评价中扮演着重要的角色。     

Ⅲ、药物流行病学研究方法——分析性研究(四)

1 病例对照研究与队列研究的特点比较 1.1 功能和效果 病例对照研究可研究多个因素引起的疾病病因,即多因一病。因为是从果到因的研究,其暴露与疾病发生的时间先后,有时难以判     

建立环境健康指标与健康危险度评价的关系

环境健康指标（EHIs）是环境健康决策者的常用工具之一,在环境保护和管理方面具有十分重要的作用。环境健康指标即是一个环境指标或一个健康指标加上已知的环境暴露与健康效应的关系。而作为一种建立环境暴露与健康效应关联的方法,危险度评价可能在构建以关联为基础的EHIs方面起着重要作用。健康危险度评价的作用包括定量评价环境暴露的健康危险度和暴露人群的特征。     

手术人员血源传染性疾病职业暴露预防与控制

目的观察手术人员血源传染性疾病职业暴露预防与控制分析。方法将在我院手术室2016年10月～2018年1月接收血源性疾病患者总计233例(台手术),其中83人手术人员参与,设为对照组,其中发生7例(8.43%)职业暴露,分析暴露的传染性疾病情况、方式、处理办法、预后等情况,分析高危因素,并制定相应的控制措施。将2018年2月～2019年2月我院接收的血源性疾病患者总计197例(台手术),其中79人手术人员参与,设为实验组。比较两组患者手术室内手术人员对血源传染性疾病相关知识评分、预防职业暴露方法评分、对血源传染性疾病态度评分,并比较两组暴露率。结果实验组手术人员对血源传染性疾病相关知识评分、预防职业暴露方法评分、对血源传染性疾病态度评分明显高于对照组,而实验组手术人员职业暴露率为1.27%,对照组为8.43%,差异具有统计学意义(P <0.05)。7例职业暴露的医务人员在发生职业暴露后均进行伤口处理、风险评估、预防性用药及暴露后血清学检测,检测结果全部为阴性。结论手术人员血源传染性疾病职业暴露,多因对相关知识认识与重视性不到位所致,而护士为职业暴露发生率较高者,因此应加强手术室医护人员相关知识与态度的教育,获得理想效果。     

人单克隆抗体

现今,应用单克隆抗体诊断和治疗人类疾病已成为许多研究者的主要目标,一个限制因素是使用人单克隆抗体而不是小鼠或大鼠单克隆抗体。为使由于应用异种动物蛋白所产生的过敏反应和免疫复合物形成的临床表现的危险性,以及抗体效应消失等问题减少到最低限度,对病人的诊断和治疗就必需使用人单克隆抗体。     

美国药品风险减低措施及其对中国的启示

 文中通过介绍美国药品风险减低举措历程及异维A酸案例，分析美国FDA药品风险减低措施，为我国药品风险减低相关举措的发展提供参考。我国可通过明确责任主体、开发合适工具、制定执行机制、开展评估活动等措施加强药品风险减低行动。     

Life-table calculations of excess risk for incidence versus mortality: Ethylene oxide case study

In US EPA’s evaluation of ethylene oxide (EO) in 2006, the calculation of the excess risk of lymphohematopoietic (LH) cancer incidence was flawed. The calculation was inappropriately based on an exposure-response model for LH mortality instead of LH incidence. This is especially inappropriate for EO because EO exposure may not increase LH incidence except at high doses. The observed increases in LH mortality with EO exposure in males in the NIOSH epidemiology study, although not statistically significant, can be explained at all but the highest doses by exposure-dependent changes in the survival time between LH onset and LH mortality without any changes in LH incidence. Furthermore, EPA’s life-table calculations of excess risk of incidence used formulas that are only appropriate for mortality. All of these concerns strongly suggest that EPA should limit their excess risk calculations to mortality unless they have data from an epidemiology study of incidence from which to derive an exposure-response model. What excess risks are calculated and how they are calculated is important for a scientifically-defensible regulatory assessment of EO and other substances.     

银杏叶提取物注射液不良反应的文献分析

银杏叶提取物注射液为银杏叶制剂,临床使用广泛。通过采用回顾性研究方法对银杏叶提取物注射液国内文献报道中上市后安全性信息进行重点分析,梳理出其主要不良反应为过敏反应,特点为速发型,单独用药或联合用药均可引起用药风险;主要涉及消化系统损害、中枢及外周神经系统损害、皮肤及其附件损害、心血管系统损害等,包括胃肠道不适、恶心、稀便、腹泻、应激性溃疡、头痛、头晕、皮肤潮红、多汗、血压降低、心悸、眼结膜充血、脑出血、失眠等表现。进而提出符合药品本身特点的风险控制措施,为安全、合理使用该药提供建议。     

儿童退热类化学药安全性问题的相关研究

通过采用回顾性分析方法,分别对乙酰氨基酚、布洛芬、安痛定、安乃近、赖氨匹林不良反应进行文献分析。运用比较研究法,介绍美国FDA和欧盟EMA用药指南、风险管理策略及风险干预措施,对比国内外对乙酰氨基酚和布洛芬的儿科说明书情况,对我国儿童用退热药管理中存在的问题进行汇总分析,进而为儿童退热类化学药品的合理使用提供建议和参考。     

