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烟草制品管制科学基础报告 WHO研究组第八份报告

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作者:WHO烟草制品管制研究小组著胡清源,侯宏卫译

出版社:科学出版社

定价:198.00

ISBN:9787030794970

出版时间:2024-09-01

分类:图书,行业职业,工业技术,轻工业

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目录

译者序 i

WHO烟草制品管制研究小组第十次会议 iii

致谢 xi

缩略语 xv

1.引言 1

参考文献 3

2.加热型烟草制品中的有害物质及其暴露、健康影响和风险降低声明 5

摘要 5

2.1 背景 5

2.2 加热型烟草制品释放物中的有害物质 7

2.2.1 测量有害物质的实验室方法 7

2.2.2 烟碱 8

2.2.3 其他有害物质 9

2.3 加热型烟草制品的体外暴露和实验动物暴露及影响 15

2.3.1 体外研究 15

2.3.2 实验动物研究 17

2.4 加热型烟草制品中有害物质的人体暴露及健康影响 18

2.4.1 产品用途和使用模式 18

2.4.2 暴露和效应生物标志物 19

2.4.3 被动暴露 22

2.4.4 健康影响 23

2.5 加热型烟草制品风险或危害降低的证据审查 25

2.5.1 烟草制品危害降低 25

2.5.2 风险降低声明 25

2.6 小结和公共卫生影响 28

2.6.1 数据摘要 28

2.6.2 公共卫生影响 29

2.7 研究差距和优先事项 30

2.8 政策建议 31

2.9 参考文献 31

3.加热型烟草制品的吸引力和致瘾性:对认知和使用的影响及关联效应 40

摘要 40

3.1 背景 41

3.2 HTP的吸引力 42

3.2.1 WHO FCTC第9条和第10条中吸引力的定义 42

3.2.2 HTP的吸引力特性 42

3.2.3 了解ENDS和ENNDS并应用到HTP 45

3.3 HTP的致瘾性 46

3.3.1 致瘾性 46

3.3.2 了解ENDS和ENNDS并应用到HTP 49

3.3.3 HTP的总体滥用倾向 49

3.4 ENDS、ENNDS和HTP的吸引力和致瘾性对风险、危害和使用认知的影响 50

3.4.1 吸引力和致瘾性对开始、转换、补偿和戒除传统卷烟的贡献 50

3.4.2 了解ENDS和ENNDS并应用到HTP 51

3.5 讨论 52

3.5.1 不同群体不同使用方式的行为影响 52

3.5.2 公共卫生影响 53

3.5.3 研究差距、优先事项和问题 53

3.5.4 政策建议 54

3.6 结论 54

3.7 参考文献 55

附录 IQOS、卷烟和JUUL产品中的薄荷醇浓度 62

4.加热型烟草制品之间的差异:考虑因素及影响 63

摘要 63

4.1 背景 63

4.1.1 概述 63

4.1.2 缔约方大会FCTC/COP8(22)号决议 64

4.1.3 范围与目标 64

4.2 市场上产品的差异 64

4.2.1 产品类别和类型的概述 64

4.2.2 加热型烟草制品之间的差异 66

4.2.3 产品类型和类别的市场分布 66

4.3 产品特征和设计特点 67

4.3.1 产品的温度分布情况和操作性能 67

4.3.2 电池性能 68

4.3.3 烟草插片、烟棒和胶囊的特性 68

4.4 产品的成分、释放物及总体设计 69

4.4.1 成分和释放物 69

4.4.2 烟碱递送 70

4.4.3 风险概况 71

4.4.4 加热型烟草制品成分的监管意义 72

4.4.5 释放物的监管意义 73

4.5 产品、制造商和销售点的差异 73

4.5.1 制造商和销售点 73

4.5.2 对客户吸引力的影响 74

4.6 讨论 75

4.7 结论 75

4.8 研究差距、优先事项和问题 76

4.9 政策建议 77

4.10 参考文献 77

5.加热型烟草制品的使用:产品转换以及双重或多重使用 82

摘要 82

5.1 概述 82

5.2 关于HTP在人群层面使用的信息 83

5.3 从传统卷烟转向HTP的动态情况:双重或多重产品联用是过渡态还是较为态? 85

5.4 HTP作为传统卷烟替代品的潜在作用 87

5.5 双重/多重使用者的烟碱暴露及潜在健康风险 88

5.6 动物药代动力学 91

5.7 人体药代动力学 91

5.8 使用HTP和传统卷烟的主观效应 95

5.9 讨论和影响 96

5.10 研究差距 97

5.11 政策建议 97

5.11.1 戒烟政策 97

5.11.2 监督政策 97

5.11.3 研究政策 97

5.11.4 合作政策 98

5.12 参考文献 98

6.加热型烟草制品和电子烟碱/非烟碱传输系统相关法规以及国家措施和监管障碍 106

