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1 Embase 数据库功能和使用 全球最权威的生物医学和药理学数据库 爱思唯尔 ( 北京 ) e.liu.1@elsevier.com 潍坊医学院 2018 年 4 月 18 日

2 2 Elsevier 生命科学解决方案产品线 Characterize & understand disease Design effective approach & validate lead Cull leads more quickly for safety & efficacy Improve clinical trial design by better selecting patient cohorts Manage risk & compliance & improve patient care Target ID & Validation Lead ID & Validation PRE- CLINICAL CLINICAL POST- MARKET Text Mining & Data Integration

3 3 讲座内容 Embase 数据库及 Emtree 主题词表介绍 Embase 支持药物和疾病检索 Embase 支持循证医学和系统评价研究 Embase 支持药物警戒的应用

4 Embase 数据库涵盖的内容与特点

5 5 Embase 数据库发展历程 Excerpta Medica Abstract Journals 荷兰医学文摘 (1947/8) EMBASE database online (1974) EMBASE integrated with Medline (2003) EMBASE becomes Embase (2009) 5

6 6 Embase 数据库简介 全球最佳的生物医学数据库, 涵盖期刊以及学术会议摘要索引 内容广泛 : 确保您不会错过任何有用信息帮助您发现其他数据库无法找到的信息 深度索引 : 确保从大量研究文献中找到相关的实时更新的生物医学信息以及文章来自所有相关的 最新的生物医学研究文献 精准搜寻 : 找出最相关的结果深入准确地关注研究信息, 强有力的信息提取工具 超过 8500 种期刊 超过 2900 种期刊在 Medline 数据库上无法检索到 尤其是那些在北美以外国家的期刊 每年有来约 7600 个会议的超过 250 万条的会议摘要 (since 2009)* 独有的信息资源 基于 Emtree 生命科学同义词汇编词库做深入的药物以及医疗设备信息索引 Embase.com ~ 3440 万篇文献 8500 种期刊 MEDLINE ~ 2300 万文献 5600 种期刊 PubMed~2500 万文献 6

7 7 Embase 收录的文献领域 完全涵盖同行评审的生物医学期刊和会议 药理学 & 毒理学 12% 临床医学 11% 遗传学, 生化 & 分子生物学 10% 神经病 & 行为医学 8% 微生物 & 传染病学 7% 心脏病 & 血液学 6% 精神病 & 精神卫生学 6% 肿瘤学 5% Healthcare Policy & Management 4% 过敏 & 免疫学 4% 儿科学 4% 内分泌 & 代谢学 3% 产科 & 妇科学 3% 生物医学工程 & 医疗器械 3% 麻醉 & 重症监护学 3% 肠胃病学 2% 呼吸道医学 2% 肾脏 & 泌尿学 2% 皮肤病学 2% 其他学科 28% Including public health, basic biomedical MEDLINE 包含公共卫生 基础生物医学以及 Medline 包含的学科领域 7

8 Embase.com vs. MEDLINE (on PubMed) 8

9 9 内容 : 全面性和实时性对比 生物医学 医疗健康, 含有更多的药理 毒理 疾病和医疗器械信息 8500 种期刊 7600 个会议, 250 万条文摘 超过 3300 万记录 51% 欧洲 31% 北美 11% 亚洲 包含了全部 Medline 内容, 以及独有的 2900 种期刊 Emtree 词表 75,000, 涵盖所有 MeSH 每年更新 3 次 生物医学 医疗健康信息 5600 种期刊 无会议记录 2400 万条记录 49% 欧洲 39% 北美 8% 亚洲 包含 Medline 期刊 27,883 医学主题词 MeSH 每年更新 1 次

10 10 Embase/Medline 在不同地区国家覆盖情况 World wide EU NA AP ROW Source: Embase journal List May 2017

11 11 Embase 收录亚洲期刊情况 Country Embase (total) MEDLINE Unique in Embase India Japan China South Korea Pakistan Singapore Taiwan Hong Kong Bangladesh Malaysia Nepal Thailand Indonesia Sri Lanka Philippines 2 1 1

12 12 Embase 收录非英语期刊情况 Language Embase (per year) MEDLINE (per year) Unique in Embase English ** 1,413, , ,727 Chinese 23,798 13,675 10,123 French 12,094 6,170 5,924 Spanish 12,333 4,273 8,060 Japanese 6,703 5,010 1,693 Russian 5,522 3,979 1,543 Portuguese 2,718 1,493 1,225 Polish 1, Turkish 1, ,113 Korean [1] Search query: e.g [ ]/sd NOT [ ]/sd AND [dutch]/lim AND [embase]/lim NOT [medline]/lim [2] Searched in Embase.com

13 13 Embase 收录更多 RCT 研究 Language Embase.com MEDLINE (PubMed) Embase Advantage Percent Chinese % French % Spanish % Japanese % Russian % Portuguese % Polish % Turkish % Korean % [1] Search query: e.g. 'randomized controlled trial'/not [ ]/sd AND [french]/lim [2] Search query: e.g. ((("1000/1/1"[MeSH Date]:"20exp 17/5/31"[MeSH Date] AND medline[sb]) AND Randomized Controlled Trial[ptyp])) AND french[language]

14 14 Emtree 生命科学辞典 生命科学辞典, 对生物医学文献进行主题分析 标引和检索时使用的权威性词表 便于检索 超过 73,000 个主题词汇以及超过 290,000 个同义词汇 海量的药物以及医疗设备检索 实时更新 化学名, 商品名, 实验室 / 研发代码, 以及超过 31,000 个药物和化合物首选词汇 (FDA, EMA and WHO) 超过 3,000 个设备和医疗设备专属词汇 (e.g. endoscopes, catheters, prostheses) 以及数千个医疗过程相关词汇 (e.g. endoscopy, catheterization) 每年 3 次更新最新的药物, 疾病, 生物体以及医疗过程的索引 ; 包括所有的 FDA 以及 EMA 记录的药物名称和 WHO 从 2000 起记录的所有国际非专利名称 (INNS). 包含词汇 包括所有的 MeSH 词汇, 并且与超过 23,000 个 CAS 号进行了链接 14

