A vaccine against nicotine for smoking cessation: a randomized controlled trial.
A vaccine against nicotine for smoking cessation: a randomized controlled trial.
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针对尼古丁戒烟的疫苗：一项随机对照试验。
DOI：
10.1371/journal.pone.0002547
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发表时间：
2008-06-25
期刊：
影响因子：
3.7
通讯作者：
Cerny, Thomas
中科院分区：
文献类型：
--
作者：
Cornuz, Jacques;Zwahlen, Susanne;Jungi, Walter Felix;Osterwalder, Joseph;Klingler, Karl;van Melle, Guy;Bangala, Yolande;Guessous, Idris;Mueller, Philipp;Willers, Joerg;Maurer, Patrik;Bachmann, Martin F.;Cerny, Thomas
烟草依赖是全世界可预防的死亡和残疾的主要原因，尼古丁是造成烟草成瘾的主要物质。在一项为期6个月的随机、双盲、II期戒烟研究中，对341名吸烟者进行了尼古丁疫苗试验，随后进行了6个月的随访。229名受试者随机接受5次肌肉注射尼古丁疫苗，112名受试者每月接受一次安慰剂。所有受试者接受个人行为戒烟咨询。该疫苗是安全的，一般耐受性良好，免疫原性高，诱导100%的抗体应答率后，第一次注射。第2个月时戒烟的时点患病率显示，尼古丁-Q β治疗受试者（47.2%）和安慰剂治疗受试者（35.1%）之间存在统计学显著差异（P = 0.036），但第2个月和第6个月之间的持续戒烟率无显著差异。 然而，在符合方案人群的亚组分析中，抗体水平最高的受试者中的三分之一（56.6%）从第2个月至第6个月的持续戒烟率高于安慰剂治疗受试者（31.3%）（OR 2.9; P = 0.004），而中等和低抗体水平并未增加戒烟率。 12个月后，安慰剂组受试者与高抗体应答受试者之间的持续戒烟率差异保持不变（差异20.2%，P = 0.012）。 尽管尼古丁-Q β并未显著增加意向治疗人群的持续戒烟率，但符合方案人群的亚组分析表明，当达到足够高的抗体水平时，尼古丁疫苗接种可显著增加吸烟者的持续戒烟率。免疫疗法可能为尼古丁成瘾的治疗开辟一条新的途径。瑞士医学登记2003 DR 2327; ClinicalTrials.gov NCT 00369616
Tobacco dependence is the leading cause of preventable death and disabilities worldwide and nicotine is the main substance responsible for the addiction to tobacco. A vaccine against nicotine was tested in a 6-month randomized, double blind phase II smoking cessation study in 341 smokers with a subsequent 6-month follow-up period. 229 subjects were randomized to receive five intramuscular injections of the nicotine vaccine and 112 to receive placebo at monthly intervals. All subjects received individual behavioral smoking cessation counseling. The vaccine was safe, generally well tolerated and highly immunogenic, inducing a 100% antibody responder rate after the first injection. Point prevalence of abstinence at month 2 showed a statistically significant difference between subjects treated with Nicotine-Qβ (47.2%) and placebo (35.1%) (P = 0.036), but continuous abstinence between months 2 and 6 was not significantly different. However, in subgroup analysis of the per-protocol population, the third of subjects with highest antibody levels showed higher continuous abstinence from month 2 until month 6 (56.6%) than placebo treated participants (31.3%) (OR 2.9; P = 0.004) while medium and low antibody levels did not increase abstinence rates. After 12 month, the difference in continuous abstinence rate between subjects on placebo and those with high antibody response was maintained (difference 20.2%, P = 0.012). Whereas Nicotine-Qβ did not significantly increase continuous abstinence rates in the intention-to-treat population, subgroup analyses of the per-protocol population suggest that such a vaccination against nicotine can significantly increase continuous abstinence rates in smokers when sufficiently high antibody levels are achieved. Immunotherapy might open a new avenue to the treatment of nicotine addiction. Swiss Medical Registry 2003DR2327; ClinicalTrials.gov NCT00369616
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