摘要 106

6.1 背景 106

6.1.1 缔约方大会的介绍和要求(FCTC/COP8(22)) 106

6.1.2 范围和目标 108

6.1.3 来源 108

6.2 新型烟草制品的监管情况 108

6.2.1 HTP的可用性 108

6.2.2 产品分类 109

6.2.3 减少烟草需求的监管框架和措施 113

6.3 监管、实施和执行政策的考虑事项和障碍 118

6.3.1 实施政策时的监管考虑 118

6.3.2 实施和执行政策的障碍 119

6.3.3 其他考虑和意外后果 119

6.4 讨论 120

6.5 结论 121

6.6 研究差距 121

6.7 政策建议 121

6.8 参考文献 122

7.电子烟碱传输系统和传统卷烟的烟碱暴露评估 127

摘要 127

7.1 背景 128

7.2 电子烟碱传输系统的烟碱暴露 129

7.2.1 电子烟碱传输系统的烟碱释放 129

7.2.2 电子烟碱传输系统电功率对烟碱释放的影响 129

7.2.3 电子烟碱传输系统烟油中烟碱和其他化合物浓度对烟碱释放的贡献 130

7.3 伴生物质的暴露概述 131

7.4 电子烟碱传输系统的烟碱递送 131

7.5 与使用有关的暴露行为模式 132

7.5.1 使用者群体和使用者模式的定义 132

7.5.2 影响行为模式的因素 133

7.6 被动暴露于烟碱和其他有害成分 135

7.7 烟碱通量 135

7.8 讨论 137

7.9 结论 138

7.10 研究差距、优先事项和问题 138

7.11 政策建议 139

7.12 参考文献 139

8.电子烟碱/非烟碱传输系统和加热型烟草制品相关个体风险的量化方法探索:对人体健康和监管的影响 148

摘要 148

8.1 背景 148

8.1.1 量化风险的挑战 150

8.2 使用ENDS和ENNDS相关的风险评估与量化 151

8.2.1 与特定成分或无意添加的物质相关的健康风险 152

8.2.2 ENDS和ENNDS的潜在健康影响 154

8.2.3 非使用者的风险 156

8.3 量化风险的方法 156

8.3.1 毒理学关注的阈值 158

8.3.2 基于单个化合物的风险评估 158

8.3.3 相对风险方法 159

8.3.4 暴露边界值法 159

8.3.5 非致癌作用 159

8.3.6 评估框架 160

8.4 加热型烟草制品 162

8.5 对监管的影响 162

8.6 讨论 164

8.7 建议 165

8.8 结论 166

8.9 参考文献 166

9.新型烟草制品的风味 175

摘要 175

9.1 背景和引言 175

9.2 风味电子烟的流行病学(使用频率、模式和原因,按社会人口统计变量) 177

9.2.1 电子烟碱/非烟碱传输系统 178

9.2.2 传统卷烟和无烟烟草制品 179

9.2.3 加热型烟草制品 180

9.3 调味物质对吸引力、尝试使用、使用和持续使用的影响 180

9.3.1 青少年和年轻人 180

9.3.2 成年人 182

9.4 常见调味物质特性、健康效应及其对公众健康的影响 183

9.4.1 电子烟和烟草制品中常见的调味物质 183

9.4.2 风味电子烟中常见调味物质的化学和物理性质 183

9.4.3 调味物质的毒性 184

9.5 风味产品的监管 185

9.5.1 全球风味电子烟监管 185

9.5.2 全球风味烟草制品监管 186

9.5.3 常用方法的优缺点 188

9.5.4 对烟碱产品特定风味监管产生的影响 188

9.5.5 调味物质的未来监管 189

9.6 讨论 191

9.7 研究差距、优先事项和问题 191

9.8 政策建议 192

9.9 参考文献 192

10.新型烟草制品的全球营销和推广及其影响 206

摘要 206

10.1 背景 206

10.2 电子烟碱传输系统和电子非烟碱传输系统 208

10.2.1 引言 208

10.2.2 电子烟市场、产品和营销策略 209

10.2.3 电子烟的全球使用情况和使用流行程度 212

10.2.4 电子烟的广告、促销和赞助趋势 216

10.2.5 控制电子烟的广告、促销和赞助的措施 217

10.2.6 建议 218

10.2.7 电子烟的研究差距 220

10.3 加热型烟草制品 221

10.3.1 引言 221

10.3.2 市场参与者、产品和策略 221

10.3.3 加热型烟草制品的全球使用和流行情况 224

10.3.4 加热型烟草制品的广告、促销和赞助趋势 225

10.3.5 加热型烟草制品广告、促销和赞助的控制措施 227

10.3.6 对监测加热型烟草制品的广告、促销和赞助趋势的建议 227

10.3.7 对监管机构的建议 228

10.3.8 加热型烟草制品研究的研究差距 229

10.4 总结 229

10.5 参考文献 230

