Evins A Eden, West Robert, Benowitz Neal L, Russ Cristina, Lawrence David, McRae Thomas, Maravic Melissa Culhane, Heffner Jaimee L, Anthenelli Robert M
Department of Psychiatry, Massachusetts General Hospital, Boston (Evins, Maravic); Department of Psychiatry, Harvard Medical School, Boston (Evins); Department of Epidemiology and Public Health, University College London, London (West); Departments of Medicine, Biopharmaceutical Sciences, Psychiatry, and Clinical Pharmacy, University of California, San Francisco (Benowitz); Pfizer, New York (Russ, Lawrence, McRae); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle (Heffner); Department of Psychiatry, University of California, San Diego (Anthenelli).
Psychiatr Serv. 2021 Jan 1;72(1):7-15. doi: 10.1176/appi.ps.202000032. Epub 2020 Nov 3.
This study aimed to evaluate the efficacy and safety of varenicline, bupropion, and nicotine replacement therapy (NRT) among smokers with schizophrenia spectrum disorders in post hoc analyses of Evaluating Adverse Events in a Global Smoking Cessation Study data.
Smokers with schizophrenia spectrum disorder (N=390) and without a psychiatric illness (control group, N=4,028) were randomly assigned to receive varenicline, bupropion, NRT patch, or placebo for 12 weeks. Outcomes included abstinence rates during treatment and follow-up, number needed to treat (NNT) for abstinence, incidence of neuropsychiatric adverse events (NPSAEs), and temporal relationship between NPSAEs and abstinence status.
Smokers with schizophrenia smoked more and had greater dependence and fewer prior trials of cessation pharmacotherapy at baseline. At each time point, smokers with schizophrenia assigned to varenicline had significantly greater odds of abstinence compared with their matched placebo group, with NNT comparable to the control group. Bupropion and NRT increased odds of abstinence; confidence intervals (CIs) included 1 for some comparisons, and NNT for smokers with schizophrenia was greater than for the control group. No treatment was associated with significantly more NPSAEs, compared with placebo, in either cohort. The estimated NPSAE rate was 5% (95% CI=3.0-7.7) for smokers with schizophrenia and 1% (95% CI=0.6-2.1) for the control group. Over one-third of NPSAEs occurred during partial or full abstinence, suggesting a multifactorial nature.
For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group. A significant proportion of NPSAEs occurred during early abstinence. No treatment significantly increased NPSAE prevalence.
本研究旨在通过对“评估全球戒烟研究中的不良事件”数据进行事后分析，评估伐尼克兰、安非他酮和尼古丁替代疗法（NRT）在患有精神分裂症谱系障碍的吸烟者中的疗效和安全性。
患有精神分裂症谱系障碍的吸烟者（N = 390）和无精神疾病的吸烟者（对照组，N = 4028）被随机分配接受伐尼克兰、安非他酮、NRT贴片或安慰剂治疗12周。结局包括治疗期间和随访期间的戒烟率、戒烟所需治疗人数（NNT）、神经精神不良事件（NPSAEs）的发生率，以及NPSAEs与戒烟状态之间的时间关系。
患有精神分裂症的吸烟者在基线时吸烟更多、依赖性更强，且之前尝试戒烟药物治疗的次数更少。在每个时间点，与匹配的安慰剂组相比，接受伐尼克兰治疗的患有精神分裂症的吸烟者戒烟几率显著更高，NNT与对照组相当。安非他酮和NRT增加了戒烟几率；部分比较的置信区间（CI）包含1，且患有精神分裂症的吸烟者的NNT大于对照组。与安慰剂相比，两个队列中均没有治疗与显著更多的NPSAEs相关。患有精神分裂症的吸烟者的估计NPSAE发生率为5%（95%CI = 3.0 - 7.7），对照组为1%（95%CI = 0.6 - 2.1）。超过三分之一的NPSAEs发生在部分或完全戒烟期间，提示其具有多因素性质。
对于患有精神分裂症的吸烟者，伐尼克兰导致显著更高的戒烟率，且NNT与对照组相当。相当一部分NPSAEs发生在早期戒烟期间。没有治疗显著增加NPSAE患病率。