15 15 Emtree 生命科学辞典 对生物医学文献进行主题分析 标引和检索时使用的权威性词表 解剖学概念 生物学功能 生物医学学科, 科学和艺术 化学 物理和数学现象 化学和药物 疾病 地理名称 按照性别和年龄分组 卫生保健概念 人群分组 生物体 / 有机体 程序, 参数和仪器 社会与环境 文章或研究的类型 History This term was added to Emtree in 2000 Synonyms 4 [4 (methylsulfonyl) phenyl] 3 phenylfuran 2 (5h) one; alfof; ceoxx; dolib; mk 0966; mk 966; mk0966; mk966; refox; rhuma-cure; rofetab; rofiz gel; sivoz; toroxx mt; versatil; vioxx; vioxx forte; zyrof CAS Registry Numbers ; Dorland's dictionary rofecoxib = a nonsteroidal antiinflammatory drug of the COX-2 inhibitors group, used in treatment of osteoarthritis, acute pain, and dysmenorrhea; administered orally. Vioxx = trademark for a preparation of rofecoxib. Definition from Dorland's Medical Dictionary, 32nd edition, copyright 2011 by Elsevier. For more information please go to

16 全球销售前 10 的药品在 Embase 和 PubMed 检索记录 16

17 ScienceDirect.com 17

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19 19

20 20 Embase 中医药词表体系 Figure 1 Structure of TCM taxonomy in Emtree Figure 2 Information sources for building TCM taxonomy in Emtree

21 21 推荐使用 Embase 的政府 国际性标准制定机构和研究机构 Committee for Medicinal Products for Veterinary Use (CVMP) (cfda Drug Evaluation Guideline, draft) 药品文献评价指导原则国家食品药品监督管理局药品评价中心 ( 征求意见稿 )

22 Embase 支持药物和疾病检索

23 TITLE OF PRESENTATION Embase 登录界面 基本检索模块 快速检索 PICO PV Wizard 高级检索 药物检索 疾病检索 器械检索 文献检索 作者检索 浏览模块 Emtree 检索 期刊检索

24 TITLE OF PRESENTATION 24 Embase 中的词语连结 利用布尔运算符和位置算符 and, or, not near/n, next/n NEAR, 不考虑前后两个词语的顺序 NEXT, 需要考虑顺序

25 TITLE OF PRESENTATION 25 Embase 中的 Emtree 浏览 Tips: Find Term 可以直接输入概念, 系统将自动匹配 Emtree,

26 TITLE OF PRESENTATION 年新功能 Index Miner Index miner 允许用户查看所有的索引词, 关键可以让使用者按照一定的方式找到索引词

27 TITLE OF PRESENTATION 年新功能 Find similar records Similar 检索 按照文献中 major focus 的索引词, 进行组合检索 给出 Top 100 的记录

28 28 关于某个药物的临床试验文献的查询 检索需求 : 查询关于 gefitinib 的临床试验研究的文献 输入药物名称 选择临床试验对应的选项

29 共检索到 gefitinib 关于临床试验的记录 4670 篇 29

30 30 可以通过 Results Filters 对检索结果进行相应的筛选和查找 Source 可以筛选文章的来源 Drugs 可以挑选出这些文章中还出现了其他药物的五种关键分类的文章 可以分别挑选出来自 Embase,Medline 以及两者同时收录的文章 五种关键的分类 (Key subheading) 包括药物不良反应, 药物联用, 药物比较, 药物相互作用, 药物之类五大分类

31 获取 gefitinib 与 pacitaxel 联合用药的记录 31

32 获取 gefitinib 与 pacitaxel 联合用药的记录 32

33 33 可以通过 Results Filters 对检索结果进行相应的筛选和查找 Disease 可以挑选出这些文章中还出现了其他疾病的两种关键分类的文章 Age 可以帮助你挑选出参加临床试验的不同年纪的人群的文章 两种关键的分类 (Key Subheading) 包括药物治疗和副作用 这些关于参与人群的年龄分类包括 : 胚胎, 胎儿, 新生儿, 婴幼儿,1-12 岁的小孩, 学龄前儿童 (1-6 岁 ), 学校儿童 (7-12 岁 ), 青少年, 青年人, 成年人, 中年人, 老年人, 高龄老年人

34 34 可以通过 Results Filters 对检索结果进行相应的筛选和查找 Gender 可以帮你挑选出你想看的性别的相应的文章 Study type 可以帮你挑选出属于不同研究类型的文章 研究的类型包括 : 关于人类的, 临床试验的, 非人类的, 临床三期, 临床二期, 对照研究, 随机对照临床试验,Meta analysis, systematic review, 体外研究, 循证医学, 剂量比较

35 35 可以通过 Results Filters 对检索结果进行相应的筛选和查找 Journal Titles 帮助你筛选你来自于不同期刊的文章 Publication years and Authors 帮助你选择来自于不同作者和年份的相应文章 例如里面出现的 : 1. The Lancet Oncology 柳叶刀肿瘤学 2. Nature Reviews Clinical Oncology 3. British Journal of Cancer 可以紧盯领域内的牛人的最新的文章

36 36 可以通过 Results Filters 对检索结果进行相应的筛选和查找 Drug Trade Names 帮助你筛选涉及到药品商品名的文章 Drug Manufactures 帮助你筛选涉及到药品制造商发的文章 例如非小细胞肺癌中的常用药物 : 易瑞沙, 特罗凯等, 同时还包含一些在研究的化合物的实验室代码例如 (zd 1839,ccl 799, ptk 787,azd 2171 等 这些制药企业包括 : 阿斯利康, 基因泰克, 辉瑞, 诺华,GSK 等