11.烟草中的烟碱形态、化学修饰及其对电子烟碱传输系统的影响 241

摘要 241

11.1 背景 241

11.2 烟碱的化学修饰及其对烟碱传输的影响 243

11.2.1 烘烤对烟碱的影响 243

11.2.2 碱改性 244

11.2.3 酸改性 244

11.3 对电子烟碱传输系统产品和多样性的影响 245

11.3.1 电子烟碱传输系统中游离态烟碱与烟碱盐 245

11.3.2 有效浓度和滥用倾向 246

11.3.3 对产品刺激性可能的掩饰 247

11.3.4 健康影响和监管考虑 247

11.4 讨论 248

11.5 研究差距、优先事项和问题 248

11.6 建议 249

11.7 考虑因素 249

11.8 参考文献 249

12.电子烟碱传输系统或雾化产品使用相关肺损伤 258

摘要 258

12.1 背景 258

12.1.1 与电子烟和雾化产品相关的呼吸影响 258

12.1.2 电子烟碱传输系统或雾化产品使用相关肺损伤(EVALI) 259

12.1.3 与EVALI有关的产品和化学制品 259

12.2 EVALI 260

12.2.1 详细说明和历史记录 260

12.2.2 症状 260

12.2.3 临床表现 261

12.2.4 报告病例 261

12.3 EVALI的识别 261

12.4 对EVALI的监测 262

12.4.1 国家监测机制 262

12.4.2 地区监测机制 262

12.4.3 国际监测机制和验证 262

12.5 讨论 262

12.6 考虑事项 263

12.7 建议 263

12.7.1 主要建议 263

12.7.2 其他建议 264

12.8 参考文献 264

13.总体建议 266

13.1 主要建议 267

13.2 对公共卫生政策的意义 268

13.3 对WHO规划的影响 269

13.4 参考文献 269

Participants in the 10th meeting of the WHO study group on tobacco product regulation vii

Acknowledgements xiii

Abbreviations and acronyms xvii

1.Introduction 273

References 277

2.Toxicants in heated tobacco products,exposure,health effects and claims of reduced risk 278

Abstract 278

2.1 Background 279

2.2 Toxicants in heated tobacco product emissions 281

2.2.1 Laboratory methods for measuring toxicants 281

2.2.2 Nicotine 282

2.2.3 Other toxicants 284

2.3 Exposure and effects of HTPs in vitro and in laboratory animals 291

2.3.1 In-vitro studies 291

2.3.2 Studies in laboratory animals 293

2.4 Exposure of humans to toxicants in HTPs and implications for health 295

2.4.1 Product use and topography 295

2.4.2 Biomarkers of exposure and effect 296

2.4.3 Passive exposure 300

2.4.4 Impact on health outcomes 302

2.5 Review of the evidence for reduced risk or harm with use of HTPs 304

2.5.1 Harm reduction in the context of tobacco products 304

2.5.2 Claims of reduced risk 304

2.6 Summary and implications for public health 308

2.6.1 Summary of data 308

2.6.2 Implications for public health 310

2.7 Research gaps and priorities 311

2.8 Policy recommendations 312

2.9 References 312

3.The attractiveness and addictive potential of heated tobacco products:effects on perception and use and associated effects 320

