Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users.

No pharmacotherapies have been shown to increase long-term (> or = 6-month) abstinence rates among smokeless tobacco (ST) users. Available evidence suggests that underdosing may occur with standard-dose nicotine replacement therapy (NRT) in ST users. We investigated the effect of high-dose nicotine therapy on tobacco withdrawal symptoms among ST users in a randomized, controlled clinical pilot study. A total of 42 ST users using at least 3 cans or pouches per week were randomized to nicotine patch doses of 63, 42, or 21 mg/day or placebo for 8 weeks. Multiple daily assessments of tobacco withdrawal and nicotine toxicity were obtained with an electronic diary. During the first week of nicotine patch therapy, we observed a dose-response relationship such that higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.87, p = .009), less negative affect (chi2 = 3.85, p = .05), and less restlessness (chi2 = 3.90, p = .048). During the second week, higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.77, p = .009). Overall, the frequency of nicotine toxicity symptoms did not differ by dose group. Of specific symptoms, nausea was observed to be more frequent in the 63 mg/day dose group compared with placebo (p = .035). In conclusion, high-dose nicotine patch therapy resulted in a greater reduction of tobacco withdrawal symptoms among ST users using at least 3 cans per week. High-dose nicotine patch therapy is safe and well tolerated in this population of tobacco users.     

国内口用型无烟气烟草制品专利分析

为使我国烟草行业相关科技人员准确把握口用型无烟气烟草制品的研发现状,预测今后的发展趋势,对国家知识产权局1985—2018年公开公告的有关口用型无烟气烟草制品的专利进行了检索和统计分析。结果表明:(1)1985—2018年口用型无烟气烟草制品中国专利共计270件,其中发明233件、实用新型28件、外观设计9件。其中袋装口含型专利占50%以上,是目前口用型无烟气烟草制品专利的主流技术。(2)2008年以来,口用型无烟气烟草制品中国专利申请经历了活跃期和高峰期,国内烟草行业专利申请总量于2013年超过国外烟草公司,专利申请量以云南中烟工业有限责任公司和中国烟草总公司郑州烟草研究院领先。国外烟草公司申请的口用型无烟气烟草制品中国专利中,雷诺士烟草公司的申请量最多,其次是菲利浦·莫里斯烟草公司和美国无烟烟草公司,且均为发明专利。(3)袋装口含烟关键技术是产品配方、制备技术、包装技术等,含化烟关键技术是制备工艺、产品形态、产品配方等;袋装口含烟专利在包装方式、缓释技术、熟化技术等领域涉及较少,含化烟专利在缓释技术、成型技术等领域涉及较少。     

无烟气烟草制品技术发展现状及趋势研究

为把握国外无烟气烟草制品研发的技术特点和发展趋势,借助Thomson Innovation 专利分析工具对1985 ～ 2014 年间无烟气烟草制品技术专利进行分析,系统揭示近30 年来无烟气烟草制品的研发现状与态势、研发热点以及技术分布。分析结果表明:专利申请变化趋势受政策影响较大;中国和美国是无烟气烟草制品技术专利申请的主要国家;3 类无烟气烟草制品技术研发热点各有不同;以跨国烟草公司为代表的企业通过收购与并购成为无烟气烟草制品技术研发的主导力量。      

烟草及其制品中游离烟碱的测定方法研究进展

综述了近30年烟草及其制品中游离烟碱含量测定方法的研究进展,包括溶剂萃取法、顶空固相微萃取法、核磁共振法、Henderson-Hasselbalch法和光谱法等,总结了各个方法的优缺点,并展望了烟草及其制品中游离烟碱含量检测方法未来的研究方向。     

无烟气烟草制品中TSNAs的分析研究

用100 mmol/L乙酸铵溶液萃取样品后,用0.22μm水相针式过滤器过滤,采用液相色谱-电喷雾串联质谱(LC-ESI MS/MS)测定烟草特有N-亚硝胺,建立了无烟气烟草制品中4种烟草特有N-亚硝胺(TSNAs)的同时测定方法。利用建立的方法测定了72个不同品牌种类的无烟气烟草制品中TSNAs的含量。结果表明,N-亚硝基降烟碱(NNN)、4-(亚硝基甲氨基)-1-(3-吡啶基)-1-丁酮(NNK)、N-亚硝基新烟草碱(NAT)和N-亚硝基假木贼碱(NAB)的检出限分别是0.03、0.08、0.03和0.02 ng/mL,回收率在93.17%-105.25%之间,精密度在2.03%-4.80%之间。方法的检测限低,特异性好,适合于无烟气烟草制品中TSNAs的检测。实验发现不同品牌的无烟气烟草制品TSNAs的含量差别较大,TSNAs的总含量范围从0.54μg/g到31.91μg/g,相差59倍,平均含量为5.06μg/g。     

Cost-effectiveness of self-help smokeless tobacco cessation programs.