37 Antibody 单抗药物信息的检索 37

38 38 生物制药行业总体趋势 最近的二十年来, 依托生物技术发展的生物制药行业得以迅猛发展, 生物技术的更新也是日新月异 根据中国化学制药行业协会的最新统计 : 2015 年 2000 亿美元 2019 年预计将突破 3860 亿美元 生物制剂抗体药物 其中抗体药物占据巨大的市场份额

39 39 已上市的抗体药物的总体趋势分析 从 1986 年首个抗体药物 Orthoclone OKT3 获批上市, 经过 30 年的发展, 截至 2017 年上半年,FDA 累计批准上市了 70 余种抗体药物

40 TITLE OF PRESENTATION Antibody 单抗药物信息的检索 需要解决的问题 Keytruda 相关文献与会议信息 Keytruda 为主要内容的文献 ( 加权检索 ) Keytruda 药理, 动物模型, 毒理, 临床信息等

41 TITLE OF PRESENTATION 41 单抗药物的检索 Embase 快速检索具体药物 Keytruda Tips: 当输入检索词时, 会自动匹配出词库中搜录的 preferred term, 检索时会自动联想同义词, 把检索词汇及其同义词在 标题, 摘要, 索引词 中出现的文献找到

42 TITLE OF PRESENTATION 检索结果 1 2 Tips: 可以利用副标题和快速筛选工具帮助我们拿到毒理, 药理, 临床等相关文献

43 TITLE OF PRESENTATION 43 限定结果集文献范围 找到结果集文献中, 主要内容与检索词汇相关文献 Tips: 选择 major focus 可以把结果集中, 文献主要内容跟检索词相关的文献快速筛选出来供查看

44 TITLE OF PRESENTATION 44 筛选结果 : 经过筛选,1500+major focus 的文献从 文献中被筛出

45 TITLE OF PRESENTATION 45 通过索引词阅读快速了解文章主要内容 : Tips: 黑色加粗字体, 快速提示文章主要内容 : Pembrolizumab (Keytruda),advanced cancer( 晚期癌症 ) uterine cervix cancer ( 宫颈癌 ),cancer chemotherapy ( 化疗 )

46 TITLE OF PRESENTATION 46 3 级索引更多原文细节展示 Tips: Embase 数据库对很多文献的 index term 进行人工的标注概述该词在文献中相关信息是什么 鼠标悬停在有 下划线 的词汇上即可显示 pembrolizumab 在该文中, 有 副作用反应 药物处方 药物毒理 相关信息

47 TITLE OF PRESENTATION 47 组合信息检索 检索 Keytruda 的药理学信息, 词汇 组合检索 逻辑关系 检哪里 检什么 Tips:Embase 数据库可以简单高效进行词汇组合检索, 既可以在单个信息框进行 逻辑语言编辑 也可以在多个信息框中直接输入词汇组合

48 TITLE OF PRESENTATION 48 检索结果 命中不同检索词汇的同时, 也进行了不同颜色的高亮, 便于阅读

49 TITLE OF PRESENTATION 49 快速筛选 - 药理学为主要内容文献 快速筛选, 主要内容与 组合检索词汇 相关的文献 Tips: 组合词汇检索出来的结果, 同样可以进行 major focus 快速筛选啊, 组要内容与检索词汇组相关的文献

50 TITLE OF PRESENTATION 50 其他副标菜单的应用 在 keytruda 的药理学为主要内容的文献中, 找到与 动物模型 相关的文献 Tips:Embase 数据库提供的多种副标筛选器, 能对检索信息进行多次梳理, 拿到更加准确的信息 1. 动物模型 2. 年龄段限定 2 1

51 TITLE OF PRESENTATION 51 筛选结果 87 篇 Keytruda 的药理为主要内容的文献中, 又快速的分类出了 4 篇跟动物模型有关的文献

52 TITLE OF PRESENTATION 52 Filter - 筛选器的应用 在 keytruda 的药理学为主要内容的文献中, 找到与临床相关的文献 历史导航栏可以方便的点击回到历史检索结果, 点击回到 #2 结果 及 87 篇 Keytruda 的药理学为主要内容的文献 2. 通过左侧的筛选器 (filters) 对结果集进行快速分类

53 筛选临床相关文献 TITLE OF PRESENTATION 53

54 筛选结果 TITLE OF PRESENTATION 54

55 Embase 支持循证医学系统评价研究

56 56 循证医学的重要意义 慎重 准确和明智地应用当前所能获得的最好的研究证据, 同时结合临床医生的个人专业技能和临床经验 考虑病人的价值和愿望, 将三者完美地结合指定出病人的治疗措施

57 57 循证医学 : 长期的循证实践的医学过程 提出问题搜寻证据评估证据得出结论后效评价 PICOS 此前所有 当前最佳 真实 可靠 适用 与时俱进 1. 选择关键词 2. 构建搜寻指令 Embase.com 阅读全文连接 ScienceDirect The Cochrane Library 3. 查找文献 4. 判断证据等级 MEDLINE 文献管理 注释 分享连接 EndNote Quosa * Straus, S. E., Glasziou, P., Richardson, W. S., & Haynes, R. B. (2011). Evidence-based medicine: How to practice and teach it (4th ed.). Edinburgh: Churchill Livingstone Elsevier.

58 58 寻找到最佳的证据 系统评价是什么? 以某一具体临床问题为基础, 系统 全面地收集全世界所有已发表或未发表的临床研究结果, 采用临床流行病学严格评价文献的原则和方法, 筛选出符合质量标准的文献, 进行定性或定量合成, 得出综合可靠的结论, 并随着新的临床研究的出现及时更新 The systematic review provides a verdict on unsettled medical debates based on a painstaking reassessment of all the relevant research the impact can be enormous. Official guidelines and best practices are established or changed after systematic reviews. Legal standards defining malpractice may be set; insurers may decide which treatments to pay for and which to decline.