Abstract 320

3.1 Background 321

3.2 Attractiveness of HTPs 323

3.2.1 Definition of attractiveness in the context of Articles 9 and 10 of the WHO FCTC 323

3.2.2 Attractive features of HTPs 323

3.2.3 What we can learn from studies on ENDS and ENNDS and relevance to HTPs 327

3.3 Addictiveness of HTPs 328

3.3.1 Addictiveness 328

3.3.2 What we can learn from ENDS and ENNDS and relevance to HTPs 332

3.3.3 Overall abuse liability of HTPs 332

3.4 Effects of the attractiveness and addictiveness of ENDS,ENNDS and

HTPs on perceptions of risk and harm and use 333

3.4.1 Contributions of attractiveness and addictiveness to initiation,switching,complementing and quitting conventional tobacco products 333

3.4.2 Learning from ENDS and ENNDS and application to HTPs 334

3.5 Discussion 335

3.5.1 Behavioural implications of different patterns of use in different groups 335

3.5.2 Implications for public health 336

3.5.3 Research gaps,priorities and questions 337

3.5.4 Policy recommendations 338

3.6 Conclusions 339

3.7 References 339

Annex 3.1.Menthol concentrations in IQOS,cigarettes and JUUL products 345

4.Variations among heated tobacco products:considerations and implications 346

Abstract 346

4.1 Background 347

4.1.1 Overview 347

4.1.2 Decision FCTC/COP8(22) of the Conference of the Parties 347

4.1.3 Scope and objectives 347

4.2 Variations among products on the market 348

4.2.1 Overview of product categories and types 348

4.2.2 Variations among heated tobacco products 350

4.2.3 Market distribution of product types and categories 350

4.3 Characteristics and design features of products 352

4.3.1 Temperature profiles of products and operational capabilities 352

4.3.2 Battery characteristics 352

4.3.3 Properties of tobacco inserts,sticks and capsules 352

4.4 Content,emissions and general design of products 353

4.4.1 Content and emissions 353

4.4.2 Nicotine delivery 356

4.4.3 Risk profiles 356

4.4.4 Regulatory implications of the contents of heated tobacco products 357

4.4.5 Regulatory implications of emissions 358

4.5 Variations among products,manufacturers and selling points 359

4.5.1 Manufacturers and selling points 359

4.5.2 Implications for customer pulling power 360

4.6 Discussion 361

4.7 Conclusions 362

4.8 Research gaps,priorities and questions 363

4.9 Policy recommendations 363

4.10 References 365

5.Use of heated tobacco products:product switching and dual or poly product use 369

Abstract 369

5.1 Introduction 370

5.2 Information on HTP use at population level 370

5.3 Dynamics of switching from conventional cigarettes to HTPs:Is dual or poly use a transitional or permanent state? 373

5.4 Potential role of HTPs as a substitute for conventional cigarettes 376

5.5 Exposure to nicotine and potential health risks among poly users 377

5.6 Pharmacokinetics in animals 380

5.7 Pharmacokinetics in people 380

5.8 Subjective effects of use of HTPs and conventional cigarettes 385

5.9 Discussion and implications 386

5.10 Research gaps 387

5.11 Policy recommendations 387

5.11.1 Cessation policy 387

5.11.2 Surveillance policy 387

5.11.3 Research policy 388

5.11.4 Cooperation and partnership policy 388

5.12 References 388

6.Regulations on heated tobacco products,electronic nicotine delivery systems and electronic non-nicotine delivery systems,with country approaches,barriers to regulation and regulatory considerations 395