我国新药临床试验的风险管理模式探讨

目的从临床试验研究者的角度探索新药临床试验的风险管理模式,为其在我国的建立与实施提供参考。方法分析风险管理的通用模式与架构,借鉴发达国家成熟药品风险管理体系的法规与原则,阐述我国新药临床试验风险管理的发展现状,开拓创新适合我国国情的风险管理模式。结果与结论 基于一般风险管理及药品风险管理的理论与实践,提出适合我国新药临床试验的风险管理新模式的构想。     

A reassessment of risk associated with dietary intake of ochratoxin A based on a lifetime exposure model

Mycotoxins, such as ochratoxin A (OTA), can occur from fungal growth on foods. OTA is considered a possible risk factor for adverse renal effects in humans based on renal tumors in male rats. For risk mitigation, Health Canada proposed maximum limits (MLs) for OTA based largely on a comparative risk assessment conducted by Health Canada (), in which analytical data of OTA in foods were used to determine the possible impact adopting MLs may have on OTA risks. The EU MLs were used for comparison and resultant risk was determined based on age–sex strata groups. These data were reevaluated here to determine comparative risk on a lifetime basis instead of age strata. Also, as there is scientific disagreement over the mechanism of OTA-induced renal tumors, mechanistic data were revisited. On a lifetime basis, risks associated with dietary exposure were found to be negligible, even without MLs, with dietary exposures to OTA three to four orders of magnitude below the pivotal animal LOAEL and the TD₀₅. Our review of the mechanistic data supported a threshold-based mechanism as the most plausible. In particular, OTA was negative in genotoxicity assays with the highest specificity and levels of DNA adducts were very low and not typical of genotoxic carcinogens. In conclusion, OTA exposures from Canadian foods do not present a significant cancer risk.     

刍议美国罗格列酮的风险评估与减低计划

目的分析美国对罗格列酮的上市后风险管理,以期为我国上市后药品风险管理提供参考和借鉴。方法通过检索FDA和CFDA网站以及相关文献,收集并整理分析罗格列酮相关信息,详细回顾了FDA对罗格列酮采取的风险评估与减低计划（REMS）,同时分析了我国对罗格列酮的上市后监管,并对中美风险干预措施进行比较。结果与结论美国罗格列酮的REMS是罗格列酮上市后风险管理的一项重要举措,严格限制了罗格列酮的使用,对我国上市后药品风险管理具有指导意义。     

Risk Competence in Dealing With Alcohol and Other Drugs in Adolescence

Background: Adolescence is a critical phase for the development substance use patterns. We propose that individual competence in dealing with psychoactive substances is crucial for the development of healthy substance use behavior and prevention of substance misuse or addiction. Objectives: We present a new concept of health related skills in dealing with alcohol and other drugs in adolescence, its operationalization and validation. Our conception of risk competence (RICO) consists of the four major factors being Reflective, Informed, Self-Controlled and Life-Oriented, and their sub-facets. Methods: Based on a sample of N = 753 adolescents we used classical test theory as well as item response theory to create a new measure of RICO. Validity was investigated in a new sample of N = 229 with regard to substance use, risk perception, and measures of personality (Big Five, sense of coherence, general self-efficacy). Results: RICO contains 7 scales with 28 items that measure independent aspects of risk competence. Cross-sectional criterion validity for most of the scales could be shown. Conclusions/Importance: The new RICO scales are a valid measure of different aspects of risk competence in dealing with psychoactive substances. The questionnaire can be used in general research settings, but may also be applied to assess the effects of interventions.     

Benefit assessment of therapeutic products: the Centers for Education and Research on Therapeutics

The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable uncertainty remains about the methods of defining benefit and how to operationalize this knowledge. In this 'think tank,' part of a larger series on risk management, issues were divided into those that can be identified before a study is initiated, those that commonly arise after a study is completed, biomarkers and surrogates, use of benefit findings in defining quality and performance indicators, implementation of findings into health systems and formularies, and methods of comparative trials. Key categories for the establishment of a research agenda to fill in gaps in our understanding of assessing benefit were developed by the group.     

Calculating excess risk with age-dependent adjustment factors and cumulative doses: Ethylene oxide case study

U.S. EPA’s Supplemental Guidance in 2005 documented their procedure for incorporating age-dependent adjustment factors (ADAFs) into lifetime excess risk calculations. EPA’s first attempt to implement an ADAF when the dose–response model had a cumulative dose metric was for ethylene oxide and that attempt (US EPA, 2006) failed to successfully follow EPA’s own guidelines. The failure suggested that the incorporation of ADAFs would increase the lifetime excess risk for ethylene oxide by approximately 66%. However, if the procedure in the guidelines were followed correctly, then the increase would have only been 0.008% or approximately 8,000 fold less. Because cumulative exposure is a common dose metric in dose–response models of epidemiological data, a correct implementation of the guidelines is of widespread importance.