59 60 循证医学对人类健康带来了积极影响 Prevention of prenatal death by antenatal corticosteroid therapy for fetal maturation 1972 年, 一项 RCT 报告显示早产儿的母亲如果在胎儿出生前短期使用肾上腺皮质激素可以改善结果 至 1991 年, 已有 7 篇 RCT 报道, 使原有系统评价证据进一步加强 Meta-analysis: Steroids lower death risk with 30-50% 1989 年以前, 由于没有针对上述 RCT 的系统评价发表, 多数产科医生并未认识到这一疗法的显著疗效, 导致成千上万的早产儿死亡和高额医疗费用 The Cochrane Handbook recommends that both MEDLINE and EMBASE be searched to generate a comprehensive Systematic Review.

60 61 系统综述基础上主要应用 临床实践指南 based on a systematic evidence review, developed by panel of multidisciplinary experts, provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of the recommendations Tell clinicians how to practice Published by national and international authority Favoured by health care systems Example:

61 62 系统综述基础上主要应用 临床实践指南 ( 中国 ) 指南的制定遵循循证医学的应用步骤 1. 提出问题 2. 用恰当的主题词 ( 关键词 自由词 ) 检索获取证据 3. 对指南的质量进行评价 4. 审视指南是否回答临床所需解决的问题 5. 应用证据和指南 6. 最后进行后效评价

62 63 系统综述基础上主要应用 卫生技术评估 HTA systematic evaluation of properties, effects, and/or impacts of health technology, provided by an independent agency. The purpose is to Inform policymaking for technology in health care. Regulatory agencies about whether to permit the commercial use of a drug, device or other regulated technology Payers (health care authorities, health plans etc.) about technology coverage, coding (assigning proper codes to enable reimbursement), and reimbursement (how much to pay) Standards-setting organizations for health technology and health care delivery Government health department officials about undertaking public health programs (e.g., immunization, screening, and environmental protection programs) 最新的医改方案中, 也明确添加了要 采用医药经济学评估技术用于药品等定价 的语句.

63 如何撰写高标准和高质量的系统综述? 64

64 65 系统评价指导手册 (2010) 第一章第三节 ( 二 ) 系统评价的方法和步骤 第二章系统评价信息检索, 第三节系统评价信息资源 主要的数据库包括 The Cochrane Library, PubMed, Embase, Science Citation Index, 中国生物医学文献数据库 系统评价指导手册 (2010) 杨克虎 ( 作者, 编者 )

65 66 系统综述最终成果 Criteria for considering studies for this review Search methods for identification of studies Data collection and analysis Link:

66 * The Handbook editorial team is currently updating Handbook versions 5.0, 5.1 and 5.2 for a planned release of Version 6 in This is a major update. 67 General Methods for Cochrane Reviews Chapter 6: Searching for studies Key points: Review authors should work closely from the start with the Trials Search Co-ordinator (TSC) of their Cochrane Review Group (CRG). Studies (not reports of studies) are included in Cochrane reviews but identifying reports of studies is currently the most convenient approach to identifying the majority of studies and obtaining information about them and their results. Trials registers and trials results registers are an increasingly important source of information. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE (if access is available to either the review author or TSC) should be searched for all Cochrane reviews, either directly or via the CRG s Specialized Register. Searches should seek high sensitivity, which may result in relatively low precision. Too many different search concepts should be avoided, but a wide variety of search terms should be combined with OR within each concept. Both free-text and subject headings should be used (for example Medical Subject Headings (MeSH) and EMTREE). Existing highly sensitive search strategies (filters) to identify randomized trials should be used, such as the newly revised Cochrane Highly Sensitive Search Strategies for identifying randomized trials in MEDLINE (but do not apply these filters in CENTRAL). Version [updated March 2011] Julian PT Higgins and Sally Green*

67 68 Cochrane 干预措施系统评价手册 ( 中文翻译版 ) 第六章文献检索 Key points: 系统评价作者在系统评价初始就应当与他们的 Cochrane 系统评价小组的试验检索协调员紧密合作 纳入 Cochrane 系统评价的是研究, 但鉴定研究报告是目前尽可能多地检出研究 获取研究相关信息及结果的最方便方法 临床试验注册库和试验结果注册库逐渐成为重要的信息源 所有 Cochrane 系统评价应检索 Cochrane 中心对照试验注册库 (CENTRAL) MEDLINE 和 EMBASE( 如果系统评价作者或 TSC 能进入上述数据库 ), 这些检索或是直接检索, 或是通过 CRG 的专业注册库 检索应力求高敏感性, 但同时可导致相对低的精确度 应当避免太多的不同检索概念, 但是各种各样的检索词应在同一概念之内用 OR 进行组配 自由词和主题词都应该使用 ( 例如医学主题词表 (MeSH) 和 EMTREE) 应用现有的高敏感性检索策略 ( 过滤器 ) 检索随机对照试验, 例如用新修订的 Cochrane 协作网高敏感性检索策略检索 MEDLINE 中的随机试验 Cochrane 干预措施系统评价手册中文翻译版 *

68 69 系统评价手册 ( 中国 ) Cochrane 干预措施系统评价手册中文翻译版 系统评价指导手册 (2010) 杨克虎 ( 作者, 编者 ) 中西医结合诊疗指南制定手册 (2016) 卢传坚, 杨克虎 ( 作者 ) 全国高等学校循证医学类教材 : 循证临床实践指南的制定与实施 (2016) 王小钦, 王吉耀 ( 编者 )

69 70 Using the PICO Framework to Structure a Question PICO Population, Patient, Problem PICO - Intervention PICO - Comparison PICO - Outcome