Abstract 395

6.1 Background 396

6.1.1 Introduction and the request of the Conference of the Parties (FCTC/COP8(22)) 396

6.1.2 Scope and objectives 397

6.1.3 Sources 398

6.2 Regulatory mapping of novel and emerging nicotine and tobacco products 398

6.2.1 Availability of HTPs 398

6.2.2 Product classification 399

6.2.3 Regulatory frameworks and measures to reduce tobacco demand 404

6.3 Considerations and barriers to regulation,implementation and enforcement of policies 411

6.3.1 Regulatory considerations in implementing policies 411

6.3.2 Barriers to implementing and enforcing policies 413

6.3.3 Other considerations and unintended consequences 413

6.4 Discussion 414

6.5 Conclusions 415

6.6 Research gaps 416

6.7 Policy recommendations 416

6.8 References 417

7.Estimation of exposure to nicotine from use of electronic nicotine delivery systems and from conventional cigarettes 421

Abstract 421

7.1 Background 422

7.2 Exposure to nicotine from ENDS 424

7.2.1 ENDS nicotine emission 424

7.2.2 Influence of ENDS electrical power on nicotine emission 424

7.2.3 Contribution of the concentrations of nicotine and other

compounds in ENDS liquids to nicotine emissions 425

7.3 Overview of exposure to accompanying substances 426

7.4 Nicotine delivery from ENDS 427

7.5 Behavioural patterns of exposure according to use 428

7.5.1 Definition of user groups and user patterns 428

7.5.2 Factors that influence behavioural patterns 428

7.6 Passive exposure to nicotine and other toxicants 430

7.7 Nicotine flux 431

7.8 Discussion 433

7.9 Conclusions 434

7.10 Research gaps,priorities and questions 435

7.11 Policy recommendations 436

7.12 References 436

8.Exploration of methods for quantifying individual risks associated with electronic nicotine and non-nicotine delivery systems and heated tobacco products:impact on population health and implications for regulation 444

Abstract 444

8.1 Background 445

8.1.1 Challenges to quantifying risk 447

8.2 Risk assessment and quantification of risks associated with use of ENDS and ENNDS 449

8.2.1 Health risks associated with specific ingredients or unintentionally added substances 450

8.2.2 Potential health effects of ENDS and ENNDS 453

8.2.3 Risks for bystanders 455

8.3 Methods for quantifying risk 455

8.3.1 Threshold of toxicological concern 458

8.3.2 Risk assessment based on individual compounds 458

8.3.3 Relative risk approaches 459

8.3.4 Margin-of-exposure approach 459

8.3.5 Non-carcinogenic effects 460

8.3.6 Evaluation frameworks 460

8.4 Heated tobacco products 463

8.5 Implications for regulation 463

8.6 Discussion 466

8.7 Recommendations 467

8.8 Conclusions 468

8.9 References 469

9.Flavours in novel and emerging nicotine and tobacco products 476

Abstract 476

9.1 Background and introduction 477

9.2 Epidemiology of flavoured products (frequency,patterns and reasons for use by sociodemographic variables) 479

9.2.1 Electronic nicotine and non-nicotine delivery systems 480

9.2.2 Traditional smoked and smokeless tobacco products 481

9.2.3 Heated tobacco products 482

9.3 Effects of flavours on appeal,experimentation,uptake and sustained use 483

9.3.1 Adolescents and young adults 483

9.3.2 Adults 484

9.4 Common flavours,properties,health effects and implications for public health 486

9.4.1 Common flavours in electronic nicotine delivery systems and tobacco products 486

9.4.2 Chemical and physical properties of common flavours in flavoured products 486

9.4.3 Toxicity of flavours 487

9.5 Regulation of flavoured products 488

9.5.1 Global regulation of flavoured ENDS 488

9.5.2 Global regulation of flavoured tobacco products 490

9.5.3 Pros and cons of common approaches 492

9.5.4 Impact of regulation of specific flavoured nicotine products 492

9.5.5 Future regulation of flavours 493

9.6 Discussion 495

9.7 Research gaps,priorities and questions 496

9.8 Policy recommendations 497

9.9 References 497

10.Global marketing and promotion of novel and emerging nicotine and tobacco products and their impacts 509