This study assessed the cost-effectiveness of two low-intensity programs for quitting smokeless tobacco, based on results of a randomized trial with 1,069 volunteer participants. Cost data were collected for two levels of intervention: manual only (a self-help manual) and assisted self-help (the manual plus a videotape and two supportive phone calls from tobacco cessation counselors). Incremental cost-effectiveness ratios were calculated for assisted self-help vs. quitting on one's own, using the manual-only quit rate and data from another study as alternative proxies for no intervention. A threshold analysis was conducted to determine the spontaneous quit rate at which the manual-only intervention becomes more cost-effective than assisted self-help. The cost to provide and receive the assisted self-help intervention averaged US $56 per participant vs. $20 for the manual-only intervention (societal perspective, Year 2000 dollars). Estimates for incremental cost per quit for the assisted self-help intervention ranged from $922 to $1,758, depending on the proxy used for no intervention. The manual-only intervention was more cost-effective than assisted self-help if quitting among motivated chewers who do not receive treatment does not exceed 3.4%. Support from a wife or partner added little cost to a quit attempt for male chewers ($3-$4). Providing a manual, video, and brief phone counseling to smokeless tobacco users who want to quit is a reasonable use of health care resources. The self-help quitting guide also may be a cost-effective treatment, but it remains to be demonstrated whether it is more effective than quitting on one's own.     

基于专利数据分析的无烟气烟草制品研发趋势研究

为了解国内外无烟气烟草制品专利申请的情况,把握无烟气烟草制品的研发趋势,为我国烟草行业无烟气烟草制品的研究开发与市场发展提供决策参考和技术依据,对国内外无烟气烟草产品技术专利进行了检索分析,并对国际大型烟草公司在无烟烟草方面的进展做了的调查。结果表明:（1）无烟气烟草制品技术专利申请量在2008、2009年这两年时间内取得了较大的进展;（2）2000年以后,无烟气烟草制品的研发热点转移到嚼烟、鼻烟领域;（3）国际大型烟草公司相继进入无烟烟草领域,无烟气烟草制品已成为各大烟草公司的研发热点。      

Nicotine delivery capabilities of smokeless tobacco products and implications for control of tobacco dependence in South Africa

Objectives: Smokeless tobacco (SLT) use is popular among black South African women and children. The study sought to determine the nicotine delivery capability of popular industrialised and traditional SLT brands in South Africa, and to provide information for policy action by regulatory authorities.

Design: Laboratory chemical analysis of four industrialised and one traditional SLT products commercially available, using previously published analytical methods. Potential for dependence was inferred from nicotine delivery capabilities determined by the percentage free base nicotine.

Measurements: Moisture, pH, total nicotine, and percentage free base nicotine.

Results: Total nicotine content was between 6–16 mg/g. The pH varied between 7–10 and this correlated with percentage free base nicotine, which ranged between 10–99%. The nicotine delivery capability of the traditional product was lower than that of the industrialised products except for the recently introduced portion bag snus, which had comparable total nicotine but the lowest pH and percentage free base nicotine. The most popular SLT brands showed the highest percentage free base nicotine ever reported for any industrialised SLT or cigarette brands. Small cans contained higher nicotine than the large cans of the same brand tested. Findings from the study support a potential for limited "product graduation" by users.

Conclusions: South African SLT users are mostly exposed to potentially very highly addictive levels of nicotine that may favour tobacco dependence and its consequent health risks. The increasing use of SLT by women of childbearing age support the need for intensified policy action to control its use.