70 71 PICO 搜索 PICO 或任何生物医学研究关键词 案例 A: 使用 SSRI ( 选择性血清素回收抑制剂 ) 治疗抑郁症儿童或青少年是否会增加其自杀风险? Browse Emtree Patient Intervention Comparison Outcomes depression SSRI Suicide 交集 PICO 或多个关键词 ( 筛选研究类型 )

71 TITLE OF PRESENTATION 72 PICO 检索构建 Step 1 搜索范围的定义 Tips: 搜索范围的定义, 也可以针对每个字段进行定义

72 TITLE OF PRESENTATION 73 PICO 检索构建 Step 2 输入 PICO 所有的检索条件 Patient Intervention Comparison Outcomes depression SSRI Suicide 每一个字段在输入的时候都可以调整检索范围

73 PICO 检索构建 Step 2 全部条件输入后的结果 TITLE OF PRESENTATION 74

74 TITLE OF PRESENTATION 75 检索到的结果 使用 Filter 进行过滤

75 TITLE OF PRESENTATION 76 结果处理 添加更多的条件 Tips: Age 的选项不只是年龄的数据,

76 TITLE OF PRESENTATION 77 更多的用于循证医学的筛选 Tips: 1. Embase 直接给出了专门用于 EBM 的筛选, 可以快速用于 CR,SR,Meta 分析方面文献的获得 2. 更多零散方面的证据可以通过 Study Type 来获得, 如 Case Report,Cohort Analysis 等

77 最后的结果 TITLE OF PRESENTATION 78

78 检索策略的输出 TITLE OF PRESENTATION 79

79 TITLE OF PRESENTATION 80 检索结果的输出 支持多种结果的输出, 可以导入到各种文献管理软件中

80 81 Using the PICO Framework to Structure a Question PICO Example (1) Question: What are the best empirical antibiotic treatment options for bacterial meningitis? 什么样的经验性抗生素用于治疗细菌性脑膜炎最有效 P Population = patients with bacterial meningitis I Intervention = antibiotic agent C Compariso n = no treatment O Outcome = (blank)

81 82 Using the PICO Framework to Structure a Question PICO Example (2) Question: In patients with prostate cancer, do androgen deprivation therapy, compared to no treatment, reduce the recurrence rate? 使用雄激素剥夺疗法的前列腺癌患者和没有采取治疗的患者, 哪个复发率比较高 P Population = patients with prostate cancer I Intervention = androgen deprivation therapy C Comparison = no treatment O Outcome = reduction in recurrence rate of prostate cancer

82 Embase 在药物警戒研究的应用

83 84 什么是药物警戒 Pharmacovigilance Pharmacovigilance is all about adverse drug reactions 药物警戒是一项发现 评价 理解和预防不良反应或其他任何可能与药物有关问题的科学研究与活动 药物警戒的最终目标为合理 安全地使用药品 ; 对已上市药品进行风险 / 效益评价和交流 ; 对患者进行培训 教育, 并及时反馈相关信息

84 85 沙利度胺悲剧导致药物不良反应监测系统 瑞士诺华制药的前身 ciba 药厂首先合成了沙利度胺 具有一定的镇静催眠作用, 还能够显著抑制孕妇的妊娠反应 ( 止吐等反应 ) 因服用反应停而导致的畸形婴儿据保守估计大约有 1 万人, 还有大约 5000 到 7000 个婴儿在出生前就已经因畸形死亡 更为严格的药物检测和审批要求 美国国会 1962 Kefauver-Harris Amendments 1967 WHO: international monitoring of ADR McBride WG. Thalidomide and congenital abnormalities. Lancet. 1961;278:1358

85 86 Good pharmacovigilance practices in Europe GVP I XVI: 12 modules* covering pharmacovigilance processes and providing guidance, e.g. pharmacovigilance system quality, inspections, audits, risk management systems, post-authorisation safety studies, as well as for the suspected adverse reactions to medicines etc GVP Module VI legal requirements for MAHs and Agency, regards to collections, data management and submission of individual reports of suspected adverse reactions (serious and non-serious) associated with medicines GVP Module VI (EMA/873138/2011 Rev 2*) * The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency s website

86 88 GVP Module VI VI.B Literature reports The medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. Reports of suspected adverse reactions from the medical literature, including relevant published abstracts from meetings and draft manuscripts, should be reviewed and assessed by marketing authorisation holders to identify and record ICSRs. In addition, marketing authorisation holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation, and to bring them to the attention of the company safety department as appropriate. VI.B.6. Special situations Use of a medicinal product during pregnancy or breastfeeding, in a paediatric or elderly population, lack of therapeutic efficacy, overdose, abuse, misuse, medication error or occupational exposure

87 89 Guidance for Industry - Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines Types of Post-Marketing Adverse Event Data Spontaneous/voluntary reporting of cases - National (FDA MedWatch) - Local or Regional (Joint Commission Requirement) - Scientific literature publications Post-marketing studies (voluntary or required) - Observational studies (including automated healthcare databases) - Randomized clinical trials Active surveillance - Drug-Induced Liver Injury Network (DILIN) - Sentinel initiative serious, unexpected adverse experiences reported in the scientific literature (or in an unpublished scientific paper) that are known to the applicant must be submitted as 15-day reports... Applicants can use literature search services (e.g., Weekly Reactions) to identify adverse experiences in the scientific literature When a serious, unexpected adverse experience is based on a foreign language article or manuscript, the applicant should translate the publication into English promptly Ref: ttps://

