Abstract：
BACKGROUND: We evaluated the impact of heating conventional cigarettes with a novel heated tobacco product (HTP) device on biomarkers and cigarette use patterns in Chinese adult smokers unwilling to quit smoking.
METHODS: In this pilot randomized controlled trial, 50 eligible participants were allocated to either Control group (smoking conventional cigarettes) or HTP device group (switching to using heated conventional cigarettes by the HTP device). Participants in the HTP device group went through a 2-day run-in period then used heated conventional cigarettes exclusively for 5 days, followed by flexible use for 14 days. Five biomarkers of exposure (BoEs) were measured at baseline and on Day 7. Thirteen biomarkers of biological effect (BoBEs) were measured at baseline and on Day 21. Safety, daily cigarette consumption, craving, withdrawal symptoms, and device acceptability, were assessed.
RESULTS: BoE levels decreased by 26.4 % to 71.4% from baseline in the HTP device group, while BoBE levels did not significantly change in either group. In the HTP group, 56% exclusively used heated conventional cigarettes during the flexible use period, experiencing reduced cravings and withdrawal symptoms, while dual users consumed more cigarettes. Mild to moderate device-related reactions were reported in 36% of users. Satisfaction, taste, and harm reduction belief scores averaged 7.4, 6.6, and 8.7 (out of 10), respectively.
CONCLUSIONS: Switching to heated cigarettes with the HTP device may reduce short-term exposure to smoke toxicants. However, it can lead to increased tobacco use among dual users. Further investigation is needed to confirm these preliminary findings.
CONCLUSIONS: This study is the first to evaluate the impact of heating conventional cigarettes with a novel heated tobacco product (HTP) device on health-related biomarkers and cigarette use patterns among Chinese adult smokers. This novel HTP device can directly heat conventional cigarettes without the necessity for specifically designed tobacco products, avoiding potential additive risks of traditional HTPs. If the results of this study could be further verified by randomized controlled clinical trials with larger sample sizes, this novel HTP device could serve as a short-term harm reduction alternative for smokers unwilling to quit.
METHODS: In this pilot randomized controlled trial, 50 eligible participants were allocated to either Control group (smoking conventional cigarettes) or HTP device group (switching to using heated conventional cigarettes by the HTP device). Participants in the HTP device group went through a 2-day run-in period then used heated conventional cigarettes exclusively for 5 days, followed by flexible use for 14 days. Five biomarkers of exposure (BoEs) were measured at baseline and on Day 7. Thirteen biomarkers of biological effect (BoBEs) were measured at baseline and on Day 21. Safety, daily cigarette consumption, craving, withdrawal symptoms, and device acceptability, were assessed.
RESULTS: BoE levels decreased by 26.4 % to 71.4% from baseline in the HTP device group, while BoBE levels did not significantly change in either group. In the HTP group, 56% exclusively used heated conventional cigarettes during the flexible use period, experiencing reduced cravings and withdrawal symptoms, while dual users consumed more cigarettes. Mild to moderate device-related reactions were reported in 36% of users. Satisfaction, taste, and harm reduction belief scores averaged 7.4, 6.6, and 8.7 (out of 10), respectively.
CONCLUSIONS: Switching to heated cigarettes with the HTP device may reduce short-term exposure to smoke toxicants. However, it can lead to increased tobacco use among dual users. Further investigation is needed to confirm these preliminary findings.
CONCLUSIONS: This study is the first to evaluate the impact of heating conventional cigarettes with a novel heated tobacco product (HTP) device on health-related biomarkers and cigarette use patterns among Chinese adult smokers. This novel HTP device can directly heat conventional cigarettes without the necessity for specifically designed tobacco products, avoiding potential additive risks of traditional HTPs. If the results of this study could be further verified by randomized controlled clinical trials with larger sample sizes, this novel HTP device could serve as a short-term harm reduction alternative for smokers unwilling to quit.
摘要：
背景：我们评估了使用新型加热烟草产品（HTP）设备加热传统香烟对不愿戒烟的中国成年吸烟者的生物标志物和香烟使用模式的影响。
方法：在这项初步的随机对照试验中，50名符合条件的参与者被分配到对照组（吸烟常规香烟）或HTP设备组（切换到通过HTP设备使用加热的常规香烟）。HTP设备组的参与者经历了2天的磨合期，然后仅使用加热的常规香烟5天，然后灵活使用14天。在基线和第7天测量5种暴露生物标志物(BoE)。在基线和第21天测量13种生物标志物的生物学效应(BoBE)。安全,每日香烟消费，渴望,戒断症状,和设备可接受性，被评估。
结果：在HTP装置组中，BoE水平从基线下降了26.4%至71.4%，而BoBE水平在两组中均无显著变化。在HTP组中,56%的人在灵活使用期间专门使用加热的传统香烟，经历减少的渴望和戒断症状，而双重用户消费更多的香烟。36％的用户报告了轻度至中度的设备相关反应。满意,味道,伤害减少信念得分平均为7.4、6.6和8.7(满分10分)，分别。
结论：使用HTP装置切换到加热的香烟可以减少短期暴露于烟雾毒物。然而,它可能导致双重使用者的烟草使用增加。需要进一步调查以证实这些初步发现。
结论：这项研究首次评估了使用新型加热烟草产品（HTP）设备加热传统卷烟对中国成年吸烟者健康相关生物标志物和卷烟使用模式的影响。这种新颖的HTP装置可以直接加热传统香烟，而无需专门设计的烟草产品，避免传统HTPs的潜在添加剂风险。如果这项研究的结果可以通过更大样本量的随机对照临床试验进一步验证，这种新型HTP装置可以作为不愿意戒烟的吸烟者的短期减害替代品.
方法：在这项初步的随机对照试验中，50名符合条件的参与者被分配到对照组（吸烟常规香烟）或HTP设备组（切换到通过HTP设备使用加热的常规香烟）。HTP设备组的参与者经历了2天的磨合期，然后仅使用加热的常规香烟5天，然后灵活使用14天。在基线和第7天测量5种暴露生物标志物(BoE)。在基线和第21天测量13种生物标志物的生物学效应(BoBE)。安全,每日香烟消费，渴望,戒断症状,和设备可接受性，被评估。
结果：在HTP装置组中，BoE水平从基线下降了26.4%至71.4%，而BoBE水平在两组中均无显著变化。在HTP组中,56%的人在灵活使用期间专门使用加热的传统香烟，经历减少的渴望和戒断症状，而双重用户消费更多的香烟。36％的用户报告了轻度至中度的设备相关反应。满意,味道,伤害减少信念得分平均为7.4、6.6和8.7(满分10分)，分别。
结论：使用HTP装置切换到加热的香烟可以减少短期暴露于烟雾毒物。然而,它可能导致双重使用者的烟草使用增加。需要进一步调查以证实这些初步发现。
结论：这项研究首次评估了使用新型加热烟草产品（HTP）设备加热传统卷烟对中国成年吸烟者健康相关生物标志物和卷烟使用模式的影响。这种新颖的HTP装置可以直接加热传统香烟，而无需专门设计的烟草产品，避免传统HTPs的潜在添加剂风险。如果这项研究的结果可以通过更大样本量的随机对照临床试验进一步验证，这种新型HTP装置可以作为不愿意戒烟的吸烟者的短期减害替代品.