Abstract 509

10.1 Background 510

10.2 Electronic nicotine delivery systems and electronic non-nicotine delivery systems 512

10.2.1 Introduction 512

10.2.2 Markets,products and strategies used in marketing ENDS and ENNDS 513

10.2.3 Global use of ENDS and prevalence of use 518

10.2.4 Trends in advertising,promotion and sponsorship of ENDS

products 521

10.2.5 Measures to control advertising,promotion and sponsorship of ENDS products 523

10.2.6 Recommendations 524

10.2.7 Research gaps for ENDS and ENNDS 527

10.3 Heated tobacco products 528

10.3.1 Introduction 528

10.3.2 Market players,products and strategies 529

10.3.3 Global use and prevalence of use of HTPs 532

10.3.4 Trends in advertising,promotion and sponsorship of HTPs 533

10.3.5 Measures to control advertising,promotion and sponsorship of HTPs 535

10.3.6 Recommendations for monitoring trends in marketing,advertising,promoting and sponsorship of HTPs 536

10.3.7 Recommendations for regulators 536

10.3.8 Gaps in research on HTPs 538

10.4 Summary 538

10.5 References 539

Supplementary sections 548

11.Forms of nicotine in tobacco plants,chemical modifications and implications for electronic nicotine delivery systems products 549

Abstract 549

11.1 Background 550

11.2 Chemical modification of nicotine and influence on nicotine delivery 553

11.2.1 Brief summary of the effect of curing on nicotine 553

11.2.2 Modification with alkali 553

11.2.3 Modification with acid 554

11.3 Implications for ENDS products and diversity 554

11.3.1 Free-base nicotine vs nicotine salt in ENDS 554

11.3.2 Feasible concentrations and abuse liability 556

11.3.3 Potential masking of the harshness of products 557

11.3.4 Health implications and potential regulations 557

11.4 Discussion 558

11.5 Research gaps,priorities and questions to members regarding further work or a full paper 558

11.6 Recommendation 559

11.7 Considerations 559

11.8 References 560

12.EVALI:e-cigarette or vaping product use-associated lung injury 567

Abstract 567

12.1 Background 568

12.1.1 Respiratory effects associated with e-cigarettes and vaping 568

12.1.2 E-cigarette or vaping product use-associated lung injury (EVALI) 568

12.1.3 Products and chemicals implicated in EVALI 569

12.2 EVALI 569

12.2.1 Detailed description and history 569

12.2.2 Symptoms 570

12.2.3 Clinical presentation 570

12.2.4 Reported cases 571

12.3 Identification of EVALI 571

12.4 Surveillance for EVALI 571

12.4.1 National surveillance mechanisms 571

12.4.2 Regional surveillance mechanisms 572

12.4.3 International surveillance mechanisms and validation 572

12.5 Discussion 572

12.6 Considerations 573

12.7 Recommendations 574

12.7.1 Key recommendations 574

12.7.2 Other recommendations 574

12.8 References 574

13.Overall recommendations 576

13.1 Main recommendations 577

13.2 Significance for public health policies 579

13.3 Implications for the Organization’s programmes 580

13.4 References 581

内容简介

本报告介绍了WHO烟草制品管制研究小组第十次会议的结论和建议。该次会议讨论了新型烟草制品,如电子烟碱传输系统(ENDS)、电子非烟碱传输系统(ENNDS)和加热型烟草制品(HTP)管制科学基础方面的优先事项。研究小组审查了专门为会议编写的九份背景文件和两份补充文件,涉及以下专题:①HTP中的有害物质及其暴露、健康影响和风险降低声明;②HTP的吸引力和致瘾性:对认知和使用的影响及关联效应;③HTP之间的差异:考虑因素和影响;④HTP的使用:产品转换以及双重或多重使用;⑤HTP、ENDS和ENNDS相关法规以及国家措施和监管障碍;⑥电子烟碱传输系统和传统卷烟的烟碱暴露评估;⑦ENDS、ENNDS和HTP相关个体风险的量化方法探索:对人体健康和监管的影响;⑧新型烟草制品的风味;⑨新型烟草制品的全球营销和推广及其影响;⑩烟草中的烟碱形态、化学修饰及其对电子烟碱传输系统的影响;⑪电子烟碱传输系统或雾化产品使用相关肺损伤。研究组关于每个主题的建议在相关章节末尾列出,最后一章为总体建议。

本书会引起吸烟与健康、烟草化学和公共卫生学诸多应用领域科学家的兴趣,为客观评价烟草制品的管制和披露措施提供必要的参考。

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