88 90 药品文献评价指导原则 ( 征求意见稿 ) 文献 包括已公开发表的文献 未公开发表的文献 ( 即灰色文献 ) 等 文献评价 是指尽可能全面系统地收集一定时间范围内 特定药品的安全性 有效性研究文献, 在对文献进行质量评价 资料提取 归纳整理的基础上, 进行综合地分析评价, 并形成评价报告的过程 确定检索计划, 包括数据库 检索词 检索式 ( 即检索词组合方式 ) 和文献发表的时间范围 采取各种有效途径 ( 包括电子检索 / 手工检索 ) 在各种数据资料中全面查找证据 数据资料包括常用数据库 专业数据库 政府网站 会议摘要 学术论文集 灰色文献等 如果在查找证据时限制了发表文献语种 时限 设计类型等条件, 应当在报告中注明 Ref:

89 91 PV Search Strategy Part 1: Drug subheadings [drug subheadings] Search example: 'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction' Search summary: [drug]/[subheadings]

90 92 PV Search Strategy Part 2: Drug name and variants [drug names] [drug subheadings] Search summary: [drug]/[subheadings] OR [drug names] Search example: 'paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti OR '4 hydroxyacetanilide':tn,ab,ti OR '4` hydroxyacetanilide':tn,ab,ti OR 'abenol':tn,ab,ti OR 'acamol':tn,ab,ti OR 'acamoli forte suppositories for kids':tn,ab,ti OR 'acenol':tn,ab,ti OR 'acephen':tn,ab,ti OR 'acet suppositories':tn,ab,ti OR 'acetalgin':tn,ab,ti OR 'acetamino phenol':tn,ab,ti OR 'acetaminophen':tn,ab,ti OR 'acetaminophene':tn,ab,ti OR 'acetaminophenol':tn,ab,ti OR 'acetamol':tn,ab,ti OR 'acetomenophen':tn,ab,ti OR

91 93 PV Search Strategy Part 3: Adverse drug reaction concept [adverse drug reactions] 11.7M [drug names] [drug subheadings] Search summary: [drug]/[subheadings] OR ([drug names] AND [adverse drug reactions]) Search example: ('adverse drug reaction'/exp OR adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2 (effect* OR reaction* OR event* OR outcome*)):de,ab,ti OR 'side effect'/exp OR 'complication'/exp OR complication*:de,ab,ti OR OR 'drug interaction'/exp OR 'toxicity'/exp

92 94 PV Search Strategy Part 4: Special situations [adverse drug reaction] 11.7M [drug names] [drug subheadings] [special conditions] 6.8M Search example: 'pregnancy'/exp OR 'fetus'/de OR 'embryo'/de OR 'prenatal':de,ab,ti OR elderly:de,ti,ab OR 'drug abuse'/exp OR 'falsified drug':de,ab,ti OR 'medication error'/exp Search summary: [drug]/[subheadings] OR ([drug names] AND ([adverse drug reaction] OR [special conditions]))

93 95 PV Search Strategy Part 5: Human limit [adverse drug reaction] 11.7M [drug names] [drug subheadings] [special conditions] 6.8M Search summary: [drug]/[subheadings] OR ([drug names] AND ([adverse drug reaction] OR [special conditions])) AND [human limit] [human limit] 19.9M

94 96 PV Search Strategy Results [adverse drug reaction] 11.7M [drug names] [drug subheadings] [special conditions] 6.8M Search summary: [drug]/[subheadings] OR ([drug names] AND ([adverse drug reaction] OR [special conditions])) AND [human limit] [human limit] 19.9M

