一项在印度进行的关于伐伦克林治疗无烟烟草依赖的双盲安慰剂对照随机试验。
A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India.
机构信息
National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, India;
出版信息
Nicotine Tob Res. 2014 Jan;16(1):50-7. doi: 10.1093/ntr/ntt115. Epub 2013 Aug 14.
INTRODUCTION
The rate of smokeless tobacco use in India is 20%; its use causes serious health problems, and no trial has assessed behavioral or pharmacological treatments for this public health concern. This trial evaluated varenicline for treating smokeless tobacco dependence in India.
METHODS
This was a double-blind placebo-controlled randomized trial of varenicline (12 weeks, 1mg, twice per day) with 237 smokeless tobacco users in India. All participants received behavioral counseling. Outcomes included self-reported and biochemically verified abstinence at the end of treatment (EOT), lapse and recovery events, safety, and medication adherence.
RESULTS
Self-reported EOT abstinence was significantly greater for varenicline (43%) versus placebo (31%; adjusted odds ratio [AOR] = 2.6, 95% CI = 1.2-4.2, p = .009). Biochemically confirmed EOT abstinence was greater for varenicline versus placebo (25.2% vs. 19.5%), but this was not statistically different (AOR = 1.6, 95% CI = 0.84-3.1, p = .15). Compared with placebo, varenicline did not reduce the risk for a lapse (hazard ratio [HR] = 0.86, 95% CI = 0.69-1.1, p = .14), but it did increase the likelihood of recovery to abstinence (HR = 1.2, 95% CI = 1.02-1.4, p = .02). Greater adherence increased EOT cessation rates for varenicline (39% vs. 18%, p = .003) but not for placebo (28% vs. 14%, p = .06). There were no significant differences between varenicline and placebo in rate of side effects, serious adverse events, hypertension, or stopping or reducing medication.
CONCLUSIONS
Varenicline is safe for treating smokeless tobacco dependence in India, and further examination of this medication for this important public health problem is warranted.
介绍
印度无烟烟草使用率为 20%；其使用会导致严重的健康问题，且针对这一公共卫生关注问题，尚无试验评估行为或药物治疗。本试验评估了用于印度治疗无烟烟草依赖的伐伦克林。
方法
这是一项在印度进行的双盲安慰剂对照随机试验，涉及 237 名无烟烟草使用者，参与者接受伐伦克林（12 周，1mg，每日 2 次）或安慰剂治疗。所有参与者均接受行为咨询。结局包括治疗结束时（EOT）的自我报告和生物化学验证的戒断、复发和恢复事件、安全性和药物依从性。
结果
与安慰剂组（31%）相比，伐伦克林组（43%）的 EOT 自我报告戒断率显著更高（调整后的优势比[OR] = 2.6，95%可信区间[CI] = 1.2-4.2，p =.009）。与安慰剂组相比，伐伦克林组 EOT 的生物化学验证戒断率更高（25.2% vs. 19.5%），但差异无统计学意义（OR = 1.6，95% CI = 0.84-3.1，p =.15）。与安慰剂相比，伐伦克林并未降低复发风险（风险比[HR] = 0.86，95% CI = 0.69-1.1，p =.14），但增加了恢复到戒断的可能性（HR = 1.2，95% CI = 1.02-1.4，p =.02）。更高的依从性增加了伐伦克林的 EOT 戒烟率（39% vs. 18%，p =.003），但对安慰剂无影响（28% vs. 14%，p =.06）。伐伦克林与安慰剂之间在副作用、严重不良事件、高血压或停药或减少药物方面的发生率无显著差异。
结论
伐伦克林治疗印度无烟烟草依赖是安全的，需要进一步研究该药对这一重要公共卫生问题的疗效。
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