     

LC-MS/MS法测定口含烟中的4种亚硝基氨基酸

建立了液相色谱-四级杆串接质谱(LC-MS/MS)测定口含烟中N-亚硝基肌氨酸(NSAR)、3-(N-甲基亚硝基氨基)丙酸(MNPA)、4-(N-甲基亚硝基氨基)丁酸(MNBA)、亚硝基氮杂环丁烷-2-羧酸(NAzCA)的分析方法.样品经水萃取,硅藻土液液萃取柱净化后浓缩,进LC-MS-MS分析.结果表明:①NSAR、...     

Nicotine lozenges for the treatment of smokeless tobacco use.

Nicotine lozenges have been shown to increase tobacco abstinence rates in cigarette smokers, but they have not been evaluated in smokeless tobacco (ST) users. We conducted an open-label, one-arm, phase II clinical trial to evaluate the efficacy of the 4-mg nicotine lozenge for the treatment of withdrawal and craving associated with tobacco abstinence among ST users. Eligible subjects received 4-mg nicotine lozenges for 6 weeks followed by a 6-week taper. Subjects completed daily tobacco withdrawal diaries, and data on lozenge use, adverse events, and lozenge acceptability were collected. Urine anabasine was collected at 3 and 6 months for biochemical confirmation of self-reported tobacco abstinence. Participants were 30 ST users with a mean age of 35.4 years (SD=6.5) using an average of 4.2 cans or pouches (SD=3.2) of ST per week for a mean of 15.1 years (SD=6.5). Among subjects continuously tobacco abstinent for the first 2 weeks, no significant increases in composite withdrawal symptoms were observed, compared with baseline symptoms, whereas craving decreased significantly. Biochemically confirmed 7-day point-prevalence tobacco abstinence was 53% (95% CI=34%-72%) at 12 weeks (end of treatment) and 47% (95% CI=28%-66%) at 6 months. Few adverse events attributable to the nicotine lozenge occurred, and the lozenge was perceived as helpful in assisting subjects quit ST. The use of the 4-mg nicotine lozenge appears promising for the clinical treatment of withdrawal symptoms and craving associated with tobacco abstinence in ST users. Future phase III clinical trials investigating the efficacy of nicotine lozenges are warranted.     

Review of the evidence that pH is a determinant of nicotine dosage from oral use of smokeless tobacco

OBJECTIVE: To determine whether manipulation of the pH of moist-snuff products by manufacturers could control the delivery of nicotine. DATA SOURCES: Medline database 1966-97 using the following subject headings and keywords: nicotine, absorption, mouth mucosa, skin, hydrogen-ion concentration, smokeless tobacco, biological transport, and membranes; computer database of the tobacco bibliography maintained by the US Centers for Disease Control and Prevention's Office on Smoking and Health; bibliographies of pertinent journal articles, books, and governmental reports; personal communications with experts in nicotine pharmacology and addiction; and Brown & Williamson Tobacco Corporation documents in the Tobacco Control Archives of the University of California, San Francisco. STUDY SELECTION: Included all relevant animal studies, in-vitro studies, nicotine replacement therapy trials, and human observational studies. DATA SYNTHESIS: We found that the effects of pH on drug absorption have been well established in animal models for nicotine and many other acidic or basic compounds. Increased alkalinity promotes the absorption of nicotine and increases its physiological effects. Human studies, which are more limited, confirm these processes. For example, nicotine absorption is directly related to the pH when nicotine is delivered in either tobacco smoke or nicotine polacrilex gum. CONCLUSIONS: Although other factors could influence the rate of nicotine absorption from oral tobacco, manipulating tobacco pH appears to be the primary means by which the speed of nicotine absorption is determined in moist-snuff products.


     

模拟溶出法研究袋装口含烟烟碱口腔释放规律

为准确探究袋装口含烟中烟碱溶出规律,利用新型口腔模拟溶出装置,模拟人体消费行为,建立了一种可靠、可控的烟碱体外溶出方法。应用该方法对几种典型袋装口含烟进行研究,结果表明:①通过对模拟口腔溶出装置参数包括温度、唾液流速、唾液加入量和口腔压力的调节,烟碱的体内体外溶出释放规律基本一致,说明该方法能很好地模仿袋装口含烟中烟碱的体内溶出规律。②不同类型口含烟烟碱溶出规律都呈现先快后慢的趋势,在20 min时所有产品烟碱溶出量都能达到60%以上,最高可达80%。③无纺布对袋装口含烟的烟碱溶出有一定的阻碍作用,烟碱复合盐型袋装口含烟较烟草粉末型产品具有高的烟碱溶出率。