95 97 PV Search Strategy full 'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction' OR 'paracetamol-induced':de,ab,ti OR ('paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti OR '4 hydroxyacetanilide':tn,ab,ti OR '4` hydroxyacetanilide':tn,ab,ti OR 'abenol':tn,ab,ti OR 'acamol':tn,ab,ti OR 'acamoli forte suppositories for kids':tn,ab,ti OR 'acenol':tn,ab,ti OR 'acephen':tn,ab,ti OR 'acet suppositories':tn,ab,ti OR 'acetalgin':tn,ab,ti OR 'acetamino phenol':tn,ab,ti OR 'acetaminophen':tn,ab,ti OR 'acetaminophene':tn,ab,ti OR 'acetaminophenol':tn,ab,ti OR 'acetamol':tn,ab,ti OR 'acetomenophen':tn,ab,ti OR 'acetylaminophenol':tn,ab,ti OR 'adorem':tn,ab,ti OR 'afebrin':tn,ab,ti OR 'algiafin':tn,ab,ti OR 'algotropyl':tn,ab,ti OR 'alphagesic':tn,ab,ti OR 'alvedon':tn,ab,ti OR 'amadil':tn,ab,ti OR 'anacin 3':tn,ab,ti OR 'anaflon':tn,ab,ti OR 'analgiser':tn,ab,ti OR 'apamide':tn,ab,ti OR 'apap':tn,ab,ti OR 'apirex':tn,ab,ti OR 'apotel':tn,ab,ti OR 'arthralgen':tn,ab,ti OR 'atamel':tn,ab,ti OR 'ben-u-ron':tn,ab,ti OR 'benuron':tn,ab,ti OR 'biogesic':tn,ab,ti OR 'biogesic suspension':tn,ab,ti OR 'bodrex':tn,ab,ti OR 'calapol':tn,ab,ti OR 'calodol':tn,ab,ti OR 'calonal':tn,ab,ti OR 'calpol':tn,ab,ti OR 'causalon':tn,ab,ti OR 'cemol':tn,ab,ti OR 'christamol':tn,ab,ti OR 'claradol':tn,ab,ti OR 'clocephen':tn,ab,ti OR 'cp 500':tn,ab,ti OR 'cp500':tn,ab,ti OR 'dafalgan':tn,ab,ti OR 'daga':tn,ab,ti OR 'datril':tn,ab,ti OR 'depon':tn,ab,ti OR 'depyretin':tn,ab,ti OR 'dirox':tn,ab,ti OR 'dismifen':tn,ab,ti OR 'disprol':tn,ab,ti OR 'dolal':tn,ab,ti OR 'dolex':tn,ab,ti OR 'dolex 500':tn,ab,ti OR 'doliprane':tn,ab,ti OR 'dolitabs':tn,ab,ti OR 'dolofen':tn,ab,ti OR 'dolomol':tn,ab,ti OR 'dolorol':tn,ab,ti OR 'dolotemp':tn,ab,ti OR 'dolprone':tn,ab,ti OR 'doltem':tn,ab,ti OR 'drilan':tn,ab,ti OR 'dristan af':tn,ab,ti OR 'duorol':tn,ab,ti OR 'dymadon':tn,ab,ti OR 'efferalgan':tn,ab,ti OR 'efferalgan 500':tn,ab,ti OR 'efferalganodis':tn,ab,ti OR 'efferelgan':tn,ab,ti OR 'enelfa':tn,ab,ti OR 'eneril':tn,ab,ti OR 'eraldor':tn,ab,ti OR 'expandol':tn,ab,ti OR 'febrilix':tn,ab,ti OR 'fendon':tn,ab,ti OR 'fervex':tn,ab,ti OR 'fibrinol':tn,ab,ti OR 'fortolin':tn,ab,ti OR 'gelocatil':tn,ab,ti OR 'geluprane 500':tn,ab,ti OR 'gunaceta':tn,ab,ti OR 'headache strength allerest':tn,ab,ti OR 'hedex':tn,ab,ti OR 'infants` feverall':tn,ab,ti OR 'injectapap':tn,ab,ti OR 'janupap':tn,ab,ti OR 'kamolas':tn,ab,ti OR 'kyofen':tn,ab,ti OR 'lemgrip':tn,ab,ti OR 'letamol':tn,ab,ti OR 'liquiprin':tn,ab,ti OR 'lotemp':tn,ab,ti OR 'lyteca':tn,ab,ti OR 'malidens':tn,ab,ti OR 'medamol':tn,ab,ti OR 'meforagesic':tn,ab,ti OR 'metagesic':tn,ab,ti OR 'metalid':tn,ab,ti OR 'mexalen':tn,ab,ti OR 'milidon 500':tn,ab,ti OR 'minopan':tn,ab,ti OR 'mypara':tn,ab,ti OR 'n acetyl 4 aminophenol':tn,ab,ti OR 'n acetyl para aminophenol':tn,ab,ti OR 'n-acetyl-p-aminophenol':tn,ab,ti OR 'nalgesik':tn,ab,ti OR 'napamol':tn,ab,ti OR 'napap':tn,ab,ti OR 'naprex':tn,ab,ti OR 'nektol 500':tn,ab,ti OR 'neocitran':tn,ab,ti OR 'neodalmin':tn,ab,ti OR 'neopap':tn,ab,ti OR 'nevral':tn,ab,ti OR 'nilapur':tn,ab,ti OR 'nobedon':tn,ab,ti OR 'nysacetol':tn,ab,ti OR 'ofirmev':tn,ab,ti OR 'pacemol':tn,ab,ti OR 'pacimol':tn,ab,ti OR 'pamal':tn,ab,ti OR 'pamol':tn,ab,ti OR 'panadol':tn,ab,ti OR 'panadol actifast':tn,ab,ti OR 'panadol soluble':tn,ab,ti OR 'panamax':tn,ab,ti OR 'panasorb':tn,ab,ti OR 'panodil':tn,ab,ti OR 'para acetamidophenol':tn,ab,ti OR 'para acetylaminophenol':tn,ab,ti OR 'para hydroxyacetanilide':tn,ab,ti OR 'para suppo':tn,ab,ti OR 'paracet':tn,ab,ti OR 'paracetaminophenol':tn,ab,ti OR 'paracetamol':tn,ab,ti OR 'paracetamol ester':tn,ab,ti OR 'paracetamole':tn,ab,ti OR 'parageniol':tn,ab,ti OR 'paragin':tn,ab,ti OR 'paralen':tn,ab,ti OR 'paralief':tn,ab,ti OR 'paramax':tn,ab,ti OR 'paramidol':tn,ab,ti OR 'parapaed':tn,ab,ti OR 'parapaed junior':tn,ab,ti OR 'parapaed six plus':tn,ab,ti OR 'paratabs':tn,ab,ti OR 'parvid':tn,ab,ti OR 'pasolind':tn,ab,ti OR 'pasolind n':tn,ab,ti OR 'paximol':tn,ab,ti OR 'pedipan':tn,ab,ti OR 'penral-night':tn,ab,ti OR 'perfalgan':tn,ab,ti OR 'phenaphen':tn,ab,ti OR 'pinex':tn,ab,ti OR 'polarfen':tn,ab,ti OR 'predimol':tn,ab,ti OR 'puernol':tn,ab,ti OR 'pyrigesic':tn,ab,ti OR 'raperon':tn,ab,ti OR 'rapidol':tn,ab,ti OR 'relaphen':tn,ab,ti OR 'reliv':tn,ab,ti OR 'remedol':tn,ab,ti OR 'revanin':tn,ab,ti OR 'rhinapen elixir':tn,ab,ti OR 'rhodapap':tn,ab,ti OR 'roxamol gelcaps':tn,ab,ti OR 'salzone':tn,ab,ti OR 'sedes a':tn,ab,ti OR 'serimol':tn,ab,ti OR 'setamol':tn,ab,ti OR 'sinaspril':tn,ab,ti OR 'sinedol':tn,ab,ti OR 'sinpro':tn,ab,ti OR 'tabalgin':tn,ab,ti OR 'tachipirin':tn,ab,ti OR 'tachipirina':tn,ab,ti OR 'taganopain':tn,ab,ti OR 'tapar':tn,ab,ti OR 'tempra':tn,ab,ti OR 'tempte':tn,ab,ti OR 'temzzard':tn,ab,ti OR 'termofren':tn,ab,ti OR 'tralgon':tn,ab,ti OR 'tralgon elixir':tn,ab,ti OR 'tramil':tn,ab,ti OR 'treuphadol':tn,ab,ti OR 'turpan':tn,ab,ti OR 'tylenol':tn,ab,ti OR 'tylenol (caplet)':tn,ab,ti OR 'tylenol (geltab)':tn,ab,ti OR 'tylenol extra fuerte':tn,ab,ti OR 'tylenol forte':tn,ab,ti OR 'tylenol nr 1':tn,ab,ti OR 'tylex':tn,ab,ti OR 'valadol':tn,ab,ti OR 'winadol':tn,ab,ti OR 'winasorb':tn,ab,ti OR 'xebramol':tn,ab,ti OR 'zolben':tn,ab,ti OR 'zydinol':tn,ab,ti AND ('adverse drug reaction'/exp OR 'adverse drug reaction':lnk OR adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2 (effect* OR reaction* OR event* OR outcome*)):de,ab,ti OR 'side effect'/lnk OR 'side effect'/exp OR 'complication'/lnk OR 'complication'/exp OR complication*:de,ab,ti OR 'worsening':de,ab,ti OR 'case report*':de,ab,ti OR 'pharmacovigilance':de,ab,ti OR 'postmarketing surveillance'/exp OR 'drug interaction':lnk OR 'drug interaction'/exp OR 'toxicity'/exp OR 'drug toxicity':lnk OR toxic*:de,ab,ti OR intox*:de,ab,ti OR 'safety':de,ab,ti OR poison*:de,ab,ti OR pharmacotox*:de,ab,ti OR neurotox*:de,ab,ti OR cardiotox*:de,ab,ti OR nephrotox*:de,ab,ti OR hepatotox*:de,ab,ti OR immunotox*:de,ab,ti OR immunocytotox*:de,ab,ti OR cytotox*:de,ab,ti OR carcinogen*:de,ab,ti OR cancerogen*:de,ab,ti OR mutagen*:de,ab,ti OR terato*:de,ab,ti OR 'fatal outcome'/exp OR 'death'/exp OR death*:de,ab,ti OR 'suicide'/exp OR suicid*:de,ab,ti OR mortal*:de,ab,ti OR fatal*:de,ab,ti OR 'risk'/exp OR nocebo:de,ab,ti OR 'lethal concentration'/exp OR 'iatrogenic disease'/exp OR 'fertility'/exp OR 'substance-related disorders'/exp OR 'chemically induced':de,ab,ti OR 'morbidity':de,ab,ti OR 'congenital disorder':de,ab,ti OR infertility/exp OR injury/exp OR 'pregnancy'/exp OR pregnant*:de,ab,ti OR pregnanc*:de,ab,ti OR 'pregnancy complication'/exp OR 'pregnancy disorder'/exp OR 'abortion'/exp OR 'abortion':de,ab,ti OR 'lactation'/exp OR 'breast feeding':de,ab,ti OR 'breastfeeding':de,ab,ti OR 'breast milk':de,ab,ti OR 'reproduction'/de OR 'fetus'/de OR 'embryo'/de OR 'prenatal':de,ab,ti OR 'perinatal':de,ab,ti OR 'newborn':de,ab,ti OR parameters concerning the fetus, newborn and pregnancy /exp OR aged/exp OR elderly:de,ti,ab OR geriatric*:ti,ab OR ((environmental OR occupational) NEXT/1 exposure*):de,ab,ti OR 'compassionate use':de,ab,ti OR (named NEXT/1 (use OR patient*)):ab,ti OR 'inappropriate prescri*':de,ab,ti OR 'drug metabolism'/exp OR 'organ dysfunction':de,ab,ti OR 'organ failure':de,ab,ti OR 'hypersensitivit*':de,ab,ti OR allerg*:de,ab,ti OR counterfeit:de,ab,ti OR 'falsified drug':de,ab,ti OR ('unavailab*' NEAR/2 drug):de,ab,ti OR 'drug resistance'/exp OR 'drug resistance':de,ab,ti OR 'withdrawal syndrome'/de OR (drug* NEAR/3 (withdrawal OR toleran* OR interact* OR exposure* OR induc* OR resist* OR ineff* OR nonrespon* OR unrespon*)):de,ab,ti OR 'drug tolerance'/exp OR ((drug* OR treatment) NEXT/1 (failure* OR contraindication*)):de,ab,ti OR 'medication error'/exp OR (near NEXT/1 miss*):ab,ti OR ineff*:ti OR nonrespon*:ti OR unrespon*:ti OR ((lack OR no OR non OR 'not') NEXT/2 (eff* OR respon*)):ab,ti OR 'device failure':de,ab,ti OR manufacturing near/3 (error or fault or mistake or failure or contamination or impurity) OR patient compliance /exp OR overdos*:de,ab,ti OR 'drug abuse'/exp OR abus*:de,ab,ti OR misus*:de,ab,ti OR 'off label':de,ab,ti OR unlicensed:de,ab,ti) AND ('human'/exp OR human OR m?n OR wom?n OR child OR boy OR girl)) Designed to produce 100% recall against the gold set.

96 TITLE OF PRESENTATION 98 Tips: PV Wizard 用于监控药物上市后的的不良反应

97 TITLE OF PRESENTATION 99 检索步骤 输入药品名称 检索吉非替尼上市后的不良反应 只需要输入药品名称

98 TITLE OF PRESENTATION 100 检索步骤 Next 添加同义词 如果不需要, 可以关闭

99 TITLE OF PRESENTATION 101 Next,Next,Next 时间设定

100 TITLE OF PRESENTATION 102 最后的结果与提醒设置 药物警戒的提醒设置

101 感谢您对 Embase 的关注 如需了解更多信息, 请联系